The Federal Food, Drug, and Cosmetic Act (FDC Act) defines "drug" as any article (except devices) "intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or function of the body." All drugs and devices must be labeled with adequate directions for all intended uses. Labeling includes any written, printed or graphic material that accompanies a product. Intended use is determined by the facts at hand. Products not generally recognized as safe and effective by experts are considered "new." Improper labeling is called misbranding. Marketing a "new" or misbranded drug or device in interstate commerce is a federal crime. Marketing without adequate directions for use is also a federal crime.
When products are marketed improperly, the FDA may issue a warning letter specifying the violations and demanding to know how the problem will be corrected. If a warning is ignored, or if the FDA decides to begin with more forceful action, the agency can initiate court proceedings for a seizure, injunction, or criminal prosecution. Marketers of legitimate products usually correct the problems immediately. Marketers of quack products vary. Some comply, but many stall, attempt to obfuscate, and/or continue to do as much as they think they can get away with.
Warning letters issued since November 1996 are posted to a database on the FDA's web site that enables searches by company, subject, issuing office, date, and text content. Quackwatch plans to list most of the actions related to foods, dietary supplements, herbs, homeopathic remedies, and devices marketed with misleading health claims. The letters issued in 2001 are summarized below in reverse chronological order
Tobin Farms Velvet Antler, Stoneham, Mass. (12/12/01). Warning to company president Darrell L. Tobin that claims made for two products were illegal:
Jean's Greens, Norway, N.Y. (11/28/02). Warning to owner Jean Argus that it was illegal to claim that Forticel (brewed tea) and Forticel Mix is effective against cancers; ulcer and kidney disorders; digestive and intestinal problems; headaches; and crhonic and degenerative conditions.
ScienceBased Health, Corte Madera, Calif. (11/9/01). Warning to company CEO R. Scott Hunter that it was illegal to claim that MaculaRx and MaculaRx Plus were designed to address age-related degenerative conditions of the human eye and "may help reverse symptoms of macular degeneration and eye disorders."
Institute of Integrative Health, Knoxville, Tenn. (10/26/01). Warning to Dr. Dennis Jones that Colostrex, Colostrex-D, Echibiotic, COQ10SODase, Thistlex, Tagmatol, Marshmallow Herbal Cough Syrup, Lymphogen, and St. Easewort were being marketed with illegal statements or suggestions that they are useful against a large number of diseases and conditions.
Omni Neutraceuticals, Los Angeles, Calif. (10/16/01). Warning to company president and CEO Klee Irwin warning that it was illegal to claim that the glucosamine in Inholtra Joint Pain Plus Caplets could provide "healthy long-term joint support."
Kabco, Inc., Amityville, N.Y. (9/26/01). Warning to company president Saiful Kinria that his company's cholesterol Support Capsules could not be marketed as a dietary supplement. The product, made from red yeast rice powder, contained a significant amount of lovastatin (the active ingredient in the cholesterol-lowering prescription drug Mevacor). For that reason, the letter stated, marketing is illegal without FDA approval as a drug.
Ovimmune, Columbus, Ohio (7/24/01). Warning to company president Marilyn A. Coleman, PhD, that it is illegal to market eggs containing antibodies produced by immunization of chickens with investigational vaccines. The letter objected to claims on the company's web site that the eggs can replace the immunity lost during AIDS, transplants, burn, and cancer; ameliorate the effects of routine infections; and "potentially treat all known diseases."
Feel Good for Life, Inc., Lakewood, Colorado (7/20/01). Warning to company president Jason R. Zinn that it was illegal to claim that its magnetic products were effective against cancer, viral infections, bacterial infections, parasites, heart disease, broken bones, severe burns, cuts, ulcers, diabetic peripheral neuropathy, fibromyalgia, phlebitis (blood clot), bronchitis, menstrual cramps, carpal tunnel syndrome, arthritis, degenerative joint conditions, allergies, obesity, high blood pressure, habitual headache, multiple sclerosis, cerebral palsy, polio, postpolio syndrome, and "all the other crippling and killer diseases known to man." The letter also objected to claims that the products could speed wound healing; improve circulation; change the migration of calcium ions; alter pH, enzyme activity, and hormone production; enhance the lymphatic system,;affect pain receptors,;and untrap trapped blood proteins.
