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Oversight of Supplements

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March 19, 2019

News From the Food and Drug Administration

The FDA recently announced plans to modernize and reform the regulation of dietary supplements, which are taken regularly by 3 of every 4 adults in the United States, according to the agency.

Since Congress passed the Dietary Supplement Health and Education Act (DSHEA) 25 years ago, dietary supplements have grown from a $4 billion to $40 billion industry. Along with this growth come concerns about the marketing of potentially dangerous, adulterated, or misbranded products with unproven health benefits.

To balance consumer access to supplements with protection from unsafe products, the agency plans to find new ways to quickly inform the public about potential harm from ingredients in dietary supplements. Other steps include “ensuring that [the FDA’s] regulatory framework is flexible enough to adequately evaluate product safety while also promoting innovation, continuing to work closely with our industry partners, developing new enforcement strategies and continuing to engage in a public dialogue to get valuable feedback from dietary supplement stakeholders,” FDA Commissioner Scott Gottlieb, MD, said in the announcement.

As part of these efforts, the agency sent 12 warning letters to companies illegally marketing dietary supplements with unproven claims of preventing, treating, or curing Alzheimer disease, among other health conditions.

Over the upcoming months, the FDA plans to roll-out additional details about these strategic plans and engage the public in dialogue regarding whether additional steps are needed to modernize DSHEA.

read more at Jama