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FDA announces extension on new labeling requirements for OTCs, supplements


ROCKVILLE, Md. The Food and Drug Administration on Friday announced that it has extended by one year the date after which it will begin enforcing new labeling requirements—that labels of over-the-counter medicines and nutritional supplements include contact information, either a complete domestic address or phone number, so that consumers can report serious adverse events associated with the use of those products.

The FDA will begin enforcing those labeling requirements Jan. 1, 2010, now.

“We believe that it is reasonable to allow an additional two-year period for firms whose labels do not yet meet the requirements … to bring their labeling into full compliance,” the agency stated in a guidance. “This period of enforcement discretion should be adequate to enable all firms to meet the new labeling requirements.”

Currently, under FDA’s “Drug Facts” regulations, the labels of OTC drug products may include a telephone number as a source to answer questions about the product, with the heading “Questions?” or “Questions or comments?”

After Jan. 1, 2010, the agency is recommending OTC and dietary supplement manufacturers spell out for consumers that the contact information is for purposes of reporting serious adverse events. “Although [the regulation] does not require the label to include anything other than a domestic address or phone number for the [manufacturer], FDA recommends that the label bear a clear, prominent statement informing consumers that the domestic address or phone number is for reporting serious adverse events associated with use of the product,” the agency stated in its guidance.

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