|
When does the function of
an additive need to be included in the
ingredient statement and what differentiates an
incidental additive from an approved chemical
preservative? I note that 21 CFR 101.100 states
that incidental additives with no technical or
functional effect are exempt from labeling,
whereas 21 CFR 101.22(j) states that approved
chemical preservatives "must include both the
common or usual name of the preservative and the
function of the preservative."
(April 2014)
Ingredients added as chemical preservatives must
always be declared by both name and function in
the Ingredient Statement, i.e., potassium
sorbate (to preserve freshness).
When a chemical preservative is present in a
sub-ingredient, it could be considered incidental to
the finished product if it loses its
functionality as a preservative in the finished
product. In this case, you are not required to
declare it. If you are unsure about an
ingredient's functional effect in the finished
product, we advise that, "when in doubt, call it
out." For other Reader Q&As on this topic, see
here,
here and
here.
|
I would like to know when
labeling of Daily Values is required on a label.
Is it determined by the size of the container or
net weight of the contents?
(March 2014)
U.S. regulations require that percent Daily
Values (%DV) of certain nutrients be displayed
within the Nutrition Facts Panel. This is
independent of the products net weight or size.
There are two categories of nutrients that
require %DV. In each category there are
nutrients that must be displayed within the
Nutrition Facts Panel (Mandatory) and those that
are generally optional (Voluntary).
1) |
Nutrients
that require both quantitative amount
and %DV: Mandatory
nutrients include Total Fat, Saturated Fat,
Cholesterol, Sodium, Total Carbohydrate
and
Dietary Fiber (Protein requires %DV when a
protein claim is made).
Voluntary nutrients includes Potassium. |
2) |
Nutrients
that require only %DV: Mandatory
nutrients include Vitamin A, Vitamin C,
Calcium and Iron.
Voluntary nutrients include Vitamin D, Vitamin
E, Vitamin K, Thiamin, Riboflavin,
Niacin, Vitamin B6, Folate, Vitamin B12,
Biotin, Pantothenic Acid, Phosphorus,
Iodine, Magnesium, Zinc, Selenium,
Copper, Manganese, Chromium, Molybdenum
and
Chloride. |
|
The CFR section
101.9(c)(8)(i) states that Servings Per
Container between 2 and 5 need to be rounded to
the nearest half (0.5). Some of our packages
contain 3.89 servings on an unrounded basis. We
initially thought that we should round to 4, but
we are wondering if we should round down to 3.5
instead. I would really appreciate your input.
(February 2014)
If your calculations yield an unrounded number
of 3.89 Servings Per Container, then you should
report the Servings Per Container as "about 4"
within the Nutrition Facts Panel. Note use of
the word about to signify a rounded number. If
however your unrounded number of Servings Per
Container is calculated as 3.69, then you would
report the number of servings as "about 3.5"
within the Nutrition Facts Panel.
|
On the product label, our
company information has been stated as
Manufactured for (Company Name), Address. Is it
possible to add some phrase such as "under
exclusive license" in the middle, so it will
come out as: Manufactured under exclusive
license for (Company Name)?
(January 2014)
Yes. The Code of Federal Regulations has no
restrictions for adding this type of language to
the distribution information as long as it is
truthful and not misleading.
|
Can I choose to use
either a tabular/horizontal or linear Nutrition
Facts panel instead of the standard panel due to
space availability on a particular product? Does
FDA have any terms or conditions for using this?
(December 2013)
Yes. FDA allows for flexibility in presentation
of the Nutrition Facts based on package size. If
the standard/vertical layout does not fit and/or
the package has less than 40 square inches of
total space available for labeling, there is a
hierarchy of options you may consider.
If the standard/vertical layout does not fit and
a package is larger than 40 square inches of
total space available for labeling, then your
first choice is to consider the
side-by-side/split layout. If this layout also
does not work, then you may opt for the
tabular/horizontal layout.
If a package is smaller than 40 square inches of
total space available for labeling, then you may
use the shortened Daily Values footnote,
approved abbreviations, and/or the Not a
Significant Source statement in either the
vertical or horizontal orientation. Very small
packages that will not accommodate either the
vertical or horizontal column display may use
the linear layout. See
examples of Nutrition Facts Labels
based on package size.
|
We are using a tiny
amount of tricalcium phosphate (~0.2%) in the
production of one of our sugar products that we
sell retail. The purpose of this ingredient is
to aid in process flow. Do we need to list
tricalcium phosphate on the finished product
label?
(November 2013)
All retail products must list all ingredients
that have a technical or functional effect in
the finished product. If the tricalcium
phosphate aids in the flow of the finished
product, then it must be declared.
There are situations where ingredients are added
and need not be declared on the finished product
label because they qualify as incidental
additives or processing aids. See an earlier
Reader Q&A for complete definitions.
|
A client with celiac
disease who is carefully following a gluten free
diet has concerns about ingredient labeling when
he sees the word "spices". Does he need to avoid
foods that have "contains spices" on the
ingredient label?
(October 2013)
Spices are by definition gluten-free. A consumer
following a gluten-free diet can feel
comfortable eating food that contains spices,
provided the manufacturer is reputable and has
followed all FDA labeling requirements. If in
doubt, a consumer can always call the company's customer service line to verify.
FDA defines spices as "any aromatic vegetable
substance in the whole, broken, or ground form,
except for those substances which have been
traditionally regarded as foods, such as onions,
garlic and celery; whose significant function in
food is seasoning rather than nutritional; that
is true to name; and from which no portion of
any volatile oil or other flavoring principle
has been removed. Spices include the spices
listed in 182.10 and part 184 of this chapter,
such as the following: Allspice, Anise, Basil,
Bay leaves, Caraway seed, Cardamon, Celery seed,
Chervil, Cinnamon, Cloves, Coriander, Cumin
seed, Dill seed, Fennel seed, Fenugreek, Ginger,
Horseradish, Mace, Marjoram, Mustard flour,
Nutmeg, Oregano, Paprika, Parsley, Pepper,
black; Pepper, white; Pepper, red; Rosemary,
Saffron, Sage, Savory, Star aniseed, Tarragon,
Thyme, Turmeric. Paprika, turmeric, and saffron
or other spices which are also colors, shall be
declared as spice and coloring unless declared
by their common or usual name." (21 CFR 101.22)
If a spice blend contains added ingredients (for
example salt or sugar, or a carrier such as
wheat starch) then those ingredients must be
called out separately in the ingredient list and
any allergens need to fully comply with the
allergen labeling requirements.
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My client wants to use OG
as an abbreviation for organic in the ingredient
statement (for example, stating OG Cocoa Butter
instead of Organic Cocoa Butter). They said
someone from the confectionery field told them
that this type of abbreviation was okay. Is that
right?
(September 2013)
No. There is no provision in the organic
labeling rules to abbreviate Organic as OG.
Find the
National Organic Program rules
here. More reader
questions about organic can be found
here and
here.
|
We have developed a line
of Sauces, two of which have honey in the
ingredients. We want to have a Vegan call-out on
our label. As I researched this online, it
appears that many in the Vegan community do not
consider honey to be Vegan. Can we legally make
a Vegan claim if the product has honey?
(August 2013)
Neither FDA nor FTC has any labeling regulations
for vegetarian or vegan statements, other than
being "truthful and not misleading." There is a
popular understanding that honey is not allowed
in a vegan diet, although this is a subjective
area and may not be consistently adopted. A
clarifying "contains honey" statement near the
"vegan" call-out would help to ensure that the manufacturer
is making truthful and not misleading statements
while giving consumers the information they need
to make informed decisions.
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I'm using dry lentils in
a product and the supplier is telling me that
lentils are a rotational crop for wheat and
therefore may contain wheat. Does this mean that
I need to declare wheat in the Allergen
Statement? Or is this an incidental additive
that would not contribute any meaningful amount
of gluten to the finished product? Any insight
you could share would be greatly appreciated.
(July 2013)
In the case you described, the possible presence
of wheat is unintentional. Therefore, listing
wheat is not required in either the Ingredient
Statement or a separate Allergen (Contains)
Statement.
You may wish to include an allergen advisory
statement such as "May contain wheat" or "May
contain trace amounts of wheat due to rotational
crop farming practices." For further information
on allergen advisory statements see a
previous Reader Q&A. In addition,
information can be found in the FDAs
Food Labeling Guide.
|
I need to know what is
the allowable weight tolerance for a
pre-packaged food product. For example, if we
are declaring a net weight of 5 oz. can we sell
products with a weight lower than 5.0 oz. in the
U.S.? What are the FDA regulations on net weight
tolerance?
(June 2013)
The FDA regulation on Net Weight is found in 21
CFR 101.105. In this regulation FDA makes
allowance for reasonable variations caused by
loss or gain of moisture during the course of
good distribution practice or by unavoidable
deviations in good manufacturing practice. FDA
states that variations from the stated quantity
of contents should not be unreasonably large.
While FDA does not provide a specific allowable
tolerance for Net Weight, this matter could come
under FTC jurisdiction. FTC has proposed
regulations that would unify USDA and FDA Net
Contents labeling and incorporate information
found in the National Institute of Standards &
Technology (NIST) Handbook 133.
NIST Handbook 133 specifies that the average net
quantity of contents in a lot must at least
equal the net quantity declared on the label.
Plus or minus deviation is permitted when caused
by unavoidable variation in weighing and
measuring that occur in good manufacturing
practice. The maximum allowable variance for a
package with a net weight declaration of 5 oz is
5/16 oz. Packages under-filled by more than this
amount are considered non-compliant.
|
If we are processing raw
product, can we show the cooked nutritional
values on the label instead of the raw
nutritionals? If this were allowed, wouldn't we
need a two-column Nutrition Facts Panel as
packaged and as prepared?
(May 2013)
FDA requires that nutrition information shown on
the package is for the product as sold. You are
also allowed to include a second column to the
right of the "as packaged" information that
shows the "as prepared" values. This is called a
dual declaration panel.
For example, if you sell dehydrated potatoes the
nutrition information must be for the amount of
uncooked dehydrated potatoes needed for one
serving. A second column can be added to show
the nutritional values when milk and butter are
added to make the finished product. See
graphic examples of dual
declaration Nutrition Facts Labels.
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What is the minimum
required percentage of an ingredient that a food
manufacturer must disclose when using that
ingredient?
