What the FDA's actions mean for dietary supplements

Cornelia Mascio
Febbraio 12, 2019

The U.S. Food and Drug Administration announced a crackdown Monday on dietary supplements. In recent months, the agency has also gone after a number of other products, including male enhancement supplements and those claiming to treat opioid addiction.

Supplements are big business, as three out of four Americans consume some type of dietary supplement, such as a daily vitamin or herbal supplement, as part of their regular routine. Yet despite their widespread use, the multibillion-dollar supplement industry has long operated with little federal supervision. He said dietary supplements are regulated like foods because they pose less of a risk than drugs.

In the US, dietary supplements are considered to be food products.

The dietary supplements industry group, the Council for Responsible Nutrition, said it looked forward to working with the FDA, and praised Gottlieb for "rooting out bad actors".

"As the popularity of supplements has grown, so have the number of entities marketing potentially unsafe products or making unproven or misleading claims about the health benefits they may deliver", Gottlieb added.

Q: Does the FDA plan to change that rule? The industry has swelled with 10s of thousands of products collectively worth more than $40 billion, he added.

The FDA's improved oversight plan includes the development of a new "rapid-response tool" that would warn consumers to avoid purchasing potentially unsafe products, Gottlieb explained. Supplement makers are required to alert the FDA of any ingredients in their products that weren't sold in the USA before 1994.

"As the popularity of supplements has grown, so have the number of entities marketing potentially risky products or making unproven or misleading claims about the health benefits they may deliver", Gottlieb said.

In a statement announcing the FDA's action, Commissioner Scott Gottlieb said 12 warning letters, and five advisory letters had been sent to supplement companies whose products "are being illegally marketed as unapproved new drugs" because they claim to "prevent, treat or cure Alzheimer's disease, as well as health conditions like diabetes and cancer".

A study published in October found that almost 800 dietary supplements sold over the counter from 2007 through 2016 contained unapproved drug ingredients, based on an analysis of FDA data. The agency said these claims can cause real harm when people forgo approved treatments that have been proven safe and effective. The companies have 15 days from the receipt of the letters to tell the regulator how they will correct the violations.

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