Some manufacturers that make cheap supplements for arthritis and other diseases appear more concerned marketing lowest prices rather than for quality, safety and effectiveness, according to federal officials and research studies. Pervasive pesticide usage abroad, coupled with failure by supplement makers to conduct sufficient testing, results in undetected contaminated products. Laboratories have discovered supplements for sale containing only trace amounts of the advertised ingredient and undeclared substitutions including drugs. 1,3
Many dietary supplements target specific needs. Popular examples include arthritis joint pain, weight loss, sexual enhancement, cancer and muscle building. But today’s consumer has abundant reasons to wonder whether the ingredients listed on the label of a poor quality product match what is contained in the bottle, or is safe to consume.
A segment of the industry practices “economic adulteration, substituting less-expensive for more expensive ingredients, including fillers in cheap supplements and related substitute species to maximize profits,” according to the authors of the Perspective, Breaking the gridlock: Regulation of dietary supplements in the United States, in the journal Drug Testing & Analysis in 2016.1
Some unscrupulous manufacturers spike their products with hidden pharmaceuticals to increase effectiveness. Such practices are completely illegal and risk serious injury or death to unsuspecting consumers.
The Food and Drug Administration (FDA) recently recalled Pro ArthMax, promoted and sold as a dietary supplement for joint, muscle and arthritic pain, after its analysis discovered it contained six undeclared pharmaceuticals (chlorzoxazone, nefopam, diclofenac, ibuprofen, naproxen, and indomethacin).1, 2
Government recalls may have little effect on the continued availability of spiked products. One would think that supplement recalls cleans the market of these products, but a recent study found dozens of recalled supplements were still available for purchase, two-thirds still containing banned ingredients.4
Industry critics believe weaknesses in regulations governing dietary supplements opens the door to cheating by unethical opportunists that produce cheap supplements. No standardized testing to ensure purity of raw ingredients and finished products is required by the current Good Manufacturing Practices (cGMP) industry guidelines. Undiscovered contaminated products can result.
The vague rules require only the conduction of “at least one test” but do not dictate protocol. To test comprehensively is expensive. To do so scrupulously adds significant additional cost, reduces profits, and is not required by law Makers of cheap supplements--also known as discount supplements--cannot stay competitive unless their production costs remain low.“We’re seeing some real problems out there,” said Dr. Daniel Fabricant, who headed the FDA’s division of Dietary Supplement Programs, referring to manufacturing issues affecting large numbers of dietary supplement companies. He said tainted foreign-sourced botanicals raises questions about the safety of so-called health products sold here. “What we’re finding is that manufacturers are not testing their products.”5
In addition to contaminated herbal substances, consumers also are put at risk by the import of what Fabricant calls “the alphabet vitamins”—A, B, C, D and E—which have provenance in China and some, like botanicals, are tainted by contaminants, according to quotes in the article, FDA Official: 70% of supplement companies violate agency rules by Delthia Ricks in Newsday, August 2013. 5
The cGMP statutes are rooted in the Dietary Supplement Health and Education Act (DSHEA) of 1994. These regulations place accountability for safety on supplement makers, not on the enforcement arm of the FDA, which intercedes post-market, but not pre-market. Contrary to prevailing opinion, the FDA does not approve, inspect or even see dietary supplements before they’re sold. 5A, 5B
The nutritional supplement group of products known as vitamins, minerals and supplements (VMS) is one of the fastest growing industries in the world, projected to nearly double in size topping $60 billion in 2021.6
An article sums up cheap supplements, as follows: “You do have unrestricted, free access to mostly low-quality, ineffective discount vitamins and nutritional supplements,” writes Rolf Hefti, an independent industry commentator in his article, Dietary Supplement Regulation, in which he added, “Indeed, an evaluation and comparison of over 1,600 health supplements revealed that the vast majority of products are of low or mediocre quality (MacWilliam, 2007 & 2011).”7
Some supplement industry critics observe that exploding growth, ease of entry into the industry, weak legislative policies and a lack of FDA enforcement leads to a market permeated with cheap supplements. These include so-called discount vitamin products typically found in drug stores or big box retailers.
“Currently, consumers and physicians remain uninformed because premarket testing of supplement safety is not required,” wrote Pieter A. Cohen, M.D., a nationally known researcher from Cambridge Health Alliance. “This asymmetry of information between sellers and consumers leads to domination of the market by low-quality products because the regulatory framework creates financial disincentives to sell high-quality supplements.”8
Consumer demand fosters cheap supplements. Many people presume that supplements sold in the marketplace are government approved. In our culture consumers most often make purchase decisions based on cost, rather than value. In addition, many fail to recognize the true value of their health.
