FDA Issues AER Guidance

The US FDA has issued a guidance document for comment purposes regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act. The document includes information about what must be included on the label of a dietary supplement to enable consumers to report serious adverse events, comments regarding a purpose statement associated with this information, and the observation that the effective date of the labeling requirements were December 22, 2007, but FDA will exercise enforcement discretion until January 1, 2009.

In answering the question " What information must be included on the label of a dietary supplement to enable consumers to report serious adverse events associated with the use of the dietary supplement?", FDA responds that when a domestic address rather than phone number is provided, the manufacturer must provide a complete U.S. mailing address including the street address or P.O. box, city, state, and zip code of the responsible person. When using the phone number, FDA responds that the statute requires the phone number on the product label to include the area code.

Draft Guidance on FDA Website

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