Adding to the evidence that dietary supplements require greater regulation by the FDA, the OIG just released a report on a study of label claims for two common classes of dietary supplements. The study examined label claims for 127 weight loss and immune support products found either in retail stores or advertised on the internet. Evaluation of the claims analyzed whether they were restricted to structure-function claims, which are allowed on dietary supplements, or if they included disease claims, which are prohibited. The OIG also evaluated whether manufacturers had notified the FDA of the label claims, and whether the label claims matched those in the notification letters. Manufacturers of the supplements were also contacted and the substantiations for the label claims were requested. Substantiations submitted by the manufacturers were evaluated with regard to the extent to which they met the FDA recommendations for the amount, type, and quality of evidence considered to be competent and reliable.
Highlights of the OIG’s report included observations that submitted clinical studies did not meet FDA recommendations for competent and reliable evidence, and much of the evidence provided by manufacturers could be considered only as indirect evidence of efficacy or as nonsupportive of the label claims. Also notable was that FDA had difficulty locating notification letters from the manufacturers to the FDA, and of those that were able to be located, most submitted to the FDA were incomplete. Though it was found that only a small percentage of labels failed to include the required structure-function disclaimer, 20% of the supplement labels examined included prohibited disease claims on labels.
Recommendations by the OIG include the following:
- FDA seek statutory authority to review structure-function claims to assure that they are truthful and not misleading;
- FDA improve its notification tracking system to make it more organized, complete, and accurate; and
- FDA expand its surveillance of the market to ensure that appropriate claim disclaimers appear on labeling and disease claims are removed.
It is reasonable to expect that this report will be used by those in Congress and by public interest groups to push for tightening regulation and enforcement of the dietary supplement industry.
Posted by Carrie Rabe, Senior Consultant. For more information, please contact Carrie at email@example.com.