(April 2013)
All ingredients that are used in a food must be
disclosed in the Ingredient Statement on the
label. Ingredients must be listed in descending
order of predominance by weight. A statement
such as "Contains 2% or less:" may be used at
the end of the Ingredient Statement and
ingredients thereafter do not need to be listed
in order of predominance. Processing aids and
incidental additives that have no functional or
technical effect in the finished product are
exempt from ingredient labeling. See a
previous Reader
Q&A for more information about incidental additives
and processing aids.
|
When you put a serving
size and the appropriate nutritional breakdown
with it on a child's cereal, how do you
calculate their daily nutritional needs? For
example, if it's a cereal and it contains 10g of
fat per serving, how can the percentage of a
four-year-old's intake be the same as an
eight-year-old's? (March 2013)
While FDA has special requirements for nutrition
labeling of products intended for children
under the age of 2, children 2 to <4 years old,
and pregnant/lactating women, there are no
special labeling requirements for children 4 years
old and older. The Daily Values (DVs) to use are those required for the general population.
Reference Daily Intakes (RDIs) vary with age and
gender, however FDA has established a
single set of Daily Values (DVs) for use in
nutrition labeling on products intended for
adults
and children ages 4 and up. These values are
based on the reference caloric intake of 2,000
calories. Reference: 21 CFR 101.9(c)
Fat, 65 g
Saturated Fat, 20 g
Cholesterol, 300 mg
Total Carbohydrate, 300 g
Dietary Fiber, 25 g
Sodium, 2,400 mg
Potassium, 3,500 mg
Protein, 50 g
Vitamin A, 5,000 IU
Vitamin C, 60 mg
Calcium, 1,000 mg
Iron, 18 mg |
Vitamin D,
400 IU
Vitamin E, 30 IU
Vitamin K, 80 mcg
Thiamin, 1.5 mg
Riboflavin, 1.7 mg
Niacin, 20 mg
Vitamin B6, 2.0 mg
Folate, 400 mcg
Vitamin B12, 6 mcg
Biotin, 300 mcg
Pantothenic acid, 10 mg |
Phosphorus, 1,000 mg
Iodine, 150 mcg
Magnesium, 400 mg
Zinc, 15 mg
Selenium, 70 mcg
Copper, 2.0 mg
Manganese, 2.0 mg
Chromium, 120 mcg
Molybdenum, 75 mcg
Chloride, 3,400 mg
|
|
We have 54 single serving
pouches each weighing 0.9 OZ that go into a
carton. The nutrition facts serving size on the
carton is labeled 1 pouch (26g). Which is
correct for the net weight statement? (February 2013)
54 0.9 OZ (25.5g) Pouches, 48.6 OZ (3LB 0.6
OZ) 1.37kg
or
54 0.9 OZ (26g) Pouches, 49.5 OZ (3LB 1.5 OZ)
1.40kg
The net weight statement must be the true
product net weight and not a rounded value.
Therefore, the first option is correct.
Regulations for serving size in nutrition
labeling and regulations for net weight labeling
are different and in some cases produce
different values for the same package. When the
serving size in the Nutrition Facts panel is
greater than 5g, the regulations require that
the gram weight be rounded to the nearest whole
number. However, regulations for net weight
labeling require that the product weight not be
overstated, and therefore cannot automatically
be rounded to the nearest whole number.
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If you use the USDA
organic symbol on your food labels, are you
required to also have a statement indicating the
certifying agent? Assuming you follow the USDA
National Organic Program rules, have the
appropriate certification and show the organic
symbol but do not have the name of the agent on
the label, what are the possible consequences
(i.e. penalties, not being able to import, not
being able to sell, etc.)?
(January 2013)
Foods labeled as "Organic" including those with
the USDA Organic symbol on the package must
list the name of the certifying agency with the
phrase "Certified organic by (certifying
agency)" on the Information Panel, immediately
below the Signature Line. If you have failed to
list the certifying agency on the package, you
will need to work with the agency to correct that. Be
aware that ignoring compliance issues could
result in discontinued organic certification by
your certifying agency, among other possible
consequences.
Some operations are exempt from USDA organic
certification, including organic farmers who
sell $5,000 or less. All other operations that
handle or process organic products, including
blending, packaging, or labeling must be
certified.
In the event a product certified as organic is
missing the name of certifying agent, the agency
will likely issue a non-compliance warning and
the company must work out an action plan to
correct the labeling error. This could include a
temporary re-stickering of the information until
future label reprinting can occur.
If the product is not certified organic and not
exempt from certification, but is labeled as
organic, the fines can be up to $11,000 per
violation.
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For an already printed
box, wed like to add a stamp that says Contains
Milk as the box is supposed to say Contains Milk
and Wheat but currently only says Contains
Wheat. We would like to put the stamp under the
statement that says "made on shared equipment
with products containing milk, soy, tree nuts,
etc." Can we do that?
(December
2012)
It is not acceptable to separate the allergen
information into multiple Contains statements.
However, it is permissible to use stickers to
make changes in labeling as long as the sticker
is firmly affixed and will adhere to the
packaging under the intended storage conditions.
Please be advised that incorrect allergen
labeling is a major reason for FDA warning
letters and recalls so you will want to ensure
that your allergen labeling is 100% compliant.
One solution is to over-sticker the current
allergen statement and allergen advisory
statement with the corrected version: "Contains
Wheat and Milk. May Contain Soy, Tree Nuts,
etc."
The Food Allergen Labeling and Consumer
Protection Act of 2004 (FALCPA) requires that
each of the "Big 8" allergens are clearly
identified in plain English in one of two ways:
1) within the Ingredient Statement, or 2) in a
separate Allergen (Contains) Statement at the
end of the Ingredient Statement.
Per FDA guidance, the Allergen (Contains)
Statement must contain all "Big 8" allergens
present and needs to be placed immediately after
or adjacent to the Ingredient Statement; it
cannot be preceded or interceded by an allergen
advisory statement. See questions 13, 14 and
others in the
guidance.
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According to my reading
and understanding of the FDA guidelines, Vitamin
E does not need to be included in the Nutrition
Facts Panel unless a claim is made about it on
packaging or when it is added as a supplement.
Is this correct? The FDA guidelines are so
detailed! Just wanted to make sure I get it
right.
(November
2012)
You are correct. Vitamin E is a voluntary
nutrient for U.S. Nutrition Facts labeling
unless it is the basis for a claim on the label,
in labeling or advertising, or is used to
fortify the food.
The mandatory nutrients required to be shown
within the Nutrition Facts Panel are: Calories,
Calories from Fat, Total Fat, Saturated Fat,
Trans Fat, Cholesterol, Sodium, Total
Carbohydrate, Dietary Fiber, Total Sugars,
Protein, Vitamin A, Vitamin C, Calcium and Iron.
The voluntary nutrients are Polyunsaturated Fat*,
Monounsaturated Fat*, Potassium,
Soluble Fiber, Insoluble Fiber, Sugar Alcohol**,
Other Carbohydrate, Vitamin D, Vitamin E,
Vitamin K, Thiamin, Riboflavin, Niacin, Vitamin
B6, Folate, Vitamin B12, Biotin, Pantothenic
Acid, Phosphorus, Iodine, Magnesium, Zinc,
Selenium, Copper, Manganese, Chromium,
Molybdenum, Chloride. When a voluntary nutrient
is the basis for a claim or is used to fortify a
food, then the nutrient becomes mandatory and
must be included within the Nutrition Facts
Panel.
* Polyunsaturated Fat and
Monounsaturated Fat must both be included in
the Nutrition Facts when one is included,
and must also be included when a fatty acid
or cholesterol claim is made.
** Sugar Alcohols is a required
listing within the Nutrition Facts when
sugar alcohols are present in a food and a
sugar claim is made.
Note that nutrients or food components excluded
from the mandatory and voluntary lists cannot be
declared within the Nutrition Facts Panel. For
example, it is not permissible to include
Omega-3 Fatty Acids or Bioflavonoids within the
Nutrition Facts box on a food label.
|
I know the following
statement needs to be on an imported FDA food
product - Product of "X" - but does it need to
be on the Principal Display Panel or can it be
anywhere on the package?
(October
2012)
When a U.S. company distributes or imports a
product and declares its name and address within
the signature line of the product, FDA guidance
says that the country of origin must appear in
close proximity to the signature line in at
least comparable size lettering. If, however, a
foreign manufacturer is listed within the
signature line, then the country of origin is
part of the address and the words "Product of"
can be shown after the signature line or any
other conspicuous place on the label.
Please note that the country of origin statement
is not a requirement of the Federal Food, Drug &
Cosmetic Act, therefore there is no official
FDA regulation concerning its placement and
use. However, the Tariff Act of 1930 does
require the country of origin statement and it
is codified into the U.S. Customs and Border
Protection regulations under
19 CFR 134.
Contrary to FDA-regulated foods, USDA-regulated
foods must show the country of origin statement
directly under the product name as specified in
9 CFR 327.14.
References:
FDA Food Labeling Guide (Sec. 4, No. 11)
FDA Compliance Policy Guide (Sec. 560.200)
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What is the best way to
disclose sugar alcohol on the ingredient
statement? Can we just mention "low calorie
sweeteners"?
(September
2012)
Sugar alcohols, like all other low and reduced
calorie sweeteners, must be declared in the
ingredient statement by common or usual
name (e.g., sorbitol, maltitol); it is not
allowable to identify these ingredients
as "low calorie sweeteners" within the
ingredient statement.
Note also that two of the sugar alcohols -
mannitol and sorbitol - along with polydextrose
(which contains small amounts of bound sorbitol)
require a label statement such as Excess
consumption may have a laxative effect when
certain threshold amounts are exceeded. See 21 CFR 172.841 regarding polydextrose, 21 CFR
180.25 for mannitol, and 21 CFR 184.1835 for
sorbitol.
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I'm creating a gift set
to be sold wholesale. All items in the gift set
are pre-packaged and labeled with the
nutritional information. I need to know
regulations on labeling the outer box with
contents included.
(August
2012)
The outer label for a gift pack sold at retail
must contain all five of the required label components
with one exception: the nutrition information
may be included either on the outer label,
inside the package, or attached to the outer
package. See
21 CFR 101.9(h)(3).
Even when the nutrition information is placed
inside the gift pack, the outer gift package
must bear the following, which some companies
choose to do via a hang tag:
product identity (contents of the gift
package using allowable product names for each
component)
a net contents declaration (contents of each
component, as well as contents of the entire
package)
a listing of all ingredients contained in the
package
the signature line (name and address of the
responsible party)
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Is there a standard
to call an FDA or USDA product a meal
replacement?
(July
2012)
Although there is no standard definition for
meal replacement, there are four references
in Title 21 of the Code of Federal Regulations
for this term:
21 CFR 101.12(b), Table 2: relating to reference
amounts customarily consumed for milk
and milk-based drinks (meal
replacement is one example given)
21 CFR 105.66(e): relating to label terms
suggesting usefulness of meal replacements as
low calorie or reduced calorie foods
21 CFR 122.345(h): relating to folic acid
fortification
21 CFR 172.380(c): relating to Vitamin D
fortification
|
If a single flavor
compound is added to a product for flavor,
do you list it as flavor or by its common
name in the ingredient statement?
