Attention arthritis sufferers: Two-thirds of supplement companies inspected fail to pass the most elementary of the industry’s safety guidelines. This alarming trend has existed for seven years from 2010 through 2016. During this period, the Food & Drug Administration (FDA) has found an average of 65.3% of dietary supplement makers in non-compliance of current Good Manufacturing Practices (cGMP) rules. 1, 4
For fiscal year 2016, the FDA issued non-compliance (Form 483) letters to 362 of 583 (62%) supplement companies inspected. The industry had shown some improvement after averaging 70% non-compliance for each of the three years from 2010-2012. 4 The next three years percentages were 65%, 62% and 58% for 2013-2015, according to details obtained from FDA in March 2017 via Freedom of Information Act (FOIA) by Consumerlab.com. 1
Through inspections, the FDA has discovered that supplement companies often break basic manufacturing rules by failing:
These non-compliant aspects of agency law are described by an annoyed industry official as “basic, basic kindergarten steps.’ 2
“These are the basics to ensure consumers get products that meet minimal quality standards,” said Daniel Fabricant while in his former position as director of FDA’s division of dietary supplement programs. “This is the proverbial crawling before you run. Companies have got to be able to do this,” he continued. “Without the confirmation of ingredient testing, you don’t know what you are putting in a product is basically what supplement companies are telling consumers. That’s a big problem.”2
[Editor’s note: If you found this arthritis-relief-naturally website while investigating the quality of supplements you use (or, if you’re considering using supplements), we confidently recommend the industry’s leading manufacturer we have personally trusted since 1989].
Supplement companies are supposed to test incoming ingredients to verify whether the components listed on the supplier's Certificate of Analysis (CoA) are accurate and affirm the manufacturer's order. “We’re finding some companies are not testing at all,” Fabricant said.
Manufacturers are also required to test a completed product. "Too frequently, firms are not confirming the identity, strength and composition of their finished supplements," said Pieter Cohen, M.D., an assistant professor at Harvard Medical School, who has studied supplement safety for many years. "This leaves consumers wondering, 'what's actually in my botanical supplement?"2These failures to properly test ingredients places dietary supplement consumers into a 'buyer beware' corner. Tainted and fake supplements are purchased daily by unsuspecting consumers from retailers they believe are reputable.
Retailers are not responsible for supplement problems. The law holds the manufacturer answerable, period.
A supplement industry association executive, Steve Mister, president and CEO for the Council for Responsible Nutrition (CRN) compared failing basic cGMP rules to a person about to follow grandma’s cookie recipe.
Mister described the cGMP as simply “a more elaborate way of making sure when you make your grandmother’s cookies from her cookie recipe, you are going to end up with something that tastes like your grandmother’s cookies,” he said.
He compared failing to test incoming supplement ingredients akin to reaching into a canister for flour to make cookies without looking inside. “For all you know, you picked up sugar or baking soda instead of flour,” he said.
In expressing his disappointment in the industry, he added, “The level of trust that consumers have in our products is much higher than a chocolate chip cookie. So, we owe it to our consumers to have a specification for what that product looks like and to do a batch record test to make sure we have followed the recipe.” 2
Consumers of dietary supplements need to be “more savvy” about their purchasing decisions, Mister recommended. “They need to purchase products from supplement companies they trust.”2Indeed, FDA cautions consumers: “Remember, FDA cannot test all products on the market to identify those that contain potentially harmful hidden ingredients. Consumers must also be aware of these dangerous products and learn how to identify and avoid them."9
While it’s difficult to quantify today, 52% of respondents in 2008 were unaware that dietary supplements had not been approved by the government while 63% were unaware that the advertisement for that supplement had not been pre-approved, according to a Journal of Community Health study. 10
Dietary supplements are not FDA approved. Under the law (Dietary Supplement Health and Education Act of 1994) dietary supplement makers do not need FDA approval prior to marketing their products. On the contrary, it’s the manufacturer’s responsibility to make sure its own products are safe and that any claims are true. 9
Unlike prescription drugs that go through rounds of rigorous testing and clinical trials before they reach a pharmacy, the current system requires supplement companies to make sure they adhere to guidelines established by the FDA 5
