“Overall, substantiation documents for the sampled supplements were inconsistent with FDA guidance on competent and reliable scientific evidence,” the agency stated in a press release. “FDA could not readily determine whether manufacturers had submitted the required notification for their claims. Seven percent of the supplements lacked the required disclaimer, and 20% included prohibited disease claims on their labels. These results raise questions about the extent to which structure/function claims are truthful and not misleading.
“We recommend that FDA seek explicit statutory authority to review substantiation for structure/function claims to determine whether they are truthful and not misleading,” the press release continued. “We recommend that FDA improve the notification system for these claims to make it more organized, complete, and accurate. We also recommend that FDA expand market surveillance to enforce the use of disclaimers for structure/function claims and to detect disease claims. In its comments on the draft report, FDA did not explicitly concur with our first recommendation, but said it would consider it. FDA concurred with our second and third recommendations.”
Following are responses from the supplement industry.
Council for Responsible Nutrition – Steve Mister, president and CEO:
“We are disappointed that despite the fact that the large majority of dietary supplement companies in this industry are holding up their end of the bargain with consumers, there are still some companies that are not meeting their obligations under the law. Further, we are concerned by FDA’s apparent lack of enforcement against problems that are easily visible and clearly illegal. Both the industry and FDA should do better on behalf of the more than 150 million Americans who take dietary supplements.”
CRN said consumers need to be aware that dietary supplements cannot be sold with labels that specifically promise to treat, cure, prevent or mitigate a disease, to which Mr. Mister added, “We hope that FDA will take immediate action against these companies whose mislabeling makes those products adulterated under the law.”
CRN said it was “also dismayed at the lack of supporting science provided by some of the companies whose products were reviewed—one even using a handwritten college term paper to support its structure/function claims. Companies selling legitimate products need to have in their possession reputable scientific literature to support claims, and we believe our member companies do. Handwritten papers, your own advertisements, or your mother’s blessing just don’t cut it. What is acceptable for structure/function claims under the government’s regulations is a variety of credible evidence including results from animal, observational, and randomized clinical trials.”
CRN also stated that the IOG report is not a representative sample of the industry’s products.
National Products Association – John Shaw, executive director and CEO:
“More than half of all Americans take dietary supplements safely and effectively as part of a healthy lifestyle. The Office of Inspector General reviewed just 127 supplements out of an estimated 29,000 products on the market. This small sample of supplements shouldn’t smear the entire industry. The report itself says they do not intend for the results to be generalized to all dietary supplements.
“Nevertheless, this report puts supplement makers on further notice about their responsibilities under the law. The Natural Products Association is concerned any time a violation may be found with a supplement label and it’s an issue we take seriously. Supplement makers must be sure to register their facilities with the FDA, include a phone number or address for adverse event reports, keep substantiation on file for any structure/function claims, notify the FDA before marketing their products, and not make disease claims.
“It’s important to emphasize that dietary supplements are part of a fully-regulated industry. NPA has been steadfast in supporting increased resources for the FDA. We agree with the OIG that the FDA should streamline the notification process and expand market surveillance, and we encourage the FDA to take swift and appropriate action against those who have shown a blatant disregard for the law.”