Some tainted supplements (also known as fake supplements), may be endorsed by fake advertising, fake doctors, fake testimonials, fake literature and fake product labels. At issue are products marketed as harmless dietary supplements for arthritis and other conditions that contain hidden or deceptively labeled ingredients, such as the active ingredients in government-approved drugs or closely related drugs, as well as other compounds, such as synthetic steroids that don’t qualify as natural ingredients.1
Dietary supplements have caused serious adverse reports associated with their consumption, including strokes, artery blockage in the lungs, kidney failure, acute liver injury, and death. An estimated 23,000 emergency department visits in the United States every year are attributed to adverse events related to supplements, according to research reported October 2015 in the New England Journal of Medicine (NEJM).2
Most commonly, the tainted products marketed as dietary supplements are for losing weight, sexual enhancement, or muscle building. Tainted supplements, however, are promoted for nearly every health condition of record, including osteoarthritis, gout, rheumatoid arthritis, cancer, diabetes, heart disease and many others.
Dietary supplements include vitamins, minerals, herbs, amino acids, plant and whey protein, creatine and weight loss pills. They cannot contain pharmaceutical drugs. The Food and Drug Administration (FDA) is responsible for enforcing the current Good Manufacturing Practices (cGMP) safety guidelines for supplement manufacturers.
The consumer is responsible for detecting the possibility of tainted supplements. The FDA depends on reports of adverse health reactions to help identify potentially harmful products. Once the FDA confirms a tainted supplement, it initiates enforcement measures with the manufacturer, including recalls.
The following disclaimer appears on the FDA webpage, Dietary Supplements—How to Report a Problem:
“FDA does not approve dietary supplement products before they are sold to the public. Therefore, it is particularly important for consumers, health professionals, and industry members to report serious health-related reactions or illnesses (also known as adverse events) to FDA, so we can take action to protect the public from unsafe products.”3
On its webpage, Tainted Products Marketed as Dietary Supplements, the FDA warns the public of tainted supplements and publishes the following disclaimer::
“This list only includes a small fraction of the potentially hazardous products with hidden ingredients marketed to consumers on the internet and in retail establishments.FDA is unable to test and identify all products marketed as dietary supplements on the market that have potentially harmful hidden ingredients. Even if a product is not included in this list, consumers should exercise caution before using certain products.”4
The FDA also maintains a Tainted Arthritis Pain Products page with a partial list of tainted supplements promoted for arthritis.5
In addition, FDA publishes warnings for fake supplements. For example, an FDA Public Notification was issued October 30, 2017 for Linsen Double Caulis Plus, a tainted supplement containing hidden drug ingredients. The notification advises consumers not to purchase or use Linsen Double Caulis Plus, a product promoted on various websites for joint pain, gout, and back pain. The agency’s laboratory analysis confirmed the dietary supplement contains dexamethasone, a pharmaceutical corticosteroid commonly used in short-term situations to treat inflammatory conditions (like rheumatoid arthritis) and may not be appropriate for all patient cases.6Whenever the FDA discovers undeclared drugs in a supplement, it changes the dietary supplement classification to an unapproved new drug. An automatic recall is initiated. There have been many supplement recalls of products promoted for arthritis pain and joint discomfort that contain illegal hidden drugs.
Tainted supplements can slip through cracks of weakness in the manufacturing practices rules. The cGMP has no standardized raw materials testing requirement. FDA facilities inspections find some supplement companies conduct only superficial testing or none at all.
Dietary supplement manufacturers are not only allowed to make products without FDA approval, but also market them without the FDA ever seeing the finished product. In addition, manufacturers do not need to prove the effectiveness of their products. No clinical studies are required. Under the Dietary Supplement Health & Education Act (DSHEA) of 1994, supplements are in a food category, not drugs.
The FDA has primary responsibility for claims on dietary supplement labeling, including packaging, inserts and other promotional materials distributed at the point of sale. The Federal Trade Commission (FTC) has primary responsibility for claims in advertising, including print and broadcast ads, infomercials, catalogs and similar direct marketing materials.7
On October 5, 2016 the FTC announced a $150 million judgment against a liquid glucosamine and chondroitin supplement, Supple, which the sellers agreed made false claims about the product. The company had inadequate evidence to support advertising claims the supplement was scientifically proven to provide complete relief from chronic and severe joint pain caused by arthritis and fibromyalgia.8
“Companies need solid scientific evidence to back up the health claims they make,” said Jessica Rich, Director of the FTC’s Bureau of Consumer Protection. “Consumers should not have to take it on faith that products claiming to provide pain relief will live up to their billing.”
The sellers also sponsored an infomercial with one company principal acting as a fake medical show-style host and falsely represented herself as an independent, impartial medical expert. Another company principal, who created the product, falsely represented himself as a third-party testimonial guest. The infomercial did not disclose the fact the two were married.
From 2011 to 2015 the defendants took in more than $150.6 million from nationwide sales of the supplement, which was marketed through infomercials, social media and other internet marketing’ radio ads, brochures, and in-person pitches at community events. Settlement includes $150 million judgment, suspended due to the financial status of the company.For further information on the FDA and FTC enforcement programs to protect consumers from false and misleading claims about the safety and benefits of dietary supplements, see the FTC’s web page, Dietary Supplement Concerns? Tell the FTC and FDA.
