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A Crash Course in Dietary Supplement Adverse Event Reporting

While dietary supplement complaint review and reporting requirements have been legal requirements for more than 10 years, FDA’s ongoing safety and health priorities, and recent actions regarding dietary supplement products, continue to highlight the need for companies to fully understand their responsibilities related to dietary supplement product complaints.

Reviewing and monitoring consumer complaints is important to every business. For dietary supplement companies, this helps ensure customers satisfaction with the products purchased and is a vital and mandatory component for ensuring safety and quality of these products. FDA requires review of product complaints and reporting of certain complaints as part of dietary supplement post-market surveillance programs. As a public health agency, FDA’s product complaint requirements support the agency’s dietary supplement priorities, which include protecting consumers and ensuring product integrity.

While dietary supplement complaint review and reporting requirements have been legal requirements for more than 10 years, FDA’s ongoing safety and health priorities, and recent actions regarding dietary supplement products, highlight the need for companies to fully understand their responsibilities with regard to dietary supplement product complaints.

The Basics

Handling product complaints requires companies to engage in a number of activities, from labeling to monitoring and reviewing complaints, to reporting certain types of complaints to FDA. Specifically, companies that manufacture, package, label or hold dietary supplements must establish and follow written procedures for handling product complaints and must report complaints that describe serious adverse events (SAEs) to FDA. SAEs: 1) result in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability, or incapacity, or a congenital anomaly or birth defect; or 2) require, based on a reasonable medical judgment, a medical or surgical intervention to prevent an outcome described above (Food, Drug and Cosmetic Act (FDCA) § 761(a)(2)). Examples of SAEs include heart attacks, strokes, liver or kidney failure, and death.

Product complaint regulatory responsibilities are described in more detail below.

Are dietary supplement products labeled in a manner that allows a company to receive product complaints?

To facilitate the reporting of adverse events, the labels of dietary supplements marketed in the United States must include “a domestic address or domestic phone number through which the responsible person … may receive a report of a serious adverse event with such dietary supplement” (FDCA § 403(y)).

Does a company have in place a program, as part of its good manufacturing practices (GMPs), to review and investigate dietary supplement complaints?

FDA manufacturing regulations require companies that manufacture, package, label or hold dietary supplements to establish and follow written procedures for handling product complaints. As part of these requirements, an individual with appropriate training and expertise must review dietary supplement product complaints to determine whether it involves a possible failure of a dietary supplement company to meet any specifications or other manufacturing requirements.

Does a company have a procedure in place using qualified, knowledgeable employees to determine which complaints are considered SAEs and report these events to FDA?

Whether an event must be reported requires an understanding of whether the event resulted in a health outcome described above or required a medical intervention to prevent such an outcome. SAEs must be reported to FDA by the manufacturer, packer or distributor whose name appears on the label of a dietary supplement product within 15 business days of that entity receiving the report of the serious adverse event, requiring companies to act quickly once a complaint is received.

FDA’s Review of Adverse Events

FDA reviews all reported events. In addition to mandatory reporting requirements for dietary supplement companies, FDA routinely encourages consumers and health care providers to report SAEs to help FDA collect as much information as possible about a potential adverse health outcome. To this end, FDA may consult with other agencies when reviewing adverse events, such as the U.S. Centers for Disease Control and Prevention (CDC), or foreign government entities, such as Health Canada.

FDA recognizes submitting a serious adverse event report (SAER) will not be construed “as an admission that the dietary supplement involved caused or contributed to the adverse event being reported,” as indicated in a 2013 guidance, “Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act.” Rather, FDA uses this information as part of its overall strategy to monitor the safety of dietary supplements and flag potential hazards. The information in SAERs provided to FDA can, and has, led to product investigations, targeted inspections, product testing, import alerts, warning letters and enforcement actions.

Starting in 2016, FDA began making data it receives public to help make information on adverse events transparent to the public and to encourage consumers and health care providers to give detailed and complete information regarding a dietary supplement adverse event. Prior to 2016, this information was only available through Freedom of Information Act (FOIA) requests.

FDA’s review of SAEs has recently been highlighted, as FDA has flagged a number of SAEs associated with kratom—an ingredient that has been found in products labeled as dietary supplements—in multiple statements issued by the agency when discussing safety concerns about these products. FDA has faced criticism for its use of AERs associated with kratom, including the reports may be anecdotal and do not demonstrate how kratom was responsible for the events. Despite any criticism of FDA’s use of adverse events to make conclusions about the safety of a product, however, it remains clear FDA uses this reporting system to help prioritize investigations, inspections, recalls and other actions.

Not only do dietary supplement companies need to monitor product complaints to fulfill regulatory requirements, but these companies should treat dietary supplement complaints as an important element when reviewing the totality of safety evidence for any dietary supplement product they manufacture or distribute. Companies should be prepared to work with FDA should these complaints trigger investigations or other agency actions.

Megan Olsen is the assistant general counsel, Council for Responsible Nutrition, the leading trade association for the dietary supplement and functional food industry.

 

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