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FDA Guidance Changes Regarding Labeling

Direct Sales Industry Update Kevin D. Quigley

In September 2009, the FDA issued final guidance regarding the requirements for dietary supplement labeling. Dietary supplement manufacturers, packers and distributors should be aware that this guidance adds two notable requirements to dietary supplement labeling. Specifically, the new requirements address: (1) the contact information to be provided for consumers to report a serious adverse event; (2) the placement of an introductory statement before that contact information; and (3) the intended date that the FDA will begin enforcing the labeling requirements.

Contact Information for Adverse Event Reporting:

The Dietary Supplement and Nonprescription Drug Consumer Protection Act (the "Act") requires the label of a dietary supplement to 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." If the label does not include this information, the dietary supplement is considered misbranded.

The final guidance provides that if the responsible person (the manufacturer, packer, distributor or retailer) chooses to provide a domestic address for adverse reporting, the label must bear a full U.S. mailing address that includes the street address or P.O. box, city, state and zip code of the responsible person. The guidance also explains that if the responsible person chooses to provide a domestic phone number, the phone number must include an area code.

This "domestic address" requirement is in contrast to the labeling requirement that provides that dietary supplements are misbranded unless the product label bears the name and place of business of the manufacturer, packer or distributor of the dietary supplement. The FDA's regulations interpret this "place of business" to require only the entity's city, state, and zip code to appear on the product label, as long as the entity's street address is listed in a current phone directory or other city directory. Thus, simply placing the place of business on the label is not adequate to comply with the requirement for a full domestic address for adverse event reporting.

Introductory Statement

The Act does not specifically require a label to include anything other than the domestic address or phone number for adverse event reporting. However, in the guidance the FDA recommends that the label also include a clear, prominent statement informing consumers that they may report serious adverse events to the domestic address or domestic phone number on the label. Moreover, the guidance states that the label can also clarify that a physician should be called for medical advice. These statements may be combined with the address or phone number-for example: "You should call your doctor for medical advice about serious adverse events. To report a serious adverse event or obtain product information, contact…."

Effective Dates:

According to the guidance, while the labeling requirements apply to all dietary supplements labeled after December 22, 2007, the FDA will begin to exercise enforcement discretion September 30, 2010.

For more details on the requirements for dietary supplement labeling, or if you have any questions, please contact Kevin Quigley at 602-229-5433 / or your Quarles & Brady attorney.