Some tainted products are discovered during FDA facilities inspections of dietary supplement manufacturers. FDA inspects only a fraction of more than 15,000 domestic and international makers of supplements sold in the United States due to limited resources, according to a 2015 study in the journal Drug Testing and Analysis.10
The FDA inspected a total of 2,137 unique dietary supplement facilities (including 184 foreign facilities) between January 2010 and September 2017, according to Merle Zimmermann, PhD, American Herbal Products Association (AHPA), in an article published January 5, 2018 in Nutraceuticals World. The latest data shows that FDA inspected 610 facilities in fiscal year 2017, an increase over previous years, with less violations.11
Most experts believe it’s too soon to project the affect the Trump Administration may have with the FDA’s enforcement ability with dietary supplements. Many of his key appointments were stalled in Congress during Trump’s first year in office, making a meaningful assessment difficult. The Senate did not confirm Scott Gottlieb. M.D. as the new Commissioner of the FDA until May 9, 2017.
President Trump has promised to ease government regulations. He has not hesitated to call out the pharmaceutical industry over high drug prices. Have the FDA dietary supplement inspectors looked the other way on some of the lesser violations? No one knows for sure. For FY 2017, there were less Form 483 non-compliances issued than previous years. Was this by edict? Fiscal year 2018 should provide better insight.
If dietary supplement manufacturers are held to even lesser regulatory standards than during the Obama Administration, will the industry see an increase in tainted supplements? Only time will tell. Whatever the answers, the American public will likely continue to serve as guinea pigs when consuming harmful supplements.
The FTC reports on its Dietary Supplements webpage that in the last few years the FDA has discovered hundreds of tainted supplements containing drugs or other chemicals.9
Some tainted supplements are for products that promote relief for osteoarthritis, rheumatoid arthritis, gout and other health conditions, but particularly in products for weight loss, sexual enhancement, or bodybuilding.
Tainted supplements often contain hidden ingredients, not listed on the label, but that could cause serious side effects or interact in dangerous ways with medicines or other supplements.
To recognize tainted supplements, the FTC says look for the following:
Are your dietary supplements for osteoarthritis, gout or rheumatoid arthritis the best that money can buy? Are they organic; or as our recommended company explains, beyond organic? Are their ingredients tested for contaminants? Are they safe? Are they supported by clinical studies? Are they tested for efficacy prior to marketing to confirm effectiveness in the human body? Are the contents accurately listed on the product label? Surprisingly, for a large majority of dietary supplements on the market, the answer to many of these questions is a resounding NO.
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1 Doheny, Kathleen., Article, FDA Targets Tainted Dietary Supplements, WebMD, December 15, 2010 www.webmd.com/food-recipes/news/20101214/fda-targets-tainted-dietary-supplements#1
2 Geller, A.I., M.D., et al, Study: Emergency Department Visits for Adverse Events Related to Dietary Supplements, Engl J Med 2015; 373:1531-1540 DOI: 10.1056/NEJMsa1504267, October 15, 2015
3 Report an Adverse Event, Food & Drug Administration (FDA), Dietary Supplements—How to Report a Problem, November 29, 2017 https://www.fda.gov/Food/DietarySupplements/ReportAdverseEvent/default.htm
4 Medication Health Fraud Page, Food & Drug Administration (FDA), Tainted Products Marketed as Dietary Supplements, updated June 26, 2018 https://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?filter=&sortColumn=1a&sd=tainted_supplements_cder&page=1
5 Medication Health Fraud webpage, Food & Drug Administration (FDA); Tainted Arthritis/Pain Products, last updated October 30, 2017. https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/
6 Medication Health Fraud webpage, Food & Drug Aministration (FDA), Public Notification: Linsen Double Caulis Plus Contains Hidden Drug Ingredient, October 30, 2017 https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/
7 Business Center Guidance webpage, Federal Trade Commission (FTC), Dietary Supplements: An Advertising Guide for Industry, accessed July 1, 2018 https://www.ftc.gov/tips-advice/business-center/guidance/dietary-supplements-advertising-guide-industry
8 Press Release, Marketers of Joint Pain Supplement Agree to Settle FTC Charged of Deceptive Advertising, Endorsements, Federal Trade Commission (FTC), October 5, 2016 https://www.ftc.gov/news-events/press-releases/2016/10/marketers-joint-pain-supplement-agree-settle-ftc-charges
9 Health & Fitness Healthy Living webpage, Federal Trade Commission (FTC), Dietary Supplements, Accessed July 1, 2018. https://www.consumer.ftc.gov/articles/0261-dietary-supplements
10 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
11 Zimmermann, M., PhD, Article: Data from GMP inspections of dietary supplements. Nutraceuticals World, January 5, 2018 https://www.nutraceuticalsworld.com/issues/2018-01/view_columns/data-from-gmp-inspections-suggests-increased-compliance/
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