FDA Steps Up Efforts to Regulate Dietary Supplements

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Three out of four U.S. consumers regularly take dietary supplements, according to the U.S. Food and Drug Administration (FDA), and the agency has just announced the most significant change in dietary supplement regulation since the enactment of the Dietary Supplement Health and Education Act (DSHEA) more than 25 years ago.

Prior to the DSHEA, supplements were a $4 billion industry made up of about 4,000 products. Now, there are upwards of 80,000 products and business worth more than $40 billion a year. In a statement, FDA Commissioner Scott Gottlieb, M.D., acknowledged the role of dietary supplements in health and the responsibility of the FDA to provide consumers with safe supplements that meet the agency’s high-quality standards.

Here are some of the regulatory steps the FDA plans to take:

  • Let the public know as soon as possible when concerns about a dietary supplement arise
  • Ensure that the regulatory system is flexible enough to provide safe products while promoting innovation
  • Work closely with supplement manufacturers to ensure safety
  • Engage in a dialogue with the public to obtain valuable feedback

To add strength to the regulatory approach, the FDA sent out 17 notices to "foreign and domestic companies that are illegally selling more than 58 products, many that are sold as dietary supplements, which are unapproved new drugs and/or misbranded drugs that claim to prevent, treat or cure Alzheimer’s disease and a number of other serious diseases and health conditions."

If you have a question or concern about supplements, you can report them on the FDA’s MedWatch page.

Sourced from: FDA