The fact that the FDA does not review or even see a new supplement before it is marketed is a distinction that regulators are concerned consumers may not know about. “I do think it’s a very important thing to be able to point out to the customer that there is essentially no pre-market review that’s done at the FDA before these products go on the market,” said the agency’s then acting commissioner, Dr. Stephen Ostroff, in an interview for a PBS Frontline documentary, Supplements and Safety, in January 2016.5
Supplement companies don’t have to win FDA approval before bringing a product to market, unless it contains a new ingredient that’s never been marketed before, which is not often. The FDA does oversee labeling, but it usually can’t determine whether a manufacturer is following its guidelines until there’s a problem. 9
“Just because you see a supplement product on a store shelf does NOT mean it is safe or effective,” the FDA warns on its online ‘Dietary Supplements and the FDA’ page, which continues: “When safety issues are suspected, FDA must investigate and, when warranted, take steps to have the product recalled from the market. However, it is much easier for a firm to get a product on the market than it is for FDA to take a product off the market.”. 9
More often than from inspections, the agency steps in after consumers experience adverse health events from a product that’s already on the shelves that’s misbranded or found to be adulterated. 9
The FDA does not routinely analyze the content of dietary supplements before or after they are sold to consumers. An FDA website says, “….. FDA has limited resources to analyze ……. dietary supplements, it focuses these resources first on public health emergencies and products that may have caused injury or illness.” 8
FDA continues: “Enforcement priorities then go to products thought to be unsafe or fraudulent or in violation of the law. The remaining funds are used for routine monitoring of products pulled from store shelves, or collected during inspections of manufacturing firms.” 8
Once a supplement is on shelves, the FDA relies on inspections of the manufacturer to assess whether the product actually contains what it says it does. For the reasons outlined, FDA annually inspects a fraction of 15,000 registered domestic and foreign owners.3, 5, 6
FDA spot re-inspects some of the supplement companies who were previously sent noncompliance Form 483 letters. Half of the follow-up re-inspections during fiscal year 2015 resulted in additional significant noncompliance with cGMPs, according to a June 2016 story for Natural Products Insider by Josh Long.3
These firms were targeted by the FDA as “high risk” and had previously failed inspections. They were categorized as subjects of a “official action indicated (OAI)”, a regulatory classification described on FDA’s website as “objectionable conditions were found, and regulatory action should be recommended.”
According to Insider, the two most common failures included incomplete Batch Production Records (BPR) and failing to test ingredients, two basic and vital regulations of the cGMP.
“That’s of course concerning that these firms are not bringing the basic aspects of the GMP system into compliance,” said Cara Welch, Ph.D., FDA’s senior advisor in the Office of Dietary Supplement Programs, in a phone interview with Insider. “We’ve cited them. We go back, and they still have the same violations.”
Insider also quoted Daniel Fabricant, Ph.D., executive director and CEO of the Natural Products Association (NPA) in Washington, referring to the overall slim chance of a reinspection, “There is a pretty high percentage of people that are gambling that, ‘Hey, FDA got me once, but they’re not going to get (inspect) me again.’”
The FDA will never have adequate resources to inspect firms as often as they would like, noted Michael McGuffin, president of the American Herbal Products Association to Insider. “The agency will always have to make decisions about resource allocation,” he said in a phone interview. 3
Supplement companies that fail industry safety guidelines potentially put consumer health at risk. The GMP rules were crafted to protect public health from harmful and contaminated products.
Regulations require persons who manufacture, package, label, or hold a finished dietary supplement to establish and follow cGMPs to ensure the quality of the dietary supplement, and that it’s packaged and labeled as specified in the Master Manufacturing Record (MMR).11
Supplement companies are required to ensure the identify, purity, quality, strength and composition of both their ingredients and the finished product.
This includes a 100% identity testing requirement by the manufacturer for incoming raw materials and finished product testing to ensure identity, purity, quality, strength and composition of dietary supplements.
In addition, the regulations impose requirements for sanitary practices, proper training of personnel, cleaning of equipment, and in-process controls to ensure consistency of product quality.
Dietary supplements are not regulated the same way as medications. This lack of oversight puts consumers’ health at risk. Yet Americans often turn to supplements as a presumed natural and safe alternative to the side effects of prescription medications.
