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Dietary Supplement and Non Prescription Drug Consumer Protection Act: The Basics

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Although FDA believes dietary supplement firms may be underreporting the number of serious health problems potentially connected to their products, their failure to submit the data to FDA is probably unrelated to the intricacies of the law that gave birth to the obligations.

As federal laws go, the Dietary Supplement and Nonprescription Drug Consumer Protection Act is fairly concise, easy to digest and straightforward. Distributors, manufacturers and packers of dietary supplements in the United States must report serious medical problems that are associated with their products.

Not all incidents must be reported, only those defined as a "serious adverse event," which includes the following: "death," "a life-threatening experience," "inpatient hospitalization," "a persistent or significant disability or incapacity" or "a congenial anomaly or birth defect." Supplements firms also must report an incident if it "requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described" above.

Although firms are not obligated to submit reports on more mild incidents, such as gastrointestinal (GI) distress and headaches, they may voluntarily do so.

The mandatory reports must be submitted to FDA no later than 15 business days after the firm receives the information. Firms also must provide the agency any new medical information within a year of the initial report.

Supplement businesses are required to maintain records on the reports for six years and grant regulators access to them during an inspection. FDA analyzes the records while inspecting a supplement facility for the chief purpose of confirming compliance with cGMPs (current good manufacturing practices). In monitoring compliance with the AER requirements, inspectors evaluate whether a business has a process in place to report serious adverse events, checks whether the business has failed to submit any reports to FDA, and reviews labels to see if they include the required contact information, according to the U.S. Government Accountability Office (GAO). A dietary supplement is "misbranded" in violation of federal law unless a label includes a domestic address or domestic phone number through which a firm can be contacted.

FDA requires, at a minimum, certain information in the reports: an identifiable patient, the name of the person who notified the supplement business, the identity and contact information for the business, the name of the supplement and the adverse event or outcome.

The law explicitly recognizes that submission of the reports "shall not be construed as an admission that the dietary supplement involved caused or contributed to the adverse event." This provision has become increasingly important to energy drink companies in the wake of widely publicized reports linking the caffeine-laden beverages to a number of deaths and other serious medical problems.

Finally, supplement firms cannot sugarcoat the information they receive from their customers because falsifying an AER is a prohibited act under the Federal Food, Drug and Cosmetic Act.

TAGS: Regulatory
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