AHPA nudges supplement-makers on allergen labeling

By Staff Reporter

- Last updated on GMT

Related tags: Food allergy

The American Herbal Products Association has issued a reminder to
supplement makers whose products contain major food allergens that
as of January 1 2006 they, like all food companies, must include
specific warnings on their labeling.

The food allergen labeling requirement forms part of the 2004 Food Allergen Labeling and Consumer Protection Act, itself an amendment to the Federal Food, Drug, and Cosmetic Act.

According to the National Institute of Allergy and Infectious Diseases, between six and eight percent of children under the age of four have a food allergy, and four per cent of adults. The major food allergens, accounting for 90 percent of all food allergies, are milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans.

Ingestion of these foods by someone with an allergy can lead to anaphylaxis which, if not treated in time, may result in death. Each year around 150 Americans, mostly adolescents and young adults, die as a result of food allergies.

The most severe reactions are believed to be to peanuts or tree nuts, such as almonds, pecans or walnuts. Nut allergies affect approximately 0.6 percent and 0.4 percent of the US population.

AHPA spokesperson Karen Robin told NutraIngredients-USA.com that most of the foods on the major allergens are not botanicals, with the exception of soy, peanuts and tree nuts.

"We are waking people up to the fact that the law was passed,"​ she said. "As supplements are regulated as food, manufacturers need to be aware of it."

The regulation also extends to ingredients containing protein derived from any of these foods. This means that supplements containing shrimp-derived glucosamine and whey protein from milk are amongst those that will need to carry the warnings, as are those containing omega-3 from fish oil.

There are two forms they may take: specific wording that reads "Contains: (foodstuff from which the allergen is derived)"​ can be placed after or adjacent to the ingredient list or Supplement Facts panel.

Or the warning can be included as part of the ingredients or Supplement Facts information, with the common name of the allergen following the derivative ingredient - eg. "Ingredients: whey (milk)"​.

Companies might be wise to take early steps to ensure they are in compliance with the new requirement, but there is no need for them to withdraw existing products with labels lacking allergen info, since the requirement it relates only to labels applied on or after January 1. Products labeled before that date can still be shipped and sold.

Earlier this month, the FDA issued the industry with a set of allergy labeling guidelines on this subject (http://www.cfsan.fda.gov/~dms/alrguid.html), which includes the warning that non-compliance may result in the company facing civil sanctions and/or criminal penalties, and seizure and recall of products.

AHPA has said that it confirmed with the FDA that the guidance is applicable to dietary supplements as well as conventional foods. The industry organization plans to hold tele-seminars on the requirement in the next two months.

Related topics: Regulation

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