FDA says new ingredient premarket verification is a priority

Joshua Sharfstein, MD, FDA principle deputy commissioner, has two lists in his office—one for top priorities regarding quality and safety issued in the dietary supplement industry and another for less urgent needs. Sharfstein says the latter list is blank. At the Council for Responsible Nutrition's Annual Dietary Supplement Conference in Rancho Palos Verdes in Calif, Sharfstein spoke in place of Dr. Margaret Hamburg, FDA commissioner, who had to testify before the Food Safety Hearing today.

At the top of his list of priorities is tightening up policies and practices for new ingredient premarket notification. Sharfstein believes strongly that if ingredients are properly identified as either new (NDI) or established (grandfathered) then FDA will have an adequate opportunity to oversee new ingredient introductions.

The caveat, Sharfstein admitted is that FDA has yet to offer any frame of reference for such a list. The Council for Responsible Nutrition and the American Herbal Products Association earlier attempts to provide a list of grandfathered ingredients was met with skepticism by FDA in past years. Sharfstein said this is one aspect that FDA must address, which may require collaboration between the agency and the industry.

Sharfstein emphasized that FDA and the industry are working closely on quality, enforcement and problem solving. He thanked organizations such as CRN, as a vital player in solving quality control problems and defining best practices to overcome problems of product adulteration and product spiking.

He outlined priorities for FDA and the dietary supplement industry:

  • FDA must take action and enforce existing laws. Sharfstein emphasized said there is no FDA plan or strategy in place to get rid of DSHEA, but that changes may be in order. Sharfstein agreed that DSHEA gives the agency a lot of tools to work that still haven't been fully utilized, but even so DSHEA in its current form may not be enough to overcome the current problems within the industry. "The world has changed since DSHEA," he said, citing examples of multiple forms of the same single ingredient and multiple formulations for the same brand particularly for supplements for weight loss and erectile dysfunction.
  • GMPand quality control— FDA needs a stronger authority and collaboration to strengthen oversight in foreign companies, but this will not come by FDA overseeing everything. The agency needs to work more closely with our allies to collaborate and encourage technical support other countries and government agencies that have established standards and oversight. "This is an issue that keeps Dr. Hamburg up at night," Sharfstein said.
  • Post market surveillance and serious adverse events—Sharfstein would like to see the industry take a more aggressive role in reporting problems with products that are adulterated, deceptive or pose a risk. "Everybody has to feel like this is their job," Sharfstein said." He encouraged the ethical players in the industry to notify FDA when problems are discovered. If one sees a problem, dietary supplement industry companies should report it, just as a food company does so for food safety issues as defined within the Reportable Food Registry. Food companies are obligated to do so, but the supplement industry could do the same by voluntarily reporting problems.

Editor's Note: Sharfstein's comments today were well received by the audience at the CRN conference. He is a firm believer in dietary supplements, especially since lactase dietary supplements allowed him to put ice cream back on his menu after many years of avoiding dairy products. In all the impression that I noted from this tone is there are serious problems to address such as adulteration and spiking, but that in the coming year, as GMPs move toward smaller, outlier companies, that many of the bad players will finally be identified through enforcement actions and/or mandatory GMP compliance issues. The audience questions were specific to recent enforcement actions surrounding hydroxycut, adverse event reports and upcoming legislation on food safety bills in the House and Senate.

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