Supplements are unregulated nostrums, says reputable journal

By Lorraine Heller

- Last updated on GMT

Related tags: Dietary supplements, Dietary supplement

An editorial published in a reputable journal states that dietary supplements are “nostrums” that are unregulated by FDA and make vague health claims to avoid the need for validation.

Published in The Journal of the Federation of American Societies for Experimental Biology (FASEB), ​the editorial has already invited a formal letter of complaint to the journal’s managing editor from a food and supplement lawyer.

The article’s author, Gerald Weissmann, writes: “Unfortunately, the $24bn/year ‘dietary supplement’ industry peddles subprime concoctions that can only be recalled after​ someone blows a whistle.”

He goes on to state that since 1994 FDA “has had no effective regulatory authority over dietary supplements, unless these nostrums cause harm or are doped with prescription drugs”.

StarCaps case study

The editorial, which implies that supplements found to be adulterated are purposefully made with “hidden ingredients”, ​uses the recent high-profile StarCaps recall as an example.

StarCaps, a brand of weight loss dietary supplements, was in the news at the end of last year, after professional football players who had taken the supplement tested positive to the diuretic, bumetanide.

This prompted the product’s marketer Balanced Health to conduct further testing and to ultimately issue a recall.

“Omission of bumetanide isn’t the only flaw in the description of the capsules. StarCaps ads also failed to note that papain is an effective protease that can be absorbed topically, that valerian has proven soporific effects in humans, and that the magnesium salts contained in the capsule affect the gut,”​ wrote Weissmann.

DSHEA criticized

The editorial goes on to criticize the Dietary Supplement Health and Education Act (DSHEA), which was passed in 1994 to provide a distinct regulatory framework for dietary supplements.

Weissman states that DSHEA allows manufacturers to describe a supplement’s effects on the structure or function of the body without substantial scientific proof, and without being required to carry drug-style warning labels.

In addition, nutritional support statements made on supplement products to not need to be pre-approved by FDA, he wrote.

“That’s why you see so many claims for supplements that promote ‘joint health’, ‘breast health’, or ‘male vigor’ rather than more precise claims that would have to be validated by the FDA in following ethical pharmaceuticals.”

Response

However, according to food and supplement lawyer Marc Ullman, partner at Ullman Shapiro & Ullman, Weissman’s comments relating to DSHEA “demonstrate an utter lack of understanding of the Federal Food, Drug and Cosmetic Act (FDCA)”.

“Dietary supplements are rigorously regulated by the FDA. Since 1939, the FDCA has prohibited the marketing of any food, drug, device, or cosmetic that is adulterated or misbranded,”​ he wrote yesterday in a letter to the FASEB managing editor.

FDCA provides that a product is misbranded if its labeling is “false or misleading in any particular”.

“Among other things, a product is considered adulterated if it contains any ingredient that is harmful to human health or is manufactured under unsanitary conditions,”​ he wrote.

Ullman, who acted as counsel to StarCaps marketer Balanced Health Prodcuts, also said the editorial’s portrayal of the StarCaps recall is inaccurate and misleading in its attempt to “depict Balanced Health as an outlaw company”.

Source:The Atlanta Falcon and Tono-Bungay:​ Dietary Supplements as Subprime Drugs​The FASEB Journal. 2009;23:1279-1282Gerald Weissmann, Editor-in-Chief

To access the editorial, click here​.

Related topics: Regulation, GMPs, QA & QC

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