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FDA Seeks to Clarify Dietary Supplement Rules

With about two-thirds of all Americans taking some sort of dietary supplement, the U.S. Food and Drug Administration (FDA) is seeking clarification on safety rules in effect for dietary supplements, and is issuing draft guidelines, said Reuters. The guidelines are in place for supplement makers, which must notify regulators about new ingredients used; the agency […]

With about two-thirds of all Americans taking some sort of dietary supplement, the U.S. Food and Drug Administration (FDA) is seeking clarification on safety rules in effect for <"https://www.yourlawyer.com/practice_areas/defective_drugs">dietary supplements, and is issuing draft guidelines, said Reuters.

The guidelines are in place for supplement makers, which must notify regulators about new ingredients used; the agency is currently seeking public comment on the document.

Reuters explained that the guidelines are meant to assist with firms’ compliance with the 1994 regulation of “new dietary ingredients in tablets, powders, liquids, and other supplements,” and mandates makers file a safety notification with the agency prior to marketing any dietary ingredient that was not on the market in 1994.

Since the law’s passage, the FDA said it only received about 700 such notifications, but believes over 55,000 dietary supplement products are being sold and marketed today, noted Reuters.

In January, a food safety reform law that had been passed was constructed with a mandate to the FDA that allowed the agency 6 months to issue the draft guidelines for filing notification for new dietary ingredients (NDI), as well as the evidence needed to prove product safety, said Reuters. The draft apparently responds to issues concerning, for instance, if NDI notification is required for ingredients that are considered a food and which are not marketed as a dietary ingredient, said Reuters, which noted that yes, notification is needed. The guidelines now include a template to help manufactures with the filing of these notices.

According to a prior Wall Street Journal report, Americans are taking dietary supplements such as, “vitamins, minerals, and herbal products,” said industry trade group, the Council for Responsible Nutrition. Supplements made from products available on the U.S. market prior to 1994 can be sold without agency review, including a wide variety currently available. Sellers of products containing substances unavailable prior to 1994, need only advise the FDA and do not require approval to be sold.

We previously wrote that Consumer Reports discussed its concern with the 1994 Dietary Supplement Health and Education Act (DSHEA), which it said is industry friendly and does not enable the FDA to regulate supplements as prescription medications. Of note, said Reuters at the time, the Federal Trade Commission (FCC) is the agency that regulates herbal supplement marketing, which includes a ban on claims of medical condition treatment.

“Supplements are marketed with very seductive and sometimes overblown sales pitches for increasing your performance in the bedroom, slimming down, or boosting your athletic prowess,” said Nancy Metcalf, senior program editor for Consumer Reports. “And consumers are easily lulled into believing that supplements can do no harm because they’re ‘natural’,” Metcalf noted, quoted Reuters previously.

To date, the FDA has only ever banned one supplement ingredient: ephedrine alkaloids.

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