By William M. London
I have stories to share with you about dietary supplements spiked with approved and unapproved drugs, but I haven’t found any stories to share with you about approved drug products spiked with supplements.
What does that tell you about dietary supplements?
In the United States, under the Dietary Supplement and Health Education Act of 1994 (DSHEA), dietary supplements are supposed to contain “dietary ingredients” alone or in combinations. Ingredients can include vitamins, minerals, amino acids, enzymes, tissues from organs/glands, several other substances that are supposedly dietary, and botanical preparations—which, by their nature, contain a variety of untested chemicals in amounts that vary significantly from extract to extract.
While pharmaceutical companies are required to put chemicals through a rigorous laboratory and clinical testing process before the federal Food and Drug Administration (FDA) will consider them for approval as drug products, you don’t need any premarket approval in order to sell untested combinations of many different chemicals as dietary supplements. You don’t need to do any testing to establish that a dietary supplement product you want to bring to market is safe and effective for an intended health-related purpose. You can legally label your supplement product with claims about: (1) nutrient content (which often are inaccurate), (2) health (including dubious assertions such as “supports immune health” or “supports digestive health”), and (3) maintaining normal body structure or function (e.g. “promotes healthy joints and bones”). You just have to:
- Avoid labeling the product as a treatment, prevention or cure for a specific disease or condition.
- Label the product appropriately: include a descriptive name; indicate that it’s a “supplement;” provide the name and place of business of the manufacturer, packer, or distributor; give a complete list of ingredients and the net contents of the product (and don’t expect regulatory actions if the dosage of ingredients doesn’t match what the label says).
- Notify the federal Food and Drug Administration (FDA) if your supplement contains a dietary ingredient not sold in the U.S. before DSHEA was passed and explain why the ingredient ought to be safe (with no need to test the ingredient for safety or effectiveness for any intended purpose).
- Include on the label when making structure/function claims a disclaimer that Peter A. Lipson, M.D. has called the Quack Miranda Warning: “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.”
- Avoid false advertising.
By taking those five precautions, marketers can legally sell chemical concoctions (that should be viewed as drugs) as dietary supplements. And they often get away with selling unsafe chemical concoctions without taking all those precautions. But when dietary supplement companies authorize or allow ingredients (such as imports from China) not permitted under DSHEA to be included in product formulations, they leave themselves open to regulatory actions.
Healthy Life Chemistry By Purity First B-50
FDA conducted laboratory analysis of the supplement Healthy Life Chemistry By Purity First B-50, which was sold on various websites and in retail stores, and found that it contained two potentially harmful, anabolic steroids—methasterone, a controlled substance, and dimethazine. The analysis was carried out after FDA received 29 reports of adverse incidents associated with use of the product and one hospitalization. Reported problems included:
- muscle cramping
- myalgia (muscle pain)
- abnormal laboratory findings for liver and thyroid function, and cholesterol levels
- unusual hair growth and missed menstruation among females
- impotence and findings of low testosterone among males
In August 2013, following a July 2013 warning issued to consumers by FDA, the manufacturer, Mira Health Products Ltd., recalled all the products manufactured between June 1, 2010 and May 31, 2013.
Inspections of Mira’s manufacturing facility revealed that Mira failed to ensure that “components, dietary supplements, packaging and labels were not mixed-up, contaminated or deteriorated.”
On July 1st, 2014, the Consumer Protection Branch of the Justice Department’s Civil Division together with the U.S. Attorney’s Office for the Eastern District of New York filed a complaint on behalf of the United States against Mira, its chief operating officer, Michael S. Ragno Sr., and its quality assurance manager, Michael S. Ragno Jr., all of Farmingdale, New York. United States District Court Judge Joseph F. Bianco of the Eastern District of New York entered the consent decree for permanent injunction against Mira Health Products Ltd. on July 1, 2014. Representatives of Mira informed the court that the company is out of business.
The New York Daily News reported that in June 2014, self-proclaimed diet expert Nikki Haskell, who for decades has promoted weight-loss nostrums, was fined $60,000 for selling her StarCaps, marketed as “a natural blend of papaya and garlic from the higher Andes of Peru” adulterated with the drug bumetanide, a diuretic used in the treatment of congestive heart failure that has potentially serious side effects. Earlier this year she pleaded to misdemeanor charges. Her company is now reportedly defunct.
