Persistent encounters of supplement fraud from illegally spiked products has prompted the Food and Drug Administration (FDA) and industry associations to post website warnings of health hazards, including death, associated with some dietary supplements.
Tainted products that contain hidden drugs and other dangerous substances are marketed by unscrupulous manufacturers who willfully ignore industry regulations and the safety of users. Consumers for arthritis, weight loss, body building, sexual enhancement, and other issues are targeted most often.1,2
An FDA supplement fraud webpage, Tainted Arthritis/Pain Products provides public notification links to nine arthritis supplement recalls between August 22, 2013 and October 30, 2017 for containing dangerous hidden pharmaceuticals. When accessed, the most recent involved the dietary supplement, Double Caulis Plus, promoted for joint, gout and back pain. An FDA laboratory analysis confirmed it contained dexamethasone, a corticosteroid commonly used to treat inflammatory conditions. As part of the warning, the FDA outlined side effects from the drug and urged unsuspecting consumers to consult a physician for supervised withdrawal from use. 3,4
Fraudulent supplements have captured the attention of federal regulators because of their public safety issues. The FDA site Beware of Fraudulent Dietary Supplements warns consumers that tainted products being marketed as dietary supplements actually contain hidden or deceptively labeled ingredients, such as:
“These products are masquerading as dietary supplements—they may look like dietary supplements, but they are not legal dietary supplements,” says Michael Levy, director of FDA’s Division of New Drugs and Labeling Compliance. “Some of these products contain hidden prescription ingredients at levels much higher than those found in an approved drug product and are dangerous.”2
FDA has received numerous reports of harm from supplement fraud associated with the use of these products, including stroke, liver injury, kidney failure, heart palpitations, and death.
In addition to arthritis, rheumatoid arthritis and gout, fake supplements spiked with pharmaceuticals are promoted most often for weight loss, sexual enhancement, and bodybuilding, according to the FDA.
“We need consumers to be aware of these dangerous products and learn how to identify and avoid them,” says Levy.2
Supplement fraud is also the deceptive sale or advertising of products that claim to be effective against medical conditions or otherwise beneficial to health, but which have not been proven safe and effective for those purposes, according to the webpage, FDA 101: Health Fraud Awareness.5
On this awareness page, the FDA refers to supplement fraud as “health scams”, which it says wastes billions of consumer dollars each year and can lead patients to delay proper treatment and cause serious—even fatal—injuries.
“Since the 1990s, peddlers of fraudulent ‘health’ products have used the Internet as a primary tool to hawk their wares. This has kept the FDA and other agencies busier than ever in protecting the public from health fraud,” the FDA said.
Another federal agency, the U.S. Federal Trade Commission (FTC), says consumers spend about $2 billion annually on unproven arthritis remedies that are not backed by adequate science.5 (For current, accurate information on natural arthritis treatments proven by clinical studies, visit this 'pain trio' page).
In addition to arthritis, other common types of health fraud include cancer, HIV/AIDS, weight loss, sexual enhancement, body building and diabetes, according to the FDA Health Fraud Awareness page.5
When supplements that claim to treat disease are not documented sufficiently by clinical studies, the FDA considers them to be drugs for making claims that only an approved pharmaceutical can make. The agency labels these products as bogus dietary supplements.
Dietary supplements, in general, are not FDA-approved. Under the Dietary Supplement Health and Education Act (DSHEA) of 1994, dietary supplement firms do not need FDA approval prior to marketing their products. It is the company’s responsibility to make sure its products are safe and that any claims are true. 6,7
Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited by regulation from marketing products that are adulterated or misbranded. That means that these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of the DSHEA, including its counterpart, the current Good Manufacturing Practices (cGMP) rules. FDA is responsible for initiating corrective action against any adulterated or misbranded dietary supplement product after it reaches the market. 6,7
For example, an arthritis supplement on a store shelf or sold on a website does NOT mean it is safe or effective, according to the FDA. When safety issues are suspected, FDA must investigate and, when warranted, take steps to have the product removed from the market. However, it is much easier for a firm to get a product on the market than it is for FDA to take a product off the market. 2
The FDA does not analyze dietary supplements for arthritis, rheumatoid arthritis, gout or any other purpose, before they are sold to consumers—they never even see the finished product. The FDA says it “has limited resources to analyze the composition of dietary supplements” through spot checks of products for sale.7
While the FDA is aware that fraudulent supplements exist on the market currently, it “focuses resources first on public health emergencies and products that may have caused injury or illness. Enforcement priorities then go to products thought to be unsafe or fraudulent or in violation of the law. The remaining funds are used for routine monitoring of products pulled from store shelves or collected during facilities inspections of manufacturing firms.”7
Leading trade associations from the dietary supplement industry and the U.S. Anti-Doping Agency (USADA) jointly expressed support of the October 31, 2017 warning against using illegal Selective Androgen Receptor Modulators (SARMs) in sports nutrition products marketed for body-building, according to the Council for Responsible Nutrition.1
The Natural Products Association (NPA), along with five other dietary supplement trade associations, authored a news release December 3, 2015 in support of reorganization within the FDA to help increase the agency’s abilities to take more aggressive enforcement of perpetrators of supplement fraud.
