Contaminated supplements from the intentional addition of hidden pharmaceuticals continues to plague the industry. Undeclared drugs were discovered in 746 supplement brands between 2007 and 2016, according to evidence gleaned in an original investigation of data from the U.S. Food and Drug Administration (FDA).
The results were published October 12, 2018 by the authors of the quality improvement study that evaluated the agency’s records.1
A total of 146 dietary supplement companies were implicated. Most adulterated products with unlabeled drugs were marketed for sexual enhancement (46%), weight loss (41%), or muscle building (12%). One hundred fifty-seven products (20%) contained more than one unapproved ingredient. Fourteen others were masqueraded to assist with various conditions, primarily inflammation due to arthritis and joint pain, but also including muscle pain, osteoporosis, bone cancer, sleep issues, gout and prostate health.1
Commenting on the lack of supplement quality and safety, the authors warned: "These products have the potential to cause severe adverse health effects owing to accidental misuse, overuse, or interaction with other medications, underlying health conditions, or other drugs within the same dietary supplement.”1
The most common adulterants were sildenafil for sexual enhancement supplements, sibutramine for weight loss supplements and synthetic steroids or steroid-like ingredients for muscle building supplements. Twenty-eight products were named in 2 or 3 warnings more than 6 months apart yet remained for sale on the market. Of these products, 19 were reported to contain new unapproved ingredients in the second or third warning, consistent with the assumption that the FDA found the product to be adulterated more than once.1
“Active pharmaceuticals continue to be identified in contaminated supplements, even after FDA warnings,” the researchers concluded. The study was led by Madhur Kumar, of the California Department of Public Health's Food and Drug Branch and was published in the online Journal of the American Medical Association’s JAMA Network Open.1
According to the above study, more than 50% of adults in the United States consume supplements, fueling a $35 billion industry. Dietary supplements include vitamins, minerals, botanicals, amino acids, enzymes, probiotics, protein powders and other forms, such as a bar, that according to the FDA are classified as a subset of foods, not drugs, and must be labeled a dietary supplement.1,2
In a comment on supplement quality and safety, researchers cited a previous study that found dietary supplement use was associated with 23 000 emergency department visits and 2000 hospitalizations in the United States each year. Serious adverse events reported with the use of dietary supplements include stroke, acute liver injury, kidney failure, pulmonary embolisms, and death.1
Dietary supplements are not intended to treat or prevent disease. If a supplement’s label promotes the prevention or cure for a specific disease or condition, the FDA considers the product as an unapproved—and thus illegal—drug.3
Whenever a manufacturer makes a structure/function claim—how the ingredients affects the structure or function of the body—it must provide the following label disclaimer:
Only a drug can legally make such a claim 4
The following disclaimer appears on the FDA web page, 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.”5
The consumer is responsible for detecting the possibility of contaminated 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 mostly voluntary recalls.
On its web page, 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.”6
For arthritis, the FDA maintains a separate contaminated supplements page, Tainted Arthritis Pain Products with a partial list of tainted supplements promoted for arthritis.6A
The problem of contaminated supplements appears to have grown in scope in recent years, with 57 percent of all warnings having been issued since 2012, the researchers said.1
"Back in 2009, it appeared that there might be less than 150 brands of supplements that contain drugs," said Dr. Pieter Cohen in an editorial that accompanies the new analysis. "Now it's clear that there are well over 1,000 brands of supplements that contain active drugs."1
"Over the past decade, ever since I first began tracking the problem, I have only seen the number of supplements adulterated with drugs increase rapidly,"1
Dr. Cohen is a general internist with the Cambridge Health Alliance, and an associate professor at Harvard Medical School in Boston. He has long been a critic of the FDA and weaknesses in the laws that govern the industry.7,8,9
In 2009, Dr. Cohen’s perspective on impaired supplement quality, American Roulette—Contaminated Dietary Supplements, he wrote: “Lenient regulatory oversight of dietary supplements, combined with the FDA’s lack of resources, has created a marketplace in which manufacturers can introduce hazardous new products with virtual impunity. Under current regulations, dietary supplements are presumed to be safe with very little control.”9
Contaminated supplements slip through cracks of weakness in the current Good Manufacturing Practices (cGMP) rules. The cGMP does not require standardized raw materials testing by manufacturers. Instead, it allows each company to follow its own protocols, requiring only “a minimum of at least one test. Nor do the regulations require pre-market testing for efficacy. And, the FDA never even sees the product pre-market.
The cGMP is under the umbrella of the industry-friendly1994 Dietary Supplement Health and Education Act (DSHEA). The FDA is not authorized to review dietary supplement products for safety and effectiveness before they are marketed, according to the FDA web page Dietary Supplements: What You Need to Know.10
Quoting the FDA: “Manufacturers are required to produce dietary supplements in a quality manner and ensure that they do not contain contaminants or impurities and are accurately labeled according to the cGMP and labeling regulations.”10.
When the FDA identifies contaminated supplements already on the market, it publishes public warnings. 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 the product, which was promoted on various websites for joint pain, gout, and back pain. 6B
The agency’s laboratory analysis confirmed the supplement was violated. It was intentionally spiked (but not labeled) with 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.6B
Whenever the FDA discovers supplement quality undermined by undeclared drugs, it changes the dietary supplement classification to an unapproved new drug classification. A voluntary recall is initiated. There have been many supplement recalls of products promoted for arthritis pain and joint discomfort that contain illegal hidden drugs.
The FDA does not have the resources to conduct facilities inspections of manufacturers, except for a small percentage of 15,000 registered producers.11 During these inspections, FDA has found some supplement companies conduct only superficial testing or none at all.
Under the cGMP, dietary supplement manufacturers are expected to make quality products without FDA approval and to market them without the FDA ever inspecting the finished product. They’re on the “honor system” to follow the rules to ensure quality and safety.
“The honor system isn’t working,” John Bradley, the editor in chief of Nutrition Business Journal, wrote in an editorial February 2, 2015. “The best way forward for the nutritional supplements industry will be to accept at least a bit more oversight. However well-intentioned the DSHEA might have been, that 1994 law opened the door to cheating and malfeasance that, even if committed by only a minority of players, is destroying public trust.12
“You may not be buying what you think you’re buying, and even if you are, if might not do you any good,” Bradley said. “That’s not an argument the industry can press-release its way out of. Consumers are no longer willing to accept a system in which anyone can sell anything until it’s proven to be ineffective or dangerous,” he added, while calling for changes in the DSHEA.12
In the article, Five Questions to Ask When Considering Health Supplements, in Frontline of PBS.org on January 18, 2016, the author, Katie Worth, comments that under the cGMP/DSHEA “the FDA does not evaluate a supplement’s contents or effectiveness before it hits the shelves. Even then, the agency has only a modest capacity to test the pills. The result is a more than $30 billion industry that is largely regulated by the honor system.” 13
The following quote appears in the WebMD archived article, Supplements don’t benefit prostate cancer patients by Alan Mozes, HealthDay News on October 19, 2015: “Facilities involved in manufacturing dietary supplements must register with the FDA, but manufacturers and distributors are on the honor system when it comes to the truth of labeling claims.”14
To avoid purchasing contaminated supplements, the FDA recommends that consumers find the best supplement quality by doing their homework.. As we've framed in this article, Big Brother isn't in your corner to protect you from dietary supplements. They're foods, not pharmaceutical drugs, and we’ve noted that compared to pharmaceuticals, regulations to market supplement industry products are weak and poorly enforced, to put it mildly.
To find the best supplement quality, consider the following questions:
Surprisingly, the answer to most of these questions is a resounding NO for an overwhelming majority of dietary supplements on the market,
This link directs you to why the #1 natural nutrition company in the US is different and recommended. It is the one manufacturer that answers YES to each question.
The reason most companies cannot answer YES to most questions is because regulations don’t say they have to. Why should they go to the extra expense? While this sounds incredible, it's 100% true.
If you’re considering organic dietary supplement quality to improve your health and arthritis symptoms, look for trusted brands from companies in business for some time. In the dietary supplement market, you get what you pay for—too low in cost could translate to lower quality and less results. Here is a link to 30 Questions to help you find the best dietary supplement company. When we use products from this industry leader (since 1956) we don't have to worry about contaminated supplements.
