Public notifications of supplement risks from adulterated products promoted for arthritis and other health disorders have recently been issued by the Federal Trade Commission (FTC) and Food and Drug Administration (FDA). The agencies discovered misbranded and tainted dietary supplements that contain hidden pharmaceutical ingredients, and some that make illegal drug claims.
These agencies are responsible for protecting the American consumer of supplement risks from harmful products currently sold in the marketplace. Dietary supplements can be beneficial to your health—but they can have supplement risks. The FDA does not have the authority to review dietary supplement products for safety and effectiveness before they are marketed, according to the FDA webpage, Dietary Supplements: What You Need to Know.
Some critics believe the Dietary Supplement Health & Education Act (DSHEA) of 1994 and subsequent 2007 current Good Manufacturing Practices (cGMP) guidelines are too lax as they don’t require a premarket review by the FDA for safety, nor do they require product efficacy. As a result, a company can design, develop, manufacture, and sell a product without meaningful external review.
Illinois Senator Richard Durbin bluntly stated that in the absence of such review, the American consumer is “playing the role of the rat in the laboratory, the guinea pig,” as quoted in a 2016 study in the journal Drug Testing and Analysis 1
“The significant growth and the various ways supplements reach consumers outpace FDA’s resources to regulate this industry,” wrote Stephen Ostroff, M.D., Acting Commissioner of the FDA in his blog post January 20, 2016.2
Protecting consumers from supplement risks from unsafe or contaminated dietary supplements is extremely important to the FDA, he said. The dietary supplement business is one of the fastest-growing in the world. The FDA’s challenge is the sheer volume of the industry, Dr. Ostroff explained, referencing six-fold growth in annual sales from $5.3 billion in 1994 to $35 billion in 2016 boosted by an estimated 200 million American consumers.2
Dr. Ostroff said tracing products is difficult because supply chains are often fragmented, with a single product sometimes passing through numerous suppliers, manufacturers and distributors of all kinds, sizes, and locations including those overseas.2
Ultimately, he writes, “when proper quality control and record keeping procedures are not followed across the supply chain, it can be difficult to guarantee what ingredients in what amounts are in the final product, and whether the ingredients are safe or even qualify as dietary supplements.”2
The dietary supplement industry now consists of an estimated 15,000 manufacturers producing up to 90,000 unique products. With increasing internet enterprise, the FDA’s job is even tougher. Under DSHEA, FDA does not have the authority to approve dietary supplements before they are marketed to consumers.2
To prevent risky supplements, FDA does have the authority to take enforcement actions after a product is on the market—only when FDA can establish that the dietary supplement is adulterated (e.g., unsafe), misbranded (e.g., misrepresentations are made on the product labeling), or cannot be marketed as a dietary supplement (e.g., because the reality is it’s an unapproved new drug).2To identify instances of supplement risks, the FDA monitors the marketplace through market surveys, undercover buys, label reviews, a review of reports of illness or deaths, and product testing. When necessary, they take actions to protect public health, including issuing public warnings, taking legal action, and working with the offending company to recall products. But all this must be done based on evidence and within the bounds of FDA’s legal authority and limited resources.2
Here are examples of products promoted for arthritis and inflammation found to have health risks by the FDA. Links lead to official FDA correspondence.
January 24, 2018 FDA issued a warning letter to Young Health Products, LLC following a website review that found statements and testimonials about certain products to be drug claims, including Flax Seed & Omega 3-6-9 Fish Oil promoted for arthritis and as “a very anti-inflammatory” for pain and Young Health Shake promoted for inflammatory conditions and other chronic diseases. Testimonials for the Shake included an osteoarthritis patient as well as naming many other diseases, including arthritis and autoimmune disorders. Drug claims create supplement risks.
December 13, 2017 FDA issued a warning letter to GnuPharma Corporation following a facilities inspection which found the products Relief Capsules, Foundation capsules, Foundation herbal tea and Relief Tea, all of which were promoted for pain and/or inflammation, to be adulterated because they were prepared under conditions that violate the cGMPs. In addition, statements on product labels and the company’s website were found to be drug claims.
On January 21, 2018 FDA publishd a health risk notification regarding a voluntary recall by Arthri-D, LLC of its joint pain supplement, Arthri-D (120 count) due to supplement risks of possible Salmonella contamination. The supplement was distributed nationwide through mail orders. Salmonella was discovered in one bottle after routine testing. No presence was subsequently found, but out of an abundance of caution, Arthri-D decided to recall the product.