For the 2016 report by Jeneen Interlndi, Consumer Reports, with the help of an expert panel, identified 15 supplement ingredients to avoid that were linked to serious medical problems including organ damage, cancer, and cardiac arrest. Their investigation found those substances in products sold at some of the country’s most trusted retailers, including Costco, GNC, and Whole Foods.13
In the magazine’s 2012 review of supplement companies, a main danger was product-caused adverse events, including signs of heart, kidney, or liver problems, allergic reactions, etc. that caused emergency room visits and hospitalizations. 12A second danger involved recalls of dietary supplements spiked with hidden prescription drugs, which the FDA's Daniel Fabricant described as "the largest threat" to consumer safety. Adulterated products can cause some of the same side effects and interactions that consumers may have been trying to avoid by choosing supplements over drugs.12
The 'gold standard' company for quality, safety and efficacy in the dietary supplement industry since 1956, is the same California-based firm the FDA sought input from when forming the industry's manufacturing guidelines. Many requirements and protocols for manufacturing that are now included in the cGMPs mimic the earlier processes developed by this trusted leader.
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1. ConsumerLab, Recalls and Warnings Posted March 17, 2017; FDA Finds Problems at 62% of Supplement Mfg Sites in U.S. and Abroad; Non Compliance percentages; login required, accessed June 19, 2018: https://www.consumerlab.com/recall_detail.asp?recallid=14053
2. Long, Josh; article: FDA Still Finds Basic GMP Violations in Supplement Industry. Kindergarten Steps. Natural Products Insider. March 31, 2016. https://www.naturalproductsinsider.com/manufacturing/fda-still-finds-basic-gmp-violations-supplement-industry
3. Long, Josh, article; FDA Targets High-Risk Firms for Dietary Supplement GMP Reinspections, published Natural Products Insider June 20, 2016 https://www.naturalproductsinsider.com/blogs/insider-law/2016/06/fda-targets-high-risk-firms-for-dietary-supplemen.aspx
4. Long, Josh, article; FDA Data: Supplement cGMP Compliance Rates (in 2013 65% of supplement firms inspected reflected violations of the cGMP. Also non-compliance percentages for 2010, 2011, 2012. Natural Products Insider, February 27, 2014 https://www.naturalproductsinsider.com/manufacturing/fda-data-supplement-cgmp-compliance-rates-show-modest-improvement
5. Boghani, Priyanka, article, Can Regulators Keep Up with the Supplements Industry, “85,000 supplements on market”; PBS Frontline, January 19, 2016 https://www.pbs.org/wgbh/frontline/article/can-regulators-keep-up-with-the-supplements-industry/
6. Kapoor, A; Sharfstein, JM. Study, Breaking the gridlock: Regulation of dietary supplements in the United States, journal Drug Testing & Analysis, November 2, 2015. 15,000 supplement manufacturers. https://doi.org/10.1002/dta.1892 http://onlinelibrary.wiley.com/doi/10.1002/dta.1892/full
7. US Food and Drug Administration, FDA 101: Dietary Supplements, accessed June 19, 2018 https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm050803.htm
8. US Food and Drug Administration, Questions and Answers on Dietary Supplements accessed June 18, 2018 https://www.fda.gov/Food/DietarySupplements/UsingDietarySupplements/ucm480069.htm
9. US Food and Drug Administration, Beware of Fraudulent Dietary Supplements (FDA Does Not Approve) accessed June 15, 2018 https://www.fda.gov/forconsumers/consumerupdates/ucm246744.htm
10. Birnal, H et al; Study, Patients’ Understanding of the Regulation of Dietary Supplements (53% unaware FDA does not approve dietary supplements), Journal of Community Health, February 2008 Vol 33 Issue 1, pp 22-30 https://rd.springer.com/article/10.1007/s10900-007-9063-7?no-access=true
11. Pdf document, What’s the Difference? Food and Dietary Supplement Regulations Compared. Accessed June 20, 2018, Council for Responsible Nutrition https://www.crnusa.org/system/files/2016-11/CRN-RegulatoryComparison-Food-Supplements-1116.pdf
12. Report, 10 surprising dangers of vitamins and supplements—Don’t assume they’re safe because they’re ‘all natural’, published Consumer Reports Magazine September 2012. https://www.consumerreports.org/cro/magazine/2012/09/10-surprising-dangers-of-vitamins-and-supplements/index.htm
13. Report, Supplements Can Make You Sick (Dietary supplements are not regulated the same way as medications. This lack of oversight puts consumers’ health at risk). Published Consumer Reports Magazine, July 27, 2016 https://www.consumerreports.org/vitamins-supplements/supplements-can-make-you-sick/
14. Shaklee News, How Well do You Understand the Shaklee Difference? (Ten Reasons Why Shaklee is Best). Accessed June 20, 2018 http://events.shaklee.com/shaklee_difference/
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