(June
2012)
The ingredient statement of the food to which
the flavor is added may declare the flavor
as natural flavor or artificial
flavor as long as the flavor additive meets the
applicable definition in
21 CFR 101.22.
Note that ingredients such as salt, monosodium
glutamate, and protein hydrolysates must be
declared by their common or usual name. Also
note that, per FDA regulations, an ingredient
such as dehydrated onion, dehydrated garlic,
onion powder, garlic powder, or celery powder
must be declared by its common or usual name
(not as a natural flavor.) USDA, however, has
guidance that allows the
powdered form of onion, garlic, and celery to be
labeled as a natural flavor.
|
Regarding FDA and
nutrient content claims, is it true that FDA
sees any restatement of the Nutrition Facts on
the front-of-pack as a nutrient content claim?
If so, can you direct me to the ruling?
(May
2012)
Yes, that is correct. If you make a statement of
fact such as 0g trans fat per serving on the
front-of-pack, this is enforced as a nutrient
content claim and you are required to include
the disclosure statement when your product
exceeds threshold levels of total fat, saturated
fat, cholesterol and sodium.
Regulations specific to your question are
outlined in 21CFR101.13(b) and 21CFR101.65(a).
Also of interest, FDA issued several warning letters
related to this issue in February,
2010. See a
previous Food Label News article
and our
March 2009 Reader Q&A for earlier
reports on this topic.
|
I plan on distributing
a jarred tomato sauce to my friends, family and
through a farmers market. I want to label it as
All Natural. However, the bulk tomato sauce I
buy has some preservatives added to extend the
shelf life. Must I include the preservatives on
my label even though I cook it for hours?
(April
2012)
Yes, if preservatives are used in a product or
as a sub-ingredient of another ingredient, they
must be declared on the label. Therefore, if you
want to have an all natural product, you will
need to source a bulk tomato product that does
not contain preservatives.
FDAs policy for natural indicates that this
claim can only be used when a product contains
no added colors from any source, no artificial
flavors, and no preservatives. Read about the
difference between natural on U.S. and Canadian
regulations in the
Food Label News archives
(Oct/Nov 2009).
|
I am in a start-up
candy business and plan to cut the candy bar
into pieces on a tray. How exact does the weight
need to be per piece given that I may cut the
bar inaccurately and the nuts or chocolate may
be unevenly distributed?
(March
2012)
For products with a variable weight per piece
such as your candy bar, pickles, shrimp, or
scallops, the Serving Size used for Nutrition
Facts labeling is the amount in ounces rounded
to the nearest half-ounce that most closely
approximates FDA's Reference Amount Customarily
Consumed (RACC), along with a visual unit of
measure.
The RACC for chocolate and most other candies is
40 grams. We translate this to serving size by
selecting the ounces that is the closest to 40
grams. In this case 1.5 ounces (at about 42.52
grams) is closer to the 40 gram RACC than 1
ounce (at about 28.35 grams). Putting it all
together, if the Net Weight of the entire
package is 6 oz (170g) and there are typically 7
to 9 pieces in the tray, then the Serving Size
line on the Nutrition Facts would be written as:
Serving Size 1.5 oz (43g/about 2 pcs)
Note: Gram weights for serving size are always
expressed as whole numbers for weights over 5
grams.
|
A customer of ours used the
4-4-9 calculation to validate calories on our
Nutrition Facts and got a different value than
what we show. How do I explain the difference? (February
2012)
The 4-4-9 method is just one of five methods FDA
allows for calorie labeling on Nutrition Facts.
This method is the least accurate of the five
because it uses "average factors" 4 calories
per gram for carbohydrate, 4 calories per gram
for protein, and 9 calories per gram for fat.
These "average factors" generally overstate
calories because specific ingredients often
contain fewer calories than the average factor
would indicate. For example, dextrose (a
carbohydrate) contains 3.4 calories per gram,
not 4 calories per gram as the 4-4-9 method
would indicate.
The five methods FDA allows for calorie
determination are: (1) a 4-4-9 calculation; (2)
an adjusted 4-4-9 calculation where insoluble
fiber is subtracted from the carbohydrate total
before multiplying by 4 (since insoluble fiber
does not impact the calorie value of foods); (3)
specific Atwater factors; (4) other specific
food factors approved by FDA; and (5) bomb
calorimetry.
Food Consulting Company uses a database
nutritional analysis with Atwater or other food
factors for most of the ingredients and relies
on an adjusted 4-4-9 calculation for those
ingredients where specific food factors are not
available. Over time we have found this to
result in a more accurate (and lower) calorie
value than the simple 4-4-9 calculation used in
most laboratory nutritional analyses.
|
Is the
use of "natural-identical flavor" appropriate in
USA? I only found guidelines in CFR (Code of
Federal Regulations) for "natural flavor" or
"artificial flavor." I think natural-identical
flavor is mostly used as a standard for Europe. (January
2012)
You are correct. There is not a classification
for "natural-identical flavors" in the U.S. The
term natural-identical (or nature-identical) is
used in Europe for a particular class of flavors
that are synthetically produced, but chemically
identical to substances found in nature. In the
U.S., these synthetically-derived
nature-identical flavor ingredients need to be
labeled as artificial flavors.
For the FDA definition of natural and artificial
flavors, see the U.S. Code of Federal
Regulations at
21 CFR 101.22.
|
If one is
making a product consisting of three simple ingredients
with no salt, sugar or preservatives added, how
extensive does the nutrition statement have to
be for the label on such a product? (December 2011)
It depends on the profile of the finished
product per serving and whether nutrient content
claims are made. If the finished product has no
significant nutrients to list (i.e., all label
values are zero) and no nutrition claims
are made, the Nutrition Facts panel can be
omitted. Spices and teas for example do not
always require that the label includes the
Nutrition Facts.
If the profile is such that at least 8 of the
mandatory nutrients can be listed as zero, then
a simplified format can be used. See
Nutrition Facts examples in the
simplified format.
|
What should
a serving size be for a retail baking flavor?
There are so many uses from cookies to
smoothies, which would have significantly
different serving sizes and nutrition
information? (November 2011)
The Code of Federal Regulations (CFR) does not
include a specific reference amount customarily
consumed (RACC) for baking flavors.
FDAs Food Labeling Guide in section L62
includes suggested RACCs for a number of product
categories not included in the CFR. Products
marketed as flavor substances for baking would
most closely resemble flavoring oils with a
suggested RACC of 1 tsp (__g).
In this scenario, it would be helpful to
consumers to include a second column within the
Nutrition Facts that shows nutrition information
for other intended uses (such as smoothies). See
an example of a
dual declaration Nutrition Facts Label.
|
How much alcohol
can be used in an FDA-regulated food
product, and how is it regulated? (October 2011)
Ethyl alcohol is generally recognized as safe in
foods but only for specific uses including: in
the extraction process as a solvent for certain
colors (21 CFR 73) and flavors (21 CFR 169), in
defoaming agents for coatings (21 CFR 176.200),
and as an antimicrobial agent on pizza crusts
prior to final baking (21 CFR 184.1293). FDA
considers flavored beverages with traces of
alcohol (<0.5% by volume) from flavoring
extracts or natural fermentation to be
"non-alcoholic."
The Tax and Trade Bureau (TTB) regulates the
labeling of alcoholic beverages including
distilled spirits, malt beverages, and wine with
7% or more alcohol by volume. Beverages such as
diluted wine and cider which have an alcohol
content of less than 7% by volume and are not
defined in the Federal Alcohol Administration
Act, are subject to the labeling requirements of
the Federal Food, Drug, and Cosmetic Act and
Fair Packaging and Labeling Act; therefore they
must follow FDA labeling rules. See
Compliance Policy Guide.
|
Is enriched flour "natural"
in Canada? (September 2011)
No. Per Canadian regulations, "a natural food or
ingredient of a food is not expected to contain,
or to ever have contained, an added vitamin,
mineral nutrient, artificial flavouring agent or
food additive." For discussion on this topic
including natural requirements in the EU, join us on
the
LinkedIn Food Label Community.
|
What label components must
be on products that are only sold in farmers markets and on
the Internet? (August 2011)
There are no special provisions for products
sold at farmers markets or on the Internet.
Regardless of the sales channel, all foods sold
in the U.S. must be in full compliance with FDA
food labeling requirements that are
specified in the U.S. Code of Federal
Regulations.
Foods sold in farmers markets and on the Internet (like every other
retail food) must be labeled with the five
requirements for all foods: product identity,
net contents, nutrition facts,
ingredients/allergens, and company name/address.
However, small businesses may be
exempt from nutrition facts
labeling, but the other four label components
must still be displayed in the manner specified
in the U.S. Code of Federal Regulations. See an earlier
Reader Q&A for more on the small
business exemption.
|
What label information is needed to sell
products wholesale? Is the same label
information necessary for selling to
foodservice? (July 2011)
There are five mandatory label components
required for both wholesale and foodservice
items. These include:
1)
product identity
2)
net contents statement
3)
nutrition facts (exempt on some
foodservice items)
4)
ingredient/allergen statement
5)
name/address of the manufacturer or
distributer
For wholesale items, the outer packaging (i.e.,
shipping containers used solely for
transportation) does not require the mandatory
label components, however the inner packaging
does.
For foodservice items, nutrition facts may be
omitted if the items will be further processed
(not sold in the packaging) and do not carry
nutrient content or health claims on the label
or labeling. However most manufacturers
of foodservice items choose to voluntarily include nutrition
information because their restaurant customers
are now requiring it to comply with restaurant
menu labeling regulations.
|
What criteria
must be met for a product to be labeled
vegetarian? How can we label our product to
alert vegetarians who do not eat dairy or egg
products? (June 2011)
Neither FDA nor FTC has any labeling regulations
for vegetarian statements, other than being
"truthful and not misleading." The most
conservative course of action is to ensure that
the product is free of any animal-derived
ingredient or ingredient components and use the
term "vegan" when appropriate. This means that
the product has no ingredients from animal
origin such as milk, eggs, honey or gelatin.
Since there are different types of vegetarians,
it is also possible to include a clarifying
statement defining the type of vegetarian for
which the product is intended to ensure that the
statement is clear to the consumer and meets the
"truthful and not misleading" requirement for
all labels (e.g., this product is suitable to
lacto-ovo vegetarians).
|
For our Frozen
Italian Dessert, can we refer to this collection
of ingredients as "chocolate coating": sugar,
palm oil, cocoa powder and soy lecithin? (May 2011)
No. You would need to identify the above
ingredients as chocolate flavored coating
since the standard of identity for sweet
chocolate (21CFR163.123) is not met. The key
difference in your ingredients and those of
standardized chocolate is the use of palm oil
instead of cocoa butter.
Though it does not apply to this situation, it
is worthy of noting that some chocolate food
items that are flavored only with cocoa and not
expected to contain the other elements of
standardized chocolate (such as chocolate milk
and chocolate pudding) can be called chocolate
as outlined in the FDA Compliance Policy Guide.
The
Compliance Policy Guide states
non-standardized food product that contains
cocoa as the chocolate flavoring ingredient may
bear the term "chocolate" so long as it can be
demonstrated that consumers have long recognized
that the food product may be made from cocoa and
do not expect it to contain some other chocolate
ingredient.
|
Is there a U.S.
labeling regulation that establishes the
allowable variance for the analyzed value vs.
what is printed on the label? If so, what is the
specific regulation? (April 2011)
Yes, FDA regulations published at 21CFR101.9(g)
specify two classes of nutrients; the allowable
variance is different for each. Regardless of
the class, the analyzed value is derived from a
composite sample of twelve consumer units, with
one unit coming from each of twelve different
randomly chosen shipper cases.
Class I nutrients are nutrients added to
fabricated foods for the purpose of
fortification, such as vitamins, minerals,
protein and dietary fiber. For this class, the
analyzed value must be at least equal to the
label value.
Class II nutrients are naturally-occurring
nutrients. For this class, the analyzed value
for the "beneficial nutrients" (vitamin,
mineral, protein, total carbohydrate,
polyunsaturated fat, monounsaturated fat or
potassium) must be at least 80% of the label
value and the analyzed value for the "nutrients
to limit" (calories, sugars, total fat,
saturated fat, cholesterol or sodium) must not
be greater than 120% of the label value. These
allowable variances are commonly referred to as
the "80/120 rule."
|
I am working on a
Canadian label with a sugar-free claim. The
product has less than 0.4g sugar and 2g
carbohydrate. Does this product qualify for the
claim? (March 2011)
In Canada, only products that are both
sugar-free (less than 0.5g sugar per serving)
and calorie-free (less than 5 calories per
serving) qualify for a "sugar-free" claim.
Though the calorie content of the product wasn't
included with your question, using the standard
factor of 4 calories per gram of carbohydrate,
your product likely contains at least 8 calories
per serving. Therefore, a sugar-free claim would
not be permitted on this product in Canada.
In the U.S., a product qualifies as sugar-free
if it has less than 0.5g sugar per serving and
per reference amount for the product category.
The claim can be made on the product label
providing two conditions are met: (1) the
calorie profile is also disclosed on the label
(either low calorie, reduced calorie or not a
low calorie food), and (2) the product does not
include an ingredient that is a sugar or is
generally understood by consumers to contain
sugars unless that ingredient appears with an
asterisk linked to a statement such as "adds a
trivial amount of sugar" below the ingredient
statement.
|
I work for the
Anchorage school district for student nutrition
and we have students that have an allergy to
MSG. I need to know if it is used in CN-labeled
foods? (February 2011)
Whenever MSG (monosodium glutamate) is added to
a food, it must be declared in the ingredient
statement. This is true for foods labeled for
the Child Nutrition (CN) program or any other
foods. There are some ingredients, however, that
contain naturally occurring monosodium
glutamate. This naturally occurring substance is
the result of a free glutamate that combines
with sodium in processing to create monosodium
glutamate. Some ingredients that contain free
glutamate are: yeast extract, autolyzed yeast
extract, disodium inosinate, disodium guanylate,
and hydrolyzed vegetable proteins.
|
Our sales team wants to
create a food package that would be equally
acceptable in Mexico and the U.S. Is this
do-able? (January 2011)
We consulted with Mexican colleagues who
confirmed that yes, it is possible to have a
single food label that satisfies the
requirements of both U.S. and Mexico. Of course,
the label must be bilingual.
Mexico has new food labeling regulations, known
as
NOM-051, that went into effect on January 1,
2011. There are several new requirements
including a calculation for the Mexican
Recommended Dietary Intake (RDI) when different
from the U.S. Daily Value (DV) and a
quantitative ingredient declaration for any
ingredients that are highlighted on the label. A
U.S. bilingual label can be used as long as the
additional mandatory information for Mexico is
also included.
|
When a product like
Fruitabu or V8 vegetable juice says "contains a
serving of fruit" or "contains a serving of
vegetables" what does that mean? What
methodology are they using, because when you
look at the NLEA serving sizes or the USDA
serving size for a fruit or vegetable, the
calories, total sugar and fiber are inconsistent
with how the product is labeled? (December 2010)
FDA does not define serving sizes for food
groups (i.e., fruits, vegetables, grains). FDAs
Reference Amounts (the NLEA serving sizes) are
the amounts customarily consumed; they are
defined for 135 product categories (i.e.,
breads, crackers, puffed cereals, high fiber
cereals). These
Reference Amounts do not necessarily correlate
with serving sizes for food groups. Serving
sizes for food groups vary depending upon which
food group system you use: diet exchanges, Child
Nutrition program information, USDA's MyPyramid
information for a 2,000 calorie diet, or the NLEA
serving sizes.
The number of servings for a particular food
group can be listed on the label as long as it
is truthful and not misleading. The method used
to calculate or determine the number of food
group servings needs to be listed or referenced
by a symbol near the statement of the number of
servings. For example:
A FULL SERVING OF FRUIT IN EACH 8 FL OZ
GLASS
Each 8 fl oz glass provides ½ cup of fruit.
USDA's MyPyramid recommends a daily intake of
2 cups of fruit for a 2,000 calorie diet.
NOTE: MyPyramid was the USDA food guidance
system when this answer was published in
December 2010. It has since been replaced with
MyPlate. However, the concepts discussed above
remain relevant.
|
Can my product (an aseptically shelf stable
ready-to-eat pudding) that is made in the U.S.
and labeled for sale in Canada state "2% or 1%
or less" in the ingredient statement? (November 2010)
Canadian regulations make no mention of an "X%
or less" clause for ingredient statements. In
the U.S., the clause "2% or less of the
following" (or 1.5%, 1%, or 0.5%, as
appropriate) can be used at the end of the
ingredient statement to list minor ingredients
in any order. Canadian regulations specify that
ONLY specific classes of ingredients can be
shown at the end of the ingredient statement in
any order. For these specific classes of
ingredients in Canada, the "X% or less of the
following" clause could be used, but it is not
common practice because it significantly
lengthens the ingredient statement given the
English-French bilingual labeling requirement.
In
Canada, the specific classes of ingredients that
can be shown in any order at the end of the
ingredient statement include: spices, seasonings
and herbs (except salt), natural and artificial
flavors, flavor enhancers, food additives, and
vitamin and mineral nutrients and their
derivatives or salts.
For more information about Canadian ingredient
labeling, consult the Canadian Food & Drug
Regulations (FDR), Section B.01.008. For
information about U.S. ingredient labeling,
consult the U.S. Code of Federal Regulations (CFR),
Title 21, Part 101.4.
|
How many milligrams of Vitamin
C can I add to my beverage without having to
declare "ascorbic acid (Vitamin C)" under the
beverage's ingredient listing?
(October 2010)
If ascorbic acid is added to the beverage, it
must be listed in the ingredient statement.
Furthermore, if the function of the ascorbic
acid is as a preservative, this must also be
disclosed in the ingredient statement (i.e.
"ascorbic acid to preserve freshness" or
something equally descriptive).
According to the Code of Federal Regulations at
21 CFR 101.4, all food ingredients (except
incidental additives as defined in 21 CFR
101.100) must be listed in descending order of
predominance by weight. Rules for declaring
spices, flavorings, colors and preservatives can
be found in 21 CFR 101.22.
|
Could you give me the
current status on labeling for gluten-free
products. What are the rules? (September 2010)
The Food Allergen Labeling and Consumer
Protection Act of 2004 (FALCPA) mandated that
FDA establish a definition for the term
"gluten-free" and uniform conditions for its use
in the labeling of foods. FDA has published a
proposed rule for "gluten-free".
In this proposed rule, the use of the term
"gluten-free" is voluntary. However, it will not
be allowed for foods that contain any species of
the following prohibited grains: wheat, rye,
barley or a crossbred hybrid of these grains.
Furthermore, a "gluten-free" claim will not be
allowed if the food contains 20ppm or more
gluten. If the food is inherently free of
gluten, the claim must acknowledge that all
foods of that same type are gluten-free (i.e.,
"all milk is gluten-free" or "milk, a
gluten-free food").
|
Our
ingredient supplier insists that insoluble fiber
does not need to be included in total calories,
however this would not make sense in context of
the 4-4-9 formula. Is it allowable to have
insoluble fiber listed as part of carbohydrates
on the Nutritional Facts Panel but not included
in the calorie consideration? (August 2010)
In the U.S., your ingredient supplier's approach
is allowed according to FDA regulations. In
Canada however, this approach is not allowed.
For the U.S., FDA allows several different
methods for calorie determination [21
CFR101.9(c)(1)(i)]] such as general factors or
specific Atwater factors. Most companies use the
general factors 4-4-9 (4 calories per gram for
carbohydrates and protein and 9 calories per
gram for fat). It is allowable but not required
to subtract insoluble fiber from the total
carbohydrate value for the purpose of
calculating calories. Insoluble fiber must be
included in the Nutrition Facts Panel if any
claims about insoluble fiber are made --
otherwise it is a voluntary nutrient. If
insoluble fiber is shown, companies can choose
whether or not they subtract the calories from
this type of carbohydrate. To list the fewest
number of calories and to avoid confusing
consumers, you can subtract the insoluble fiber
from the carbohydrates before applying the 4-4-9
formula but then you would not want to include
the optional 4-4-9 footnote on the Nutrition
Facts Panel.
For Canada, it is unacceptable to subtract the
weight of dietary fiber from the weight of
carbohydrate prior to applying the 4-4-9 formula
when calories for the specific fiber source have
not been determined. To date, Health Canada has
only approved reduced calorie levels for wheat
bran (0.6 calories per gram) and specific inulin
sources (2.2 calories per gram).
|
I am using all
natural ingredients in a package. It says it has
vanillin in it. I think vanillin is a compound,
so does that mean I cannot say "all natural
ingredients"? (July 2010)
Vanillin is typically a synthetically-derived
compound (artificial flavor). FDA does not allow
a "natural" claim for products that contain
artificial flavors, added colors (from any
source), or chemical preservatives. See
June 2008 Food Label News
for further discussion about "natural" claims on
FDA, USDA and CFIA-regulated products.
|
Which is better
for getting the most accurate results: lab or
database analysis? (June 2010)
FDA does not require a specific method of
analysis for Nutrition Facts, but the Agency
does require label values to be accurate
within the tolerances specified in the Code of
Federal Regulations.