The trade associations also expressed their concern over “blatant” criminal activity in the supplement industry and that elevating the Division of Dietary Supplement Programs (DDSP) to an official FDA Office would help increase FDA’s visibility and attention for supplement safety and compliance measures. The NPA represents the entire natural products industry 8
Speakers from the FDA’s Division of Drug Information (DDI) Webinar Series stressed that fraudulent supplements when discovered to contain hidden pharmaceutical drugs, lose their classification as 'dietary supplements', according the article by Steve Myers in Natural Products Insider, November 21, 2017. 9
The webinar was aimed at current and prospective doctors, nurses and pharmacists. “’Tainted supplements’ is not the correct term for products adulterated with active pharmaceutical ingredients (APIs),” said one of the speakers, Capt. Jason Humbert, R.N., national health fraud coordinator in FDA’s Office of Regulatory Affairs. “These are not considered dietary supplements, but drugs pretending to be dietary supplements,”. he noted, while adding the practice of selling tainted products “defies logic.”
The list of adulterants found in various supplement fraud categories can range from bodybuilding compounds (e.g. anabolic steroids, analogues, aromatase inhibitors), prescription drugs, corticosteroids and banned/illicit drugs, according to the article.
The webinar also featured Nicole Kornspan, M.Ph., consumer safety officer at FDA, who said while weight-loss, bodybuilding and sexual enhancement products top the list of supplement fraud, “adulteration crosses many health targets, including arthritis, diabetes, chronic pain, hypertension, high cholesterol and hypothyroidism.”9
When the FDA does catch a company peddling tainted products, a class 1 recall is almost always issued. Many supplement recalls involve arthritis-related products. These are termed voluntary recalls requested by the FDA, which then oversees the recall strategy and implementation. “We hardly ever, if never, receive or are notified by a firm selling tainted products that ‘I just realize my products are tainted and I need to recall those;’ instead this is the agency approaching the firm to conduct a voluntary recall,” Humbert was quoted in the article.9
The glucosamine market over the past decade has exhibited steady growth globally, driven by a growing aging population, and promotions by companies regarding the health benefits of glucosamine as a vital dietary supplement for joint health conditions like knee osteoarthritis. The global market is expected to reach $1.2 billion by 2020, according to a study by Grand View Research, Inc. 10
Supplement claims, when not backed by conclusive clinical studies, are considered supplement fraud. One large manufacturer is in trouble with a group of class action plaintiffs.
The producer of the popular joint health glucosamine supplement, Osteo Bi-Flex is under fire in a lawsuit alleging the company committed supplement fraud by making exaggerated benefit claims about the product. The suit has drug through the court system for several years, but a preliminary second settlement was approved by a Federal District Judge on February 1, 2017. The first agreement required the defendant to pay a total of $5.6 million. The second settlement to pay out a total of $9 million.11
The lawsuit was brought against The Nature’s Bounty Company (NBTY), their subsidiary group Rexall Sundown, Inc., and numerous major retailers including Target, Costco and CVS. The brands and supplements specifically listed in the court documents include Osteo Bi-Flex Triple Strength, Flex-a-Min Triple Strength, Kirkland Glucosamine Chondroitin, and CVS Triple Strength Glucosamine Chondroitin with MSM. Should the settlement move forward, several dozen related brands will be affected 11
The defendant has maintained the allegations aren’t true, however they agreed to remove key statements on scores of brands and products. For example, they stopped stating that the supplements help to repair and/or build cartilage. According to court documents, Rexall is barred from using the phrases “fixing, mending, reconditioning, rehabilitation, increasing, developing, building, repairing, rebuilding, renewing, re-growing, adding, regenerating or rejuvenating cartilage.” Also prohibited from making other types of structure/function claims, such as the covered products “support, protect, or promote joint comfort, mobility, or health.”11
Fraudsters who add active ingredients but deliberately hide them from labels to avoid detection commit Dietary Supplement Fraud (DSF), which the FDA often classifies as Economically Motivated Adulteration (EMA), according to comprehensive research, Defining the Public Health Threat of Dietary Supplement Fraud, published November 2013 in the journal Food Science & Food Safety.12
“Fraudsters spike supplements with illegal drugs or previously banned substances in order to increase effectiveness and therefore customer satisfaction with the finished products,” the lead author, Virginia Wheatley said. “But consumers remain unaware.”
