ABSTRACT
The Nutrition Labeling and Education Act (NLEA) of 1990 resolved many of the concerns related to the use of health claims on food labeling. However, it did not directly address how to deal with health claims for dietary supplements. Rather, it deferred to the FDA to decide how to handle health claims on these products. In deciding on approval or rejection of health claims for dietary supplements, the FDA proposed using the same “significant scientific agreement" standard that it applies to the approval of health claims on conventional food labeling. But the FDA indicated that it would be unlikely for dietary supplement health claims to meet this standard. As expected, the dietary supplement industry was not pleased with the FDA’s proposed approach. In addition, the FDA also suggested that it was considering regulating ingredients in dietary supplements as “food additives.” If ever finalized, this regulatory approach would have required dietary supplement manufacturers to obtain premarket approval of their ingredients before being permitted for sale. This process would require that manufacturers provide evidence of safety and effectiveness of the ingredient. In response to these proposed FDA regulations and future regulatory strategies, Congress began exploring legislative solutions that would significantly restrict FDA’s authority over the dietary supplement industry.