When performed correctly, the database method is
typically a better predictor of the nutritional
analysis from multiple production runs than a
single laboratory analysis. This is because the
database method uses the statistical average for
commodity products that can vary with growing
conditions and other factors. FDA actually
encourages the use of nutrient databases as a
low-cost alternative to laboratory analysis. In
fact nearly all Food Consulting Company clients
choose this approach; exceptions are for
products that contain ingredients for which
nutrient data is not available or for foods that
undergo processing where the nutrient changes
cannot be confidently predicted.
When you select database analysis you will
provide your product formulations, raw material
specifications, and processing information to us
under strict confidentiality. We will
analyze your product to
determine the 100-gram data.
With laboratory analysis you will provide us
with the 100-gram data lab report.
Contact Us if
you need a referral for a new lab analysis.
In both cases we use the findings of the
analysis to develop the Nutrition Facts panel
for your product. As part of this work we
determine the FDA-regulated serving size and
servings per container, then calculate the
nutrient profile per serving, apply the rounding
rules, and determine percent daily values for
the required Nutrition Facts panel components.
Finally we produce a camera-ready Nutrition
Facts panel formatted according to your package
dimensions and FDA specifications. This is what
you provide to your printer, artist, or package
designer.
|
Can you
reference me to the section of the CFR that
deals with synthetic and/or artificial
substances that are exempt in trace amounts as
food processing aids? Also include information
on secondary synthetics (synthetic and/or
artificial substances that are exempt due to
being ingredients in ingredients)? (May 2010)
Ingredient exemption information can be found in
21 CFR 101.100 - Food; exemptions from labeling.
Under this provision of the Code of Federal
Regulations, incidental additives present in a
food at insignificant levels with no technical
or functional effect in that food are not
required to be listed in the ingredient
statement.
Incidental additives are:
-
ingredients that are incorporated in the
food as an ingredient of another food
-
processing aids which are added during
processing but removed, converted to a
normal constituent of the food at normal
levels or are present at insignificant
levels
-
substances migrating from equipment or
packaging
Insignificant level means there is no technical
or functional effect at the level used.
Incidental additives should always be listed in
the ingredient statement when they are allergens
(i.e. soy lecithin as a lubricant on equipment),
when they are sulphiting agents at detectable
levels (greater than 10ppm), or when the
manufacturer is uncertain if the additive is
functional in the finished product (for example,
a preservative could be functional when
incorporated as an ingredient of another food).
|
We have
four different flavors of a beverage packaged in
a box. Do we need four different nutritional
statements on the box or can we just put the
nutrition info on each bottle instead? (April 2010)
The regulations specify that labeling must be
placed on the retail sales package. This enables
the consumer to be informed when they make their
purchasing decision. For a multi-pack, the
labeling needs to be on the outer package unless
there is a transparent wrapper that joins the
individual packages together so that the
labeling can be seen on the individual packages
at the point of purchase.
The labeling can also
be on both the outer and individual packages. If
the labeling is on the outer package only, then
the individual packages must include a phrase to
indicate that they are not labeled for
individual retail sale. This is true for both
USA and Canada.
|
What does FDA
require regarding redemption value labeling for
beverage containers? (March 2010)
FDA does not regulate this aspect of beverage
labeling. Rather, it is regulated by the
individual states. The requirements vary
depending on type of container (plastic, glass,
aluminum, etc.), contents of the container
(carbonated, non-carbonated, juice, etc.) and if
the container is marketed as single or
multi-serving. The Container Recycling Institute
maintains a website at
bottlebill.org that outlines the various
requirements for U.S., Canada and worldwide.
|
If lecithin is
present, does soy need to be claimed as an
allergen? (February 2010)
Yes, for FDA regulated foods, if lecithin is
derived from soy then soy needs to be listed in
plain, common English within the ingredient
statement. In addition, soy would also be
included if you are using a separate "Contains"
allergen statement.
In
FDA Guidance Specific to Soy Lecithin, FDA
specifies that if lecithin is derived from soy
then the plant source of the ingredient (soy)
must be included in the ingredient name within
the ingredient statement. Additionally, if you
are using a separate "Contains" allergen
statement, soy must be included with all of the
"big eight" allergens (eggs, milk, soy, wheat,
peanuts, tree nuts, fish, crustacean shellfish)
present in the product.
For additional information read
June 2006 Food Label News
report about allergen labeling for incidental
additives.
NOTE: FDA withdrew the above guidance document
on February 22, 2013, because the exercise of
enforcement discretion stated in the policy no
longer reflects the agency's current thinking.
FDA believes that companies have had ample time
to comply with the requirement and that
enforcement discretion is no longer applicable.
|
When we designed our
bags for popcorn, we naturally used the label
warning from our contract manufacturer
"Manufactured in a facility that also processes
peanuts, tree nuts and milk ingredients." Our
contract manufacturer is no longer using nuts in
their products and we are thinking about
eliminating the peanut warning. However, to do
this economically and not create a whole new
printing plate, we would also need to eliminate
the warning about milk being processed in the
factory. Is it OK to eliminate the milk warning
or does that violate a code or present a serious
risk to those with milk allergies? (January
2010)
The use of an allergen advisory statement such
as the one you use "Manufactured in a facility
that also processes peanuts, tree nuts and milk
ingredients" is voluntary so you are free to
eliminate the statement or any other allergen
advisory statement from your labeling if you
choose.
For more information on allergen labeling, see
FDA's Guidance for Industry regarding food
allergens or a
Food Consulting Company article that
helped companies prepare for allergen labeling
when the Food Allergen Labeling and Consumer
Protection Act went into effect on January 1,
2006.
|
If you sell foodservice products to restaurants by the case, are
you required to label each 'package', 'packet'
or 'bottle' in the case? (December 2009)
No, you are not required to label the individual
units within the case. The required labeling for foodservice items
(product identity, net quantity of contents,
ingredient statement, and signature line) can be
on either the individual units or on the
shipping container; it does not have to be in
both places.
Foodservice items are exempt from nutrition
facts labeling, except when a nutrient content
claim is made. If a company elects to label
individual units and uses the exemption for
Nutrition Facts labeling, then it is wise to
include a label statement such as "not labeled
for individual retail sale."
|
Can we label our agave syrup
as a natural low glycemic sweetener in the U.S.? (November 2009)
This question has two parts: "natural" and "low
glycemic." As outlined in last month's Food
Label News, FDA does not restrict the term
"natural" on food labels provided the product is
free of artificial flavors, chemical
preservatives, or added colors (from any
source). The FDA has not defined the term
"glycemic." If you use the word "low" with
"glycemic," you must have authoritative basis
for the claim and include the reference on your
label to ensure that the label is truthful and
not misleading.
Rather than labeling a product as "low
glycemic," we suggest using a statement such as
Agave Syrup: glycemic index = X, compared to
Granulated Sugar: glycemic index = Y. This is a
statement of fact (provided you have research
documentation to substantiate your values) and
provides the consumer with comparison data
without using the descriptive phrase "low."
|
Can enzymes used in dough
conditioners in a bakery product be declared by
a class name "enzymes" or must they be declared
by the actual name of the enzymes in the
Ingredient List? (October 2009)
The enzymes used in dough conditioners need to
be listed in the ingredient statement by "common
or usual name" (actual name of the enzyme). This
is true for both USA and Canada.
|
I have a new product
and need help with food labels. Do I need to
send a sample of my product to you? What
information will you need from me?
(September 2009)
Food Consulting Company uses database analysis
of a products recipe formulation so a sample is
not needed. Database analysis is a lower cost
alternative to laboratory analysis and is an
excellent predictor of a products nutritional
content.
To produce the nutritional information for your
product, Food Consulting Company needs
information about your recipe formulation,
processing and packaging. The regulatory
specialist who will be working on your project
can help you determine the specific information
you will need for your
recipe formulation, your
processing and your
packaging.
View an example.
|
Will either the
LEAN Act or the MEAL Act affect supermarket
foodservice operations? (August 2009)
LEAN Act and MEAL Act are separate bills introduced
to the U.S. Congress that would require
mandatory nutrition disclosure in certain
restaurant/retail food service establishments. In
June 2009, the bills were subject to compromise
in the U.S. Senate and the compromise is to be a
component of health reform legislation currently
being debated.
Very little detail about the compromise was made
public and so the answer to the original question
is not known. It might be helpful though to consider
how FDA has defined the term "restaurants"
per
FDA's Restaurant Labeling Guide:
-
The term "restaurant" applies broadly to
establishments where food is served or sold for
immediate, on-site consumption (e.g.,
institutional food service establishments such
as schools, hospitals, and cafeterias;
transportation carriers such as trains and
airplanes; delicatessens and catering operations
with facilities for immediate consumption
on the premises).
-
The definition of "restaurant" extends to
establishments where foods are generally
consumed immediately where purchased or while
walking away (e.g., lunch wagons, cookie
counters in a mall, vending machines,
and similar foods sold from convenience
stores); and food delivery systems or
establishments where ready-to-eat foods are
delivered to homes or offices for immediate
consumption.
See Food Label News
archive (April 2009, June 2009, July
2009) for reports on LEAN, MEAL and compromise.
|
I heard that stevia can now
be used in conventional foods (and not just
dietary supplements). If true, are there special considerations I need to
be aware of for labeling? (July 2009)
Only rebaudioside A (RebA), an isolated
component of the stevia plant is allowed by FDA
for use in conventional foods. In December 2008,
FDA responded to notices from Whole Earth
Sweetener Company LLC and Cargill Incorporated
requesting GRAS status for rebaudioside A
purified from Stevia rebaudiana (Bertoni)
Bertoni. In both responses (1,2)
FDA stated that the agency
has no questions at this time regarding the
conclusions that rebaudioside A is GRAS under
the intended conditions of use.
The ingredient statement needs to indicate the
presence of the purified form "RebA" - "stevia"
is not appropriate labeling nomenclature for
this ingredient.
|
My products are
syrups and fruit toppings; what determines if
the label should use 'fluid ounces' or 'net
weight' to declare net quantity of contents? (June 2009)
The Code of Federal Regulations says that the
'net quantity of contents' statement is to be
expressed in terms of fluid measure, weight,
numerical count, or a combination of numerical
count and weight or fluid measure. The statement
is to be in terms of fluid measure if the food
is liquid, or in terms of weight if the food is
solid, semisolid or viscous, or a mixture of
solid and liquid. If syrups are pourable and do
not contain solid pieces of anything the net
quantity statement will be in terms of fluid
measure as in the U.S. gallon of 231 cubic
inches and quart, pint, and fluid ounce
subdivisions as appropriate for the product
container. If the fruit toppings are a
mixture of syrup and pieces of fruit the net
quantity statement will be by weight in terms of
pound and ounce.
Exception to the above regulations is possible;
if there is a firmly established general
consumer usage and trade custom of declaring the
contents of a liquid by weight, or a solid,
semisolid or viscous product by fluid measure,
it may be used. In all cases 'net quantity of
contents' statement must facilitate value
comparisons by consumers and must not cause
consumer confusion.
