Sharfstein Says Still Work to Be Done

RANCHO PALOS VEDES, Calif.At the Council for Responsible Nutrition (CRN) Annual Symposium for the Dietary Supplement Industry, Joshua Sharfstein, principal deputy commissioner at FDA, told the industry that there is still work to be done relative to dietary supplement safety and regulation.

While he noted FDA and the supplement industry has worked together in recent years to bring new regulation such as mandatory serious adverse event reporting (SAER) and good manufacturing practices (GMPs), he said there are still products on the market that pose serious risks to consumers. One of FDAs biggest concerns is the problem of dietary supplements spiked with potentially dangerous pharmaceuticals, he told the crowd, before immediately making an example of steroids in sports supplements. The steroid problem is the most high profile safety issue facing the nations supplement supply. He also referenced recent Senate hearing  testimony from Travis Tygart, USADA, as well as former college athlete Jareem Gunter, who suffered grave liver failure after taking a supposed supplement and who was also present at the hearing on steroid in bodybuilding products.

Sharfstein said that companies must follow and FDA must enforce the existing law. we have committed substantial resources to finding illegal products and taking action. Recently, after an extensive investigation, FDA executed a criminal search warrant and issued a warning letter against American Cellular Laboratories. FDA also recently executed a criminal search warrant at Bodybuilding.com and seized over 60 dietary supplements containing steroids. In 2008, FDA acted to seize $1.3 million in illegal synthetic steroids supplements.

He said FDA plans to continue this line of enforcement, but it is not enough. On the suggestion from American Herbal Products Association (AHPA) FDA should use the same approach it does with fraudulent swine flu (h1N1) products, he said said the agency cannot apply the same action to these two different problems. For H1N1 fraud, FDA can act against products as soon as we identify unlawful claims related to H1N1, he noted, adding FDA has halted the distribution of 120 such products. For many claims that appear on dietary supplements containing steroids, however, we usually cannot take action based on these claims alone. The claim of enhancing muscle bulk is not necessarily ground for action, because we may not have evidence that the claim is false or misleading. As a result, to take action, we must often demonstrate that steroid ingredients are present in these supplements.

In the mean time, he suggested new tools and approaches are the answer to the greater regulatory dilemma. This includes developing all the tools DSHEA gives us for improving the safety and quality of dietary supplements. Here, Sharfstein conceded more needs to be done with FDAs authority under new dietary ingredient (NDI) rules, requiring 75-day pre-market notification of any NDI. However, he argued the agencys efforts in this area have been hampered for lack of receiving a list of grandfathered ingredients, which would not be subject to NDI rules. HE suggested FDA work with industry to create a verified list of grandfathered ingredients. He added industry adherence and cooperation on GMPS and SAERs will be crucial to ensuring dietary supplement safety and quality.

Then he did what so many in the crowd wanted to see and hear; he called adulteration a crime. There are criminals out there who will dilute your ingredients with dangerous additivesfrom melamine to diethylene glycol to lead and arsenic, he said. Because you are ultimately responsible for the product you put on the market and its impact on consumers, every company in the supplement industry should be responsible for where you are purchasing their ingredients. When you find problems, you should notify the FDA, so we can take action to prevent these ingredients from being sold by other companies in your industry.

Read Sharfstein's full remarks at the FDA Web site.