After months of wrangling with Senate Democrats over a nominee for head of the FDA, the Bush administration has appointed an academic, a former federal regulator, to the number two job. Veterinarian Lester Crawford will run the agency as deputy commissioner until a permanent head is nominated and confirmed.
Crawford's previous experience at FDA (as chief of the Center for Veterinary Medicine) and expertise on food issues (as head of USDA's Food Safety and Inspection Service) will be useful. The FDA center that regulates food safety, currently directed by a lawyer reputed to be a bureaucrat's bureaucrat, is sorely in need of better priority-setting and a more prominent role for science in decision-making. For instance:
A conspicuous example of these problems is a regulation proposed earlier this year that would require the pre-market review for foods prepared with very precise and predictable gene-splicing techniques but for virtually no other foods. The FDA asks for nine categories of obligatory information whose level of detail is far greater than would be required (or could possibly be met) for food products made with less precise, less sophisticated techniques. Consider, for example, Triticum agropyrotriticum, a man-made "species" constructed decades ago by combining genes from bread wheat and a grass called quackgrass or couchgrass. Possessing all the chromosomes of wheat and one extra whole genome from the quackgrass thereby adding tens of thousands of genes T. agropyrotriticum was independently produced in the former Soviet Union, Canada, United States, France, Germany, and China, and is grown for both forage and grain. But these new genetic constructions are exempt from regulation, while under the FDA's new policy the addition of a single quackgrass gene to wheat with gene-splicing techniques would require an extensive (and hugely expensive) pre-market review.
The FDA's new, nonsensical approach to biotech foods is tantamount to regulators singling out cars with disk brakes, seat belts, and radial tires for a punitive tax and then imposing a lower speed limit on them.
Another targeted food is olestra, a cooking oil that is not absorbed from the gastrointestinal tract, and which has been a resounding success as a fat substitute used in chips, crackers, and other snack foods. Since olestra was approved in 1996, Americans have bought more than 3 billion servings of snacks cooked with it. If they had eaten regular, full-fat chips instead, they would have consumed an additional 245 billion calories and 36,000 tons of fat. However, the FDA has declined even to consider applications for wider approval, although olestra is uniquely versatile in that it can be used instead of margarine, lard, butter, and other oils in frying, baking, and sauteing.
As quickly as possible, consumers should be allowed access to a broader spectrum of olestra-containing foods. Widespread use of olestra could enable more Americans to adhere to the American Heart Association's recommendation to consume less than 30 per cent of total calories from fat. Olestra in our diets could be as great a boon to public health as the recognition that lowering blood pressure reduces heart disease and stroke.
The FDA tests tens of thousands of domestic and imported foods annually for pesticide residues, although relatively few are positive and only a minuscule fraction exceeds the EPA-imposed (and overly conservative) limits. Contrary to popular mythology, there is no evidence that pesticides in or on food have been responsible for any cases of cancer or other diseases in American children or adults. Even if the FDA were to discontinue such testing (which costs tens of millions of dollars annually), America's food supply would remain the safest in the world. And this would free up significant resources for projects that Crawford and other experts deem to be of high priority.
Finally, the FDA needs to close the regulatory loophole enjoyed by the overly broad class of products called "food supplements," which can be marketed without their manufacturers having to prove that they are either safe or effective. Even those that are "natural" products, such as herbs, can and do pose the same kinds of dangers as potent drugs. Many of them have significant side effects and have been responsible for severe illnesses and deaths.
As scientists at the New York-based American Council for Science and Health have recommended, the FDA should at least hold dietary supplements to the same labeling standards as food products accuracy and "materiality," or relevance and any interference with other medications or potential side-effects, such as toxicity or birth defects, should be disclosed. (In order to accomplish this completely, Congress might have to pass new legislation, but the FDA could unilaterally effect some improvements immediately.)
While at the FDA, Les Crawford was a competent administrator and an exceedingly nice guy but seldom willing to take risks or make waves. Therefore, both FDA's stakeholders and Crawford's political masters will need to apply pressure to ensure that science will not be trampled by the FDA's bureaucratic tendencies. "Dogs bark, cows moo, and regulators regulate," a former FDA commissioner once quipped. The challenge for Crawford will be to get regulators to regulate according to good science and good sense.
Dr. Miller is a fellow at the Hoover Institution, a Director of the American Council on Science and Health, and author of To America's Health: A Proposal to Reform the FDA. He was an official at the FDA from 1979-1994.