The study concluded such operations are a direct threat to public health and further magnify the issue as unscrupulous owners continually evade regulatory hurdles and established quality controls.12
“Fraudsters are focused on taking advantage of regulatory loopholes for their own economic profit, but do not consider or do not care about the public health consequences of their activities,” the author wrote. “Savvy fraudsters took advantage of opportunities to promote health benefits without strict oversight of their marketing activities. As a result, misbranded and adulterated products reach consumers.”12.
The purpose of the research was to provide a comprehensive overview on the public health threat of DSF in response to adverse health events reported from adulterated supplements. Consumers experienced severe health effects, such as lowered blood pressure, kidney damage, heart-related complications, or have lost their lives, the study said, while calling for regulatory reform and consumer education.12
Leading trade associations from the dietary supplement industry and the U.S. Anti-Doping Agency (USADA) warned body-builder consumers about the risks of certain supplements containing illegal drugs in an announcement on November 8, 2017. The groups jointly expressed support of the FDA’s October 31, 2017 warning against using
Selective Androgen Receptor Modulators (SARMs) in body-building products marketed as dietary supplements.
“SARMs are dangerous drugs and pose an immediate risk to consumers, jeopardize the careers of athletes, and have no place in any sports nutrition regimen,” the USADA said.14
The FDA’s online brief said once a supplement is discovered to contain SARMs, it becomes classified as an unapproved drug and is no longer considered a dietary supplement. Unlike supplements, drugs must be reviewed by the FDA for safety and effectiveness.15
The USADA webpage, Vitamins, Minerals and Other Supplements, warns that “while some mainstream supplements are made by responsible manufacturers, a growing number of supplement products contain dangerous and undisclosed ingredients, including steroids, stimulants, and other dangerous drugs. It says that one major issue is unscrupulous companies are marketing supplements spiked with these substances, taking advantage of many consumers’ desires for maximized sport performance or aesthetic improvements and advertising them as healthy and safe when they’re not.” 16
The USADA says “most Americans are unaware that designer steroids and other dangerous drugs are intentionally being sold as dietary supplements and that current law makes it too easy for these products to get to the market.” It further speculates, “Best estimates suggest that there are hundreds of supplement products currently available that contain one or more of approximately 20 to 25 designer steroids alone.” 16
The collateral damage from fraudulent supplements extends to Olympic athletes who have suffered the consequences of unknowingly consuming tainted dietary supplements, then being disqualified from competitions for doping.
High-profile athletes have tested positive from contaminated or intentionally spiked supplements containing undisclosed prohibited substances.13
American Jessica Hardy, multiple swimming medal winner in the Olympics, tested positive from an undisclosed dietary supplement substance and was banned from the 2008 U.S. Olympic team. Another U.S. swimmer, Kicker Vencill, tested positive for small amounts of 19-norandrosterone. Lab tests pointed to a contaminated multivitamin. Pavle Jovanovic, a U.S. Olympic team bobsledder, was suspended for two years in 2004 for testing positive for a banned substance that was undeclared on labels of ten supplements he used the day he was tested.13
Stories of athlete’s failed doping tests from use of dietary supplements that contain hidden banned substances have been reported globally. World-class athletes whose eligibility for competition includes drug testing, receive frequent instruction about the hidden dangers from supplement use.
Olympic and world class athletes have the most stringent anti-doping regulations in sports. What they put into their bodies is critically important to them. They cannot afford to be victims of supplement fraud. The guaranty of quality and purity is of utmost importance for athletes to pass drug tests. Efficacy is also a necessity to ensure they get the performance needed to compete at the highest level.
Many of these elite athletes have chosen Shaklee Corporation in the U.S. for the nutritional supplements that have powered them to winning a combined 121 gold, silver and bronze medals at the Summer and Winter Games. They truly represent the company’s long-time commitment to creating 100% safe, pure and effective nutrition that gives athletes the healthy edge they need.
Shaklee nutritional products have helped power seven of Time-Life Books “Greatest Adventures of All Time.” They’ve helped adventurers cross both the North and South Poles, explore the deepest depths of the oceans, and fly non-stop around the planet without artificial propulsion.
