Illegal supplements intentionally formulated with hidden drug ingredients accounts for much of the unfavorable publicity that rocks the dietary supplement industry in America. Most of these products target specific needs--arthritis joint pain, cancer, sexual enhancement, body building and weight loss--and some ethnic groups. When the U.S. Food & Drug Administration (FDA) identifies a supplement “spiked” with drugs, it becomes reclassified as an unapproved new drug and is no longer a dietary supplement.
In such instances the offending product experiences automatic recall from the market. Dietary supplements are not authorized to treat disease and cannot contain pharmacological ingredients. Supplements have not withstood extensive safety and efficacy studies required for pharmaceutical drugs.1.
The dilemma of spiked supplements is not a new development. A letter from Margaret A. Hamburg, M.D., Commission of the FDA, was sent December 15, 2010 to all manufacturers of dietary supplements. It outlined the legal obligations of the manufacturers to prevent tainted supplements masquerading as dietary supplements from reaching the market. The letter warned, “FDA has numerous reports of serious adverse events and injuries associated with the consumer use of these tainted products, including stroke, acute liver injury, kidney failure, pulmonary embolism and death." 1.
Inherent leniency in the industry’s regulatory safeguards coupled with the fact that FDA conducts annual facilities inspections on only a fraction of an estimated 15,000 makers, has created a market wide open to rogue players. 1A
Industry critics point to the laxity of the governing current Good Manufacturing Practices (cGMP) rules as an invitation for some unscrupulous manufacturers to make fortunes while gambling on escaping detection.
From the time the cGMP new manufacturing guidelines were announced by the FDA in 2007, pundits predicted that illegal supplements would soon flourish in the marketplace. Health experts observed that loopholes and loose safety requirements too often leave supplement makers on the ‘honor system’. Cynics also warned that the FDA traditionally lacks resources to be an effective enforcement arm. The cGMPs are rooted in the industry-friendly Dietary Supplement Health and Education Act (DSHEA) of 1994..
“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.2A
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.” 2B
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.”3
“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,” authored Pieter A. Cohen, M.D., Cambridge Health Alliance and Harvard Medical School, in the New England Journal of Medicine (NEJM) perspective, American Roulette—Contaminated Dietary Supplements in October 2009.
“Under current regulations, dietary supplements are presumed to be safe with very little control,” Dr. Cohen said. Of special concern to Dr. Cohen are the hundreds of dietary supplements that are “contaminated with prescription medications, controlled substances, experimental compounds, or drugs rejected by the FDA because of safety concerns.” He also cautioned that the published number of illegal supplements recalled represents only a fraction of products on the market that should be recalled.4
In a subsequent 2014 article by Dr. Cohen, Hazards of Hindsight—Monitoring the Safety of Nutritional Supplements, published in the NEJM, he commented that under current law, the FDA must identify and remove dangerous illegal supplements only after they have caused harm, yet they do not require premarketing approval before the reach store shelves.
Dr. Cohen recommends the law regulating supplements be reformed. He wrote: “Every supplement ingredient should undergo rigorous safety testing before marketing. Until that happens, consumers and physicians cannot be assured that the pills, powders, and potions labeled as dietary supplements are safe for human consumption.”5A
When 117 entities and individuals manufacturing illegal supplements were caught in a massive sweep by the Department of Justice (DOJ) in November 2015, did it signal just another day in the wacky world of dietary supplements? Most of the adulterated products targeted were marketed for weight loss, sexual
enhancement and body building, but some were for pain and joint symptom relief of osteoarthritis and inflammatory rheumatoid arthritis.
The nationwide cleanup brought civil and criminal cases against mostly unnamed makers and marketers of alleged illegal supplements to focus enforcement resources in a market that is causing increasing concern among health officials. In each case, the DOJ or one of its federal partners cited unnamed supplements containing hidden label ingredients (often pharmaceutical drugs) or made health or disease treatment claims unsupported by adequate scientific evidence.5B
One unsealed criminal case, an 11-count indictment for illegal supplements, identified those arrested as producers of the widely popular workout and weight loss supplements sold under names such as Jack3d and OxyElite Pro.
