OTC/Supplement Combo Guidance, Sale Urged By Rep. Burton
This article was originally published in The Tan Sheet
Executive Summary
House Government Reform Committee Chair Dan Burton (R-Ind.) is pressing FDA to explain its intentions regarding OTC drug/dietary supplement combination products
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House Government Reform Committee Chair Dan Burton (R-Ind.) is pressing FDA to explain its intentions regarding OTC drug/dietary supplement combination products. In a Jan. 22 letter to the agency, Burton asks whether FDA is developing a guidance on OTC/supplement combos and, if so, when it will be released. If FDA does not plan to issue an official position, Burton requests that the agency "explain why not." The letter asks FDA to clarify its position regarding: combos "sold as two separate dosage forms in a single packet"; conditions under which a combo "may be sold as a single dosage"; and the "safety and labeling guidelines companies should follow in attempting to place combination products on the market." FDA has said a formal guidance is "unlikely," contending its enforcement actions speak for themselves (1 (Also see "OTC/Dietary Supplement Combination Guidance “Unlikely” – FDA" - Pink Sheet, 5 Nov, 2001.), p. 6). The agency sent warning letters in October to Omni Nutraceuticals and B.F. Ascher, marketers of products combining acetaminophen and at least one supplement ingredient (2 (Also see "OTC/Dietary Supplement Combos Cited In FDA Warning Letters" - Pink Sheet, 22 Oct, 2001.), p. 3). FDA believes the Dietary Supplement Health & Education Act does not specify such combinations can be marketed, while industry reps have reached an opposite conclusion, saying DSHEA does not prohibit combination products (3 'The Tan Sheet' Dec. 10, 2001, In Brief). The National Nutritional Foods Association has been urging FDA to provide industry with a guidance since August 2000 (4 (Also see "OTC/Supplement Combination Marketing Guidance Requested By NNFA" - Pink Sheet, 4 Sep, 2000.), p. 14). Burton suggests "this is a new consumer niche in which both large pharmaceutical companies and small specialty product companies may want to capitalize." The Indiana Republican also pressures FDA to clarify whether red yeast rice products not carrying disease claims would be eligible for marketing in the U.S. Pointing to FDA's legal victory over Cholestin marketer Pharmanex, Burton asks: "Isn't it true that the court's decision leaves within FDA the discretion to permit red yeast rice products to be sold as dietary supplements with structure/function claims relating to cholesterol maintenance benefits?" The letter also demands to know when supplement GMPs will be published, admonishing FDA for the delay. Burton requests a response by Jan. 31. |