According to the House Subcommittee on Health and Long-term Care, quackery was a $10 billion business in the United States in 1984, and growing at an alarming rate. Bogus "nutrition supplements" represent a significant part of the business.

Many nutrition supplements sold in health-food stores are claimed to treat or prevent a variety of diseases, delay aging, restore pep, and work many other wonders. These claims are made despite lack of scientific proof—and often despite plenty of scientific proof to the contrary. Health-food store owners may not know that the claims are unproven—or disproven.

You won't find these claims on the labels of the bottles that line the shelves. Instead, the treatment-and-prevention allegations appear elsewhere: in pamphlets stacked nearby, in books and magazines available for browsing or purchase, or in "bag stuffers" given away at the checkout counter. Often, buyers have no way of knowing whether this literature comes from the manufacturers of the products.

For manufacturers and distributors of nutrition supplements with inflated claims, it makes good legal sense to keep the products separate from information about their claimed benefits. If a label merely says "take 2 tablets 3 times daily as a dietary supplement," the product is arguably a food supplement—and thus not subject to the federal laws governing drugs. But a therapeutic claim—say, "take 2 pills 3 times daily for relief of arthritis"—legally qualifies the product as a drug and subjects it to regulation as such by the U.S. Food and Drug Administration (FDA).

A drug, under the law, is a product "intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals." A drug can be legally marketed if it has been approved by the FDA, or if it is "generally recognized as safe and effective." If a drug meets neither of these criteria, the FDA can seize it, prevent the company from marketing it, and seek criminal penalties.

Many nutrition supplements bear a disclaimer saying that they are "not intended to replace the services of a physician." But the claims made for them, and the manner in which they are marketed, send the opposite message to buyers.

Some unproven remedies, as detailed later in this article, can cause serious injury because they contain toxic ingredients or contaminants. Many others, though innocuous themselves, encourage the victims of serious diseases to medicate themselves, substituting ineffective substances when effective treatments exist.

Nutritional Supplements: Drugs in Disguise

In recent years, many companies have begun playing the drugs-as-foods game. To get acquainted with some of them, CU created its own health-food store in 1984. We operated our store in two different states under two different names. That way, we could be sure all the products we ordered were shipped in interstate commerce, and thus subject to federal regulations. We could also learn whether health claims were being made for the products by the manufacturers or distributors. If so, the products are legally considered drugs—even if the claims never appear on the labels.

We contacted more than 70 companies and asked for their catalogs and product information. We chose our products and sent back the order forms, along with requests for additional literature to help explain the products' uses.

In addition to more than 300 products, much literature was bestowed on us during the five months we ran our store: "Dear Retailer" letters from manufacturers explaining why their products should be prominently displayed; numerous catalogs filled with detailed product descriptions; dozens of free fliers, brochures, "fact sheets," and bag stuffers to help us "increase sales dramatically." Some of this literature did indeed contain astonishing medical claims.

Our health-food store's products and accompanying literature, of course, were not sold to consumers. Instead, they were evaluated by a seven-member panel of medical and legal experts. The panel comprised four attorneys specializing in health and health-fraud issues, a specialist in internal medicine on the faculty of a major university medical center, a nutritionist, and a pharmacologist on the faculty of another major university medical center.

The panel evaluated one or two products from each company. For each product, the panelists made a judgment about whether the product was legally a drug; whether it was known to be effective for its claimed purpose; whether it posed a direct hazard to the user; and whether it posed an indirect hazard by encouraging users to abandon other forms of therapy. Many of the products were judged indirect hazards. A few were judged direct hazards—substances that could cause harm to the user.

The final judgment the panelists made was whether the manufacturer or distributor was violating the federal Food, Drug and Cosmetic Act. New drugs must have FDA approval as being safe and effective before they can be marketed. New drugs marketed without FDA approval are considered illegal.

The panel also looked at whether the product could be legally considered "misbranded." A product is misbranded if the label doesn't provide adequate directions on how to use the product for its advertised purposes, or if the labeling (which includes any literature used in the distribution of the drug) is false or misleading in some way.