Earlier in the same week in 2015 the DOJ also filed five civil cases seeking injunctive relief against named individuals and illegal supplements 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.5B The others, uncovered from a 2014 Food & Drug Administration (FDA) Warning Letter to Bethel Nutritional Consulting, the manufacturer of arthritis-related pain supplements included Omega Max EPA, Black Cohosh, Sweet Sleep and Women Plus. 5C
The DOJ actions followed on the heels of an illegal supplements study, Adulteration of dietary supplements by the illegal addition of synthetic drugs, published October 2015 in Comprehensive Reviews in Food Science and Food Safety. This review demonstrates that dietary supplement adulteration is an emerging safety problem and that an effective control by regulatory authorities is needed to safeguard consumers. 5D
On October 30, 2017 the FDA recalled Linsen Double Caulis Plus, a product promoted for joint, gout, and back pain on various websites and some retail stores, for containing hidden drugs ingredients. An FDA laboratory analysis confirmed the supplement contained dexamethasone, a corticosteroid commonly
used to treat inflammatory conditions. Corticosteroid use can impair a person’s ability to fight infections and can cause high blood sugar levels, muscle injuries and psychiatric problems and can suppress the adrenal gland.5E
An FDA facilities inspection analysis in January 2014 of two dietary supplements marketed for joint pain and arthritis, Super Arthgold, and Pro ArthMax, found both contaminated with several drugs that could cause adverse reactions, potentially fatal. The products were blatantly labeled as “all-natural formula” and were recalled from the market and prevented from further distribution. A re-inspection in February 2014 found the failures had not been corrected.
The FDA informed the manufacturer, Human Science Foundation, it had confirmed the following undeclared ingredients from its analyses: Pro ArthMax; Chlorzoxazone, diclofenac, indomethacin, ibuprofen, naproxen and Nefopam. Super Arthgold; Chlorzoxazone, diclofenac, and indomethacin. The manufacturer was also found in violation of numerous articles of the cGMP, including failure to conduct at least one appropriate test to verify the identity of the raw materials used in the products.6
The FDA classifies illegal supplements as “fraudulent products” when they are adulterated with hidden ingredients (pharmaceuticals) or misbranded. Often such products target ethnic populations living in the United States. Fraudulent products are often offered to prevent, treat, or cure conditions such as arthritis, cancer, diabetes, obesity and HIV, according to Jonca Bull, M.D., FDA’s Assistant Commissioner, Office of Minority Health in an online article, FDA Unveils Multilingual Health Fraud Protection Initiative for Consumers, March 10, 2016. 6A.
In her blog, Dr. Bull announced that FDA is launching a new multimedia and multilingual initiative all translated into different languages. The purpose of the materials is to alert consumers of the dangers of imported tainted products falsely marketed as dietary supplement and providing tips on how to prevent health fraud scam, she said.
“Some scammers encourage their clients to stop using their prescribed medications and replace them with their products without consulting their physicians first,” Dr. Bull writes. “Sellers of tainted medical products are mostly from the United States, but often sell products that originate overseas and target certain ethnic groups. Sometimes the labels are in languages other than English and such products may be sold at flea markets, swap meets, ethnic stores, or from the homes of individuals,” said Dr. Bull.
“FDA has found that many of these products are mislabeled, and in some instances, contain active ingredients that shouldn’t be available without health care provider oversight,” she said.
“Sellers prey on under-served populations and people with limited English proficiency who are prone to fall victim to health fraud scams due to limited or inadequate access to health care services, language barriers, low health literacy, and cultural beliefs,” she observed
Not just confined to dietary supplements, “Health fraud scams are a multi-million dollar industry involving the marketing of drugs, medical devices, biologics and cosmetics,” writes Dr. Bull. “Bogus products can cause serious or fatal injuries and can harm consumers further by delaying the proper diagnosis and treatment of health conditions,”
The companies that make and sell dietary supplements aren’t required to prove that they are safe for their intended use before selling them, or that they work as advertised or even that their packages contain what the labels say they do.
