FDA Issues Labeling Guidance on SAER Law

07/01/08 The Food and Drug Administration (FDA) has issued two Federal Register notices to announce the availability of draft guidance documents on labeling of dietary supplements and nonprescription drugs, respectively, as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act. This law, which went into effect on December 22, 2007, requires marketers of dietary supplements and nonprescription drugs to maintain records of received adverse event reports associated with their products and to submit serious adverse event reports to FDA. The law also requires labels to bear “a domestic address or domestic phone number through which the responsible person … may receive a report of a serious adverse event.”

These new guidance documents specifically address three labeling issues:

• That a domestic address included on a label to satisfy the address or phone number requirement of the law must include “a full U.S. mailing address that includes the street address or P.O. box, city, state, and zip code;” or

• That a domestic phone number that serves to satisfy the address or phone number requirement of the law on a label must include the area code; and

• That FDA “recommends that the label also 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.”

In both of the newly issued draft guidance documents, FDA states that it will exercise enforcement discretion for any new labeling requirements associated with this law until January 1, 2009.

“AHPA takes no issue with FDA’s recommendation that phone numbers include an area code,” commented Michael McGuffin, president of the American Herbal Products Association (AHPA). “But AHPA is already on record as opposing a reinvention of the long-standing regulations that allows just the city, state and zip code to suffice to identify a company’s address.” Under current food labeling regulations, a company’s place of business need not include the street address “if it is shown in a current city directory or telephone directory.” Similar regulations apply for labeling requirements for drugs, medical devices and cosmetics.

“Of greater concern, however, is the fact that FDA is suggesting that all dietary supplements and nonprescription drugs bear what must be seen as a warning statement,” added McGuffin. “This was not the intent of the law, and the Senate Committee on Health, Education, Labor and Pensions clearly stated, in its official report on this bill, that it ‘does not require the label to make any statement other than providing the address or phone number.’ AHPA will strongly oppose any attempt by FDA to rewrite this good law.” 

In support of its position on the need for a complete address, FDA’s guidance claims that “when consumers notice the incomplete address [i.e., one without a street address of P.O. Box number], they may decide not to submit a report to the responsible person because they believe it will not be received.”

“This is really quite stunning,” noted McGuffin. “If FDA is stating that the information that has been required on food, drug, medical device and cosmetic labeling since 1938 is somehow inadequate to communicate to consumers, AHPA assumes that FDA would seek a global change in the law to address any perceived inadequacy, and would not single out this industry and the OTC drug industry as targets for its hypothesis.”