The Department of Health & Human Services (HHS) Office of Inspector General (OIG) has released two reports examining regulation of the dietary supplement industry, Dietary Supplements: Companies May Be Difficult to Locate in an Emergency, and Dietary Supplements: Structure/Function Claims Fail to Meet Federal Requirements. Dietary supplement manufacturers should carefully review the reports because the reports include recommendations that, if adopted, would significantly change the way FDA regulates dietary supplements. OIG recommends that FDA:
- Seek statutory authority to impose civil penalties for non-compliance with facility registration requirements,
- Seek statutory authority to require pre-market approval for structure/function claims,
- Revise the way FDA maintains records of notification letters for new marketing claims,
- Expand market surveillance of dietary supplements, and
- Educate the industry about facility registration requirements
Evaluation of Facility Registration Compliance
The report on dietary supplement manufacturer compliance with registration requirements is a follow-up to OIG’s 2009 report on FDA’s food facility registry. OIG found higher rates of non-compliance among dietary supplement manufacturers than it did among conventional food manufacturers (28% vs 7% respectively), however, differences in methodology between the two studies could account for the difference. For example, all samples for the food facility registry study were collected from retail stores, whereas samples for the dietary supplement study were collected from both retail stores and internet websites. Smaller manufacturers with fewer resources for compliance monitoring are more likely to be found on the internet.
OIG’s recommended changes to the dietary supplement facility registration requirements are consistent with the ones from the Food Facility Registry report: improve accuracy of information in the registry, seek statutory authority to impose civil monetary penalties for non-compliance, and educate the industry about registration requirements. In comments on the report, FDA agreed with OIG’s recommendations but noted that Congress was unlikely to grant authority to impose civil penalties for registration violations. Such authority was included in the House version of FSMA, but did not make it into the law passed in 2011.
Evaluation of Structure/Function Claims
OIG noted in its Work Plan for fiscal 2012 that it would evaluate dietary supplement compliance with federal requirements for structure/function claims. OIG found that substantiation documents submitted by manufacturers were not consistent with FDA guidance. Most notably, OIG found that the human studies reviewed did not appear to represent the totality of the evidence. To support this claim, OIG references statements by staff members at the National Center for Complementary and Alternative Medicine at the National Institutes of Health indicating that “a large body of science exists that contradicts existing structure/function claims.” However, OIG did not identify any specific studies contradicting the structure/function claims evaluated for this report.
In addition, OIG identified failures with FDA’s monitoring of notification letters. Under FDCA, dietary supplement manufacturers are required to notify FDA of certain structure/function claims within 30 days of the first use of the claim. However, FDA does not maintain its records of the notification letters in a manner that is readily searchable, or that would enable FDA to monitor compliance with the 30-day notification requirement.
Based on its findings, OIG recommends that FDA seek statutory authority for pre-market review of structure/function claims, improve its notification system, and expand market surveillance of dietary supplements. In comments, FDA agreed with OIG’s second and third recommendations, but not the first. OIG has asked for further clarification of FDA’s plans for seeking statutory authority for pre-market review of substantiation.