On December 26th, FDA published a guidance to reflect its current thinking with regard to reporting serious adverse events for dietary supplements. This draft guidance document is intended to assist the dietary supplement industry in complying with the labeling requirements prescribed for dietary supplement manufacturers, packers, and distributors by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Pub. L. 109-462, 120 Stat. 3469). The draft guidance covers the following topics:

(1) what “domestic address” means for purposes of the dietary supplement labeling requirements in section 403(y) of the Federal Food, Drug, and Cosmetic Act (FFD&C Act);

(2) FDA’s recommendation for the use of an introductory statement before the domestic address or phone number that is required to appear on the product label under section 403(y); and

(3) when FDA intends to begin enforcing the labeling requirements of section 403(y).

FDA’s guidance documents, including this document, do not establish legally enforceable responsibilities. Instead, guidance documents describe the agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in agency guidance means that something is suggested or recommended, but not required. The full guidance document can be accessed at http://www.cfsan.fda.gov/%7Etcjm/dsaergu2.html#q1.