The importance of GRAS to the functional food and nutraceutical industries

At a time when 150 million Americans spend over $20.5 billion on functional foods, nutraceuticals and dietary supplements, the Food and Drug Administration (FDA) is doing little to ensure that all the safe and efficacious products that could come to the market are allowed to do so. FDA has only responded slowly and reluctantly to Congressional action and to mandates from the Courts to implement the law. Additionally, FDA had set the bar too high for Health Claims and was forced by the Courts to implement a more reasonable standard, but the response, Qualified Health Claims, has failed to gain the confidence of the public because of the confusing wording of the claims demanded by FDA. Congressional efforts to assure consumer access to dietary supplements have been met with similar resistance from FDA. The Dietary Supplement Health and Education Act (DSHEA) was the product of a compromise with a lower threshold for demonstration of safety (reasonable expectation of no harm) that would be met by consumer self-policing and assumption of some risk. FDA has thwarted this effort by raising the bar for New Dietary Ingredient Notifications (NDIN) to what appears to be the higher threshold for the safety of food ingredients (reasonable certainty of no harm)--FDA apparently sees these two safety thresholds as a distinction without a difference. As a result, increasing numbers of dietary supplement manufacturers, unwilling to gamble the future of their products to a system that provides little hope for the FDA's response of "no objection", have committed the additional resources necessary to obtain Generally Recognized As Safe (GRAS) status for their supplements. The pressure on FDA and Congress for change is again building with increased dissatisfaction among consumers as the result of confusing labels. A second force for change will be a need to uncouple the FDA mandated substance-disease relationship and return to the substance-claim relationship to allow for progress in nutrigenomics and metabolomics, which will result in an increasing number of substance-biomarker claims.