In addition to stating the U.S. Customary System
terms (ounces, pounds, and fluid ounces,) food
labels must show the net contents in Metric
System
terms (grams, kilograms, milliliters, liters.)
FDA's
Food Labeling Guide gives more information
about net quantity of contents.
|
What is the 2400 milligram Daily Value for
sodium based on? (May 2009)
The Institute of Medicine's most recent (2004)
Recommended Dietary Intake for sodium
established 1.5g per day as the Adequate Intake
(AI) and 2.3g per day as the Upper Limit (UL).
The Recommended Dietary Allowances, Tenth
Edition (1989) recommended that daily intakes of
sodium chloride be limited to 6g (2.4g of
sodium) or less. This 2.4g recommendation
correlates with the 2400 mg Daily Value for
sodium established for nutrition facts panels
that became mandatory on food labels in 1993.
|
Does your company offer
shelf life testing? (April 2009)
Yes, Food Consulting Company offers a Shelf Life
Evaluation service. A food technologist
determines shelf life by testing a product
sample for pH, water activity, moisture, solids,
and other components; the findings are used
along with specifics about the product
ingredients, processing methods, and packaging
to determine the product shelf life.
Although labeling regulations do not include a
requirement for shelf life, voluntary inclusion
of a freshness date (Best Before or Use By) on
labels encourages retailers to rotate products
and lets consumers know when the time is up for
highest product quality.
|
I have seen products
with a Nutrient Content Claim (NCC) stating "0
grams trans fat." I have not found this claim to
be one of the approved NCC claims. Is the claim
illegal or allowed? (March 2009)
"0 grams trans fat per serving" is a factual statement, not a
defined nutrient content
claim. Factual statements have always been allowed on labels provided the
information is truthful and not misleading. "0 grams trans fat per
serving is truthful as long as the food contains less than 0.5 gram (1/2 g)
of trans fat per serving. "0 grams trans fat" without qualification (i.e., "per
serving") is an incomplete factual statement and should not be used on labels,
unless the product is in a single-serve
container.
While "0 grams trans fat per serving" can be used on labels, "trans fat free"
cannot be used. Per FDA regulations the term "free" is a nutrient content
descriptor. The regulations regarding the use of nutrient content claims are
specific; they are intended to ensure that the descriptive terms that
characterize or compare nutrient levels are used consistently for all types of
food products and are thus meaningful to consumers. Nutrient content claim
descriptors apply only to nutrients or dietary substances that have an
established daily value; no daily value has been established for trans fat.
In addition to "free," the existing regulations disallow claims about trans fat
using the following terms: Free, Zero, No, Without, Trivial Source of,
Negligible Source of, Dietarily Insignificant Source of, Low, Little, Few,
Contains a Small Amount of, Low Source of, Reduced/Less, Lower, Fewer, and any
synonyms of these words.
Note: If a statement of fact related to a
nutrient is made outside the Nutrition Facts
panel for a product that exceeds threshold
levels of total fat, saturated fat, cholesterol
and sodium, then the disclosure statement "See
Nutrition Information for
[name of nutrient] Content" is required.
|
I've heard that you
can't make a low-sodium claim on a product that
contains cholesterol. Is this true?
(February 2009)
A low-sodium claim can be made on a product that
contains cholesterol, but depending on the
amount of cholesterol you might have to include
a disclosure statement.
A disclosure statement is required for nutrient
content claims (e.g., low sodium, fat free,
sugar free) if certain other nutrients exceed
set thresholds. The nutrients and thresholds
are: 13.0g fat, 4.0g sat fat, 60mg cholesterol,
480mg sodium. These values are for Reference
Amount Customarily Consumed (RACC) per labeled
serving. The rules for foods with small serving
sizes and main dish/meal products are different.
A disclosure statement calls consumers'
attention to one or more nutrients in the food
that may increase the risk of a disease or
health-related condition that is diet related.
The disclosure statement identifies the nutrient
that is present above the prescribed level, e.g.
"See nutrition information for cholesterol
content." This statement must be placed
immediately adjacent to the claim in boldface
type and a type size at least as large as the
net quantity of contents declaration.
|
Is there a
regulated definition for high protein, as a
percentage of protein in a serving?
(January 2009)
Yes. Per the Nutrition Labeling and Education
Act of 1990 (NLEA), "high protein" is a
regulated nutrient content claim and the word
"high" means greater than or equal to 20% Daily
Value (DV). The Daily Value for protein is 50
grams. Therefore, a food that contains 10 grams
of protein (or more) per serving, can be
described as high protein.
If a high protein claim is made, the %DV for
protein must be stated within the Nutrition
Facts. The %DV must be calculated based on the
corrected amount of protein per serving (also
known as protein digestibility corrected amino
acid score, or PDCAAS). This is the actual
amount of protein per serving multiplied by the
amino acid score corrected for protein
digestibility.
Any time a nutrient content claim is made, a
disclosure statement is required if certain
other nutrients exceed set thresholds; the
nutrients and thresholds are: 13.0g fat, 4.0g
sat fat, 60mg cholesterol, 480mg sodium.
|
I am launching a line
of side dishes and some will contain bacon. Are
they covered by USDA or FDA labeling rules?
(December 2008)
The Food Safety and Inspection Service (FSIS) of
USDA has authority over meat and poultry
products and processed egg products. FDA has authority over
all other foods.
When meat
or poultry is part of a mixed dish product
(e.g., pepperoni pizza, chicken noodle soup,
side dish with bacon), the product might fall
under FDA rather than USDA regulations. Where it
falls depends on the formulation.
In general, mixed food products with more than
2% cooked meat or poultry (3% raw) are regulated
by USDA; products with 2% or less cooked meat or
poultry (3% or less raw) are regulated by FDA.
To determine which labeling regulations apply to
the side dish with bacon, consider the weight of
bacon in the formulation.
|
I would like to know
how many new labeling regulations will be in
effect on the January 1, 2010, uniform
compliance date? (November 2008)
FDA established January 1, 2010, as the uniform
compliance date for food labeling regulations
that are issued between January 1, 2007, and
December 31, 2008. FDA sets uniform compliance
dates to minimize the economic impact of
labeling regulation changes.
FDA does not publish a summary list of
updated/new regulations due on a uniform
compliance date. This means labelers are
themselves responsible for staying informed on
all labeling regulations activity.
Food Label News reports on updated
and new regulations as they are proposed, opened
for comment, and as they are made final. Food
Consulting Company offers
services to help labelers meet
compliance dates as economically as possible.
Labelers also have the option of reading the
daily Federal Register and making frequent
visits to FDA's website since all regulation
changes are announced in both locations
accessible through the Internet.
|
Since
fish/aquaculture are excluded from National
Organic Program standards, is labeling fish and
seafood with the term "organic" acceptable in
the U.S.? (October 2008)
An official from USDA's Agricultural Marketing
Service (AMS) told Food Consulting Company that
USDA has no jurisdiction over how organic is
used outside of the rules of the National
Organic Program (NOP). Current NOP rules say
that aquatic animals shall not be included in
the program and therefore NOP has no restriction
on using the term "organic" on a fish label at
the present time as long as the USDA Organic
seal is not used.
Fish is an FDA-regulated food product and FDA
requires that all labeling is truthful and does
not mislead the consumer. Therefore the food
labeler needs to decide if the organic claim on
a fish product meets consumer expectation for
organic.
|
In the August Q&A you
said high fructose corn syrup should be labeled
as glucose-fructose syrup in Canada. Can I also
label it as glucose-fructose syrup on my U.S.
labels for the same product?
(September 2008)
No, the required nomenclature for this
ingredient for U.S. regulated food labels is
high fructose corn syrup. Reference
Code of Federal Regulations in Title 21, Section
184.1866.
|
I've heard that
Canada does not allow high fructose corn syrup
in food products. Is this true?
(August 2008)
Canadian food regulations do not prohibit the
use of high
fructose corn syrup. However
Canadian regulations differ from U.S. regulations
regarding nomenclature for this ingredient.
The Canadian Food Inspection Agency "Guide to
Labelling and Advertising Basic Labelling
Requirements" specifies that the ingredient
equivalent to high fructose corn
syrup is to be listed as "glucose-fructose"
on Canadian food labels.
Food labelers using high fructose corn
syrup/glucose-fructose as an ingredient
may find Food Label News
archived articles from
June 2008 helpful.
|
I frequently
get incomplete nutrition information from
ingredient suppliers and my nutrient analysis
program only helps part of the time. How can I
get complete information?
(July 2008)
When complete and accurate nutrition information
is not provided by ingredient suppliers or
readily available from a particular database,
accurate values must be obtained through a
process of due diligence.
Food Consulting Company has posted an article on
the due diligence process. The content was
presented by Karen C. Duester, MS, RD, company
president, to the nutrition study group meeting
of the National Restaurant Association in May
2007 and included in a 2007 article published in
DBC Dimensions. Read
due diligence article.
|
Is St John's wort
allowed in a beverage at any level?
(June 2008)
No, this botanical is not allowed for use as an
ingredient in a beverage; this is explained in a
January 30, 2001, "Dear
Manufacturer" letter.
In the letter, FDA explains that in order for a
substance, such as the botanical St John's wort,
to be added to food, the substance must be GRAS
(Generally Recognized as Safe) or be an approved
food additive. Food additives require pre-market
approval by FDA; data demonstrating safety is
submitted by the petitioner to the agency in a
food additive petition. If the petition is
accepted, the agency issues food additive
regulations. The regulations specify the
conditions under which the additive has been
demonstrated to be safe and how it may lawfully
be used.
St John's wort is not a GRAS substance or an
approved food additive.
|
I see butter
listed on ingredient statements alone sometimes
and sometimes followed by a parenthesis around
the butter ingredients e.g., (cream, salt). How
should I list butter in my ingredient statement?
(May 2008)
If the formula includes unsalted butter, it is
correct to simply list "butter" (or specify as
"unsalted butter") in the ingredient statement
in descending order according to total weight
compared to other ingredients. However if the
formula includes salted butter, the salt in the
butter must be factored into the ingredient
statement in one of two ways.
The most concise way to accurately list the salt
in salted butter is to determine the salt weight
vs. cream weight and then add the salt weight to
the salt contributed from other ingredients. The
"butter" and "salt" from all sources will then
be listed in correct order according to their
weights compared to other ingredients.
The other option for listing salted butter (a
composite ingredient) is to list the butter in
descending order by weight followed by a
parenthetical listing of the sub-ingredients,
e.g., "butter (cream, salt)."
|
For a
product that contains multi-component
ingredients (e.g., cherry pie contains fruit
filling and crust, both with sub-ingredients),
does FDA require that the ingredient statement
show each ingredient with sub-ingredients in parentheses, or
is it ok to list the subcomponents one time in
order by total weight in the whole product?
