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Report (OEI-01-11-00211)

10-02-2012
Dietary Supplements: Companies May Be Difficult To Locate in
an Emergency

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Summary

WHY WE DID THIS STUDY

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 requires certain dietary supplement companies to register with FDA. Registration in the Food Facility Registry (the registry) is intended to provide FDA with sufficient information to contact companies in an emergency. Previous OIG work identified problems with FDA's registry. Recent recalls of dietary supplements tainted with prescription drugs, synthetic steroids, and other potentially dangerous ingredients highlight the importance of registration and adverse event contact information so that FDA can trace the source of the product. These problems raised questions about FDA's ability to identify and contact manufacturers in a food emergency to protect public health.

HOW WE DID THIS STUDY

We analyzed a purposive sample of 127 weight loss and immune support dietary supplements. For 123 of these supplements, we determined whether the companies that produced them were registered with FDA and compared the information in the registry with information obtained during structured interviews with company representatives. We also analyzed the labels of all 127 dietary supplements to determine whether they contained required adverse event contact information.

WHAT WE FOUND

Twenty-eight percent of contacted companies failed to register with FDA as required. Of the companies that did register, 72 percent failed to provide the complete and accurate information required in the registry. Finally, 20 percent of dietary supplement labels in our sample did not provide the required telephone numbers or addresses.

WHAT WE RECOMMEND

We recommend that FDA: (1) improve the accuracy of information in the registry, (2) seek authority to impose civil monetary penalties on companies that do not comply with registration requirements, and (3) educate the dietary supplement industry about registration and labeling requirements. FDA concurred with all of our recommendations.

Copies can also be obtained by contacting the Office of Public Affairs at Public.Affairs@oig.hhs.gov.

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