And because of those lax policies, supplements can be ineffective, contaminated with microbes or heavy metals, dangerously mislabeled, or intentionally spiked with illegal or prescription drugs, according to the Consumer Reports article, Supplements Can Make You Sick by Jeneen Interlandi, July 27, 2016. Illegal supplements can also cause harmful side effects by themselves and interact with prescription medications in ways that make those drugs less effective.1A
The article says consumers are unaware of the need to ask about potential problems with supplements. It points to a 2015 nationally representative Consumer Reports survey that found nearly half of American adults think that supplement makers test their products for efficacy, and more than half believe that manufacturers prove their products are safe before selling.
In a related Consumer Reports article, on July 27, 2016, Lauren Cooper writes: “Dietary supplements are supposed to be made in facilities that follow guidelines set by the FDA, but there are some that may fly under the radar. Almost anyone can blend and package a supplement—even a product that contains potentially harmful ingredients. No special training or education is required to set up a supplement business. And the products don’t need to be approved by the FDA before they’re sold.”
The article quotes Lyndsay Meyer, an FDA spokeswoman, as saying, “We have found people manufacturing supplements in residential basements and in labs that were smaller than a bathroom.”
To demonstrate the ease to order equipment, ingredients, then package a supplement that looks just like one you might find at your local vitamin store, Consumer Reports decided to create their own illegal supplements. The article explains the process and the dangerous ingredients used. They packaged 80 capsules, which they called Thinitol, in ten minutes on an office desk.
All that remained to market the product was to register their facility with the FDA, a simple process of filling in a form with basic information such company name and address. But their product never left the building.6B
To understand how illegal supplements can so readily exist in the market, is to first understand the government’s role in the industry:
In recent years, the supplement industry has been smeared by research publications, newspaper articles and stories concerning not only illegal supplements, but the incidence of failed safety inspections of dietary supplement facilities.For seven years from 2010 through 2016, two-thirds of supplement companies inspected failed to pass the most elementary of the industry’s cGMP safety guidelines. In fiscal year 2016, the FDA issued non-compliance (Form 483) letters to 62% of 583 inspections. 6C, 7
The most common violation of the cGMPs is failure to confirm the identity of dietary ingredients through testing, according to Daniel Fabricant, the director of FDA’s division of dietary ingredients in September 2013, as reported by Natural Products Insider. The article, Dietary Supplement Firms Still Violating Basic Manufacturing Rules by Josh Long, November 6, 2013 said supplement manufacturers also fail to set specifications for products and verify finished batches match the specs and facts listed on label.
“I’m really disappointed in the industry,” said Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), whose trade association represents dietary supplement manufacturers and ingredient suppliers. “These regulations (cGMP) were issued in 2007. We have had years to get ready for these,” he added 8
“Companies that make supplement are supposed to test their incoming ingredients to verify the components listed by an ingredient supplier on a Certificate of Analysis (CoA) are accurate and match what the manufacturer ordered,” the article quoted Shelly Maifarth, principal of the FDA Compliance Group, a Broomfield, CO-based firm that helps companies adhere to FDA requirements as having stated.8
A 2014 study found a high percentage of recalled dietary supplements were still on the market containing banned ingredients six months after being recalled by the FDA. The study, Presence of Banned Drugs in Dietary Supplements Following FDA Recalls, appeared in the October 22/29 issue of the Journal of the American Medical Association (JAMA). 9
The study involved recent FDA-recalled, illegal supplements adulterated with pharmaceuticals from U.S. markets.
Prior research has found that even after FDA recalls, dietary supplements remain available on store shelves. However, it has not been known if the supplements on sale after FDA recalls are free of the adulterants, according to background information in the study article.
