FDA Reform Bill Specifically Excludes Dietary Supplements

WASHINGTON—DSHEA provisions for the sale of supplements were protected as a result of congressional action to exclude them from CODEX and EU harmonization provisions in the just-passed FDA Reform Bill (S830) signed by President Clinton Nov. 21.

EU law treats vitamins, minerals and botanicals as drugs; DSHEA considers dietary supplements to be food.

The move, spearheaded by Sen. Orrin Hatch, R-UT, through language inserted into the bill, allayed supplement makers’ and consumers’ fears that DSHEA provisions would be dismantled as a result of the reform bill’s passage. Consumer-advocacy group Citizens For Health had lobbied heavily for exclusionary language.

The new law, designed to streamline many FDA procedures and processes, also removed some requirements regarding referral statements that accompany nutrient content claims on food products and establishes a premarket notification process to speed approval of new food-packaging materials.

The law also changes FDA labeling-disclosure requirements for irradiated foods, allowing irradiation to be noted in small print, and directs FDA to decide on a red-meat irradiation petition pending at the agency since 1994. In early December, the agency approved irradiation for red meat. (See related story, page 2.)