VF Works, Palm Harbor, Florida (7/20/01). Warning to company president and CEO John Postlewaite, D.C., that the company had not complied with various quality control the law requires for device manufacturers. (The company manufactures videofluoscopes that are promoted to medical doctors and chiropractors for questionable purposes.)
Biomax Formulations, San Diego, Calif. (7/13/01). Letter to Janes E. Davidson, proprietor, and Lance C. Griffin, general manager, warning that Colloidal Silver, AsthmaEnd, BioEnergy Spray, DiaBeatEze Spray, HartGard Spray, PumpUp, Pure Focus, Slumber Spray, DermaClear Spray, and BioDerm Spray were being marketed with illegal claims that they are useful for treating hundreds of health problems.
Rich Nature Neutraceutical Laboratories, Lynnwood, Wash. (6/20/01) Warning to company president Richard J. Zhang that the company's CholesCare could not be marketed as a dietary supplement. The product, made from red yeast rice powder, contained a significant amount of lovastatin (the active ingredient in the cholesterol-lowering prescription drug Mevacor). For that reason, the letter stated, marketing is illegal without FDA approval as a drug.
Neutraceutical International Corporation, Park City, Utah (6/19/01). Warning to company chairman and CEO Frank W. Gay that the company's KAL cholesterol Defense, Soloray Red Yeast Rice, and Soloway Guggul & Red Yeast Rice could not be marketed as dietary supplements because they contained a significant amount of lovastatin (the active ingredient in the cholesterol-lowering prescription drug Mevacor). For that reason, the letter stated, marketing is illegal without FDA approval as a drug.
Nature's Sunshine Products, Provo, Utah (6/19/01). Warning to company president and CEO Daniel Howells that the company's Cholest-Reg could not be marketed as a dietary supplement because they contained a significant amount of lovastatin (the active ingredient in the cholesterol-lowering prescription drug Mevacor). For that reason, the letter stated, marketing is illegal without FDA approval as a drug.
Good for You America, Syracuse, N.Y. (6/7/01). Warning to company owner Craig E. Sallin that it was illegal to claim that its prodict Maca Manna would provide hormonal balance and rejuvenation, and protect against various infections, and was useful against male impotence, infertility disorders, osteoporisis, memory disorders, prostatitis, and seberal other problems.
Natural Health Consultants, Vallejo, Calif (6/7/01). Warning to Gerald T. Wolke, R.Ph. that the Bioscan 2010, a device purported to determine the likelihood of developing a serious disease, is unregistered and unapproved and therefore illegal to sell in the United States.
OraLabs, Inc., Engelwood, Calif. (6/4/01). Warning to company president and CEO Gary H. Schlatter that the company's Cholesterx could not be marketed as a dietary supplement. The product, made from red yeast rice powder, contained a significant amount of lovastatin (the active ingredient in the cholesterol-lowering prescription drug Mevacor). For that reason, the letter stated, marketing is illegal without FDA approval as a drug.
Barlean's Organic Oils, Ferndale, Wash. (6/4/01). Warning to company president Bruce D. Barlean that 23 flax oil, borage oil and other organic seed oil products were being marketed with illegal claims that they are effective against various serious diseases. The illegal claims were made on the company's Web site, in it's "Product Selection Guide, and in various reprints and other reports that the FDA consodered to be labeling.
SnorBan (UK), West Sussex, England (5/15/01).Warning to company president Joe Hepworth that its Snorban mouthpiece was an unapproved medical device that could not be legally marketed in the United States.
Maypro Industries, Purchase, N.Y. (5/8/01). Warning to company president Steve Yamada that the company's bulk red yeast rice powder could not be marketed as a dietary supplement because it contained a significant amount of lovastatin (the active ingredient in the cholesterol-lowering prescription drug Mevacor). For that reason, the letter stated, marketing is illegal without FDA approval as a drug.
