On October 2, 2012 the Office of the Inspector General issued a study entitled: “Dietary Supplements: Structure/Function Claims Fail to Meet Federal Requirement
” (Study) and a report entitled “Dietary Supplements: Companies May Be Difficult To Locate in an Emergency
was part of the Department of Health and Human Services OIG Work Plan for 2012 and addresses concerns raised by the General Accounting Office and public interest groups over “structure/function claims” on dietary supplement labels. FDA had been “urged …to strengthen oversight of these claims because they are potentially misleading and may lack scientific support.” The Food Drug and Cosmetic Act (FDCA) grants FDA authority to pre review labels for drug and medical device products, but FDA lacks authority to pre review or approve claims for food and dietary supplements before products enter the market. While manufacturers are required to have “substantiation” (i.e. competent and reliable scientific evidence) to support claims, this support is not required to be submitted to FDA. The concern that “structure and function” claims raise for the FDA is that such products are often “intended to diagnose, treat, cure, or prevent any disease.” Such claims render the products “drugs” under the FDCA and drugs require pre approval, significant scientific support and FDA approved labeling.
The OIG reviewed a sample of dietary supplement labels “marketed for weight loss or immune system support…to determine the extent to which they complied with FDA regulations.” They further reviewed the “substantiation” for the claims as well as the reporting to FDA by the manufacturers for the claims. The OIG concluded that labeling was “inconsistent with FDA guidance on competent and reliable scientific evidence,” many labels lacked disclaimers, and 20 percent included “drug” claims. While the implication in the Study is that as much as 20 percent of marketed products violate the Act, it is not at all clear the extent to which the labels studied are representative of products purchased.
OIG made a number of significant recommendations including that “FDA seek explicit statutory authority to review substantiation for structure/function claims to determine whether they are truthful and not misleading” and that FDA improve its oversight and enforcement over such claims. FDA has agreed with the recommendation to improve oversight and enforcement and is considering the recommendation for more power regarding labeling.
Accompanying the OIG study is a report entitled “Dietary Supplements: Companies May Be Difficult To Locate in an Emergency
.” This report notes that a significant number of companies failed to register with FDA as required under the FDCA and 20% failed to provide contact information, required under the FDCA. Among the recommendations agreed to by FDA is a request for statutory authority to impose civil monetary penalties on companies that fail to comply.
These reports represent a significant step toward significantly increasing FDA’s enforcement power and the regulation of food products that are used by an estimated 80% of adults in a $20 billion dollar industry for products that supplement diets. It also represents a further warning that FDA is seeking new powers to punish those manufacturers who fail to comply with labeling requirements. Increasingly, knowledge of the rules and compliance should be the number one agenda item for all manufacturers and marketers of dietary supplements.