In 2010, the New York Times described some of her earlier legal troubles with StarCaps, which celebrities including Atlanta Falcons defensive tackle Grady Jackson and talk-show host Kathy Lee Gifford had publicly praised.
On April 14, 2014, FDA sent a warning letter to Matt Cahill of Driven Sports, Inc. of Franklin Square, NY for failing to conduct a promised recall of CRAZE after it was found to contain N,α-diethylphenylethylamine and other unapproved new dietary ingredients that are chemically similar to methamphetamine.
As noted in a USA Today investigation, CRAZE, marketed as a pre-workout powder offering the promise of “endless energy” was named “New Supplement of the Year” by bodybuilding.com in 2012. Apparently, bodybuilding.com disregarded Cahill’s record of criminal activity and marketing of harmful products as described in a USA Today investigative report.
DR. LARRY’s Tranquility
In February 2014, Health and Beyond of Boca Raton, Florida voluntarily recalled all lots of DR. LARRY’s Tranquility, a dietary supplement found in FDA tests to contain Doxepin (an antidepressant drug) and Chlorpromazine (an antipsychotic drug). According to a USA Today investigative report, Larry LeGuinn (DR. LARRY) had to give up his Florida chiropractor license in 2010 after being charged with grand theft and insurance fraud in his treatment of auto accident victims. In addition to Leguin, who later pleaded no contest to an amended charge of misleading solicitation of payments, USA Today described four other entrepreneurs with criminal histories who went on to selling tainted supplements.
Eleven Products Manufactured by Hi-Tech Pharmaceuticals
In 2012, FDA issued warning letters to companies notifying them that products containing DMAA (1, 3-dimethylamylamine, methylhexanamine or geranium extract) need to be taken off the market or reformulated without this “natural stimulant” which can elevate high blood pressure and lead to heart attacks.
Most companies that were warned complied. However, in November 2013, U.S. Marshals seized dietary supplements manufactured and held by Hi-Tech Pharmaceuticals, Inc., located in Norcross, Ga., after FDA investigators found they contained DMAA.
The names of the supplement products were: Black Widow, ECA XTREME, FASTIN, FASTIN-XR, Lipodrene, Lipodrene HARDCORE, Lipodrene XR, Lipodrene XTREME, LIPOTHERM, Stimerex-ES, and YELLOW SCORPION. Several of these names suggest a fat-burning effect.
Here’s a rule of thumb: The more suggestive the name of a dietary supplement, the more you should be wary of it.
OxyElite Pro, Jack3d, and VERSA-1
It took legal action by FDA before USPlabs, LLC of Dallas, Texas voluntarily destroyed more than $8 million worth of its DMAA-containing products OxyElite Pro and Jack3d on July 2, 2013.
Although the company agreed to stop producing DMAA-containing supplements, it went on to market OxyElite Pro Super Thermo capsules, OxyElite Pro Ultra-Intense Thermo capsules, OxyElite Pro Super Thermo Powder, and Raspberry Lemonade OxyElite Pro Super Thermo Powder, and VERSA-1 with a problematic substitute ingredient. All of these products contained the unapproved “new dietary ingredient” aegeline, a synthesized version of a natural extract from the Bael tree. By May of 2013, OxyElite Pro products were epidemiologically linked to cases of severe hepatitis in Hawaii. In November 2013, FDA announced that these products were associated with “dozens of cases of acute liver failure and hepatitis, including one death and illnesses so severe that several patients required liver transplants.”
Here’s another rule of thumb: A dietary supplement that includes “super” or “ultra” in its name is likely to be super-ultra dreck.
Reumofan Plus and Reumofan Plus Premium
In August 2012, FDA warned consumers about Reumofan Plus and Reumofan Plus Premium, sold in retail outlets, flea markets, and popular Internet sites as dietary supplements for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions because they contained prescription drug ingredients: dexamethasone, diclofenac sodium, and methocarbamol. The products were manufactured in Mexico by Riger Naturals. The FDA reported that three distributors of Reumofan Plus products in the U.S. issued recalls.
Yet another rule of thumb: If a dietary supplement is sold in a premium version and a non-premium version, premium means nothing other than more expensive.
