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Latest From Malcolm Spicer
Industrial Chemicals’ planned Feb. 28 launch of a kratom product prompted FDA, in its latest enforcement targeting the herb, to remind the firm that it has not shown that extract from the ingredient is safe for use in a dietary supplement.
The International Trade Commission (ITC) has agreed it's FDA's job to regulate the dietary supplement industry as it rejected Amarin Corp. PLC's fair trade complaint, alleging some omega-3 ingredients are unapproved new drugs.
"Nobody said these are easy questions, if they were they would have been answered a long time ago," said Steve Tave, director of FDA's Office of Dietary Supplement Programs (ODSP), referring to FDA's struggle to come up with a "grandfathered" dietary ingredient list. Industry stakeholders at an Oct. 3 public meeting recommended a reasonable threshold for evidence that verifies a dietary ingredient was available in the U.S. before Congress passed the Dietary Supplement Health Education Act (DSHEA).
Scott Gottlieb’s two stints at FDA and his support for limiting regulation that impedes innovation bode well for a supplement industry, which is anxiously awaiting a guidance on New Dietary Ingredient (NDI) notifications.
Sports Beans Energizing Jelly Beans shouldn't claim to make athletes faster while appealing to their sweet tooth, says the National Advertising Division (NAD).