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FDA Seizes Misbranded Supplement Products

Stephen Barrett, M.D.

On February 13, 2003, at the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized products from Global Source Management & Consulting, Inc., in Sunrise, Florida. The seizure, which encompassed 450 bottles and 57,000 bulk capsules worth nearly $19,000, was made because the FDA determined that these products were being marketed with illegal claims that included preventing cancers and treating arthritis. After investigating the firm's marketing practices, the agency warned that many of its products made drug claims that subject them to be regulated as drugs. During subsequent inspections, despite the warnings, FDA inspectors obtained copies of product labels and promotional catalogs that contained the illegal claims [1].

The seizure included about 20 products that were marketed under the names Vitamin Hut and RX for Health through retail booths and by mail order. The food and drug laws do not permit dietary supplements to make claims that the products will cure, mitigate, treat, or prevent disease. Moreover, the labeling must be truthful and not misleading. Because these seized products made disease claims on the labels and in promotional catalogs, FDA considers them to be unapproved new drugs. Before an unapproved new drug product may be marketed, it must be shown to be safe and effective and approved by FDA. Drug product labeling must also include adequate directions for use, which the seized products' labeling did not provide [1].

The company was founded in 1991 by Gary R. Dubin, who has BS degrees in chemistry and zoology and an MBA. It operates many Vitamin Hut retail outlets in high-volume malls, airports, and train stations. Its Web site states:

Global offers information on thousands of herbs, vitamins, minerals, biologicals and a variety of alternative care products as well as over a hundred disorders. This information is provided on the Internet from the leading experts in the field through excerpts taken from health books [2].

"Leading experts"? Are they kidding? Clicking the site's link for "Disorders Information" brings the reader to a "Supplements Relating to Disorders" table that contains links to information on "disorder descriptions, characteristics or symptoms; causes, and complementary or alternative treatments" for AIDS, cancer, multiple sclerosis, inflammation, kidney problems, tumor, ulcers, and more than 100 other diseases and conditions.

Supplements Relating to Disorders
Acidosis
Acne
ADD
ADHD
Age Spots
Aging
AIDS
Alcoholism
Allergies
Alzheimer's Disease
Anemia
Anxiety
Arteriosclerosis
Arthritis
Asthma
Backaches
Bad Breath
Bladder Infection
Blood Pressure
Bone Spurs
BPH
Bronchitis
Cancer
Candidiasis
Canker Sores
Cardiovascular Problems
Carpal Tunnel Sydrome
Cataracts
Cellulite
Cholesterol
Chronic Fatigue Syndrome
Circulatory Problems
Cirrhosis
Colds
Cold Sores
Constipation
Cramps
Crohn's Disease
Cystic Fibrosis
Depression
Diabetes
Digestion Disorder
Dizziness
Dry Skin
Edema
Emphysema
Eye Problems
Fatigue
Fibromyalgia
Flu
Fungal Infection
Gas - Flatulence
Glaucoma
Gout
Gum Disease
Hair Loss
Headache
Hearing Problems
Heart Problems
Heartburn
Heel Spur
Hemorrhoids
Hepatitis
Herpes Virus Infection
Hot Flashes
Hyperactivity
Hypertension
Hypoglycemia
Impotence
Indigestion
Inflammation
Insomnia
Kidney Problems
Lactose Intolerance
Libido
Liver Disease
Macular Degeneration
Memory Loss
Menopause
Menstrual Cramps
Migraine
Motion Sickness
Multiple Sclerosis
Muscle Cramps
Muscle Disorder
Nail Problems
Narcolepsy
Nausea
Nervousness
Neuritis
Nicotine Dependency
Night Blindness
Obesity
Osteoarthritis
Osteoperosis
Periodontal Disease
PMS
Prostate Problems
Psoriasis
Retinopathy
Rheumatoid Arthritis
Ringing in Ears
Senility
Shingles
Sleep Problems
Smoking Dependency
Sore Throat
Stress
Thyroid Problems
Tonsillitis
Toxicity
Tumor
Ulcers
Vaginitis
Varicose Veins
Vertigo
Water Retention
Weight Problems
Yeast Infection

Clicking any link brings up a page containing a description of the condition plus information about causes and treatments taken from the second edition of Prescription for Natural Healing, by James F. Balch, Jr., MD, and Phyllis A. Balch, CNC [4] James F. Balch, Jr., is a urologist who practiced in Indiana but is no longer listed as licensed in the state medical board's directory, so I assume that he now devotes his time to writing. In a predecessor book published in 1987, he described how Phyllis had counseled hundreds of his patients and used hair analysis and cytotoxic testing as a guide [5]. (Both are quack tests [6,7].) During the mid-1990s, James was also associated with A. Glenn Braswell, a mail-order retailer who flooded the country with brochures (some accompanied by letters under Balch's name) for dubious herbal and supplement products [8].

