The U.S. Department of Health and Human Services’ (HHS’) Office of the Inspector General (OIG) recently issued two reports critical of the dietary supplement industry. Titled Dietary Supplements: Structure/Function Claims Fail to Meet Federal Requirements, the first report sought to determine whether manufacturers could support claims describing “the role of a dietary supplement in the structure or function of human bodies.” To this end, OIG apparently assessed structure/function claims “for a purposive sample of 127 dietary supplements marketed for weight loss or immune system support” to establish their compliance with Food and Drug Administration (FDA) regulations. The department also reviewed the documents used to substantiate these claims as well the manufacturers’ notification letters.
OIG reportedly found that substantiation documents for structure/function claims “were not consistent with FDA guidance,” as only 34 percent of the 1,624 documents reviewed were based on human studies and “none met all of FDA’s recommendations for competent and reliable evidence.” The report further noted that 56 percent of these substantiation documents “would be considered background information according to FDA guidance” and thus are not sufficient to support structure/function claims. In addition, 7 percent of the supplements allegedly lacked the required disclaimer indicating that FDA did not evaluate the product’s claims, while 20 percent featured prohibited claims purporting to treat diseases, “such as influenza, the common cold, herpes, and HIV,” reduce cholesterol or prevent diabetes.
“These results raise questions about the extent to which structure/function claims are truthful and not misleading,” concluded OIG, which urged FDA to seek “explicit statutory authority to review substantiation for structure/function claims to determine whether they are truthful and not misleading.” The Inspector General further recommended revamping the notification system for these claims “to make it more organized, complete, and accurate,” and expanding market surveillance “to enforce the use of disclaimers for structure/function claims and to detect disease claims.”
Meanwhile, the second report focused on the ability of FDA to contact dietary supplement companies in an emergency. Using the same data set for 127 weight loss and immune support supplements, OIG found that 20 percent of labels did not provide the required telephone numbers or addresses for reporting adverse events. The Inspector General also compared the contact information that manufacturers provided to FDA upon registration with “information obtained during structured interviews with company representatives.” The results apparently revealed that 28 percent of contacted companies “had facilities that failed to register with FDA as required.” Of those companies with registered facilities, 72 percent allegedly did not give complete and accurate information.
OIG has thus called on FDA to (i) “improve the accuracy of information in the registry,” (ii) “seek authority to impose civil monetary penalties on companies that do not comply with registration requirements,” and (iii) “educate the dietary supplement industry about registration and labeling requirements.” FDA has apparently concurred with these three recommendations and agreed to improve its adverse event notification system and market surveillance in accordance with the first report’s conclusions. The agency also indicated that it would consider OIG’s request to seek explicit statutory authority to assess the documents provided in support of structure/function claims.