Grieshaber KG, Schiltach, Germany (4/25/01).
BioEclectic Research, Santa Rosa, Calif. (4/25/01).
Letters to Grieshaber director Gehrhard F.P. Braun and BioEclectic's CEO Scott Moyer noting that 13 devices they were marketing were unapproved medical devices that could not be legally marketed in the United States. The devices were:
(The Bioscan 2010 and the various Vega devices are frauds that have no diagnostic or therapeutic value.)
Norbec, Rancho Murieta, Calif. (4/3/01). Warning to company president Michael King that its Noiseless Antisnoring mouth guard was an unapproved medical device that was illegal to makret in the United States without FDA clearance.
Juice Harvest, San Bernardino, Calif. (4/2/01). Warning to company president James S. Rosenberg that claims made for four of its juice products were illegal:
Research, Incorporated, Phoenix, Arizona (3/29/01).
Warning to company president Darren Starwynn that the company's
Web site was making illegal claims directly and/or through references
and testimonials for its Acutron Mentor TENS Device. The
claims included healing acceleration of muscle and joint problems;
muscle mass enhancement; meridian therapy, analgesic nerve block;
reducing the need for surgery of the foot, knee, back, and TMJ;
and effectiveness against fibromyalgia, and Reflex Sympathetic
Dystrophy (RSD). The references and testimonials make claims that
imply therapeutic benefits relevant to facial rejuvenation; Bell's
Palsy; relief of headaches, migraines; sinusitis; tonification
of the sense organs; greatly improved skin and muscle tone; relief of visceral pain, somatic pain, phantom pain of amputation; rheumatoid arthritis; edema; contusions and sprains; myofascial pain; shoulder capsulitis; elbow tendinitis; meniscus injuries; non-surgical face lifts; HIV-related peripheral neuropathy; treatment of pre- and postsurgical carpal tunnel patients; diabetic extremity skin ulcers, neurogenic urinary bladder incontinence, severe disc injury, sciatica, broken bones; open wounds, and low back or wrist pain.
Nutrition Dynamics, Seguin, Texas, (3/12/01). Warning to company president Winston G. Morrow, D.C., that the company was making illegal claims that Valerian Root, Chinese Garlic, Coenzyme Q10, Optimum Health Essentials, and Nux Vomica Homaccord could prevent and/or treat against long lists of diseases and conditions.
Vitamin Classics, Calabasas, Calif. (2/21/01). Warning to company CEO Greg Rubin that two Burn That Fat fruit drinks were being marketed with the illegal claim that they were " formulated from a select blend of herbs and chromium picolinate to lower cholesterol."
Bioray Inc., Birmingham, Alabama (2/12/01). Warning to company president Lin Kenny that its Bioray Sound and Light Generator (a Rife device) was being illegally marketed as a diagnostic and therapeutic device.
Dixie Health, Marietta, Georgia (1/23/01). Warning to company president Ole C. Krarup that its Progestone 900 skin cream was being marketed with illegal claims in product literature that wild yam root was useful for treatying internal colic, diverticulitis, rheumatoid arthritis, muscular rheumatism, cramps, intermittent claudication, and ovarian and uterine pain.
Ocean Spray Cranberries, Lakevill-Middleboro, Mass. (1/19/01). Warning to company president Robert Hawthorne that its grapefruit juice products were being marketed with unauthorized claims that vitamin C is "associated with a reduced risk of chronic diseases such as cancer, cardiovascular disease and cataracts." The letter also noted that certain Web site claims "not only overstate any possible benefit associated with grapefruit juice consumption but also understate the very real risks associated with concomitant use of certain drugs and grapefruit juice."
Age Less Products, Albemarle, N.C. (1/16/01). Warning to company president P. Wayne Morris that its Curetage System was being marketed with illlegal claims that it "promotes the growth of thick healthy hair" and that "It's the 'CURE' Not Just The Prevention" of thinning hair.
Hormone Shop. Pararie Village, Kansas (1/9/01). Letter to owner Norman E Rose noting that claims made for four products were illegal: