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New FDA Online Portal for Reporting Problems With Dietary Supplements

Health Letter, April 2014

In January, the Food and Drug Administration (FDA) announced a new online portal for adverse event reports related to dietary supplements. The Safety Reporting Portal, available at www.safetyreporting.hhs.gov, makes it easier for consumers, health care providers, public health officials and manufacturers to submit such reports to the FDA.[1]

Reporting via the portal is not limited to dietary supplements. Consumers can also disclose problems with:

  • food;
  • pet food and drugs; and
  • tobacco products.[2]

Manufacturers and distributors can also use the new portal to submit reports. Under the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006,[3] dietary supplement manufacturers and distributors are required to report any serious adverse events related to their dietary supplement products.[4]

The FDA reviews every report submitted through the portal and can choose whether or not to contact the consumer for follow-up information. In some cases, the agency will visit the manufacturer or distributor who sold the product to see if other similar complaints were made. The FDA can also inspect the supplement manufacturer’s facilities and test product samples.

Consumer reports critical to FDA monitoring

The FDA estimates that more than 85,000 dietary supplements are currently on the market, but it has few tools to monitor their safety. Manufacturers of dietary supplements are not required to obtain premarket approval or even register their products with the agency.

Although the FDA maintains a list on its website of potentially hazardous products that are marketed to consumers as dietary supplements but contain hidden active ingredients from drugs, it has no systematic program for evaluating all dietary supplements that are sold[5] and may not investigate a product unless it receives a report about an adverse event or safety concern or has another reason to suspect problems with a particular supplement. Thus, reports from consumers are invaluable to the agency’s efforts to identify quality problems and safety issues with specific products.

Drug problems still reported at MedWatch website

The new portal supplements FDA’s MedWatch reporting system, which is still used to report problems with drugs. To submit a report involving a drug’s side effect or other problem, obtain a copy of a consumer-friendly MedWatch reporting form by visiting www.fda.gov and entering “Medwatch consumer” in the search box, or by calling 800-332-1088 between 8 a.m. and 4:30 p.m. EST.

Reporting Issues With Dietary Supplements to the FDA:

  • Report what happened as soon as possible. Give names, addresses and phone numbers of persons affected. Be sure to include your name, physical and email addresses, and phone number, as well as that of any doctor or hospital, if emergency treatment was provided.
  • Describe the product clearly. Give as complete a description of the product as possible, including any codes or identifying marks on the label or container. Provide the name and address of the company on the product label — as well as the name and address of the store where you purchased the product, with the date of purchase. (Keep the product packaging and labeling in case the Food and Drug Administration decides to contact you. These materials provide codes, numbers and dates that help to trace the product back to the manufacturing plant.)
  • Also report the problem to the manufacturer or distributor shown on the label and to the store where you purchased the product. This helps regulators and the manufacturer track whether similar problems have occurred repeatedly with the same products.[6]

More information on how to report is available at www.safetyreporting.hhs.gov.



References

[1] Food and Drug Administration. FDA Initiates new online reporting method for dietary supplement adverse events to facilitate reporting. January 13, 2014. http://www.fda.gov/food/newsevents/constituentupdates/ucm381317.htm. Accessed February 20, 2014.

[2] Safety Reporting Portal. www.safetyreporting.hhs.gov. Accessed February 20, 2014.

[3] Pub. Law 109-462. http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/ucm148035.htm. Accessed February 20, 2014.

[4] Food and Drug Administration. FDA Initiates new online reporting method for dietary supplement adverse events to facilitate reporting. January 13, 2014. http://www.fda.gov/food/newsevents/constituentupdates/ucm381317.htm. Accessed February 20, 2014.

[5] Ibid.

[6] Safety Reporting Portal: frequently asked questions. https://www.safetyreporting.hhs.gov/fpsr/FAQ.aspx#faq1. Accessed February 20, 2014.

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