Highlights from Senate Hearing on Supplements

Today's hearing on seniors and supplements before the Senate Special Committee on Aging started out looking like a big slap to the supplement industry, but in the end some good stuff may come of it. In particular, I thought CRN's Steve Mister did a great job representing the industry, Sen. Orrin Hatch (R-Utah) did a great job keeping the facts in focus, and FDA Deputy Commissioner Dr. Joshua Sharfstein presented a pretty balanced view. Click here to read the submitted testimony and opening comments, and to view the video recording of the hearing. Here are some observations if you missed the live webcast:

The GAO report that was presented clearly stated that while supplements it tested were found to contain trace amounts of heavy metals and pesticides, these amounts were not of any health concern or risk. (Still, this seems to be the lead in many of the new stories on the hearing, showing a real bias by those journalists using this as the headline). It turns out that the levels are far lower than what is allowed and typically found in things like celery, dairy products, etc. The New York Times story on the GAO report yesterday had the headline "Study Finds Supplements Contain Contaminants". If the Times still had any tiny amount of credibility on supplement issues, it is gone now.

The GAO report also revealed audio recordings from a sting operation in which GAO employees posed as older consumers and asked questions of health food store workers in DC and Florida, finding that some made medical claims, recommendations and other inappropriate statements. This needs to be fixed, and the Natural Products Association announced a new program to work on that. Certainly there is no need to change the law, but some education of retail employees is clearly needed.

The GAO testimony also included 2 supplement products making illegal claims about cancer and stroke, but during the Q&A portion of the hearing, it was established that these products are illegal under current law, and that the products were from small, unknown companies and certainly not from large, established (or even small established) companies.

The committee asked Dr. Tod Cooperman of consumerlab.com several questions about its business model. Finally, Dr. Cooperman answered the question about whether the company reveals failing test results for companies that pay the company, stating that those results are the property of the company being tested. This has been a sticking point for industry for some time, and it was nice to finally her consumerlab answer the question. The thousands of consumers who pay for access to test results will likely be interested to learn that a company that fails a test but is a consumerlab customer gets to keep those test results from being shared with the consumers who are paying for the service. An odd model at best.

FDA's Dr. Sharfstein said that the agency needs to do more in enforcement (yes!), needs to release the much awaited New Dietary Ingredient guidance, and needs to focus on GMPs. He also said that the agency expects to conduct around 250 GMP inspections this year, and that he anticipates the NDI guidance will be out by the end of the year. Of course we heard the "by the end of the year" statement regarding the release of the final GMP regulation for several years, so don't hold your breath on that one just yet. I hope it's true though.

Our Steve Myers will be providing a more detailed report, but this should give you a taste of the hearing if you couldn't tune in.