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ABC paper promises to dispel ‘myth’ of unregulated supplements

By Elaine Watson , 07-Feb-2012
Last updated on 07-Feb-2012 at 15:22 GMT

Holly Bayne: 'FDA has all the legal authority it needs to protect public health and safety and remove unsafe or mislabeled products from the marketplace'
Holly Bayne: 'FDA has all the legal authority it needs to protect public health and safety and remove unsafe or mislabeled products from the marketplace'

A new paper published by the American Botanical Council (ABC) attempts to dispel the ‘puzzling’ and pervasive ‘myth’ that the US dietary supplements trade is unregulated.

’The Regulated Dietary Supplement Industry: Myths of an Unregulated Industry Dispelled,’ was penned by Dr William Soller, clinical professor of pharmacy at the University of California, San Francisco (UCSF); food law attorney Holly J. Bayne; and UCSF researcher Christopher Shaheen, and has been published online ahead of print in the ABC’s journal Herbalgram.

The article follows the publication of a high-profile ‘perspectives’ article by Harvard professor Dr Pieter Cohen in the New England Journal of Medicine calling for a pre-market approval system for dietary supplements and tougher rules on safety testing.

Cohen, who featured on a recent episode of the Dr Oz show on supplement spiking, said: "In my opinion, the current regulatory framework creates a facade of safety for all supplements -- this creates perverse incentives to introduce poor quality and even illegal products."

And while the law was "working quite well for vitamins and minerals", a pre-market approval system for botanical ingredients marketed with structure/function claims was needed, he said.

Critics still 'echo accusation that dietary supplements are unregulated'

However, the current regulatory framework already gives the government broad powers to crack down on unsafe products and misleading claims, argue the authors of the ABC paper, who provide a detailed analysis of the 1994 Dietary Supplement Health and Education Act (DSHEA), its new dietary ingredient (NDI) requirements, adverse event reporting (AER) rules, and cGMP (current good manufacturing practice) regulations.

They also provide examples of enforcement action taken by the Food and Drug Administration (FDA) on cGMPs and labeling and the Federal Trade Commission (FTC) on advertising.

They conclude: “Under DSHEA and subsequent amendments to the Food, Drug & Cosmetic Act (FDCA), FDA has broad statutory authority to regulate dietary supplements appropriately and those who manufacture, distribute, and sell them, and to take enforcement action against unsafe or mislabeled products and those who sell them to fulfill the agency’s mandate to protect and promote public health and safety.

“Nevertheless, critics still echo the accusation that dietary supplements are an unregulated industry. This is a myth.”

ABC: Many people are still confused about how trade is regulated

Herbalgram editor and ABC founder and executive director Mark Blumenthal, said that “17 years since the passage of the Dietary Supplement Health and Education Act (DSHEA), many people are still not clear about the extent of government regulation of herbal products and other dietary supplements.

“We trust that this article, once read, will help provide more clarity to this muddled area of significant concern to many stakeholders.”

FDA has all the legal authority it needs

Said Bayne: “It is puzzling that the myth of the unregulated dietary supplement industry has continued for so many years. FDA has all the legal authority it needs to protect public health and safety and remove unsafe or mislabeled products from the marketplace."

Dr. Soller added: “Any remnant of the myth that dietary supplements are an unregulated industry is easily dispelled by a close look at the agency’s activities over the past 15 years.”

Click here to read the ABC article.

Click here to read Dr Cohen’s article, which was published on January 25 at NEJM.org (10.1056/NEJMp1113325).

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