Former FDA deputy commissioner Joshua Sharfstein suggests requiring registration with FDA for each dietary supplement available in the US and establishing standard manufacturing and ingredient testing procedures.

Sharfstein, currently a dean at Johns Hopkins University Bloomberg School of Public Health, makes the recommendations in an article included with six others published by the journal Drug Testing and Analysis about problems in the US supplement industry. Writing with research colleague Akshay Kapoor, Sharfstein also suggests giving FDA stronger authority to deem supplement products violative and to more rapidly remove them from the market.

FDA’s policies and authorities framed by the Dietary Supplement Health and Education Act are “not the regulatory system for dietary supplements sold to the American public,” they say.

Noting that differences between the compliant supplement industry and public health advocates critical of FDA’s oversight preclude making changes within the current regulatory framework – particularly requiring pre-market approval – Sharfstein and Kapoor recommend that Congress pass legislation with changes that could satisfy both groups.

They say their approach would allow “policymakers to defer conflict over efficacy” of supplements “and instead embrace the goal of promoting access to safe dietary supplements.”

They suggest implementing the changes in three phases:

Require manufacturers to register each dietary supplement product with FDA and giving the agency greater authority to extend label disclaimers so “the public better understands the nature of the agency’s oversight.”
Establish standard manufacturing procedures for botanicals along with a standard laboratory technique to characterize each product to provide greater assurance of product identity, and strengthen surveillance of potential adverse effects with authority for “FDA to suspend sales during an agency review in a setting of sufficient concern.”
Grant FDA “special authority” to restrict uses of claims, such as sexual enhancement or weight loss products, common in products that “are overwhelmingly likely to pose a risk to the public.”

Sharfstein and Kapoor also note that resources for FDA’s supplement industry oversight are considered insufficient. “In the absence of additional appropriations, a user fee arrangement, similar to what exists for drugs and devices, would provide support for many more inspections than are possible today,” they say.

Sharfstein became FDA’s first principal deputy commissioner in 2009 and left the agency in 2011 to head Maryland’s public health programs before moving to Johns Hopkins in January 2015 Also see "John Taylor Temporarily Replaces Sharfstein As FDA's Second-In-Command" - Pink Sheet, 10 January, 2011..

At FDA he spearheaded efforts to remove spiked supplements from the market, but Sharfstein has not advocated requiring pre-market approval of supplements. However, he has showed interest in mandatory registration for supplements. At an industry conference in 2010, Sharfstein said imposing registration could help the agency more easily identify and remove spiked supplements and was a "reasonable" question FDA should consider Also see "Suggested Supplement Registry To Root Out Spiked Products Sparks Debate" - Pink Sheet, 18 October, 2010..

Sharfstein Suggests Requiring Supplements Registration, Testing Standards

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