(Silver Spring, MD, October 13, 2005) -- Any food (including dietary supplements) that contains a major food allergen must include specific warnings when labeled on or after January 1, 2006. This means exactly what it says: labels applied to food or dietary supplements on or after January 1, 2006, must be compliant. Foods or dietary supplements to which the label was applied prior to January 1, 2006, may continue to be shipped.
The American Herbal Products Association intends to hold an educational tele-seminar on the new requirement at the end of November, with a repeat session in early December. Details will be announced when available.
The food allergen labeling requirement was made into law by the Food Allergen Labeling and Consumer Protection Act of 2004, which amended the Federal Food, Drug, and Cosmetic Act.
Major food allergens must be identified on product labels. These are:
fish (e.g., bass, flounder, or cod),
Crustacean shellfish (e.g., crab, lobster, or shrimp),
tree nuts (e.g., almonds, pecans, or walnuts),
An ingredient that contains protein derived from a food listed above.
Labels must include specific text immediately after or adjacent to the ingredient list or Supplement Facts labeling. That text must read, “Contains: (followed by the food source from which the major food allergen is derived)”.
Example: “Contains: Milk and egg”
Or, the ingredients or Supplement Facts labeling can include the common or usual name of the major food allergen followed in parentheses by the name of the food source from which the major food allergen is derived.
Example: Ingredients: … whey (milk) or soy isoflavones …
FDA issued a Guidance for Industry on this subject on October 5 (http://www.cfsan.fda.gov/~dms/alrguid.html). While this Guidance document refers only to foods, AHPA has confirmed with FDA that it is equally applicable to dietary supplements.
The full text of the law is on the FDA website (http://www.cfsan.fda.gov/~dms/alrgact.html), but relevant parts of the law are posted on the AHPA website (http://www.ahpa.org/05_1013_AllergenLabelingLaw.pdf). Those parts of the law that are relevant to compliance for products labeled on or after January 1, 2006, are in bold.
The American Herbal Products Association (AHPA) is the national trade association and voice of the herbal supplement industry, the only trade association devoted solely to herbal issues. AHPA is the recognized leader in representing the responsible center of the botanical trade, and is comprised of the finest growers, processors, manufacturers and marketers of herbal products. AHPA’s mission is to promote the responsible commerce of herbal products. AHPA committees generate self-regulations to ensure the highest level of responsibility with respect to the way herbs are manufactured, labeled and sold. Website: www.ahpa.org