Terranea Resort - Site of CRN Conference

I just returned from the annual Conference of the Council for Responsible Nutrition at the Terranea Resort in Racho Palos Verdes, California.  Speakers on the agenda included a variety of supplement industry heavyweights and important government regulators.

I will be blogging about several of the presentations including speeches by Joshua Sharfstein, Principal Deputy Commissioner of FDA, and David Vladek, Director of the FTC Bureau of Consumer Protection.

I will also be providing my reflections on several CRN panel discussions focusing on a range of subjects including the 15th Anniversary of DSHEA, CRN programs like “Life…supplemented“, and other supplement insider events.

This was my second year attending The CRN Conference and it continues to impress me as an excellent event.  I made several new connections, and some are reading this blog for the first time so welcome!

• None Found

When it comes to dietary supplements, it’s like the Wild West, and the bad guys know they don’t have to take the sheriff seriously.

Industry and consumer voices are split in their interpretations of a GAO report on how the FDA should regulate dietary supplements. All sides agree that the FDA needs more resources, but they are divided on how best to ensure public safety. The Booster Shots blog run by the Los Angeles Times highlighted these conclusions from the report:

• Some companies that make herbal products are not required to identify themselves as dietary supplement companies.
• Manufacturers are required to report only serious adverse events.
• The FDA has few resources for oversight.
• The FDA lacks the power to remove a product from the market.

The Council for Responsible Nutrition, which represents dietary supplement manufacturers and ingredient suppliers, agreed with parts of the report, saying in a press release that the FDA needs additional resources.  But the trade group said, “We strongly believe, however, that these resources — including agency staff time and funding — should be focused on enforcing the current laws and regulations.”

The Natural Products Association disagreed with the GAO report on several counts. Association CEO David Seckman said in a press release that the FDA:

• Has a great deal of information about individual dietary supplement products and their manufacturers.
• Has sufficient power to remove products from the marketplace.
• Should receive reports only on serious adverse events, not all events.

On the other side, the Center for Science in the Public Interest, interpreted the report as showing the FDA could not effectively monitor the industry. Here’s what CSPI legal affairs director Bruce Silverglade said, “When it comes to dietary supplements, it’s like the Wild West, and the bad guys know they don’t have to take the sheriff seriously. … The supplement industry operates in a gray area where the loopholes loom larger than the law. Congress should close those loopholes by requiring that ingredients be reviewed for safety and effectiveness and that cautionary information appear on product labels.”

There are broad divides on several issues:

• The GAO report calls for reporting all adverse events, but the CRN and NPA want the current rules on reporting just serious events.
• The CSPI wants tighter limits on labeling and claims. The industry groups say that rules are sufficient.

The NPA and CSPI do agree on having the FDA clarify when it thinks products such as teas and energy drinks should be marketed as conventional foods and when they should be listed as dietary supplements.

What’s next? In the CSPI release, Rep. Henry A. Waxman, D-Calif., who was one of the House members who commissioned the report, lamented the lack of resources at the FDA. But he didn’t call for boosting the agency’s budget. And that leaves industry and the federal regulator where they were before.

• None Found

CRN describes the basic crux of the initiative as follows:

Through a series of multi-year grants from CRN, the new initiative will allow NAD to hire an additional attorney who will focus solely on this product category. The initiative is anticipated to address not only comparative advertising claims among makers of dietary supplements, but also substantive claims that are deceptive or misleading and clearly go beyond what’s supported by research and allowed by law–claims that feed the public’s distrust of the supplement industry.

• None Found