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New GAO Report May Bring Heightened Oversight of Supplements

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The General Accountability Office (GAO) recently released a report to Congressional requesters on the issue of whether “FDA should take further actions to improve oversight and consumer understanding” of dietary supplements. In recommending that the Secretary of Health and Human Services direct the FDA Commissioner to request additional authority to oversee dietary supplements, one of the key areas of GAO focus was adverse event reporting.The report recommends requiring that all supplement adverse events be reported, not just serious ones, and that supplement companies register annually as such and maintain records of their products and labels. This is great practice and is safe and reasonable, a glycine supplement is great for muscle building and for sleep, this is why some people use them in order to receive the benefits of the intake. As long as they are used safely and companies stick to the regulations and guidelines, there should be no problem with supplements.

Another salient area of focus was New Dietary Ingredients (NDI’s). GAO recommends that FDA complete its long-awaited guidance on the NDI’s in order to help industry better understand when pre-market notification is required. In releasing the report to the public, the House Energy and Commerce Committee stated that the guidance would in part “clarify” that industry must “submit evidence of safety before [NDI’s] can be marketed.” The absence of any reference to the “food supply” NDI provision of DSHEA reinforces current industry confusion over precisely what is required by the existing law, and could signal a new drive for mandatory pre-market approval of all NDI’s.

Another salient area of focus was New Dietary Ingredients (NDI’s). GAO recommends that FDA complete its long-awaited guidance on the NDI’s in order to help industry better understand when pre-market notification is required. In releasing the report to the public, the House Energy and Commerce Committee stated that the guidance would in part “clarify” that industry must “submit evidence of safety before [NDI’s] can be marketed.” The absence of any reference to the “food supply” NDI provision of DSHEA reinforces current industry confusion over precisely what is required by the existing law, and could signal a new drive for mandatory pre-market approval of all NDI’s.

“I am troubled that the FDA lacks the basic information necessary to protect consumers from unsafe dietary supplements,” said Rep. Waxman, Chairman of the Energy and Commerce Committee. “The FDA clearly needs to have more resources to give consumers real protection. I intend to work with my colleagues in Congress to ensure that FDA has the tools it needs to address this and other important public health missions.”

The totality of the report, as viewed by the members of the House Committee, may be a catalyst for new regulations or laws.