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Power, Profit & Public Interest
Charges of profit and power motivation are being leveled against the FDA for its most recent attack on the health-food industry. Evidence appears to be mounting that the FDA sees itself not only as guardian of the drug-consuming public, but also guardian of the drug industry. The question is: Can it wear both hats?

Measuring the Risk of Death from Vitamins Based on daily consumption pat-terns over the last ten years, the incidence of someone dying from a vitamin, mineral, accessory nutrient or herb is extremely rare—less than the likelihood of a woman having quadruplets (1 in 900,000) or holding a royal flush in a poker game (1 in 649,000).

"It's apparent that these new FDA guidelines have nothing to do with protecting the health and safety of the American public, but rather power and money and who is going to control it," states Sally Khrais of Citizens for Health (CFH), a consumer group dedicated to free access of nutritional products and information. It is feared that these proposed regulations will cause an upward spiral in food supplement prices. In Europe, where several countries have reclassified nutritional supplements as drugs, a low-potency vitamin and mineral supplement such as Geritol, released as a new pharmaceutical drug, increased in price from about $10 to over $45.
Is there really any reason to believe that the FDA would place the interests of the drug companies above the interests of the tax payers?
In its Dietary Supplement Task Force Report released in June, 1993, the FDA states: "The FDA Task Force considered various issues in its deliberations including what steps are necessary to insure that the existence of dietary supplements on the market does not act as a disincentive for drug development."
An interesting statement. Does this mean that the FDA is recognizing that supplements are so effective in preventing disease that the drug industry with its notoriously high profits is in danger? Does this mean that the FDA is concerned that the FDA itself will become unnecessary if enough new drugs aren't continually being developed? Does this mean that the FDA believes it has the right to regulate anything that may pose an economic threat to the drug industry?

Historical Perspective
The FDA's current effort is not its first. In the 1960s the agency was actively engaged in a battle with nutritional supplement manufacturers and the health-food industry.
In 1972, the FDA issued an "Over the Counter Monograph" aimed at limiting the potencies of vitamins and minerals available to the public. Khrais reports, "There was such an outcry from the public when they found out what the FDA was proposing [in 1972] that Congress received more phone calls and letters on this issue than any other issue outside the Vietnam War." The result was the Proxmire Act, which provided that no government agency can arbitrarily set limits on vitamins and minerals.
In 1984, House Bill 6050, the Claude Pepper Bill, was introduced. Backed by the FDA, AMA, and the American Cancer Society, this bill proposed to outlaw all unproven medical remedies. This apparently worthy legislation contained terminology so broad that the FDA would have accomplished their goal of gaining power over dietary supplements. The public, again, clamored for defeat of the FDA's effort.
In 1990, Dr. David Kessler, the newly appointed head of the FDA, stated his plans to get tough on the dietary supplement industry and use "enforcement powers on this industry that have not been used in 20 years." In keeping with his promise, in 1991 the FDA Dietary Supplement Task Force was formed to create new regulations regarding dietary supplements and released its report revealing the agency's agenda.
Since June 18 of this year, Citizens for Health has been requesting review of the report by scientists and attorneys familiar with the Food, Drug and Cosmetic Act and the Nutritional Labeling and Education Act (NLEA) of 1990. Testimony given by Gladys Block, Ph.D., to the House Government Operations Subcommittee on July 20, 1993, included the following key points.

Getting the Facts Straight? "[the FDA] is not aware of any reports of adverse effect in humans resulting from the consumption of blackcurrant oil." — (Leslie Kux, Assistant Chief Counsel for the FDA in a deposition for FDA vs. Tracc Labs, November 26, 1991) "I have no knowledge of anyone else that is a scientist that has informed me that they would think it [linolenic acid] is unsafe." — Bert La Du, M.D., Ph.D., FDA expert witness on linolenic acid) ". . . evening primrose oil and related products, blackcurrant oil and borage oil, all of which contain gamma linoleic acid. this component poses serious health concerns related to convulsions, potential changes in blood clotting, and other tissue changes." — (FDA memorandum circulated to members of Congress and published in FDA Reports of May 31, 1993)

The evidence of a beneficial role for [antioxidant] nutrients is extraordinarily extensive.
Many Americans are not consuming even minimal, let alone excessive, amounts of nutrients.
There is no evidence that supplement users neglect their diet or other health care—quite the contrary.
The evidence of benefit is increasing explosively, and conclusions formed a decade ago are insufficient to inform us.
FDA's role in protecting public health would be much more valuable if focused on ensuring quality of supplements and providing consumers with information.