The FDA, Cohen believes, is overwhelmed by the sheer volume of supplements and discouraged by political forces from acting aggressively. When it comes to pulling a supplement ingredient, FDA’s attitude is “show us the dead bodies,” he’s quoted as saying in the article, Revealing the hidden dangers of dietary supplements published in Science Magazine August 2015. 9
That article also quoted Lyndsay Meyer, an FDA spokeswoman: “Under current law, the FDA faces a high burden before it can take enforcement action on a dietary supplement.” Concerning procurement of raw ingredients, she added that the supply chain “is extremely fragmented. The individuals and businesses selling these products may operate out of residential homes, and distribute via internet, small stores, and mail. We recognize that more can and should be done.” 9
Low-grade products are a predictable outcome of poor manufacturing standards and a lack of adherence to sound science in the conception of product development. Cheap supplements are characterized by the use of inexpensive foreign ingredients, binders and fillers that lowers their production costs, but often results in substandard quality and ineffectual performance. 1A
“A weak regulatory framework, which doesn’t hold manufacturers to account, would be expected to result in a product of lower quality. And that’s exactly what you see when you look at supplements on the market today,” author Scott Gavura wrote in the 2013 article, New concerns about the safety and quality of herbal supplements.1A
Some outcomes of quality-compromised nutritional supplements (including multivitamin/ mineral products) include too little or too much of labeled ingredients, and contaminants such as steroids, stimulants, prescription drugs, bacteria, pesticides and heavy metals.
One article by Dr. Cohen, Perspective: American Roulette—Contaminated Dietary Supplements, published in the New England Journal of Medicine (NEJM), said that the contaminated products discovered by the FDA “represent only a fraction of the contaminated supplements on the market. Unfortunately, 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,” 10
During a seven-year period from 2010-2016, the FDA has found at average of 65.3% of supplement companies inspected fail to pass the most elementary of the industry’s safety guidelines, often for insufficient or no testing of raw ingredients. The industry has shown some improvement after averaging 70% non-compliance for each of the three years from 2010-2012. For years 2013-2016 the failure rates were 65%, 62%, 58% and 62%, according to details obtained from FDA in March 2017 via Freedom of Information Act (FOIA) by ConsumerLab.com. 11,12
The most common cGMP manufacturing violation is failure to establish specifications for the identity, purity, strength and composition of finished dietary supplement batches. (Condensed, the maker did not test for impurities that could affect quality).13
“How can companies put out products that are good quality if they are not properly tested?” asks industry consultant, Marian Boardley, in response to reports FDA inspectors often discover supplement companies that neglect to establish specifications that identify the expected results of testing and examinations. 13
Kathleen Torney, an FDA investigator from Denver, said that certain firms fail to conduct tests at all, or fail to use a valid scientific testing method. Her comments were made at the Rocky Mountain Dietary Supplement Forum September 25, 2015 in Boulder, Colorado. Inadequate testing is a well-known issue within the dietary supplement industry with one in five facilities receiving non-compliance Form 483 notices for failure to verify the identity of an ingredient prior to using it through a test or examination, according to Josh Long’s article: Failing to Establish Specs is Most Common GMP Citation in Supplement Industry, October 1, 2015 in Natural Products Insider.13
“The dietary supplement industry does not have a lot of scientific expertise themselves and has to rely on contract laboratories,” observed Rocky Mountain Forum speaker Tara Lin Couch, Ph.D., an industry consultant. She noted that contract laboratories are also unfamiliar with the specifications required under the cGMP. “It took the pharmaceutical industry 20-plus years to figure out how to comply with the manufacturing regulations covering drugs,” she said. “So, eight years is not that long for the supplement industry which had no familiarity with GMP regulations whatsoever.” 13
China’s cheap labor and vast resources gives it a competitive foothold in the world’s marketplace. “China has become the go-to raw ingredients supplier for the dietary supplement industry. It is estimated that China supplies the global dietary supplement industry upward of 70% of its raw materials and ingredients”, according to the article by Theodora McCormick The Dietary Supplement Industry in the Time of Trump published in Food and Drug Law Institute (FDLI) Nov/Dec 2017 issue of Update Magazine. 14
“Companies that source ingredients from Chinese suppliers,” McCormick writes, “are worried that the Trump Administration is going to levy tariffs on imported Chinese goods. This will increase the cost of finished products which will hurt the industry.”
