Draft Guidance for Industry: Food Allergen Labeling Exemption Petitions and Notification

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Under The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), food labels are required to be identified on products that contains major food allergens (milk,eggs,crustacean shellfish,tree nuts,wheat,peanuts, and soybeans).  However;  since this major allergens can be modified to such extent that it does not contain allergenic protein or does not cause allergic reaction that can pose risk to human health, manufacturers can obtain exemption from this labeling requirement for a specific ingredient.

Food & Drug Administration is announcing the availability of a draft guidance entitled ” Draft Guidance for Industry: Food Allergen Labeling Exemption Petitions and Notifications.” This will greatly help industry to prepare petitions and notification seeking exemptions from the labeling requirements on products containing this major food allergens.

To see the draft, please click this link:  http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm395494.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

FALCPA provides two mechanisms that could consider an ingredient to become exempt from the labeling requirements of section 403 (w)(1) of the FD&C Act

  • An ingredient may obtain an exemption through submission and approval of a petition containing scientific evidence that demonstrates that the ingredient “does not cause an allergic response that poses a risk to human health (section 403(w)(6) of the FD&C Act.
  • Alternately, an ingredient may become exempt through submission of a notification containing scientific evidence showing that the ingredient “does not contain allergenic protein” or that there has been a previous determination through a premarket approval process under section 409 of the FD&C Act (21 U.S.C. 348) that the ingredient “does not cause an allergic response that poses a risk to human health (section 403(w)(7) of the FD&C Act.

There are cases where the production of an ingredient derived from these major food allergen may be altered and that the level of such allergenic protein in finished food product does not cause an allergic reaction that can pose risk to human health. The two mechanisms mentioned above can help industry get an approval for the labeling exemption. Once finalized, the draft guidance will help current views on this topic. This will help FDA evaluate whether the ingredients meet the exemption standards in FALCPA. On the other hand, this will also help manufacturer to decide whether to submit a petition or notification.  FDA seeks public comment starting May 8.

You may submit your comments by mail at:

Division of Dockets Management (HFA-305)

Food & Drug Administration

5630 Fishers Lane, RM 1061

Rockville,MD 20852

 

For more information:  http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm396167.htm