The researchers found that one or more pharmaceutical adulterant was identified in 66.7 percent (18 out of 27 products tested) of recalled supplements still available for purchase. Eighteen of the 27 supplements were for sports enhancement, weight loss, and sexual enhancement. The study did not specify which products, if any, were promoted for pain relief of arthritis or rheumatoid arthritis.
During the study, illegal supplements were purchased an average of 34 months (range 8-52 months) after the FDA recall. Seventy-four percent were produced by U.S. manufacturers. Of the subset of supplements produced by U.S. manufacturers, 65% remained adulterated with banned ingredients.
Steve Mister, president & CEO of the Council for Responsible Nutrition (CRN), a leading trade association for the supplement industry, says that its products are “well regulated” and the vast majority pose no risk. “There is a small minority of products that do contain ingredients that shouldn’t be there,” Mister said. “But the larger companies, the big brands that you and I see, the ones producing a majority of the products out there, are doing quite well and are very safe for consumers.” He has also said that the CRN has zero tolerance for products containing active pharmaceutical ingredients, welcomes product recalls for them, as well as criminal enforcement against companies that put consumers at risk. 8, 10
Michael McGuffin, President, American Herbal Products Association (AHPA) said concerning illegal supplements, “These are not cases of enterprising individuals or organizations exploiting a loophole in the Dietary Supplement Health and Education Act (DSHEA). These are cases of criminals breaking existing law. Passing new laws won’t make these activities any more illegal.”10
Loren Israelsen, President, United Natural Products Alliance, said that medium to large dietary supplement manufacturers have a better track record than smaller companies, many of which outsource manufacturing; they function mainly as marketers of the product. He said it’s these small companies that struggle with properly establishing appropriate testing and product specifications.10
Dietary supplements are part of a booming $40 billion industry used by as many as 200 million consumers in the U.S., according to Stephen Ostroff, M.D., Acting Commissioner of the FDA in 2016. 12.13.
According to the Nutrition Business Journal, supplement sales have increased by 81 percent in the past decade. The increase is easy to understand. Supplements are easier to get than prescription drugs, and they carry the aura of being more natural, and thus safer. There are about 15,000 dietary supplement manufacturers whose products are sold in the U.S., according to a 2015 study in the journal Drug Testing and Analysis, as reported by Consumer Reports. 12
Since the DSHEA became law in 1994, the number of supplement product has grown from about 4,000 to more than 90,000 today. The FDA’s budget, by comparison, has not kept up; they conduct only an about 500 facilities inspections per year.13
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 Letter from Margaret A. Hamburg, M.D. Commissioner of Food and Drugs, to Dietary Supplement Industry Manufacturers reminding of their legal obligation to prevent tainted supplements, Food & Drug Administration (FDA), December 15, 2010. A .pdf file. https://www.fda.gov/downloads/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/
1A 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
2A Bradley, John EIC; Editorial: It’s Time To Revisit DSHEA, published New Hope Network (The honor system isn’t working), February 2, 2015 http://www.newhope.com/supply-commentary/it-s-time-revisit-dshea
2B Worth, Katie. Article: Five Questions to Ask When Considering Health Supplements, published Supplements and Safety, Frontline-PBS, January 19, 2016 https://www.pbs.org/wgbh/frontline/article/five-questions-to-ask-when-considering-health-supplements/
3 Mozes, Alan, HealthDay Reporter, Article: Supplements Don’t Benefit Prostate Cancer Patients, from the WebMD Archives, October 19, 2015 https://www.webmd.com/prostate-cancer/news/20151019/mens-health-supplements-dont-benefit-prostate-cancer-patients-study#1
4 Cohen, P.A., M.D., Prospective, American Roulette—Contaminated Dietary Supplements, N Engl J Med 2009, October 15, 361:1523-1525, DOI: 10:1056/NEJMp0904768
5A Cohen, Pieter. (2014). Hazards of Hindsight - Monitoring the Safety of Nutritional Supplements. The New England journal of medicine. 370. 1277-80. 10.1056/NEJMp1315559.
