FDA Issues AER Guidance

WASHINGTONFollowing an Oct. 4 request from the American Herbal Products Association (AHPA), FDA issued a draft guidance to assist the dietary supplement industry in complying with the adverse event reporting (AER) and recordkeeping requirements required of dietary supplement manufacturers, packers and distributors by the Dietary Supplement and Nonprescription Drug Consumer Protection Act. FDA separately released guidance for the OTC (over-the-counter) and human drug product aspects of the AER act.

A mandated element of the AER act, this guidance details the minimum data requirement for serious AERs for dietary supplements. This includes guidance on how, when and where to submit a serious AER for a dietary supplement; as well as records maintenance and access for serious and non-serious adverse event reports and related documents.

Addressing key areas of concern for supplement companies, the draft guidance details how to best use the 3500A form to submit AERs for dietary supplements, a form originally designed for a clinical setting, now adapted to the consumer health products marketplace. The guidance also explains and clarifies the use of agreements for retailers to transfer of AER submission responsibility to the manufacturer.

Comments on the newly released draft guidance are to be submitted to FDA by Dec. 14. The AER law goes into effect on Dec. 22, leaving little time for compliance education for companies in the first wave of companies required to begin submitting AERs.

Congress clearly intended businesses would have at least 90 days to digest FDAs guidance and make any necessary changes to their staff or procedures in order be ready to comply with the law when it goes into effect, said Michael McGuffin, president of AHPA, upon sending a request letter to FDA on Oct. 4. As of today, weve less than 80 days, and the clock is ticking. He further asked FDA if it would exercise discretionary enforcement, considering the delay in issuing this needed guidance. Companies are already preparing to submit any serious AERs they receive, he added. However, its inefficient and confusing to establish a procedure that may change when guidance is finally produced.

Daniel Fabricant, Ph.D., vice president of scientific and regulatory affairs, Natural Products Association (NPA), said NPA expects to submit comments. As the largest [natural products] trade association representing both retailers and manufacturers, we plan to submit comments on the draft to ensure that the final guidance is fair, clear and can be implemented by those it impacts.