LESSONS FOR THE FUTURE

VI. LESSONS FOR THE FUTURE

As a nation, we have distrusted one of our most precious heritages—responsible private action within an open and free competitive marketplace—and put our trust instead in a form of control that has repeatedly failed—a government agency with complete and total As a nation, we have distrusted one of our most precious heritages—responsible private action within an open and free competitive marketplace—and put our trust instead in a form of control that has repeatedly failed—a government agency with complete and total

Our country has had a longstanding opposition to monopolies of any kind. One does not need to be an economist to understand what happens with a monopoly. Those who enjoy the privilege and protection of a monopoly need not be concerned about efficiency because they lack competition. They need not be concerned about cost because the public has no other choice. Time is of no concern because the public has no other alternative.

A monopoly is just a euphemism for a dictatorship. It does what it wants, at its own pace, in its own way, and will brook no interference by others. That is exactly what we have seen with food additives and color additives. Time is of no consequence; cost is not even considered. Technology languishes, and indeed disap- pears, because FDA has no incentive to be efficient and fair.

The proof of this analysis lies in the contrast between food additives and color additives on the one hand and GRAS food substances on the other. We have destroyed innovation in the entire color additive industry in this country and have almost achieved that objective for direct human food additives. For GRAS food substances, on the other hand, there is a thriving industry and a highly competitive marketplace. GRAS food sub- stances survive, while food additives and color additives die, precisely because there is

a free marketplace for the former and only a government monopoly for the latter. There are, presumably, three ways that one could change this system. First, FDA could reform itself from within and restore the efficiency and effective regulatory approach taken in the early 1960s. It is highly questionable, however, that this will occur. No monop- oly, in all of history, has voluntarily surrendered its power and has established competitive entities. The destruction of monopolies has always been a forced event.

Second, the statute could be amended to require that FDA take action on pending food additive and color additive petitions within the specific statutory time period, or the applications will be deemed to be approved. This is the ‘‘hammer’’ approach. It fails, however, to account for the likely FDA response. It is all too easy for FDA simply to issue continual denials of a food additive or color additive petition on the ground that further testing is needed. This is the classic FDA response and accounts for the complete failure of the system as we know it today. It is too much to expect that it would change simply because of the existence of a statutory hammer.

Third, and finally, FDA food additive and color additive regulation could be opened up to free competition, requiring the agency to be judged on a fair comparison with alterna- tive review organizations who have already shown the ability to conduct this type of evaluation in a far more efficient, less time-consuming, and less costly manner. This is the only hope for the future. The market mechanism is the greatest natural form of regula- tion the world has ever seen. Those who are inefficient go bankrupt. Those who are effi- cient and effective not only survive, but command the respect and patronage of potential customers.

Let us examine just how this could work. Let us suppose that the statute were amended to permit the manufacturer of a food additive or color additive to seek the review and evaluation of a petition either from FDA or from any other governmental or nongov- ernmental organization established to conduct these evaluations in the same way that FDA does. Any such outside organization would be required, of course, to meet criteria and standards established by FDA for this type of review. It would be required to apply safety evaluations established by Congress in the statute itself and by FDA in its regulations.

Guidelines, such as the Red Book, would represent acceptable but not mandatory safety evaluation principles, as the FDA regulations provide (110).

Perhaps the best example of an organization that would most assuredly meet those criteria is FASEB. This organization has done this type of work for FDA for thirty years, and FDA has relied upon the FASEB work product repeatedly. It would not take anything more to demonstrate that FASEB is, at this moment, the premier food substance evaluation agency in the United States, respected to a far greater degree than is FDA itself.

The question then becomes whether approval of an organization like FASEB should, in itself, be sufficient to justify immediate marketing. Even though the author remains highly critical of what has happened to the FDA food additive approval process, we must give the agency one more chance to show that it can make a new process like this one work. Following review of a new direct human food additive by an organization like FASEB, the results should be required to be submitted to FDA, to give the agency a limited time within which they can review the decision of FASEB and accept or reject it. Perhaps six months is sufficient for this purpose. If the agency could not take definitive action within six months, the FASEB recommendation would automatically become the decision of the agency.

If this type of approach were to be pursued, it would be essential to incorporate one clear limitation. Once a third party organization like FASEB has made its determination, it would in effect become a rebuttable presumption. FDA would not be permitted, in its review of that recommendation, to veto marketing of the product on the ground that it still needs further testing. The only ground on which marketing could legitimately be stopped by FDA would be if the agency determined that there was a reasonable probability that the additive was, in fact, not safe for its intended use.

This is not a radical approach. It does not dismember FDA or destroy the notion of public protection against unsafe food. It does reject the concept that FDA is the only institution in our country that understands food safety and builds upon the principle that competition, rather than monopoly, is most likely to serve the public interest. It retains in FDA the ultimate authority to protect the public health and the responsibility for enforce- ment in the marketplace. Public confidence in the food supply will therefore remain undi- minished and perhaps even enhanced because two qualified organizations, rather than just one, will have participated in the ultimate decision.