FDA Guidance Clarifies Labeling For Supplements Containing Food Allergens
This article was originally published in The Tan Sheet
Executive Summary
Manufacturers of dietary supplements are required to begin labeling products that contain major food allergens on Jan. 1 in order to comply with the Food Allergen Labeling & Consumer Protection Act of 2004 (FALCPA)
You may also be interested in...
US FDA Explains Food Allergen Evaluations, Offers Instructions On Making Requests For More
Draft asks for comments on a guidance which will outline FDA thinking evaluating public health importance of food allergens not identified as major.. Draft also provides information on submitting requests to evaluate non-listed food allergens.
US FDA Guidance Scratches Sesame Labeling Itch; House Passes ‘FASTER’ Allergen Identity Process
Food Allergy Safety, Treatment, Education, and Research Act would amend FDA regulations to include sesame as major allergen and allow agency to add other food ingredients as major allergens based on prevalence and severity of allergic reactions. FDA, meanwhile, published guidance for voluntarily labeling sesame as an allergen while it develop its factors for evaluating which food allergens in addition to the eight already specified in its regulations should be designated as requiring additional controls, including allergen labeling.
FiberChoice recall
GlaxoSmithKline announces March 20 it is recalling 144,000 bottles of FiberChoice Plus Multivitamins because fish gelatin, a known allergen, was not declared on the label. The recall affects 90-count, 16 oz. bottles that began shipping to retailers Jan. 15. No reports of adverse reactions had been reported as of the recall announcement. The Food Allergen Labeling Consumer Protection Act of 2004 requires that manufacturers of dietary supplements disclose major food allergens on product labeling (1"The Tan Sheet" Oct. 24, 2005, p. 10). GSK completed its acquisition of FiberChoice manufacturer CNS in December 2006 (2"The Tan Sheet" Jan. 1, 2007, In Brief)...