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.
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
Note: For other foods that may cause an allergic response in certain individuals, the FDA district office should contact CFSAN/Office of *Compliance* 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).
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 following represents the criteria for recommending legal action to CFSAN/Office of *Compliance/Division of Enforcement* (HFS-605):
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.
*Material between asterisks is new or revised*