1 Jenna Tucker, MPH; Madhur Kumar, MS, PhD, et al; Original Investigation Unapproved Pharmacetical Ingredients Included in Dietary Supplements Associated with US Food and Drug Administration Warnings. JAMA Network Open, October 12, 2018.; https://jamanetwork.com/journals/jamanetworkopen/article-abstract/2706496
2 FDA Webpage, Questions and Answers on Dietary Supplements, What is a Dietary Supplement? Food and Drug Administration, accessed April 20, 2019 https://www.fda.gov/Food/DietarySupplements/UsingDietarySupplements/ucm480069.htm#legal_market
3 FDA Webpage, Questions and Answers on Dietary Supplements, Is it legal to market a dietary supplement product as a treatment or cure for a specific disease or condition?, accessed April 20, 2019 https://www.fda.gov/Food/DietarySupplements/UsingDietarySupplements/ucm480069.htm#legal_market
4 FDA Webpage, Questions and Answers on Dietary Supplements, Why do some supplements have wording (a disclaimer) that says: “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease?”, accessed April 20. 2019 https://www.fda.gov/Food/DietarySupplements/UsingDietarySupplements/ucm480069.htm#legal_market
5 FDA Webpage, Report an Adverse Event, Food & Drug Administration (FDA), Dietary Supplements—How to Report a Problem, Updated September 21, 2018, accessed April 20, 2019 https://www.fda.gov/Food/DietarySupplements/ReportAdverseEvent/default.htm
6 FDA Webpage, Medication Health Fraud, Food & Drug Administration (FDA), Tainted Products Marketed as Dietary Supplements, updated February 27, 2019, accessed April 20, 2019 https://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?filter=&sortColumn=1a&sd=tainted_supplements_cder&page=1
6A FDA Medication Health Fraud webpage, Tainted Arthritis/Pain Products, last updated October 30, 2017, Accessed April 20, 2019. https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/Medication
6B FDA Medication Health Fraud, Public Notification: Linsen Couble Caulis Plus Contains Hidden Drug Ingredient, October 30, 2017, accessed April 20, 2019 https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/Medication
7 Long, Josh, Article: Harvard Medical School Professor Criticizes FDA Drop in Dietary Supplement Inspections. Natural Products Insider. December 17, 2018 https://www.naturalproductsinsider.com/regulatory/harvard-medical-school-professor-criticizes-fda-drop-dietary-supplement-inspections.
8 Cohen, P.A., M.D., Perspective: Hazards of Hindsight—Monitoring the safety of nutritional supplements. New England Journal of Medicine (NEJM), April 3, 2014 https://www.nejm.org/doi/full/10.1056/NEJMp1315559
9 Cohen, PA, M.D, Perspective, American Roulette—Contaminated Dietary Supplements, published New England Journal of Medicine, October 15, 2009, 361.1523-1525 doi: 10.1056/NEJMp0904768 (Recall numbers are a fraction of existence).
10 FDA Webpage, Dietary Supplements: What You Need to Know. Updated November 29, 2017. Accessed April 20, 2019 https://www.fda.gov/Food/ResourcesForYou/Consumers/ucm109760.htm
11 Interlandi J, Article: Supplements Can Make You Sick, published Consumer Reports, July 27, 2016 from study, Breaking the gridlock: Regulation of dietary supplements in the United States, by Akshay Kapoor, published November 2, 2015 in the journal Drug Testing and Analysis (15,000 supplement manufacturers). www.consumerreports.org/vitamins-supplements/supplements-can-make-you-sick/ and from Wiley Online Library: https://onlinelibrary.wiley.com/doi/full/10.1002/dta.1892
12 Bradley J, editorial: It’s time to revisit DSHEA, published New Hope Network, February 2, 2015 https://www.newhope.com/supply-commentary/it-s-time-revisit-dshea
13 Worth K Article: Five Questions to Ask When Considering Health Supplements, published in Frontline, January 19, 2016, https://www.pbs.org/wgbh/frontline/article/five-questions-to-ask-when-considering-health-supplements/
14 Mozes A, Article: Supplements Don’t Benefit Prostate Cancer Patients, published from WebMD Archive, October 19, 2015 (HealthDay News) https://www.webmd.com/prostate-cancer/news/20151019/mens-health-supplements-dont-benefit-prostate-cancer-patients-study#1
Contaminated Supplements Page Disclaimer: Health statements on this contaminated supplements page have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease.
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