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.

About 

Joel B. Rothman represents clients in intellectual property infringement litigation involving patents, trademarks, copyrights, trade secrets, defamation, trade libel, unfair competition, unfair and deceptive trade practices, and commercial matters. Joel’s litigation practice also includes significant focus on electronic discovery issues such as e-discovery management and motion practice relating to e-discovery.