(April 2008)
FDA regulations allow a product that contains
multi-component ingredients to use either a
"composite" ingredient statement or an
"expanded" (parenthetical) statement. Which type
to use depends on the goal for
final label appearance and on the availability
of the formula breakdown for multi-component
ingredients.
The "composite" ingredient statement is
generally a cleaner, more concise ingredient
statement that helps present a product in the
best possible light within the law. This type of
statement identifies each ingredient one time,
in descending order based on each ingredients total weight
in the whole product.
Ingredient suppliers usually do not provide
exact formula breakdowns for multi-component
ingredients, but may provide a range, e.g., 60%
to 70% sugar. The ingredient statement developer
must then be able to use the percent range
information given to create a truthful
ingredient statement. This requires skill in
understanding FDA ingredient labeling
regulations and in applying the information
provided by suppliers of multi-component
ingredients.
Unless a client requests otherwise, Food
Consulting Company normally prepares a composite
ingredient statement. The exception is when a
labeling client (or their supplier) is not able
to provide adequate
information for multi-component ingredients.
|
Do nut oils and soybean
oil have to be declared as allergens on food
labels?
(March 2008)
FDA food labeling regulations require that the
source of the oil is identified (soybean oil,
peanut oil, walnut oil, etc.) in the ingredient
statement. Per FDA guidance related to the Food
Allergen Labeling and Consumer Protection Act of
2004 (FALCPA), if a "Contains" statement is used
after the ingredient statement, then all of the
"big eight" allergens contained in the product need
to be in this statement - tree nut and legume
(soy or peanut) oils are no exception unless the
oil is highly refined and therefore free of the
allergenic protein.
For background, FALCPA exempts highly refined
oils and ingredients derived from highly refined
oils from allergen labeling. FDA does not have a
regulatory definition for highly refined oil,
however the Agency refers to the
Senate Report
that accompanied FALCPA that describes a highly
refined oil as one that is refined, bleached and
deodorized.
|
If a company is
using a safe lubricant like beef tallow or lard
to lubricate pans for baking, or is using those
animal products in the packaging of the product,
does FDA require that these additives be listed
in the ingredient list?
(February 2008)
Pan release agents are generally considered to
be processing aids and therefore are typically
exempt from ingredient statement labeling for
FDA-regulated foods. However when release agents
contain an allergen (milk, eggs, wheat,
soybeans, peanuts, tree nuts, fish, and
shellfish per the Food Allergen Labeling and
Consumer Protection Act of 2004) the lubricant
should be listed by the common or usual name in
the ingredient statement. In addition, if
omitting an ingredient would cause the product
to be misbranded because its label is misleading
or not truthful (e.g., the product is commonly
understood to be vegetarian or labeled as such
but a release agent from an animal source is
used), then the presence of the release agent
should be disclosed in the ingredient statement.
|
Is it a requirement
that vitamins and minerals (Vitamins A and
C, Calcium, Iron, etc.) in the Nutrition Facts
be reported using even numbers? If yes, what is
the logic for this, and what is the rule?
(January 2008)
FDA regulations specify "rounding rules" for the
% Daily Value of vitamins and minerals. When
the rules are properly followed the % Daily
Value for a nutrient can be an even or odd
number. Per FDA regulations for vitamins and
minerals (Vitamins A and C, Calcium, Iron,
etc.), round the Daily Value to:
- nearest 2% if less than 10%
- nearest 5% if between 10% and 50%
- nearest 10% if greater than 50%
If the Daily Value is between 1 and 2%, the %
Daily Value may be stated as 0% or 2%.
|
Does the nutritional
labeling have to be printed in black?
(December 2007)
Per the Code of Federal Regulations, the
Nutrition Facts panel must be in black or one
color type printed on a white or neutral
background with the intent that it is very easy
to read. However, the other required labels
components (ingredient statement, signature
line, etc.) can use inverse printing as in light
type with dark background. In all cases, the
information must be readable and compliant with
regulations for minimum type size and specific
placement. For compliance checks on your label
prototypes select
Label Compliance Review service.
|
Are sample food
packages required to include Nutrition Facts or
other food label components?
(November 2007)
Food samples do not have to be labeled with any
of the required label components as long as the
product package clearly identifies the product
as a sample. For example, the product packaging
can include the words "not labeled for retail
sale."
It doesn't matter if the samples are distributed
by mail, handed out, or offered for taste
testing in a retail store or other public place.
A company may voluntarily include some or all of
the required label components on a food sample
package, but if all five label components are
not presented in the manner FDA specifies, the
label must state "not labeled for retail sale"
or equivalent wording.
Providing retail-ready samples is often a smart
choice in achieving the objective of a sample
campaign; there is widespread consumer interest
in knowing the ingredients and nutritional value
of purchased foods.
To have retail sale ready sample packages, the
five required label components are: statement of
identity, statement of net contents, Nutrition
Facts, ingredient statement with allergen
labeling compliance, and name and address of
manufacturer, packer or distributor. For help
with FDA compliant food labels select
Full Label Compliance service.
|
Is FDA approval
of food labels required? If yes, does Food
Consulting Company include this step in my label
order? (October 2007)
FDA does not require or provide a service for
the Agencys approval of food labels. However,
labelers must comply fully with the labeling
regulations on their own or through the help of
their choice. Food Consulting Company helps you
produce
100% FDA compliant labels with
Full Label Compliance and
Label Compliance Review.
The requirements for food labeling are detailed
in the Federal Food Drug and Cosmetic Act, Code
of Federal Regulations, Food Labeling Guide,
Food Allergen Labeling and Consumer Protection
Act, and in FDA guidance documents all of which
can be accessed at
www.fda.gov.
The Agency learns of non-compliant labels on
foods via random checks and checks during
inspections, and through tips from consumer
groups, individual consumers and competitors.
FDA issues warning letters to food packagers
when violations are discovered; the Agency
directs food packagers to correct non-compliant
labels or face further FDA action.
|
What is the legal
definition for "trans fat free?" Can a
restaurant or product make this claim?
(September 2007)
To date, FDA has not established a definition
for "trans fat free." Therefore this
claim cannot be made on food labels or on menus and menu boards,
or in food marketing.
Per FDA regulations the term "free" is a
nutrient content descriptor. The regulations
regarding the use of nutrient content claims are
specific; they are intended to ensure that the
descriptive terms that characterize or compare
nutrient levels are used consistently for all
types of food products and are thus meaningful
to consumers. In general, nutrient content claim
regulations apply only to nutrients or dietary
substances that have an established daily value;
no daily value has been established for trans
fat.
In addition to "free," the existing regulations
disallow trans fat claims using the following
terms: Free, Zero, No, Without, Trivial Source
of, Negligible Source of, Dietarily
Insignificant Source of, Low, Little, Few,
Contains a Small Amount of, Low Source of,
Reduced/Less, Lower, Fewer, and any synonyms of
these words.
FDA regulations do allow the Nutrition Facts to
state 0g trans fat when the serving contains
less than 0.5 gram (1/2 g) of trans fat, and a
separate factual statement "0g trans fat per
serving" can be used elsewhere on the label.
Menus can also make this statement about a menu
item when it is true and factual.
FDA continues to conduct research and consider
scientific evidence that may influence the use
of nutrient content and other claims for trans
fat on food labels and menus and in marketing.
|
I want to highlight
that my dessert topping with 1.5g fat and less
than 0.5g trans fat per serving contains only a
small amount of partially hydrogenated oil
compared to competing brands that contain almost
all partially hydrogenated oil. Can I highlight
this with my simplified Nutrition Facts panel?
(August 2007)
You are puzzled about the specifics of the trans
fat labeling rules, and Food Consulting Company
agrees the rules are tricky.
Per the rules for simplified Nutrition Facts
[21CFR101.9(f)], you are not allowed to report
trans fat as a separate line item under total
fat in the Nutrition Facts panel when trans fat
is 0 (0.49g or less per serving); however in
some cases the
rules do require a declaration of trans fat in
the "not a significant source" statement.
You also have the option of using a standard
Nutrition Facts panel [21CFR101.9(c) rules].
These rules require that when total fat is a
reportable amount, saturated fat and trans fat
must both be listed as separate line items
within the Nutrition Facts panel.
See examples of correct and incorrect
Nutrition Facts panels
here.
In either case (simplified or standard) you may
state "0g trans fat" on the front label panel
but be aware, under current rules, your product
label may not state "trans fat free" or "no
trans fat."
|
My product (non
perishable grain) was stamped with an incorrect
and too early "best before" date. Does FDA allow
me to use a sticker to cover the incorrect
information with the correct date?
(July 2007)
Per FDA's
Food Labeling Guide it is
permissible to use stickers to make changes in
labeling, therefore you can correct the
best before date with an over-sticker.
Best before/shelf life labeling is not an FDA
requirement. However if used the information
must be truthful and not misleading; truthful
and not misleading is a minimal requirement for
all label statements and information.
Voluntary inclusion of a freshness date on
labels encourages retailers to rotate products
and lets consumers know when the time is up for
highest product quality. Food Consulting Company
believes that including best before/shelf life
labeling is a wise consumer-friendly business
practice.
Food Consulting Company offers
Shelf Life
Evaluation. A food technologist will test your
product sample for parameters that affect the
shelf life (pH, water activity, moisture,
solids, others); these findings will be used
along with specifics about product ingredients,
processing methods, and packaging to determine
the current shelf life of your product and help
you reach your shelf life goal.
|
I would like to sell
my product in grocery stores/gourmet shops. What
service do I order to make sure my label meets
FDA label regulations? (June 2007)
To sell an FDA-regulated product by retail in
the United States the product label must contain
five label components. These are: statement of
identity, statement of net content, Nutrition
Facts, ingredient statement with allergen
labeling compliance, and name and address of
manufacturer, packer or distributor.
Labeling rules state where each component must
be placed, minimum type size requirements, and
more.
Food Consulting Company's
Full Label Compliance service takes the
product information you provide and produces the
required components for you. The service
includes nutrition analysis, a Nutrition Facts
panel, an ingredient statement including allergen
labeling compliance, and help with product naming
and label claims. The package also includes label
layout instructions and a final label review.
You have options to successfully produce
FDA-compliant labeling:
-
Food Consulting Company can help you from
start to finish with
Full Label Compliance. With this choice,
once you supply the necessary information
for a product
you will receive ready-to-print label
components and a guarantee for accuracy.
-
Produce your labels by referring to the
FDA website. Use FDA resources (Code of
Federal Regulations, FDA Guidance Documents,
and FDA's Food Labeling Guide) and contract
with Food Consulting Company for
Ongoing
Regulatory Support to get expert
advice as needed.
