AHPA’s McGuffin: We already have a working label database so why we would shift that to a mandatory system under the FDA?

By Stephen Daniells

- Last updated on GMT

Related tags Herbal products Dietary supplement

Proposals to introduce a mandatory pre-market registration of products with the FDA have received a lot of discussion in industry circles, but a voluntary system already exists and is functioning well, says Michael McGuffin, President of the American Herbal Products Association.

Speaking with NutraIngredients-USA at SupplySide West 2015, McGuffin told us: “AHPA took a position in the last year to recommend our members submit their labels to the already existing Dietary Supplement Label Database​ that was created through a joint effort by the Office of Dietary Supplements and the National Library of Medicine. We think that accomplishes the same thing as the product registration.

“They estimate that about 15,000 supplements are already listed in that database, and we’re encouraging the further development of that. I don’t know why we would shift that to a mandatory system under the FDA when we already have a program that is working well.”

While disagreement does exist about how or when to amend the existing regulations, McGuffin stressed that the  industry is not opposed to changes, and does have a long history of pushing for changes to the existing laws. “The Proxmire Amendments to the Federal Food, Drug, and Cosmetic Act were largely due to the influence of industry trade groups and consumers,” ​he said. “We did this again in the early 1990s when the FDA was proposing to regulate herbal products as food additives. We didn’t think that was going to make sense, and it would disrupt consumer access to herbal products. That was only one of the pieces, but it lead to the passage of the DSHEA amendment to the Food, Drug, and Cosmetic Act.

“In 2003, we thought – and AHPA in particular – that it was important that we change the law again to establish a requirement for submission of serious adverse event reports to the FDA. It took about three years and we got that amendment to the Food, Drug, and Cosmetic Act. So, we’re always open to the discussion on whether something that’s not perfect, something that needs change.”

If the industry did accept changes to the regulations – if it is to ‘give’ on certain issues – what would it want in return?

“I think consumers need more information about supplements,”​ said McGuffin, “and right now the law in the US makes it unlawful for marketers of dietary supplements to tell the truth about their products even, if well-substantiated, if the truth is that the product will cure or treat or prevent a disease. You can get that information in Canada, in Australia, in Europe, but not in the United States.”

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