Don’t be misled by dietary supplement labels that contain words as “verified”, “certified,” or “approved”. Such terms do not mean the product has been tested by the FDA or is effective and safe, according to the article, What ‘USP Verified’ and Other Supplement Seals Mean, by Laurie Tarkan, in the September 2016 issue of Consumer Reports magazine.17
The United States Pharmacopeia (USP) is a nonprofit compendium of drug information for physicians and pharmacists. For dietary supplements, the organization offers the “USP Verified” label seal, which is perhaps more influential in the medical community than other supplement quality seals, such as GMP, NSF International, National Products Association (NPA) and ConsumerLab (CL).18,19
“No supplement seal guarantees the safety or effectiveness of the ingredients in the bottle,” Sharon Akabas, Ph.D., associate director of education initiatives at Columbia University’s Institute of Human Nutrition, is quoted as saying.17
None of the organizations guarantee the effectiveness of products, nor do their seals guarantee purity. They do not test every batch. In most instances the manufacturer provides the product to be certified, followed by periodic follow up tests the certifying organization purchases in stores.17,18,19
Instances of supplement fraud could still occur, but dietary supplements containing such seals have a high probability the product contains the amount of the ingredient advertised on the label and that it isn’t contaminated with dangerous substances, such as arsenic, bacteria, or lead, according to the article.
Of interest, the author adds: “Manufacturers must pay to get their supplements tested and certified, which may be a reason that only a tiny fraction of the 90,000 or so dietary supplements on the market carry one of these seals. USP, for example, has verified only 139 products to date.” Consumers should therefore be cautioned against forming any inappropriate conclusions about companies that choose not to pay the fee and participate in such programs.17,18,19
Put supplement fraud in your rear view mirror. One company does not need to buy seals because it already more than doubles the USPs purity and quality standards. Science and innovation are at the heart of the #1 natural nutrition company in America, which conducts 350 tests of raw ingredients--220 more than the standards established by the USP.
They produce the purest and best supplements because of their obsession with quality, . It’s one thing to say products are good, but another to prove they are effective through scientific studies conducted in collaboration with leading academic labs that are unrestricted and encouraged to publish their findings, whatever the results. The academics control publication of the findings, not our recommended company. This is very important.
Through these collaborations, they have published over 135 scientific papers and presentations, 100 of which are clinical studies published in peer-reviewed publications.
They’re the only supplement company we’ve heard of that clinically tests all their own nutritional products for efficacy.
To eliminate any doubt about supplement fraud,are your dietary supplements for arthritis or gout pain the best that money can buy? They may be, if they can answer YES to the following questions:
Surprisingly, for a large majority of dietary supplements on the market, the answer to many of these questions is a resounding NO
From personal use we recommend one manufacturer that answers YES to each question, the Shaklee Corporation. For arthritis relief, their pain trio of joint and muscle pain relief products are extremely safe, tested and effective
Remarkably different from other supplement companies, they operate more like a pharmaceutical manufacturer. They won’t be caught in supplement fraud because the quality and science behind their products are unmatched in the industry. They far exceed the cGMP’s for purity.
Only a tiny fraction of supplements for sale on the U.S. market are backed by clinical studies to prove effectiveness. No matter what price you pay, you’re likely throwing your money away without proof of clinical studies.
In business since 1956, this California-based leader is the gold standard supplement company. When you purchase the best joint health supplement there’s no disappointing ineffectiveness found in other supplements.
Their motto is The Golden Rule. They are a company with a conscience. Their mission is to make each of their products the best and safest that money can buy. Period. Guaranteed. And isn’t that what you want?
If you are looking for pure, safe arthritis pain products that work, follow this "pain trio" (scroll linked page for My Arthritis Story) link. You’ll be glad you did. Avoid the possibility of supplement fraud. You’ll like the way your body feels when your cells are nourished with the best supplements anywhere.
