Natural Products Insider

JUL-AUG 2018

INSIDER is the leading information source for marketers, manufacturers and formulators of dietary supplements, healthy foods and cosmeceuticals. Since 1997, INSIDER has been serving the needs of the global nutrition industry.

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34 INSIDER July/August 2018 Reviewing and monitoring consumer complaints is important to every business. For dietary supplement companies, this helps ensure customer satisfaction with the products and is a vital and mandatory component for ensuring safety and quality. 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 procedures 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. Specifi cally, 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 signifi cant 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)). Product complaint regulatory responsibilities take a variety of factors into consideration. Some examples follow. 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 they involve a possible failure of a dietary supplement company to meet any specifi cations or other manufacturing requirements. Does a company have a procedure in place using qualifi ed, knowledgeable employees to determine which complaints are considered SAEs and to report these events to FDA? Whether an event must be reported requires an understanding of whether the event resulted in a health outcome (as previously described) 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 SAE. 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. Rather, FDA uses this information as part of its overall strategy to monitor the safety of dietary supplements and fl ag 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. Not only do dietary supplement companies need to monitor product complaints to fulfi ll 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. Megan Olsen is the assistant general cou nsel, Council for Responsible Nutrition (CRN,, a leading trade association for the dietary supplement and functional food industry. Legal: AERs A Crash Course in Dietary Supplement Adverse Event Reporting by Megan Olsen

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