In August 2, 2004, the Food Allergen Labeling and Consumer Protection Act
(FALCPA) of 2004 (Title II of Public Law 108-282) was enacted. FALCPA
requires labelling for major food allergens [including fish and shellfish
which must include the species name] to apply to any food that is labeled
on or after January 1, 2006.
By definition, `major food allergen' means any of the following: (1) Milk,
egg, FISH (e.g., bass, flounder, or cod), CRUSTACEAN SHELLFISH (e.g.,
crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts),
wheat, peanuts, and soybeans. (2) A food ingredient that contains protein
derived from a food specified in paragraph (1), except the following:
(A) Any highly refined oil derived from a food specified in paragraph (1)
and any ingredient derived from such highly refined oil.
(B) A food ingredient that is exempt under paragraph (6) or (7) of section
403(w) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343-1(a)(2).
Yesterday the FDA posted questions and answers related to the January 1,
2006 implementation of this new food labeling law. Here is a summary of
the questions and answers as it pertains to seafood processing concerns.
I recommend that you visit the FALCPA questions and answers site
(http://www.cfsan.fda.gov/~dms/alrguid.html) and read the information in
its entirety:
* The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA)
(Public Law 108-282) was enacted in August 2004, and addresses, among
other issues, the labeling of foods that contain certain food allergens.
* All packaged foods regulated under the Federal Food, Drug, and Cosmetic
Act (FFD&C Act) that are labeled on or after January 1, 2006, must comply
with FALCPA's food allergen labeling requirements.
* FALCPA does not require any action with respect to products labeled
before January 1, 2006.
* Under FALCPA, a "major food allergen" is an ingredient that is one of
the following five foods or from one of the following three food groups
[which INCLUDES FISH and CRUSTACEAN SHELLFISH] or is an ingredient that
contains protein derived from one of the following:
- milk
- egg
- fish
- Crustacean shellfish
- tree nuts
- wheat
- peanuts
- soybeans
*FALCPA requires that the SPECIES must be declared for FISH (e.g., bass,
flounder, or cod) and Crustacean SHELLFISH (crab, lobster, or shrimp).
* FALCPA's requirements apply to all packaged foods sold in the U.S. that
are regulated under the Federal Food, Drug, & Cosmetic Act, including both
domestically manufactured and imported foods. FDA regulates all foods
except meat products, poultry products, and egg products.
* A company and its management may be subject to civil sanctions, criminal
penalties, or both under the Federal Food, Drug, and Cosmetic Act if one
of its packaged food products does not comply with the FALCPA labeling
requirements. FDA may also request seizure of food products where the
label of the product does not conform to FALCPA's requirements. In
addition, FDA is likely to request that a food product containing an
undeclared allergen be recalled by the manufacturer or distributor.
* FALCPA does not address the use of advisory labeling, including
statements describing the potential presence of unintentional ingredients
in food products resulting from the food manufacturing process. FALCPA
does require FDA to submit a report to Congress, a part of which assesses
the use of, and consumer preferences about, advisory labeling. In earlier
guidance, FDA advised that advisory labeling such as "may contain
[allergen]" should not be used as a substitute for adherence to current
Good Manufacturing Practices (cGMPs). In addition, any advisory statement
such as "may contain [allergen]" must be truthful and not misleading.
* FALCPA does not require FDA to establish a threshold level for any food
allergen. It is not unlikely, however, that FDA will at some point need to
consider a threshold level for one or more food allergens in the context
of reviewing a petition or a notification submitted to request that an
ingredient be exempt from FALCPA's labeling requirements.
WEB RESOURCES FOR FURTHER INFORMATION ON THE FALCPA:
Federal Food, Drug and Cosmetic Act, Chapter IV -- Food:
http://www.fda.gov/opacom/laws/fdcact/fdcact4.htm
Food Allergen Labeling and Consumer Protection Act (FALCPA):
http://www.cfsan.fda.gov/~dms/alrgact.html
Guidance for Industry, Questions and Answers Regarding Food Allergens,
including the Food Allergen Labeling and Consumer Protection Act of 2004,
Final Guidance
http://www.cfsan.fda.gov/~dms/alrguid.html
Information About Food Allergens:
http://www.cfsan.fda.gov/~dms/wh-alrgy.html
Regards,
Pamela Tom
University of California
Sea Grant Extension Program
This archive was generated by hypermail 2b29 : Thu Oct 06 2005 - 10:36:52 PDT