Whether intended for cheap supplements or otherwise, a Certificate of Analysis (COA) for Dietary Supplement Components is provided by the component supplier to its customers for each delivered lot. A COA is impressive in its scope, including numerous aspects of the qualities, tests and traceability to lot/batch numbers or codes identifying the material quantity covered by the certificate. COAs notwithstanding, the cGMPs require supplement manufacturers to perform independent testing to confirm the accuracy of the ingredients covered by the COA. There have been many instances of materials imported from China with a COA—but they’re contaminated.14
When a supplement company does not perform independent testing of ingredients, it may manufacture contaminated supplements. And neither the company nor the FDA will be the wiser until consumers are harmed.
“Please use fake COA,” an American supplement owner instructed his Chinese supplier in an email uncovered by federal authorities in an 11-count indictment against the Dallas weight loss and workout supplement maker USPLabs. Two other emails exchanged between company officials read, “China can just doctor us a COA stating it’s an extract,” and “LOL, stuff is completely 100% synthetic” referencing a dangerous and illegal stimulant, dimethylamylamine, known as DMAA.15, 16
The indictment alleged “USPLabs engaged in a conspiracy to import ingredients from China using false Certificates of Analysis and false labeling and then lied about the source and nature of those ingredients after it put them in its products.” The indictment declares that USPlabs told some of its wholesalers and retailers that the dietary supplement manufacturer used natural plant extracts in products called Jack3d and OxyElite Pro, when in fact the company was using a synthetic stimulant manufactured in a Chinese chemical factory 16
The 37-page indictment also alleges that the defendants sold some of their products without determining whether they would be safe to use. To the contrary, it notes, the defendants knew of studies that linked the products to liver toxicity, and the indictment said several people needed liver transplants to save their lives after using the products. The owners earned $400 million from the scheme.
China’s air pollution is widely documented. Haze produced by factories and automobiles sometimes make visibility impossible across the street. People seen wearing masks is common. Perhaps less chronicled is the contamination of China’s water and soil. Large amounts of China’s water and farm lands have been rendered unsafe, a result of poorly regulated industrial expansion, overmining, and uncontrolled use of pesticides and fertilizers.
This unbridled industrialization in China for the last 40 years has resulted in nearly 20% of its farm land polluted with toxic heavy metals, according to a survey report issued by the Chinese government. 17
The Survey Report on Soil Pollution in China issued in April 2014 by the Ministries of Environmental Protection and Land and Resources, says 19.4 % of China’s arable land, and 16.1% of the mainland’s soil in general is in a state of toxic contamination. According to the report, spanning a period from April 2005 until December 2013, nearly 83% of the contaminants found on farms are “inorganic” contaminants, which include cadmium, mercury, arsenic, copper and lead—all toxic heavy metals. The survey results said the overall soil environmental conditions in the China are not optimistic. 18
For years, dietary supplement industry watchdogs and public health advocates have alerted Americans that contaminated materials from China end up in finished cheap supplements sold to consumers here. A culture of buying cheap raw dietary ingredients from China, combined with the blind trust without verification of the accompanied COA’s leads to contaminated products. Verification of the COA adds costs that some manufacturers of cheap supplements refuse to take.
“Most manufacturers overlook the risk of buying foreign dietary ingredients,” said Marc Sanchez, senior counsel of a law firm focused solely on FDA and USDA regulation. “On average, the recalls handled by my firm largely stem from foreign raw dietary ingredient tainted with active pharmaceutical ingredients (APIs) or pesticides.” In some cases, he said, they have caused adverse health events to consumers. 19
“In nearly every case,” he continued, “a supplement maker’s facility failed to implement GMP requirements to properly screen foreign raw ingredients before encapsulation and sale downstream.”
The dietary supplement playing field is not equal. In addition to manufacturers of cheap supplements that import but don’t test cheap foreign ingredients, there are fraudsters who add active ingredients but deliberately hide them from labels to avoid immediate detection, according to comprehensive research published in the journal Food Science & Food Safety in 2013.20
“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.20
The illegal activities are referred to in the study as Dietary Supplement Fraud (DSF), which the FDA often classifies as Economically Motivated Adulteration (EMA). “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.”20.
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.20
The United States Pharmacopeia (USP) has been a compendium of drug information for many years. It is a nonprofit organization that annually publishes a National Formulary (NF) covering quality standards of human and animal drugs. The USP is a trusted companion for physicians and pharmacists. Its USP Verified mark on a dietary supplement label is perhaps more recognizable in the medical community than other supplement quality seals, such as GMP, NSF International, National Products Association (NPA) and ConsumerLab (CL)21
It is important to note that companies are required to pay a fee for the seals. Consumers should therefore be cautioned against forming any inappropriate conclusions about companies that choose not to pay the fee and participate in such programs.21
It is important to note that all supplement label seals suggest quality, but do not guarantee it. “No supplement seal guarantees the safety or effectiveness of the ingredients in the bottle,” says Sharon Akabas, Ph.D., associate director of educational initiatives at Columbia University’s Institute of Human Nutrition, according to the article, What ‘USP Verified’ and Other Supplement Seals Mean, in Consumer Reports. 21
To qualify for label seal, initial facilities and product inspections are usually conducted, as well as testing periodic product purchases from the market later. It is impossible to inspect all finished batches and packaging. 21
Is it possible to use ‘cheap supplements’ and ‘high quality’ in the same sentence? I don’t believe so.
