REGULATORY SUCCESS AND FAILURE

V. REGULATORY SUCCESS AND FAILURE

Looking back on the past four decades, it is easy to discern areas of success and areas

A. The GRAS Success

Regulation of GRAS substances under the Food Additives Amendment of 1958 has been an enormous success, largely because it has been implemented outside FDA. It is a classic free market approach. The Food and Drug Administration is not the only access to the market. There are alternative approaches, through equally competent and respected scien- tific organizations that are much more efficient, less costly, and thus far preferable. Individ- ual companies are free to make their own determinations based upon their own scientific expertise; independent academic experts are available; private companies that specialize in GRAS determinations can be used; and FASEB itself has now, after completing the FDA GRAS List Review, agreed to conduct private GRAS evaluations for the food indus- try. These compete among each other and with FDA. Under the inexorable rules of compe- tition, in a free enterprise environment, the most effective and efficient organization will ultimately be used.

One must question whether leaving these issues to the free market compromises public health and safety. The evidence over the past four decades provides unequivocal testimony that the public health and safety has been fully protected and not in any way compromised. Not a single food substance that has been added to the food supply under

a private GRAS determination based on a thorough and well-documented scientific evalua- tion since 1958 has been taken off the market by FDA because of a public health or safety problem. The program, in short, has been a complete success.

B. The Food Additive Failure

The failure of the food additive approval process during the past four decades scarcely needs further elaboration. It is a closed process within FDA, not subject to public scrutiny even through an FDA advisory committee, and is solely within the control of the agency. Because there is no other lawful route to the marketplace for a food additive or color additive, manufacturers have no alternative but to do whatever FDA commands. And for the same reason, FDA can demand whatever it wishes, with or without sound scientific justification, without fear of peer review, public scrutiny, or accountability to anyone else. The resulting statistics, documented earlier in this chapter, are the inevitable result.

One might consider retaining such an approach if it produced better results—that is, safer food—than other approaches might achieve. A comparison with the GRAS self- determination approach, however, demonstrates that this is not true. Far more new direct human food substances have been marketed since 1970 after an industry self-determination of GRAS than after FDA approval of a food additive or color additive petition. No product in either category has proved to present a public health hazard. The highly conservative approach of FDA thus contributes nothing more than delay, higher costs to the public for those products that eventually are approved, and a more restricted choice for consumers because the entire process has choked off innovation in this very important field.