Associations Respond to JAMA Article Critiquing Supplement Safety, Oversight

Industry associations have responded to an article published online in July in the Journal of the American Medical Association, which infers that regulatory oversight of the dietary supplements industry is lax.

Natural Products Association vice president of scientific and regulatory affairs, Cara Welch, PhD, released this statement:

“After reading Dietary Supplements-Regulatory Issues and Implications for Public Health, I’d like to address some of the concerns and misconceptions raised in the story.

First, dietary supplements are, in fact, safe and fully regulated under the Dietary Supplement Health and Education Act, or DSHEA. The Food and Drug Administration has all the authority it needs to regulate dietary supplements thanks to DSHEA. The FDA requires a pre-market safety notification process for any new dietary ingredient meant to be marketed in a supplement. In addition, structure-function claims or health claims about supplements must be submitted to the FDA with a copy of the product label. Claims that are not truthful and non-misleading can result in regulatory action from either the FDA or the Federal Trade Commission. The FDA also can remove products from store shelves that it deems to be a health risk.

Furthermore, the industry itself supports and has implemented strong self-regulatory mechanisms. Prior to the implementation by the FDA of Good Manufacturing Practices regulations, NPA launched its own GMP certification program in 1999, the first third-party GMP certification program for the manufacturing of dietary supplements and ingredients. We are proud to note that NPA’s GMP standard is based on and in some instances exceeds the FDA GMP rule. Nearly 70 companies have already achieved certification by meeting these rigorous standards.

Through the Natural Products Foundation Truth in Advertising program, the industry is working to ensure that consumers get accurate information with industry enforcement of supplement advertising standards. The industry also has backed legislative measures to help regulators do their jobs more effectively. Our industry has fought time and again for Congress and the administration to provide government agencies with additional resources they need to enforce the law. Within the past couple years, Congress provided a significant increase in funding, which led to a noticeable increase in enforcement. NPA welcomes increased enforcement and supports efforts to boost resources further.

With regards to the GAO report last year, immediately after it was presented to Congress, NPA announced an expanded effort to educate and train retailers and their staffs on what may and may not be said to customers. This included training programs at industry conferences, regular communications on this topic in NPA publications and on our website, and development of the “NPA Retailer’s Staff Education Toolkit.” All NPA members were sent a copy and it has been downloaded more than 2,500 times at www.npainfo.org/toolkit.

It’s worth noting that under existing regulations, and with strong self-regulatory efforts, the U.S. supplement industry has an excellent safety record. It’s little wonder that half of all Americans trust dietary supplements and use them as part of a healthy lifestyle. Consumers should rest assured that dietary supplements are both safe and well-regulated by the government.”