-
Refer to FDA's food labeling resources (Code
of Federal Regulations, FDA Guidance
Documents, and FDA's Food Labeling Guide)
for detailed information on labeling
requirements and proceed to produce your
product label. Submit your final label work
to Food Consulting Company for
Label Compliance Review to assure FDA
compliance.
|
Can I use my product label to tell
how my food fits into MyPyramid guidelines?
(May 2007)
FDA has not issued formal guidance on using
MyPyramid on food labels, but in conversations
with Food Consulting Company the Agency has
referred to USDA's guidance document to explain
how MyPyramid can be used on FDA-regulated food
labels.
In 2005 USDA published a Statement of Interim
Policy Guidance entitled
"Use of the USDA MyPyramid Reference on Meat and
Poultry Labeling and Whole Grain Claims."
In part, the USDA guidance advises labelers:
-
MyPyramid replaced the Food Guide Pyramid in
2005; food labels referencing the old
graphic (Food Guide Pyramid) need to be
revised to eliminate this outdated
reference.
-
MyPyramid uses discreet numbers in common
household measure, i.e., cups and ounces
(not numbers of servings).
-
MyPyramid references on food labels should
be based on the 2,000 calorie level when
stating the amount the product provides
toward the recommendation for a major food
group.
-
MyPyramid references to whole grain that
state or imply a high or increased amount
(example, excellent source of whole grains)
cannot be used on food labels. However,
truthful and not-misleading statements of
fact that do not characterize the specific
level of whole grains can be used.
For more information on FDA food label claims,
see the Center for Food Safety and Applied
Nutrition
webpage,
or contract with Food Consulting Company for
One-time or Ongoing Regulatory Support.
NOTE: MyPyramid was the USDA food guidance
system when this answer was published in May
2007. It has since been replaced with MyPlate.
However, the concepts discussed above remain
relevant.
|
If a product does not
contain any allergens should you still put
"Allergens: Contains none" on the label?
(April 2007)
Allergen labeling of foods is required by the
Food Allergen Labeling and Consumer Protection
Act of 2004 (FALCPA). The Act identifies the
"big eight" food allergens (milk, egg, fish,
Crustacean shellfish, tree nuts, wheat, peanuts,
soybeans) and specifies how labeling is to be
done. According to the Act, a "Contains"
statement is not required to indicate the
presence of allergens as long as allergens that
are present within the package are listed by
common or usual name in the ingredient
statement.
Furthermore, the statement "Allergens: Contains
none" risks being misleading and therefore
discouraged. The "big eight" allergens account
for 90 percent of food allergies and it would
not be wise to suggest that a product does not
contain any of the other possible allergens.
|
I manufacture spreads
in collaboration with a restaurant and the
restaurant name is the prominent name on the
label. Whose address should be used in the label
signature line? (March 2007)
Either entitys name with address can be used in
the signature line. If the restaurant
name/address is used, it needs to be preceded
with the words "Manufactured for" or
"Distributed by" or similar wording that
expresses the facts. If the manufacturer's
name/address is used, no lead-in is necessary.
For reference, this question is covered in the
Code of Federal Regulations (21CFR101.5).
|
I would like to
import a product from Europe for sale in both
the USA and Canada; what should I be aware of so
that my label will be allowed in both countries?
(February 2007)
It is not possible to create one label that will
satisfy both USA and Canadian labeling
requirements because: each country has different
requirements for formatting the Nutrition Facts,
the rounding rules are different, in some cases
the units for reporting nutrients differ, and
the countries have established different Daily
Values for some nutrients.
Also, the requirements for ingredient/allergen
declarations are different, and there are some
differences relating to net contents statements,
nutrition/health claims, and other aspects of
the label.
|
I'm launching my
first food product; I have heard about a small
business exemption for nutrition labeling. How
can I find out if I qualify?
(January 2007)
FDA explains the small business exemptions for
nutrition labeling
here.
In brief, the product launcher may use the
exemption if the product will be sold only by
retailers that have total annual gross sales of
not more than $500,000, or annual gross sales of
foods of not more than $50,000. A low volume
exemption might apply if the product
launcher/company meets certain requirements for number
of employees and number of product units that
are sold annually in the United States. For some
exemptions, a notice must be filed annually with
FDA.
When considering an exemption for nutrition
labeling it is very important to understand that
product labels must still be in compliance with
other FDA labeling regulations such as, but not
limited to, ingredient statement and allergen
labeling.
Also, if any nutrient content claim (e.g., "low
fat"), health claim, or other nutrition
information is provided on the label, or in
packaging or advertising, the small business
exemption is not applicable for the product.
Product launchers who choose to forego the small
business nutrition labeling exemption, and
instead opt to include Nutrition Facts:
-
better meet consumers' expectations for
product information; consumers are
accustomed to knowing such things as
servings per container and serving size,
calories and fat grams per serving, etc.
They will wonder why the nutritional
information isn't on the label
and consequently may lose interest in the
product.
-
position the new product as one that is
intended to have a serious market presence.
-
enable the company to highlight nutrition
information in labeling and advertising.
-
open more doors for product distribution;
many retailers will not be able to carry
products that are not labeled with Nutrition
Facts.
-
make a smart up-front investment; once the
Nutrition Facts label is developed, it is
good for thousands of product unit sales.
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If MSG is a sub-ingredient
of an ingredient I use and is present in a very
small amount in my product, do I have to list it
on my label? (December 2006)
Yes, FDA requires that all ingredients,
including sub-ingredients that have a functional
or technical effect, be included within the
ingredient statement. Monosodium Glutamate (MSG)
always has a functional or technical effect
(flavor enhancement) and so it must be listed.
If a company does not want to
include monosodium glutamate in the ingredient
statement, then the manufacturer should look for
an ingredient to purchase that does not contain
this flavor enhancer.
Note: Monosodium Glutamate must be listed by its
full name; MSG as an abbreviated acronym is not
acceptable.
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If my product
does not contain significant amounts of one or
more of Vitamin A, Vitamin C, Calcium, and Iron,
can I report other vitamins/minerals in this
space? (November 2006)
Yes, labelers can voluntarily list other
vitamins and minerals that naturally occur in a
food and for which a Reference Daily Intake (RDI)
or Daily Reference Value (DRV) has been
established, regardless if the four required
vitamins/minerals (Vitamin A,
Vitamin C, Calcium, and Iron), are or are not
listed in the table of nutrient values. The
voluntarily declared values are to be listed
after the required vitamins/minerals and in a
specific order.
Nutrition labeling laws require that Vitamin A,
Vitamin C, Calcium and Iron be declared in the
table of nutrient values in the Nutrition
Facts. However when any or all of these
nutrients is/are present at "zero" levels in a
food (defined as less than 2% of the RDI), then
the "not a significant source" statement can be
used instead of separate line items; the "not a
significant source" statement must be placed
directly beneath those vitamins/minerals that
have been listed in the table of nutrient
values.
Any vitamin or mineral that is added as a
nutrient supplement or for which a claim is made
in labeling or in advertising must be declared
in the table of nutrient values.
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Which is best for getting
nutrient values for my product, laboratory or
database analysis? (October 2006)
FDA does not require a specific method of
analysis for Nutrition Facts, but the Agency
does require label values to be accurate
within the tolerances specified in the Code of
Federal Regulations.
When performed correctly, the database method is
typically a better predictor of the nutritional
analysis from multiple production runs than a
single laboratory analysis. This is because the
database method uses the statistical average for
commodity products that can vary with growing
conditions and other factors. FDA actually
encourages the use of nutrient databases as a
low-cost alternative to laboratory analysis. In
fact nearly all Food Consulting Company clients
choose this approach; exceptions are for
products that contain ingredients for which
nutrient data is not available or for foods that
undergo processing where the nutrient changes
cannot be confidently predicted.
When you select database analysis you will
provide your product formulations, raw material
specifications, and processing information to us
under strict confidentiality. We will
analyze your product to
determine the 100-gram data.
With laboratory analysis you will provide us
with the 100-gram data lab report.
Contact Us if
you need a referral for a new lab analysis.
In both cases we use the findings of the
analysis to develop the Nutrition Facts panel
for your product. As part of this work we
determine the FDA-regulated serving size and
servings per container, then calculate the
nutrient profile per serving, apply the rounding
rules, and determine percent daily values for
the required Nutrition Facts panel components.
Finally we produce a camera-ready Nutrition
Facts panel formatted according to your package
dimensions and FDA specifications. This is what
you provide to your printer, artist, or package
designer.
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I'm planning to sell my
products by internet. Do I need a Nutrition
Facts Panel? (September 2006) Yes. There are no special provisions for
internet/mail order sales. By law, all foods
sold in the U.S. must be in full compliance with
FDA nutrition labeling requirements that are
specified in the U.S. Code of Federal
Regulations, regardless of the method of sale.
For reference, this question is covered in FDA's
Food Labeling Guide.
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What is FDA's stand on GMO
labeling? (August 2006)
In consumer and industry press, GMO is the
commonly-used acronym for Genetically Modified
Organisms. GMO foods are those produced through
bioengineering.
FDA guidance
states that the agency has "no basis for
concluding that bioengineered foods differ from
other foods in any meaningful or uniform way, or
that, as a class, foods developed by the new
techniques present any different or greater
safety concern than foods developed by
traditional plant breeding."
FDA position on label statements about foods
that are not genetically-modified
FDA does not generally allow food labeling such
as "GMO-free" because this would imply that the
absence of bioengineering makes a product safer
or superior to comparable products. FDA has
indicated that statements about foods that do
not contain ingredients produced from
bioengineered foods could avoid or minimize such
implication by using the following statement:
"We do not use ingredients that were produced
using biotechnology."
FDA position on label statements about foods
that are genetically-modified
FDA does allow manufacturers to use
informative statements in labeling of foods that
contain ingredients produced from bioengineered
foods, e.g., "Genetically engineered" or "This
product contains cornmeal that was produced
using biotechnology." These statements are
optional. However, if a bioengineered food is
different in any way from the food it resembles
(e.g, nutritional, organoleptic, or functional
characteristics), then FDA requires that the
label states how the food is different. The
example FDA cites is high oleic acid soybean oil
from soybeans developed using biotechnology to
decrease the amount of saturated fat.
FDA's bottom line on GMO labeling (as on all
food labeling) is that a food cannot be
misbranded in any way. A food is misbranded if
its labeling is false or misleading.
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Where can I find information
on the U.P.C. barcode? (July 2006)
The U.P.C. barcode is not a regulatory
requirement, but as a practical measure it
should be included on your food label. Retailers
will generally not stock your product without
it. The first step in getting a barcode is
becoming a member of GS1 US Partner Connections
(previously Uniform Code Council). Once you
become a member, you will receive a company
prefix for use in creating your own U.P.C.
barcodes. See
www.uc-council.org for more information.
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