In the panelists' unanimous opinion, 42 of the 70-plus companies offered products that violated both major provisions of the Food, Drug and Cosmetic Act: They were unapproved new drugs and they were misbranded. The products of a few of these companies have been seized by the FDA. One company has been criminally prosecuted by the FDA. Most, so far as we know, have never been the subject of any FDA enforcement action.

Our panel judged five products to be the worst of the entire bunch. A sixth product, glandular concentrate, was found to be legally marketed—but particularly disgusting.

Liquid Citrus Bio-Flavonoid Complex If the panel had given an award for the most outrageously illegal claims made for a product, the award might have gone to Liquid Citrus Bio-Flavonoid Complex, manufactured and distributed by Bio-Botanica Inc., of Hauppauge, New York.

Bio-Botanica sent our store numerous copies of a flier entitled "Bio-Flavonoids and You!" Although the product label was clean, the flier indicated that Liquid Citrus Bio-Flavonoid Complex can help people with the following maladies: "herpes sores ... easy bruising or hemorrhaging ... diabetic cataracts ... capillary oozing during surgical procedure ... abnormal clumping of red blood cells and blood platelets ... cancer-producing processes ... excessive inflammation ... abnormal uterine bleeding ... allergy symptoms in children ... cystitis toxicity ... capillary bleeding caused by anti-coagulants ... menopausal symptoms."

Bio-Flavonoids are a mixture of organic chemicals found in citrus fruits. Discovered in the 1930s, they were called "vitamin P" for a short time—until researchers found they were not essential for humans. They have not been proven useful for treating any human maladies.

Padma 28 Many of our health-food-store products, while not harmful in themselves, were found to be hazardous because they might prompt users to forgo effective medical treatment. Of all the products reviewed, our panel singled out Padma 28 as the most dangerous such "indirect hazard."

The Padma 28 tablets purportedly contained 22 herbs prepared "in accordance with the principles of Tibetan herbology." An ad placed by Padma Marketing, the product's Berkeley, California, maker, boasted that "Padma 28 produces results in treating angina pectoris and PAO [peripheral arterial occlusion]." A flier the company sent to our store touts Padma 28 not only for angina and PAO but also for "disabilities of old age, especially in relation to reduced circulation, such as senility, poor memory, and depressed energy levels," and for "poor circulation in general, producing cold feet, numb or antsy feeling in the arms and legs, stiffness of the joints."

The panel considered the claim that Padma 28 relieved angina "highly dangerous." Panelists said that anyone using Padma 28 for angina attacks instead of seeking help for the underlying heart problem could be making a fatal decision. Depending on the amount consumed, Padma 28 could also represent a direct hazard. One of its ingredients is the herb aconite, which is poisonous. How much aconite do you get with Padma 28? The label (unlike labels for approved drugs) didn't say.

Meganephrine "Dear Friends," the letter to our store began, "Nutritional specialty products are among the most effective agents that can be used in the prevention and treatment of coronary heart disease, stroke and related life-threatening complications." The letter was from Arteria Inc., of Concord, California. Arteria products are notable for having scientific-sounding names such as "Essential Mucopolysaccharides," "Acetylcholine Releasers," and "Electrolyte Replenisher."

Our panel reviewed claims for an Arteria product called Meganephrine. "This nutritional supplement," the company said on the order form, "is especially designed to offset adrenal insufficiency and also raise serum noradrenaline levels." Does anyone really need a higher noradrenaline level? We doubt it: Noradrenaline is made not only in the adrenal glands but also in various nerve endings throughout the body. Deficiencies have not been described in the professional medical literature.

The panel considered Meganephrine's claims dangerous. The key claim was that the product cures adrenal insufficiency. Treatment of this rare disorder requires the services of an endocrinologist and judicious use of corticosteroids. Anyone who takes Meganephrine and gets away with it almost certainly never had adrenal insufficiency. A person who actually has the disease and who uses this product instead of the usual hormone replacement therapy could become seriously ill within a day or two and might even die.