On October 30, 2017 FDA advised consumers not to purchase or use Linsen Double Caulis Plus, promoted for joint pain, back pain and gout. The product was previously recalled after it was found with supplement risks for containing the undeclared drug, dexamethasone
On December 19, 2017 FDA issued a warning letter to Maine Natural Health, Inc., following a facility inspection that found supplement risks with many of the company’s products, including SO3+D3 Fish Oil and Vanilla Recovery Whey Protein to be adulterated because they were prepared under conditions that violate cGMPs. These products were promoted for inflammation control of joint, knee and back pain. In addition, the firm was cited for making drug claims. The FDA warning letter stated: “Your products are not generally recognized as safe and effective for the above-referenced uses and therefore, the products are ‘new drugs’ and misbranded.”
On November 30, 2017 the Federal Trade Commission (FTC) announced Health Research Laboratories LLC and owner Kramer Duhon, agreed to settle charges that they made false claims about the company’s products, BioTherapex and NeuroPlus, promoted to treat arthritis, relieve joint and back pain, creating supplement risks for consumers through deceptive marketing. Their brochure resembled a scientific journal and featured fictitious medical doctors and customer testimonials. A brochure for BioTherapex features “results” of a 1,200-person clinical study on the product that was never actually conducted. A $3.7 million judgment was issued but will be suspended once the defendants pay $800,000.
On November 14, 2017 FDA sent a warning letter to Mannatech Inc. following a facility inspection that found supplement risks in several products, including BounceBack, promoted as a joint supplement, to be misbranded and adulterated in violation of cGMP for identity, purity, strength and composition of finished batches. Additionally, BounceBack contains drug claims on its label and the company website.
The FDA forewarns consumers to be aware of potential supplement risks.
Many supplements contain active ingredients that have strong biological effects in the body. This could make them unsafe in some situations and hurt or complicate your health. For example, the following actions could lead to harmful—even life-threatening—consequences.
Dietary supplements are a $40 billion industry worldwide, Cynthia Schnedar, director of the FDA’s Office of Compliance, was quoted in the CBS News article, How safe are your dietary supplements? by Mary Brophy Marcus, November 18, 2015. She said that dietary supplements is one of the most challenging areas FDA regulates and “encompass a vast amount of products, manufacturers, and supply chains.”4
How big is the problem of supplement risks? “When it comes to what percentage of supplements are of concern,” Schnedar continued. “It’s difficult for us to assess the magnitude of the problem.”
“No supplements are pre-screened for efficacy and safety by the government,” the article quoted Bryn Austin, a professor in the department of Social and Behavioral Sciences at Harvard T.H. Chan School of Public Health. “The FDA is reactive. Because of the way Congress ties their hands, they have to wait until there’s serious harm—deaths, injury, liver damage, transplants. Most consumers don’t realize their lives are on the line before the government steps in.”
Austin told CBS News that while vitamins, minerals, and botanicals are all classified as dietary supplements, botanicals are the most worrisome. “We’ve seen the most unethical behavior by the botanical manufacturers. Their products have been found to contain heavy metals, pesticides, or such high concentrations of ingredients that may be legal, but at high doses are toxic. Like green tea extract, which is wholly different from green tea, which people associate with being healthy,” Austin said.
Not only are there risks associated with dietary supplements, but Austin said the industry is “playing Russian roulette with consumers.”
The Department of Justice (DOJ) pursued civil and criminal cases naming 117 entities and individuals in a massive sweep in November 2015. The supplement risks from most of the adulterated products involved were marketed for weight loss, sexual enhancement and body building, but some were for pain and symptom relief of osteoarthritis and inflammatory rheumatoid arthritis.5
Earlier in the same week in 2015 the DOJ also filed five civil cases seeking injunctive relief against named individuals from supplement risks with products that were allegedly sold as disease cures or that were otherwise in violation of the law. The cases included five dietary supplements marketed as treatments for conditions and diseases including arthritis, rheumatism, rheumatoid arthritis, and inflammation associated with osteoarthritis and RA. One product was DMSO Cream. 5
The others, uncovered from a 2014 Food & Drug Administration (FDA) warning letter to the manufacturer, included Omega Max EPA, Black Cohosh, Sweet Sleep and Women Plus.