Magic Power Coffee
In June 2010, FDA warned consumers that this instant coffee promoted for sexual enhancement as an “all natural dietary supplement” contains a chemical similar to the active ingredient in the prescription drug Viagra and that the chemical may interact with prescription drugs.
One more rule of thumb: If a product is named magic, it’s not.
Yes, this product was marketed for male sexual enhancement. After being informed by FDA that laboratory analysis revealed the product contained sulfoaildenfil, an analogue of sildenafil (Viagra), an FDA-approved drug used as treatment for male Erectile Dysfunction (ED), RockHard Laboratories announced on November 9, 2009 that it was conducting a voluntary recall.
Rockhard Weekend is still on the market. Its label indicates that it contains 15 mg of niacin and an 850 mg proprietary blend of l-arginine, Korean ginseng, gingko biloba, maca root extract. I’m surprised that magic isn’t part of the product name.
The Bottom Line
FDA maintains a database of dietary supplements that have been found to be tainted with drugs. The database, which includes product names, companies, hidden ingredients, and product categories, currently has 546 products listed. According to FDA, this represents a small fraction of potentially hazardous dietary supplements with hidden ingredients marketed to consumers. Many serious adverse events are reported to poison control centers and never make it to FDA.
FDA advises consumers to pay special attention to the risk of dietary supplements being tainted when they are marketed for sexual enhancement, weight loss, diabetes, and bodybuilding. Currently, FDA’s Tainted Weight Loss Products index identifies about 90 products and its Tainted Sexual Enhancement Products index identifies about 70.
Athletes who use dietary supplements to improve athletic performance are frequently warned that they run the risk of testing positive for substances not permitted in competition. They should be wary of chiropractors, trainers, and sports medicine practitioners who dispense supplements to athletes. If a dietary supplement comes with a warning about testing positive for performance-enhancing drugs, they should take the warning seriously.
Warning signs of tainted supplement products include marketing primarily in a foreign language and claims of:
- being an alternative to FDA-approved drugs
- having effects similar to prescription drugs
- being a legal alternative to anabolic steroids
- rapid or long-lasting sexual enhancement effects
And just because a dietary supplement isn’t tainted with drugs doesn’t mean it’s as pure as its buyers expect. In the 2010 Government Accountability Report, almost all herbal products tested were contaminated with lead and many were contaminated with pesticide residues in excess of legal limits.
When dietary supplements are not adulterated, they are still in a problematic product category. The idea that the Quack Miranda Warning discourages consumers from using them to prevent, mitigate, treat, or cure a health problems other than real nutritional deficiencies is nonsense. They are de facto unapproved, inadequately tested drugs sold in disguise.
DSHEA has been a disaster for consumer protection and a boon to promoting nostrums as dietary supplements. Enacting the Dietary Supplement Labeling Act introduced in 2013 by Senators Dick Durbin (D-IL) and Richard Blumenthal (D-CT) would improve consumer protection, toughen registration and labeling requirements for dietary supplements, and make the dietary supplement industry (Big Placebo) and its mouthpiece of doublespeak, the Council for Responsible Nutrition, very, very sad.
William M. London is a specialist in the study of health-related superstition, pseudoscience, sensationalism, schemes, scams, frauds, deception, and misperception, who likes to use the politically incorrect word: quackery. He is a professor in the Department of Public Health at California State University, Los Angeles; a co-author of the college textbook Consumer Health: A Guide to Intelligent Decisions (ninth edition copyright 2013); the associate editor (since 2002) of Consumer Health Digest, the free weekly e-newsletter of Quackwatch; one of two North American editors of the journal Focus on Alternative and Complementary Therapies; co-host of the Quackwatch network’s Credential Watch website; a consultant to the Committee for Skeptical Inquiry. He earned his doctorate & master’s in health education, master’s in educational psychology, baccalaureate in biological science, and baccalaureate in geography at the University at Buffalo (SUNY), and his master of public health degree from Loma Linda University. He successfully completed all required coursework toward a Master of Science in Clinical Research from Charles R. Drew University of Medicine and Science, but he has taken way too much time writing up his thesis project: an investigation of therapeutic claims and modalities promoted by chiropractors in the City of Los Angeles.