Meganephrine's ingredients come mainly from animal innards. The recipe for each capsule was "250 mg Adrenal; 40 mg Hypothalamus; 50 mg Pituitary; 100 mg Medulla concentrate; 250 mg Tyrosine (an amino acid)." These ingredients are no more helpful than a hamburger.

DMSO A brochure put out by Life Extension Products, of Fort Lauderdale, Florida, advertises "DMSO in the Treatment of Cancer Patients." The ad claims that DMSO could be "one of the most effective anticancer agents known," that it "has the properties desired in any cancer drug" and has been "used successfully" with chemotherapy.

The ad does contain one fact—that DMSO "is capable of passing through body tissue taking other products with it." But that fact makes DMSO a substance that could be directly, as well as indirectly, hazardous.

DMSO is an industrial solvent. The FDA has approved a purified form solely for the treatment of interstitial cystitis, a rare bladder disease. But otherwise, DMSO has not been shown to alter the course of any other disease. Nevertheless, proponents of DMSO therapy claim miraculous relief from a variety of ailments, notably arthritis. Despite public-education efforts by the FDA, many people obtain industrial-grade DMSO from nonmedical sources and attempt to use it medically.

After receiving our DMSO from Life Extension, we read the instruction sheet on "Use of DMSO in the Treatment of Cancer." We could take it orally ("use one ounce of 100% DMSO mixed with three ounces of orange juice") or rectally, as a retention enema ("mix one ounce of 100% DMSO with three ounces of water").

DMSO could prove fatal, according to CU's panel, if used as a retention enema. As the Life Extension ad stated, DMSO does "take other products with it" as it "passes through body tissue." In the rectum, these "other products" might include bacterial toxins that DMSO could carry through the intestinal wall and into the bloodstream. For a person who is already weakened by cancer, the effect of the absorbed toxins could be life-threatening.

Another recommendation in the instruction sheet advised diabetics who use insulin to "decrease the insulin intake by 40-50% during the DMSO treatment" and to consume sugar "regularly with the DMSO doses." For some diabetics, following this advice could lead to diabetic ketoacidosis, a dangerous complication that could lead to coma and death.

Rheumoid In the literature we received, NF Physicians Formula Inc., of Portland, Oregon, called itself "An organization of health-care practitioners dedicated to the promotion of wellness." The company's 50-page catalog listed 292 diseases and conditions, ranging from Alzheimer's disease and angina pectoris to seizures, stroke, and warts. The product guide, or "Clinical Repertory," matches each ailment with the "nutritional substances" it says are effective in helping to rebalance the patient.

Our panel looked at one such "nutritional substance," called Rheumold. The Rheumoid tablets contained seven herbs, an amino acid (Lcysteine), and potassium. An NF Physicians Formula information sheet described Rheumoid as "a safe and effective alternative to the arthritis drugs currently in use"—a claim that disturbed the panel because it could encourage people to turn away from effective medications. In addition to arthritis, Rheumoid was touted for back pain, discopathy, osteomalacia, osteoporosis, and scoliosis.

Our panelists found that NF Physicians Formula was just one of many companies that purport to market products only to "health care professionals." Chiropractors appear to be the biggest customers. Federal law prevents chiropractors from writing prescriptions for FDA-approved drugs, so companies such as NF Physicians Formula offer them the chance to "prescribe" something. Chiropractic journals we reviewed are full of ads for unapproved remedies.

Gland Concentrates Long a staple of quack health spas and clinics, "raw gland concentrates" have become a health-food fad. A seller's pamphlet explained, "The theory is that like cells help like cells." So swallowing capsules of raw adrenal concentrate, for example, will supposedly "bolster the function" of your own adrenal glands.

The FDA considers glandular supplements to be inert, dried glandular meats, which are digested like other meats and have no other value. The agency says it has acted against thyroid gland supplements, which might be used by people who believe they were a substitute for prescription thyroid products. But the FDA told CU it cannot act against other organ-type products, such as dried liver, kidney, and the like, unless a drug claim is made.