5B Justice News, Office of Public Affairs, Justice Department and Federal Partners Announce Enforcement Actions of Dietary Supplement Cases, published online Department of Justice (DOJ), (117 Sweep), November 17, 2015. https://www.justice.gov/opa/pr/justice-department-and-federal-partners-announce-enforcement-actions-dietary-supplement-cases
5C Food & Drug Administration (FDA), Warning Letter, Bethel Nutritional Consulting Inc, October 9, 2014 https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm418714.htm
5D Rocha, Tiago & Amaral, Joana & Oliveira, Maria. Study: (2015). Adulteration of Dietary Supplements by the Illegal Addition of Synthetic Drugs: A Review. Comprehensive Reviews in Food Science and Food Safety. 15. n/a-n/a. 10.1111/1541-4337.12173.
5E 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
6 Food & Drug Administration (FDA), Two Warning Letters, West Coast Laboratories, Inc for ProArthMax and SuperArthGold on August 18, 2014 and September 15, 2014 for two facilities inspections during 2014..https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm410651.htm https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm414788.htm
6A Bull, Jonca M.D. and Humbert, Jason, RN CDR, Food & Drug Administration (FDA), blog post, FDA Unveils Multilingual Health Fraud Protection Initiative for Consumers, published online FDA Voice, March 10,2016 https://blogs.fda.gov/fdavoice/index.php/2016/03/fda-unveils-multilingual-health-fraud-protection-initiative-for-consumers/
6B Cooper, L., Article: We made this weight loss supplement. It was easy. It was fast. And it’s dangerous. Consumer Reports, July 27, 2016 https://www.consumerreports.org/vitamins-supplements/we-made-this-weight-loss-supplement/
6C Article, ConsumerLab, accessed June 25, 2018, FDA Finds Problems at 62% of Supplement Manufacturing Sites in U.S. and Abroad, requires log in. https://www.consumerlab.com/recall_detail.asp?recallid=14053
7 Long, Josh; Article, Failing to Establish Specs is Most Common GMP Citation in Supplement Industry, published Natural Products Insider, October 1, 2015 https://www.naturalproductsinsider.com/manufacturing/failing-establish-specs-most-common-gmp-citation-supplement-industry and Non-compliance percentages 2010, 1011, 2012 https://www.naturalproductsinsider.com/news/2013/05/fda-gmp-inspectors-cite-70-of-dietary-supplement.aspx
8 Long, J., Article: Dietary supplement firms still violating basic manufacturing rules, Natural Products Insider, November 6, 2013 https://www.naturalproductsinsider.com/news/2013/11/dietary-supplement-firms-still-violating-basic-ma.aspx
9 Pieter A. Cohen, Gregory Maller, Renan DeSouza, James Neal-Kababick. Presence of Banned Drugs in Dietary Supplements Following FDA Recalls. JAMA, 2014; 312 (16): 1691 DOI: 10.1001/jama.2014.10308
10 Article. Industry responds to JAMA letter on adulterated supplements, published Nutraceuticals World, February 1, 2014 https://www.nutraceuticalsworld.com/issues/2014-12/view_industry-news/industry-responds-to-jama-letter-on-adulterated-su
11 Paraventi, T., Article: How Safe Are Supplements? Published in Industrial Safety & Hygiene News (ISHN), February 12, 2017 https://www.ishn.com/articles/105834-how-safe-are-supplements
12 Interlandi, J., Article: Supplements Can Make You Sick, published Consumer Reports, July 27, 2016. https://www.consumerreports.org/vitamins-supplements/supplements-can-make-you-sick/
13 Ostroff, Stephen M.D., Blog Post, Food & Drug Administration (FDA), Making Progress in Protecting Consumers from Unsafe Supplements (200 million supplement users), published FDA Voice , January 20, 2016 https://blogs.fda.gov/fdavoice/index.php/2016/01/making-progress-in-protecting-consumers-from-unsafe-supplements/
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