The bill, which is an amendment to the Federal Food, Drug and Cosmetic Act (FFD&C Act) passed unanimously by the Senate and signed into law by the President in December 2006.

It was applauded by industry associations for its potential as an extra post-market precautionary measure to secure more credibility for supplement makers.

The new guidance document is intended to assist the cosmetic and food industries to comply with the labeling requirements prescribed for manufacturers, packers and distributors.

It is part of a variety of guidance documents issued by the FDA to assist in adverse events reporting associated with dietary supplements. In October, it released for comment draft guidelines comprising questions and answers concerning the mandatory reporting to FDA of serious adverse events.

FDA guidelines are not legally binding and instead represent the authority's thinking on any current topic.

The newly released guidance, which provides questions and answers on labeling, covers three points:

· The meaning of "domestic address"

· The use of an introductory statement before the address

· When the FDA will begin enforcing the act

Section 403 (y) of the FFD&C Act requires the label of a dietary supplement being marketed in the US 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."

Without this information, cosmetic products are misbranded.

The guidelines mean the responsible person to provide a full US mailing address, including street address of PO Box, city, state and zip code. If the person chooses to give a phone number, it must include the area code.

The phrase "through which the responsible person… may receive a report" emphasizes that a complete address must be provided.

The wording of the act previously referred to the "place of business", which meant the label could include limited details as long as the firm's street address was listed in a current telephone directory. The FDA has changed this to "domestic address" to further ensure a full address appears on the labels.

Although section 403 does not require the label on dietary supplements to include anything other than the contact details, the FDA recommends that it also bear a clear, prominent statement informing consumers that the address is for reporting serious adverse events associated with the use of the product.

The FDA does not object to a firm's recommended statement also saying the address can be used for other purposes, as long as the information is not false of misleading.

The labeling requirements of section 403 applied to all dietary supplements labeled after December 22, 2007. However, because the guidance is only now being issued, the FDA will exercise enforcement discretion until January 1, 2009.

The FDA is calling for comment within the next two months. The draft documents can be found at http://www.cfsan.fda.gov/~tcjm/dsaergu2.html#q1 .