Supplement Fraud Disclaimer: Health statements on this Supplement Fraud page have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease
1 Article: Dietary supplement industry and U.S. Anti-Doping Agency Warn Consumers about Dangerous, Illegal ingredients known as SARMS—Groups support strict enforcement action by FDA. Published Council for Responsible Nutrition (CRN), November 8, 2017 https://www.crnusa.org/newsroom/dietary-supplement-industry-and-us-anti-doping-agency-warn-consumers-about-dangerous
2 Webpage, Food & Drug Administration (FDA), Beware of Fraudulent Dietary Supplements, accessed July 6, 2018 https://www.fda.gov/forconsumers/consumerupdates/ucm246744.htm
3 Webpage, Food & Drug Administration (FDA), Tainted Arthritis/Pain Products, accessed July 5, 2018 https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm365987.htm
4 Public Notification, Food & Drug Administration (FDA), Linsen Double Caulis Plus Contains Hidden Drug Ingredient, October 30, 2017 https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm582968.htm
5 Webpage, Food & Drug Administration (FDA), FDA 101: Health Fraud Awareness, Accessed July 7, 2018 https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm235995.htm
6 Webpage, Food & Drug Administration (FDA), Dietary Supplements, accessed July 6, 2018 https://www.fda.gov/Food/DietarySupplements/
7 Webpage, Food & Drug Administration (FDA), Questions and Answers on Dietary Supplements. Q: Does FDA routinely analyze the content of dietary supplements? Accessed July 3, 2018 https://www.fda.gov/Food/DietarySupplements/UsingDietarySupplements/ucm480069.htm
8 News release: Dietary Supplement Trade Associations Request Elevation of DDSP to “Office” Within FDA; Natural Products Association, a .pdf; December 3, 2015 http://www.npainfo.org/App_Themes/NPA/docs/press/PressReleases/Elevating%20Dietary%20Supplement
9 Myers, Steve; Article: FDA to Healthcare Pros: Tainted Products are Illegal Drugs, Not Dietary Supplements; Natural Products Insider, November 21, 2017 https://www.naturalproductsinsider.com/regulatory/fda-healthcare-pros-tainted-products-are-illegal-drugs-not-dietary-supplements
10 Article, Global glucosamine market to hit $1.2 billion by 2020. Grand View Research Inc, New Hope Network, October 8, 2014 http://www.newhope.com/consumer/global-glucosamine-market-hit-12-billion-2020
11 Mehta, Jessica. Article: 2nd Settlement in Glucosamine Chondroitin Lawsuit. Orthopedics This Week. March 2, 2017 https://ryortho.com/2017/03/2nd-settlement-in-glucosamine-chondroitin-lawsuit/
12 Wheatley, VM, Study: Defining the Public Health Threat of Dietary Supplement Fraud, published Comprehensive Reviews in Food Science and Food Safety, November 2013 Vol 12 Issue 6 Pg 599-513; https://doi.org/10.1111/1541-4337.12033
13 Tsouderos, T, Article, Barred from the Games by Tainted Supplements, published Chicago Tribune, August 10, 2012 http://articles.chicagotribune.com/2012-08-10/health/ct-met-supplements-olympics-20120810_1_dietary-supplements-kicker-vencill-supplement-industry
14 Article: Dietary supplement industry and U.S. Anti-Doping Agency Warn Consumers about Dangerous, Illegal ingredients known as SARMS—Groups support strict enforcement action by FDA. CRN. November 8, 2017 https://www.crnusa.org/newsroom/dietary-supplement-industry-and-us-anti-doping-agency-warn-consumers-about-dangerous
15 Brief, Food & Drug Administration (FDA); FDA warns against using SARMS in body-building products, October 31, 2017 https://www.fda.gov/NewsEvents/Newsroom/FDAInBrief/ucm583021.htm
16 Webpage, U.S. Anti-Doping Agency (USADA), Vitamins, Mineral and Other Supplements, accessed July 6, 2018 https://www.usada.org/resources/nutrition/vitamins-minerals-and-other-supplements/
17 Tarkin, L., Article: What ‘USP Verified’ and Other Supplement Seals Mean. Consumer Reports. July 27, 2016, published September 2016 Consumer Reports Magazine https://www.consumerreports.org/vitamins-supplements/what-usp-verified-and-other-supplement-seals-mean/
18 Blumenthal, M., Hildreth J., Article: Dietary Supplement Quality: A Complex Situation, Doctoroz.com, April 26, 2010 http://www.doctoroz.com/article/dietary-supplement-quality
19 Article: Quality Supplements for Healthcare Practitioners (third party verification programs, quality-supplements.org, Accessed July 2, 2018 http://www.quality-supplements.org/healthcare-practitioners
Major study proves safety and benefits of Shaklee users long-term The cross-sectional clinical study, Usage patterns, health, and nutritional status of long-term multiple dietary supplement users conducted by lead author Gladys Block and the University of California at Berkeley demonstrated the powerful effects of long-term use of multiple Shaklee Corporation dietary supplements for 20 years or more. Those users had healthier levels of many chronic disease-related biomarkers including HDL cholesterol, homocysteine, and C-reactive protein. The study was published in the Nutrition Journal October 24, 2007. For additional details, please click www.landmarkstudy.com