CU's panel reviewed "raw glandulars" marketed by several companies. Because manufacturers generally don't make therapeutic claims for these products, the panel considered them to be legally marketed foods. But the panel suggested that some glandulars be tested for bacteria. We sent our 13 glandular preparations for lab analysis, and got back some interesting results.

Manufacturers often boast that they process the glands at low temperatures. For example, the labels on glandulars from Biotics Research Corp. (Houston, Texas) said, "Dehydrated at low heat (40°C./104°F.) to preserve associated enzyme factors." Such relatively low temperatures also help preserve something else: contaminating bacteria.

An expert at the U.S. Pharmacopeia considers 100 bacteria per gram an unacceptably high level. Of the 13 products tested, seven had unacceptably high bacteria levels. In the worst product, one gram had a standard plate count of 6.5 million bacteria per gram. These included 24,000 coliform bacteria—intestinal bacteria whose presence indicates that hazardous intestinal organisms may also be present. The next-worst product had "only" 4900 bacteria per gram, including 1100 coliform bacteria.

It's immaterial whether these glandular products are legally considered foods or drugs. Those with high bacterial content are adulterated and hazardous and, in our view, should be barred from distribution.

The Dubious Distributors

Another dimension to the health-fraud boom is the person-to-person peddling of nostrums within multilevel sales schemes. It's easy to become a distributor. Just visit any of the "health expos" held regularly in major cities around the country. You'll find dozens of booths filled with enthusiastic representatives explaining how you can improve your health and make good money at the same time. Thousands of Americans have become distributors for these multilevel marketing organizations selling nutrition supplements.

Distributors buy products wholesale and sell them retail to relatives, friends, and neighbors. But to make big money as a distributor, you must usually sign up others to work as distributors under you—and help your distributors get people to work, in turn, for them. You get a percentage of all sales made by your "downline." This marketing plan is commonly known as a "pyramid scheme."

At the same time that we operated our health-food store, one CU reporter trained as a distributor for several nutrition-supplement businesses. It was a frightening experience.

In one typical initiation, our undercover reporter visited an established distributor for one such organization. Nancy (not her real name) ushered our fledgling distributor into her apartment living room. Lining one wall were four shelves filled with pill bottles and boxes. Nancy explained what the products would do.

"This one," she said as she plucked a bottle off the shelf, "cures diabetes." She said she knew of cases in which diabetics taking the product had been able to come off insulin. The company can't make claims like that on the label, she said, "or the FDA would get after us."

Another item was for cancer—both prevention and cure. That product, she said, "works with the immune system" and for that reason can also cure AIDS. She personally knew three patients who took the stuff and "every one has gotten over AIDS." Can I actually tell people that? our novitiate asked. "Theoretically, you shouldn't make medical claims," Nancy said. "But I said it right off. It'll cure AIDS. Because it's true. Face to face, you can say anything you want."

Emphasize testimonials, Nancy advised. Recite cases in which the products successfully conquered disease. The new distributor's own experience with a product will also help convince people, she said. "You can say that it helped you if it did. Or even if it didn't."

Initiation rites into these distributorships vary. But the deceptive sales strategies they teach are much the same.

Why the FDA Doesn't Crack Down

Health fraud is thriving today for several reasons. Throughout the nation, there is a keen interest in health, whether you call it fitness, wellness, or prevention. Many legitimate businesses and products ride this wave of interest—and the quacks do, too.

The fear of pesticides and other chemicals—good or bad—has added to people's interest in healthful, "natural" products. Also, many people view modern medical practice as too impersonal or too profit-oriented. That distrust has also played into the quacks' hands.

The FDA didn't create the health-fraud boom. But, clearly, fighting health fraud ranks low among the agency's priorities. In 1988, the agency had a budget of more than $477 million. Of that, approximately $2.4 million, or only about one-half of 1 percent, went primarily to combat quackery. Such FDA efforts against health fraud have consisted chiefly of public-education activities and civil actions (primarily injunctions and seizures of merchandise). In 1987, the agency recommended 12 seizures, one injunction, and no criminal prosecutions. The FDA has largely abandoned criminal prosecutions as an enforcement tool in health-fraud cases.

