Earlier this month, the Department of Health and Human Services Office of the Inspector General (“HHS Inspector General”) issued a report which found that many of the dietary supplements it reviewed failed to substantiate their structure/function claims.  The office reached these conclusions after studying 127 dietary supplements marketed for weight loss or immune system support.

Background

The major findings include these: (1) none of the manufacturers who submitted human studies (557/1624 substantiation documents) met all four of FDA’s recommendations for competent and reliable evidence; (2) FDA could not determine to what extent manufacturers had complied with the structure/function claim notification procedures; (3) 7% of the supplements studied were missing the required structure/function disclaimer; and (4) 20% of the supplements had prohibited disease claims on the label.

In response to these findings, the HHS Inspector General recommended that FDA: (1) seek explicit statutory authority to review structure/function claims; (2) improve its structure/function notification process; and (3) expand market surveillance to ensure that dietary supplement companies are making the required disclaimer in their structure/function claims and simultaneously not making disease-related claims.

Click here for the full report.

What the Report Means for Your Business

This report shows the heightened attention dietary supplements are receiving in the regulatory world, and specifically the potential for FDA to devote more resources to monitor the supplement industry.  Before going to market with a dietary supplement, it is as important as ever to make sure that you have sufficient studies to substantiate your claims.  In addition, it is just as important to comply with FDA’s pre-market structure/function claim reporting requirements.  This study was based on a random sample of 100+ dietary supplements whose unsubstantiated claims only brought more negative attention to the dietary supplement community.  There is force in numbers — if we as an industry work together to comply with the current regulations, we will change FDA’s and HHS Inspector General’s opinions about the future of the supplement industry.

As always, if you are in need of legal counsel when it comes to how to ensure that you are best complying with all current, and reasonably anticipated future, regulations in the nutritional supplement industry, call us anytime at 516-294-0300.