Cheap supplements are eliminated from the equation when a company obsesses to achieve purity at whatever cost necessary to exceed compliance with every aspect of the intent of the cGMP’s.
Innovation and science 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) and 100,000 quality tests annually.
When absolute quality is the goal, a manufacturer cannot curtail production costs by not having a dedicated research and development team which develops, tests, and delivers new products. It cannot fail to acquire state-of-the-art scientific equipment to surpass the highest industry standards of product purity, safety, and effectiveness. It cannot not have exhaustive product testing.
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, not our recommended company. This is very important.
Through these collaborations, this industry leader has published over 135 scientific papers and presentations, 100 of which are clinical studies published in peer-reviewed publications and online in their Complete Research Archive. They’re the only supplement company we’ve heard of that clinically tests all their nutritional products for efficacy.
Consider the following four statements:
Are your dietary supplements for osteoarthritis, rheumatoid arthritis or gout the best that money can buy? They may be, if they can answer YES to the following questions:
Surprising, for a large majority of dietary supplements on the market, the answer to most of these questions is a resounding NO. We know of only one company so transparent that their answers are made available to the public.
From personal use since 1989, we recommend the manufacturer that answers YES to each question, the leading natural nutrition company in the U.S. For arthritis relief, their joint and muscle pain relief products are extremely safe, tested and effective.
They operate more like a pharmaceutical manufacturer and are remarkably different from other supplement companies. They won’t produce cheap supplements because the quality and science behind their products is unmatched in the industry--and that costs money. They far exceed the cGMP’s for purity.
The Shaklee study How Does Long-term Multiple Dietary Supplement Use Affect Health? demonstrated the positive effects of long-term use of multiple of its 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 Telomere Research Study showed that Shaklee long-term supplement users had a 40% lower rate of telomere shortening across the adult age range of the caps that protect the ends of chromosomes. As we age, telomeres grow shorter preventing cells from being able to replenish tissue necessary to help live a long, healthy life. Researchers determined an 80-year-old Shaklee supplement user is projected to have the same telomere length as a 41-year-old non-supplement user, based on the preliminary clinical study.
You simply cannot manufacture cheap supplements and attain high quality and performance. Shaklee is the gold standard supplement company leader, based in California since its inception in 1956. There’s no disappointing ineffectiveness when you take the best 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. They pride themselves on their difference compared to competitors. And isn’t that what you want?
If you are looking for pure, safe arthritis pain products that work, follow this "pain trio" link. You’ll be glad you did. Throw away those cheap supplements. You’ll like the way your body feels when your cells are nourished with the best supplements money can buy.
Cheap Supplements Disclaimer: Health statements on this Cheap 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
1 Kapoor, A., and Sharfstein, J. M. (2016) Breaking the gridlock: Regulation of dietary supplements in the United States. Jnl Drug Test. Analysis, Vol 8, issue 3-4, March-April, 424–430. doi: 10.1002/dta.1892.