The book's back cover describes Phyllis Balch as "a certified nutritional consultant who received her certification from the American Association of Nutritional Consultants and has been a leading nutritional consultant for almost two decades." She also founded "Good Things Naturally,"a health-food store in Greenfield, Indiana. AANC is a thoroughly disreputable organization whose only membership requirement has been payment of a $50 fee and whose "CNC" designation is based on passage of an open-book examination based mainly on the contents of quacky books [9]

About 450 of the book's 608 pages provide an A-to-Z compendium of health problems and the authors' lists of nutrients that are "essential," "very important," "important, "or "helpful." Some lists contain more than thirty items. The authors recommend daily dosages of 3,000 mg or more of vitamin C for everybody ("for maintaining good health") and higher doses (up to 20,000 mg/day "under a doctor's supervision") for dozens of problems. They also recommend daily dosages of emulsified vitamin A ranging from 50,000 to 100,000 IU for many conditions and 75,000 IU for "maintaining healthy eyes." [4:258] The vitamin C dosages are high enough to produce severe diarrhea; and the vitamin A dosages are high enough to cause liver injury. From a scientific viewpoint, the book's advice is loony from beginning to end, but the dietary supplement industry loves it because it enables retailers to refer their customers to an "authoritative" source of advice for nearly every problem the customer may have [10].

In 1993, posing as potential customers, FDA agents visited health food stores in 20 communities and asked (a) "What do you sell to help high blood pressure?" (b) "Do you have anything to help fight infection or help my immune system?" and (c) "Do you have anything that works on cancer?" In response to about 20% of the queries, the retailer looked up the answer in Prescription for Nutritional Healing or advised the agent to refer to or purchase it [11].

The 1994 Dietary Supplement Health and Education Act (DSHEA) permits sellers to provide third-party literature that contains "nutritional support" claims that are "truthful and not misleading." To be legal under DSHEA, a "nutritional support" statement must not be a "drug" claim. In other words, it should not suggest that the product or ingredient is intended for preventing or treating disease.

I do not believe that Global's use of the book is legal. The information it provides is taken from the book's nutrient tables and herbal advice, which give products and doses for preventing and/or treating diseases. Global's cancer page, for example, recommends: coenzyme Q10 ("improves cellular oxygenation"); garlic ("enhances immune function"); melatonin ("a powerful antioxidant that also aids sleep"); natural beta-carotene ("needed by all cells for repair and rebuilding"); selenium ("powerful free radical scavenger. aids in protein digestion"); shark cartilage ("for cancer treatment"); vitamin A (up to 100,000 IU/day); vitamin B complex; vitamin C ("powerful anticancer agent" -- 5,000 to 20,000 milligrams/day); vitamin E; grape seed extract; kelp or seaweed; multi-mineral complex with calcium, magnesium and potassium; multivitamin complex; dandelion; echinacea; green tea; red clover; suma; and cat's claw ("enhances immune function and has anti-tumor properties"). Green tea may have some value as a preventive, but the rest of this list has not been proven useful for prevention or treatment -- and beta-carotene supplements may even increase cancer risk [12,13].

It seems to me that the claims on Global's Web site are far more blatant than those for which the FDA took regulatory action. Since the site is a form of advertising, I believe that the Federal Trade Commission also has jurisdiction and should act.

References

  1. FDA seizes dietary supplements. FDA news release, Feb 13, 2002.
  2. Company profile. Global Source Management Web site, accessed Feb 14, 2003.
  3. Supplements Relating to Disorders.
  4. Balch JF, Balch PA. Prescription for Nutritional Healing. Garden City Park, NY: Avery Publishing Group, 1997.
  5. Barrett S. Be Wary of Gero Vita, A. Glenn Braswell, and Braswell's 'Journal' of Longevity. Quackwatch, January 21, 2003.
  6. Balch JF Jr., Nutritional Outline for the Professional and the Wise Man. Greenfield, IN: Good Things Naturally, 1987.
  7. Barrett S. Commercial Hair Analysis: A Cardinal Sign of Quackery. Quackwatch, Jan 5, 2001.
  8. Barrett S. Cytotoxic testing. Quackwatch, Oct 1, 1997.
  9. Barrett S. The American Association of Nutritional Consultants: Who and What Does It Represent? Quackwatch, Feb 15, 2003.
  10. Barrett S. Herbert V. The Vitamin Pushers: How the "Health Food" Industry Is Selling America a Bill of Goods. Amherst, NY: Prometheus Books, 1994.
  11. Unsubstantiated Claims and Documented Health Hazards in the Dietary Supplement Marketplace. Rockville, MD: U.S. Food and Drug Administration, 1993.
  12. Omenn GS and others. Effects of a combination of beta carotene and vitamin A on lung cancer and cardiovascular disease. New England Journal of Medicine 334:1150-1155, 1996.
  13. Why megadoses of beta carotene may promote lung cancer. USDA Agricultural Research Service Food & Nutrition Research Briefs, Jan 1999, p. 1.

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This article was posted on February 15, 2003.