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 FDA’s
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
FDA’s 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 food’s 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
|