1A Gavura, Scott, Article: New concerns about the safety and quality of herbal supplements, published Science-Based Medicine, November 7, 2013 https://sciencebasedmedicine.org/new-concerns-about-the-safety-and-quality-of-herbal-supplements/
2 Public Notification, Medication Health Fraud: U.S. Food and Drug Administration. FDA: Pro ArthMax Contains Several Hidden Drugs Ingredients, January 15, 2014 https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely
3 Little, D., Study. Authentication of Ginkgo biloba herbal dietary supplements using DNA barcoding. Genome. 2014, 57, 513
4 Cohen, P.A., Mailer, G, DeSouza, R; Research Letter: Presence of banned drugs in dietary supplements following FDA recalls. Published October 22-29, 2014. JAMA 2014,312(16) 16911693.doi:10,1001/jama.2014.10308
5 Ricks, D. Article, FDA Official: 70% of supplement companies violate agency rules. Newsday. August 23, 2013 https://www.newsday.com/news/health/fda-official-70-of-supplement-companies-violate-agency-rules-1.5920525
5A Webpage, Food & Drug Administration (FDA), Dietary Supplements: What You Need to Know (No FDA review for safety or effectiveness before marketing), Accessed June 30, 2018 https://www.fda.gov/Food/DietarySupplements/UsingDietarySupplements/ucm109760.htm
5B Webpage, Food & Drug Administration (FDA), Q: Is it really ‘FDA approved? A: FDA doesn’t approve dietary supplements, Accessed June 30, 2018 https://www.fda.gov/forconsumers/consumerupdates/ucm047470.htm
6 Lariviere, David, Article: Nutritional Supplements Flexing Muscles as Growth Industry, published in Forbes April 18, 2013 https://www.forbes.com/sites/davidlariviere/2013/04/18/nutritional-supplements-flexing-their-muscles-as-growth-industry/#7cc0a0bc8845
7 Hefti, Rolf, article The Policies of Dietary Supplement Regulation—Free Access to Mainly Ineffective Supplements, published Supplements-And-Health.com, Accessed July 1, 2018 https://www.supplements-and-health.com/dietary-supplement-regulation.html
8 Cohen, P.A., M.D.; Addendum to Perspective, American Roulette—Contaminated Dietary Supplements, published as .pdf, NEJM, January 21, 2010 https://www.nejm.org/doi/pdf/10.1056/NEJMc0911467
9 Couzin-Frankel, Jennifer, Feature Article: Revealing the hidden dangers of dietary supplements, published Science Magazine, August 20, 2015 http://www.sciencemag.org/news/2015/08/feature-revealing-hidden-dangers-dietary-supplements
10 Cohen, P., M.D., Perspective, American Roulette—Contaminated Dietary Supplements, published New England Journal of Medicine (JAMA) 2009; 361:1523-1525; DOI: 10.1056/NEJMp0904768
11 Recalls and Warnings, FDA Finds Problems at 62% of Supplement Manufacturing Sites in U.S. and Abroad (non-compliance percentages 2013,2014, 2015, 2016) Requires log-in; March 17, 2017 https://www.consumerlab.com/recall_detail.asp?recallid=14053
12 Long, J; article: FDA: GMP Inspectors Cite 70% of Dietary Supplement Companies, published Natural Products Insider (non-compliance percentages 2010, 2011, 2012) https://www.naturalproductsinsider.com/news/2013/05/fda-gmp-inspectors-cite-70-of-dietary-supplement.aspx
13 Long, J. article: Failing to Establish Specs is Most Common GMP Citation in Supplement Industry, Natural Products Insider, October 1, 2015 http://beta.naturalproductsinsider.com/manufacturing/failing-establish-specs-most-common-gmp-citation-supplement-industry?utm_test=redirect&utm_referrer=https%3A//search.yahoo.com/
14 McCormick, T., Artlcle: The Dietary supplement Industry in the Time of Trump: Potential Opportunities and Pitfalls, Update Magazine, Food and Drug Law Institute (FDLI), November/December 2017 https://www.fdli.org/2017/12/dietary-supplement-industry-time-trump-potential-opportunities-pitfalls/ .
15 AB Wire article: American manufacturer’s conspiracy in fake dietary supplements revealed through e-mails, published The American Bazaar Online, February 9, 2016 https://www.americanbazaaronline.com/2016/02/09/indian-american-manufacturers-conspiracy-in-fake-dietary-supplements-revealed-through-e-mails/
16. Department of Justice, Office of Public Affairs, Criminal Charges Brought against Bestselling Supplement Manufacturer, November 17, 2015 https://www.justice.gov/opa/pr/justice-department-and-federal-partners-announce-enforcment-actions-dietary-supplement-cases
17 Neuman, S., Article: China Admits that One-Fifth of its Farmland is Contaminated. National Public Radio. April 18, 2014 https://www.npr.org/sections/thetwo-way/2014/04/18/304528064/china-admits-that-a-fifth-of-its-farmland-is-contaminated
18 China government survey report on soil pollution status of the country. Ministry of Environmental Protection and Ministry of Land and Resources. April 17, 2014. http://www.mep.gov.cn/gkml/hbb/qt/201404/t20140417_270670.htm
19 Sanchez, Marc, FDA and USDA regulation specialist, founder, Contract In-House Counsel and Consultants LLC https://fdaatty.com/firm-profile-fda-attorney-washington-d-c-and-charlotte/
20 Wheatley, V. M. and Spink, J. (2013), Defining the Public Health Threat of Dietary Supplement Fraud. Comprehensive Reviews in Food Science and Food Safety, 12: 599–613. doi:10.1111/1541-4337.12033
21 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/
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