Compliance Policy Guide
Compliance Policy Guidance for
FDA Staff
Sec. 555.250 Statement of Policy for Labeling and Preventing
Cross-contact of Common Food Allergens1
This update to the Compliance Policy Guides Manual (August 2000 edition) is a new CPG.
This update will be included in the next printing of the Compliance Policy Guides Manual.
The statements made in the CPG are not intended to create or confer any rights for, or
obligations on FDA or any private person, but are intended for internal guidance.
BACKGROUND:
Each year the Food & Drug Administration (FDA) receives reports of consumers who
experienced adverse reactions following exposure to an allergenic substance in foods. Food
allergies are abnormal responses of the immune system, especially involving the production
of allergen specific IgE antibodies, to naturally occurring proteins in certain foods that
most individuals can eat safely. Frequently such reactions occur because the presence of
the allergenic substances in the foods is not declared on the food label.
To combat this problem, the agency issued a letter titled "Notice to
Manufacturers," dated June 10, 1996, which addressed labeling issues and Good
Manufacturing Practices (GMPs). This letter is available on FDAs website, www.cfsan.fda.gov/~lrd/allerg7.html.
FDA believes there is scientific consensus that the following foods can cause serious
allergic reactions in some individuals and account for more than 90% of all food allergies.2, 3, 4
Peanuts
Soybeans
Milk
Eggs
Fish
Crustacea
Tree nuts
Wheat
Note: For other foods that may cause an allergic response in certain
individuals, the FDA district office should contact CFSAN/Office of Field Programs for
guidance.
Manufacturers are responsible for ensuring that food is not adulterated or misbranded
as a result of the presence of undeclared allergens. Therefore, the districts should pay
particular attention to situations where these substances are added intentionally to food,
but not declared on the label, or may be unintentionally introduced into a food
product and consequently not declared on the label. When an allergen, not formulated in
the product, is identified as likely to occur in the food due to the firm's practices,
(e.g., use of common equipment, production scheduling, rework practices) then the district
should determine if a manufacturer has identified and implemented control(s) to prevent
potential allergen cross-contact, e.g. dedicated equipment, separation, production
scheduling, sanitation, proper rework usage (like into like).
POLICY:
Direct addition as ingredients or sub-ingredients
Products which contain an allergenic ingredient by design must comply with 21 U.S.C.
343(i)(2). Where substances that are, bear, or contain allergens are added as
ingredients or sub-ingredients (including rework), the Federal Food, Drug, and Cosmetic
Act (the Act) requires a complete listing of the food ingredients (section 403(i)(2); 21
U.S.C. 343(i)(2); 21 C.F.R.101.4) unless a labeling exemption applies.
Exemptions from Ingredient Labeling
Section 403(i)(2) of the Act provides that spices, flavors, and certain colors used in
a food may be declared collectively without naming each one. In some instances, these
ingredients contain sub-components that are allergens.5
FDAs regulations (21 CFR 101.100(a)(3)), provide that incidental additives, such
as processing aids, which are present in a food at insignificant levels and that do not
have a technical or functional effect in the finished food are exempt from ingredient
declaration. Some manufacturers have asserted to FDA that some allergens that are used as
processing aids qualify for this exemption. FDA, however, has never considered food
allergens eligible for this exemption. Evidence indicates that some food allergens can
cause serious reactions in sensitive individuals upon ingestion of very small amounts;
therefore, the presence of an allergen must be declared in accordance with
21 CFR 101.4. The exemption under 21 CFR 101.100(a)(3) does not apply to allergenic
ingredients.
Practices Used to Prevent Potential Allergen Cross-contact
Allergens may be unintentionally added to food as a result of practices such as
improper rework addition, product carry-over due to use of common equipment and production
sequencing, or the presence of an allergenic product above exposed product lines. Such
practices with respect to allergenic substances may be insanitary conditions that may
render the food injurious to health and adulterate the product under section 402(a)(4) of
the Act [21 U.S.C. 342(a)(4)].
REGULATORY ACTION CRITERIA:
The following represents criteria for direct reference seizure to the Division of
Compliance Management and Operations (HFC-210):
- The FDA district office obtains inspection evidence showing that a food was manufactured
to contain an allergenic ingredient as a primary or secondary ingredient, but the
foods label does not declare such allergenic ingredient,
and
- The allergenic ingredient is one of the eight (8) ingredients listed in this guide,
and
- The allergenic ingredient was not used as a processing aid in the production of the
food,
and
- The inspection of the firm was conducted consistent with the Guide To Inspections of
Firms Producing Food Products Susceptible to Contamination with Allergenic Ingredients.
The following represents the criteria for recommending legal action to CFSAN/Office of
Field Programs/Division of Enforcement and Programs (HFS-605):
- The food contains an undeclared allergenic ingredient that is a derivative of one of the
eight (8) ingredients listed in this guide.
- The food contains an undeclared allergenic ingredient that was used as a processing aid
in the manufacture of the product.
- The food contains an undeclared allergenic ingredient, but the ingredient is not one of
the eight (8) allergens listed in this guide.
- The food is not labeled as containing an allergen, but inspection of the firm shows that
it was manufactured under conditions whereby the food may have become contaminated with an
allergen.
- The inspection of the firm was conducted consistent with the Guide To Inspections of
Firms Producing Food Products Susceptible to Contamination with Allergenic Ingredients.
Specimen Charges:
Misbranding due to an undeclared allergen:
The article was misbranded when introduced into and while in interstate commerce and is
misbranded while held for sale after shipment in interstate commerce, within the meaning
of the Act, 21 U.S.C. 343(i)(2), in that it is fabricated from two or more ingredients,
and its label fails to bear the common or usual name of each such ingredient, namely
(specify the undeclared allergenic ingredient).
Adulteration due to food contamination with an allergen:
The article was adulterated when introduced into and while in interstate commerce and is
adulterated while held for sale after shipment in interstate commerce, within the meaning
of the Act, 21 U.S.C. 342(a)(4), in that it has been prepared, packed and held under
insanitary conditions whereby it may have been rendered injurious to health.
1. This update to the
Compliance Policy Guides Manual (August 2000 edition) is a new CPG. This update will be
included in the next printing of the Compliance Policy Guides Manual. The statements made
in the CPG are not intended to create or confer any rights for, or obligations on FDA or
any private person, but are intended for internal guidance. [Back to
ref.]
2. Food and Agriculture Organization of the United
Nations, Report of the FAO Technical Consultation on Food Allergies. Rome, Italy, November
13 to 14, 1995. [Back to ref.]
3. Hefle, S.L., et al. Allergenic Foods. Critical
Reviews in Food Science and Nutrition, 36(S);S69-S89 (1996). [Back
to ref.]
4. Sampson, H.A. Food Allergy, JAMA (278),
pp.1888-1894, 1997. [Back to ref.]
5. As noted in the 1996 letter, FDA is exploring
whether allergenic ingredients in spices, flavorings, or colors should be declared, 21
U.S.C. 343(i) notwithstanding. In the meantime, FDA strongly encourages the
declaration of an allergenic ingredient of a spice, flavor, or color by either:
- as a declaration attached at the end of the list of ingredients indicating the
presence of a specific allergen. [Back
to ref.]
Issued: 04/19/2001
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