There are three usual sources of drugs (defined as any substance that alters the body's biological function): (1) prescription, (2) over-the-counter (for example, aspirin), and (3) under-the-counter (for example, cannabis). In recent years, a growing alternative to these traditional sources has developed in the health food trade, in which vitamins and other nutrients plus other drugs are offered without seeking approval of the Food and Drug Administration.
Any vitamins sold at levels higher than can be obtained in a good diet may qualify technically as drugs, because the quantities required to catalyze certain metabolic reactions are quite small. Above these amounts, vitamins act as drugs. The same is true of other nutrients offered in health food stores; the doses may be high enough to permit unusual functions that ordinarily, because of limited dietary supply, are not possible.
Cysteine, for example, is a relatively scarce dietary amino acid. The best dietary source is eggs (each egg contains about a quarter gram). This amino acid is useful in a number of ways. It is required in many proteins, such as insulin; it acts as a potent antioxidant in the body; it also constitutes about 8 percent of human hair. Since cysteine is in such limited quantity in typical human diets, it is used by the body for the most important functions first. Hair is probably the very last to get its share. However, if a person supplements his or her diet with cysteine (see our Life Extension: A Practical Scientific Approach), it is possible for hair to have an abundance of cysteine. A person's head of hair may even be doubled in density.
The Proxmire Act of the early 1970s spared the vendors of vitamins and other nutrients the requirement that they obtain FDA approval before making these products available to consumers. Thus, drugs that are also nutrients are not necessarily subject to tight FDA restrictions that result in an average new drug taking 8–10 years and about $70 million to achieve approval and reach the marketplace.
There are other substances offered in health food stores, however, that constitute yet another category of drug: nonnutrient chemicals that never received FDA approval but seem to be offered with impunity nevertheless. A good example is DMSO. DMSO is not a nutrient. It was offered in health food and drug stores long before it received limited approval as a pharmaceutical (RIMSO-50® is listed in the 1982 Physician's Desk Reference and is FDA-approved only for "symptomatic relief of interstitial cystitis"). It continues to be offered without a prescription at the same type of stores.
Although the FDA has declared it illegal to continue to sell DMSO for drug use without a prescription, it has made no attempt to enforce its rule. In fact, it could not do so because it would never be able to shut down the small fly-by-night firms offering the material by mail order. And the cost of any attempt to sweep DMSO out of stores would be astronomical.
In a similar fashion, starch blockers were recently declared illegal (as an unapproved drug) by the FDA but continue to be offered widely. Canthaxanthin, which is a natural carotenoid nutrient, is only approved in this country as a food-coloring agent but is sold, mostly by mail order, as a sun-tanning pill. Although the FDA alleges that this is illegal, it has not halted these sales. Yet another example is BHT, a synthetic antioxidant approved as a food additive but being sold all over the country for use against herpes infections (see our August 1982 column, "Hope for Herpes").
The marketing strategies of two would-be vendors of "sober up" products are discussed in the December 20, 1982, Advertising Age. One is proceeding with an application for FDA drug approval, while the other is redesigning the label and advertising to position it as a health food store nutrient supplement. Guess which product will be the first to reach the market?
As long as no claims are made on the label, it is possible to market these unapproved drugs. Books, other media, and health food store personnel make the claims that motivate consumers to buy these substances. The FDA's powers are limited. We recently saw DMSO that had been packaged in a deodorant roll-on style bottle. The marketers told us that the FDA required that they remove from the label the designation that the DMSO is 99.996 percent pure and that it had been purchased from a French pharmaceutical company, but the FDA couldn't make them change the dispensing bottle! What did the FDA accomplish? It is simply easier now for vendors of potentially hazardous industrial-grade DMSO to compete against the high-purity product that is no longer identifiable as such. The FDA claims that it is "protecting the consumer" by doing this.
What about future offerings? A prime substance to be sold in this fashion is a CCK nasal spray for weight control. CCK is cholecystokinin, a natural hypothalamic and gut hormone that is released after a meal to signal satiation. A rat given enough CCK will never eat, even with food piled up around it, and will eventually starve to death. On the other hand, preventing the release of CCK in a rat will result in the rat eating and eating until its gut explodes and it dies. Although it is known that CCK works as the satiation signal in humans, as well, more animal experiments and double-blind, placebo- controlled human clinical trials must be conducted to determine proper dose levels and safety factors for weight control. For people who are not eating enough, such as anorexia nervosa victims during the starvation phase, monoclonal antibodies against CCK might be an effective treatment.
We see, therefore, that a fourth source of drugs is rapidly emerging: new health food store offerings packaged without therapeutic label claims or package inserts, the labels merely stating the contents. This new development is not an unmixed blessing. Many such new products are worthless, and a few could even be hazardous (for example, vitamin E acetate capsules diluted with easily peroxidized polyunsaturated filler oils). Nevertheless, the FDA's approach to drug regulation is so bad that, in many respects, no regulation at all is preferable.
Thanks to the FDA and the excessively stringent Kefauver drug approval amendments of 1962, we now find ourselves in the bizarre situation of new drugs being developed, manufactured, prescribed, and sold entirely outside of the health profession. We do not welcome the absence of health professionals in this new market. But this is a logical result of the FDA's brand of "consumer protection."
A list of scientific literature on this topic is available through REASON. Send a stamped, self-addressed envelope and ask for H&W references, April.
Durk Pearson and Sandy Shaw are consulting scientists and the authors of Life Extension.
This article originally appeared in print under the headline "Health & Welfare: The New Drug Market".