The FTC announcement of the sweep stated: “The FDA continues to warn consumers about the supplement risks associated with some over-the-counter products, falsely marketed as dietary supplements, which contain hidden active ingredients that could be harmful. In the last year, the agency has warned of more than 100 products found to contain hidden active ingredients.”
“Now it’s a cautionary tale showing how easily unscrupulous operators can find a home in the supplement industry and the irreparable harm that can result,” writes Danny Robbins in The Atlanta Journal-Constitution, May 5, 2017 in coverage of a criminal case involving manufacturers of tainted supplements. Prosecutors in that case assert that two men made millions manufacturing supplements that in fact were illegal anabolic steroids, and that one of those products was potent enough to kill.6
The case is one of several in recent years in which the FDA has sought to crack down on supplements containing so-called designer or synthetic steroids, according to the article, Supplement industry flies under the radar, poses deadly risk. Neither of the body-building supplements involved—one called Mutant Plexx, the other Mass Destruction—listed the illegal substances on their labels.
In another supplement risks story, a USA Today investigation previously found that “a wide array of dietary supplement companies caught with drug-spiked products are run by people with criminal backgrounds and regulatory run-ins,” according to the article, Makers of tainted supplements have criminal pasts, by Alison Young, December 20, 2013.7
“Consumers buying products from these firms are in some cases entrusting their health and safety to people with rap sheets for crimes involving barbiturates, crack cocaine, Ecstasy, and other narcotics, as well as arrests for selling or possessing steroids and human growth hormone,” the article said. “Other supplement company executives have records of fraud, theft, assault, weapons offenses, money laundering or other offenses,” the investigative article added.
In an industry characterized as “playing Russian roulette” with its customers, how can you avoid potentially risky products?
Can the supplement you use 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,
Only a tiny fraction of supplement manufactures administer clinical studies on their own products to prove effectiveness, which is not required by law. Yet without proof from clinical studies, no matter what price you pay, you’re likely throwing away your money, sacrificing your health, or both.
There’s only one supplement company we’ve heard of that clinically tests all their own nutritional products for efficacy, the #1 natural nutrition company in the U.S.
They operate more like a pharmaceutical manufacturer which makes them remarkably different from other supplement companies. They far exceed the cGMP’s and the U.S. Pharmacopeia (USP) for purity The quality and science behind their products are unmatched in the industry, virtually eliminating risks.
This California-based leader, founded in 1956, is the gold standard supplement company. 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?
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Supplement Risks Disclaimer: Health statements on this Supplement Risks 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 Kapoor, A., Sharfstein, J. M., Perspective, Breaking the gridlock: Regulation of dietary supplements in the United States. Journal Drug Testing & Analysis. DOI:10.1002/dta.1892, Volume 8, issue 3-4, March-April 2016, Pages 424-430
2 Ostroff, S., M.D., Blog Post: Making Progress in Protecting Consumers from Unsafe Supplements, FDA, January 20, 2016 https://blogs.fda.gov/fdavoice/index.php/2016/01/making-progress-in-protecting-consumers-from-unsafe-supplements/
3 FDA Webpage, Dietary Supplements: What You Need to Know, subsection Are there any risks in taking supplements? Accessed 2-19-2018 https://www.fda.gov/Food/DietarySupplements/UsingDietarySupplements/ucm109760.htm
4 Marcus, Mary Brophy; Article: How safe are your dietary supplements? CBS News, November 18, 2015 http://www.cbsnews.com/news/dietary-supplements-how-safe-are-they/
5 Justice DOJ, Justice News, Office of Public Affairs: Justice Department and Federal Partners Announce Enforcement Actions of Dietary Supplement Cases, November 17, 2015 https://www.justice.gov/opa/pr/justice-department-and-federal-partners-announce-enforcement-actions-dietary-supplement-cases
6 Robbins, Danny. Article: A fast track to riches; harm in their wake. Supplement industry flies under the radar, poses deadly risk. The Atlanta Journal-Constitution, May 5, 2017. http://www.myajc.com/news/crime--law/fast-track-riches-harm-their-wake/XFqcGH3efOMTx9IDpUl9AN/
7 Young, Alison; Article: Makers of tainted supplements have criminal pasts. USA Today. December 19, 2013 https://www.usatoday.com/story/news/nation/2013/12/19/dietary-supplements-executives-criminal-records-spiked/4114451/
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