Manatt Advertising Partner Discusses New Dietary Ingredient Notifications

Rock Creek Suspends Anatabloc Sales While It Tries to Resolve NDI Issue
– NutraIngredients-USA

Manatt's Ivan Wasserman, a partner in the firm's Advertising, Marketing & Media division, spoke to NutraIngredients-USA for an article on Rock Creek Pharmaceutical's sales suspension of its Anatabloc antioxidant dietary supplement, which is based on a molecule found in cauliflower and other foods.

NutraIngredients-USA reports that the company said it is attempting to clear up regulatory issues clouding the molecule's use both in supplements and drugs. The suspension will give the company time to file a New Dietary Ingredient Notification with FDA. The company had maintained that since anatabine was present in foods it was subject to the grandfather clause of DSHEA. FDA disagreed, and sent the company a warning letter in January.

Wasserman told the publication that FDA's position is that just because an ingredient is a constituent of a food (e.g. a substance in a fruit or vegetable), that does not necessarily mean it is 'present in the food supply' and thus does not require a new dietary ingredient notification. The ingredient itself must have been 'used for food.'

Read the article here



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