Death by Vitamins?
In August, 1992, FDA Commissioner Kessler's spokesperson, Mary Pendergast, appeared on the nationally syndicated television program The Larry King Live Show. During her interview with King, Pendergast declared that "Vitamin A kills a dozen or so people a year."
Reacting to these comments, Citizens for Health gathered the complete records of the American Association for Poison Control Centers (also published in the Journal of Emergency Medicine) for the reporting period of 1983-1989. Reporting on over 1.6 million poisons covering a population base of 192 million Americans falling within 35 certified poison control centers, the Association had no reports of any death due to Vitamin A (or any other vitamin) in the 1980s. Further, Citizens for Health contacted the AMA for data from the Physician Reporting System and the Center for Disease Control (CDC) for U.S. Public Health Service data. Again, no deaths were reported for any vitamin during this time period.
The claim by Pendergast appeared to be similar to FDA statements in the 1960s claiming over 6,000 cases of Vitamin A toxicity. During Congressional hearings in the 1970s no basis for this claim was found.

Jumping on the Profit Bandwagon
Record numbers of concerned health seekers are showing their interest in preventing disease by patronizing the new health industries: health food stores and restaurants, fitness centers, health spas, organic food suppliers, and a multitude of other businesses aimed at a consumer more educated and more willing to make a commitment to health. Personal health products are clearly the wave of the future.
Drug companies cannot expect to continue their current high profits unless they can crest the wave with a monopoly created by classifying supplements as drugs, thus stealing the profits now enjoyed by a growing health-food industry.
Rather than face the grim prospect of scaling down as a healthier population reduces the demand for prescription drugs, the drug industry seems to be entering the health food industry by the back door. With reclassification of food supplements as drugs, the industry stands to make huge profits.

A Matter of Definition
A major problem in regulation is one of definition. Charged with guarding the "safety" of the American public, the FDA seeks broad discretion in judging the type of data that is sufficient to establish safety. The agency seeks to use a very flexible definition of safety. With such flexibility, there would be no reason to question why Nutrasweet (which is known to cause seizures and other unpleasant symptoms in some people) was pushed to approval when saccharine fell out of favor or why stevia, a natural sweetener, has met remarkable hurdles in attempting to get FDA approval to be placed on the Generally Recognized As Safe (GRAS) list.

Stretching for Jurisdiction For decades, the amino acid L-tryptophan has been the choice for many seeking relief from pain, insomnia, anxiety and obsessive-compulsive disorders as a safe alternative to toxic, and, often enough, deadly pharmaceuticals. Four years ago, L-tryptophan was pulled from the marketplace by the FDA when a single shipment from a Japanese manufacturer proved to have been accidentally contami-nated, resulting in the deaths of a dozen people. Despite the fact that the problem was contamination, and not L-tryptophan, the FDA is attempting to cite its continued ban of L-tryptophan as a rationale for classifying all amino acids as drugs.

Also at question is the definition of the word "drug." The FDA maintains that supplements are being used therapeutically, not nutritionally, and should therefore be regulated as drugs. The opposition, on the other hand, takes the position that food should never be regulated as a drug.
The FDA declares that it will not consider a supplement to be a drug simply because it contains vitamins and minerals at levels above those found in foods. "If, however, the relationship between a substance and a disease is based on some type of physiological process other than nutritive value, this is a drug claim," states the FDA.
Now there is the problem of defining physiological processes as "Nutritive" and "Other." And so it goes.

Who Do You Trust?
A major consideration for the American public is one of trust. Do we trust ourselves to make judgments concerning our health? Do we trust the FDA to make these decisions for us? Information that is now available could become illegal under the FDA's proposed regulation. Citizens would be forced to accept the judgment of the FDA, an agency that has more on its agenda than the public interest.
If there were not so many people who have experienced positive change in their lives and health (some claim to have been snapped from the jaws of death) by food supplements, if there had been any research to back the FDA's "statistics," if these were not the folks who brought you thalidomide and hosts of other fine drugs of this ilk—maybe, just maybe, the American people could begin to think about trusting something as important as personal health decisions to the FDA.