Some FDA officials have maintained that criminal cases are always more expensive and time-consuming than civil cases. But others disagree. They say that simple, carefully chosen criminal cases need not cost more—and can have a strong deterrent effect. These officials contend that the civil actions favored by the FDA don't deter. White-collar criminals, they say, view a product seizure as merely a cost of doing business.

In its earlier days, the FDA used criminal prosecution considerably more frequently than in recent years.

At the turn of the century, dangerous patent medicines were flourishing: sinus powders containing cocaine, "soothing syrups" sweetened with opium and morphine, painkillers loaded with toxic acetanilid, cancer cures spiced with radium. To halt abuses in the sale of medicine and to combat the even larger problem of adulterated food, Congress passed the Pure Food and Drug Act. But the 1906 law didn't give much enforcement authority to the agency that later became the FDA.

A 1937 tragedy caused Congress to give the FDA the enforcement power it had previously lacked. A small Tennessee drug company concocted a liquid variant of sulfanilamide, a legitimate medicine widely used to treat bacterial infections. This "Elixir Sulfanilamide" contained a then-untested toxic solvent, diethylene glycol. It killed at least 107 people.

That disaster led to the Food, Drug and Cosmetic Act of 1938. For the first time, manufacturers had to prove their drugs were safe before marketing them. The law also removed a major enforcement hurdle. Until then the FDA, to obtain criminal convictions, had to prove fraud—that a company intentionally committed violations, such as making false therapeutic claims about its product. Under the new law, the FDA could win convictions merely by showing that the violations had occurred.

Over the next 25 years, the FDA put some notable quack promoters out of business—and often behind bars. By 1957, the FDA reported that there were "more defendants ... serving jail sentences for false curative claims than at any time in FDA history."

In 1961, FDA Commissioner George P. Larrick boasted of his agency's progress against health fraud in general and nutrition quackery in particular: "The Food and Drug Administration has had considerable success in combatting food quackery in the courts. There have been some heavy fines and some prison sentences ... Such actions have had a marked deterrent effect."

Compare that to a 1982 speech on the same subject, prepared by Arthur Hull Hayes, then the FDA Commissioner: "'Okay,' you may be thinking, 'if [quackery] is such a big problem, what is the FDA doing about it?' The answer, I'm afraid, is not much. We are ... simply overmatched."

The FDA knows about the many products and marketing schemes that violate the law. But the agency no longer vigorously enforces the law. In the fight against health fraud, it seems that the FDA has pretty much thrown in the towel.

One authority has suggested that the FDA's deemphasis of quackery stems indirectly from another drug disaster—thalidomide, the tranquilizer that produced birth defects in the children of women who used it during pregnancy. The thalidomide tragedy prompted Congress to push the FDA into much closer supervision of prescription drugs. In 1962, Congress passed the Kefauver-Harris Amendments to the 1938 law. The amendments required that drugs must be proven not only safe (as required by the 1938 law) but also effective before the FDA could allow them on the market.

The amendment vastly increased FDA responsibility for dealing with legitimate drugs—both prescription and over-the-counter. The agency had also taken on increased responsibility in the realm of food safety. With these major new duties, the FDA's priorities shifted sharply.

In 1984, following a four-year review of health fraud, the House Subcommittee on Health and Long-term Care issued a 250-page report that particularly criticized the FDA's efforts. It found that the agency, "once a formidable force in controlling quackery," no longer met that description. "Considering the thousands of known quack remedies marketed each year, the potential for harm, and the billions [of dollars] lost yearly, [the FDA's] effort and the relatively few prosecutions generated by the FDA seem minimal at best," the report concluded.

The subcommittee introduced three bills that gave nutrition-supplement quacks quite a scare. The measures would have promoted consumer health education, increased criminal penalties for quackery, and created an interagency Strike Force to enforce those penalties. Vigorously attacked by those whose livelihood depends on peddling nutritional supplements as drugs in disguise, all three bills died.

Luis Treacy

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