Dietary supplement recalls and warnings by government agencies reveal nearly two-thirds of manufacturers fail industry safety rules during facilities inspections. This alarming trend has existed for seven years from 2010 through 2016.1 Many violations involve products that target specific issues, like arthritis joint pain, cancer, weight loss, muscle building and sexual enhancement.
The Food & Drug Administration (FDA) may recall a dietary supplement after it enters the stream of commerce if it is “adulterated” or “misbranded”.
They also recall products when ingredients are causing serious adverse events, including death. The government has enforced more than 600 supplement recalls since the implementation of the current Good Manufacturing Practices (cGMP) in 2007.4
During 2016 alone, the FDA conducted 583 inspections and issued 362 non-compliance Form 483 letters, a failure rate of 62%. These violations are usually manufacturing process infractions the company is instructed to correct within a time frame. Some offenses, when reviewed by higher FDA officials, are classified as serious, resulting in formal Warning Letters that call for voluntary and prompt correction by the offender. The agency sent 61 Warning Letters in 2016.1,5,6
Not all violating companies are re-inspected. But those who are, continue to be cited for failing basic cGMP requirements, such as testing, according to the National Products Insider. “We’ve cited them. We go back, and they still have the same violations,” said Cara Welch, Ph.D., FDA’s senior advisor in the Office of Dietary Supplement Programs in the June 20, 2016 article by Josh Long.
“There is a pretty high percentage of people that are gambling that, ‘Hey FDA….got me once, but they’re not going to get me again,’” Daniel Fabricant, Ph.D., executive director and CEO of the National Products Association was also quoted in the article.2
Most supplement recalls for hidden ingredients are found in products that target weight loss, sexual enhancement and optimal athletic performance. 5 Consumer advocates caution that the number of supplement recalls represent only a sampling of the total contaminated supplements still on the market. 10
Dietary supplements are part of a mushrooming $37 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
Dietary supplements are defined as products taken by mouth that contain “dietary ingredients,” including vitamins, minerals, amino acids, herbs or botanicals, as well as other substances that can be used to supplement the diet. They’re formulated in tablets, capsules, powders, energy bars and liquids.11
Any product labeled as a Dietary Supplement cannot contain pharmaceuticals whether the drug is approved or not approved by the FDA. Supplements are not designed to treat, prevent, or cure any disease. Some deceitful manufacturers intentionally hide FDA-approved drugs into their supplements at the risk of supplement recalls, if detected. Others slip in undeclared drugs that are not approved by the FDA. Such deception results in tainted supplements that may contain serious safety risks for unaware consumers.
Consumer Lab, the widely respected independent U.S. testing organization, recently compared 21 leading arthritis supplements formulas and 26% failed to live up to their labels’ claim about amounts of beneficial ingredients and others contained unacceptably high levels of harmful lead.6.
Supplement makers do not have to prove that their products are safe or effective. The FDA does not approve or even see a dietary supplement pre-market. In fact, the FDA must prove that a finished product is unsafe before it’s authorized to take corrective action or recall products from market. Manufacturers are basically on the “honor system” to follow cGMP guidelines rooted in the Dietary Supplement Health and Education Act (DSHEA) of 1994..7.
“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,” Pieter A. Cohen, M.D. authored in the New England Journal of Medicine (NEJM) article, American Roulette—Contaminated Dietary Supplements. “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.”10
FDA funding limits annual facilities inspections to a fraction of the 15,000 companies registered to distribute supplements in the U.S. The agency’s primary agenda is the investigation of marketed products reported to be causing adverse health events. Clearly, with dietary supplements, consumers effectively serve as ‘guinea pigs’.8
A dietary supplement is recalled whenever it is found to contain pharmaceutical ingredients. When recalled, it is no longer referred to as a dietary supplement but becomes classified as an “unapproved drug”. Supplement recalls of this type occur more often than pharmaceutical industry drug recalls.
A research analysis of FDA data showed 51% of Class I supplement recalls over a nine-year period involved adulterated dietary supplements instead of a pharmaceutical drug product. These findings were reported in a Research Letter published online in the Journal of American Medical Association (JAMA) Internal Medicine by Ziv Harel, M.D. and colleagues in 2013.9
Class I recalls are the most urgent type the FDA issues--having significant and immediate danger of death or other serious injury from the use of the product being recalled. The FDA develops an individual plan specific to the product manufacturer to assure the recall is complete and the items involved are trackable.
There is no single safe retail sales outlet. Contaminated and misbranded supplements are found on shelves of nationally-known retailers, manufacturer’s websites, Amazon, swap meets, flea markets, or sold by word-of-mouth through friends, co-workers and relatives.
When a product is recalled, the objective is to be sure that all affected items are removed from the market and from people’s homes.9 Indications are that this objective is not always accomplished. Not every recalled product is taken off the market.
A Google search for some recalled supplements listed below may still be available today for purchase online or at other retail outlets.
Here are thumbnail examples of recent warning letters and recalls we found of dietary supplements marketed for arthritis and joint pain.
2018 arthritis supplement recalls & warnings
May 4, 2018 Badger Botanicals, LLC of Springville, Utah is recalling Green Suma, Red Suma, Green Hulu 2, and Red Hulu 2 kratom dietary supplements sold directly to consumers via the company website
from January 1st, 2018 to April l 12th, 2018 in pouches of 250g, because it has the potential to be contaminated with Salmonella. Kratom is a herb promoted for chronic pain relief and rheumatoid arthritis.31
April 20, 2018 NutriZone, LLC of Houston, Texas is expanding its recall of kratom dietary supplements to all lots sold due to the potential for contamination with Salmonella, found in the original recalled lots. The expanded recall is being conducted out of an abundance of caution. Kratom is a popular herbal ingredient found in products for chronic pain, including rheumatoid arthritis. 32
April 3, 2018 The FDA issued a mandatory recall of all 26 food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC because several of company's products were found to be contaminated with Salmonella. Some products promoted joint and chronic pain relief.The FDA requested that the company issue a voluntary recall several days earlier, but the company did not comply. 33
February 20, 2018 The Centers for Disease Control (CDC) advised consumers that any U.S. sold kratom supplement used for chronic pain and some arthritis types could be contaminated with Salmonella. The CDC warned that contaminated products may still be available for purchase because the outbreak investigation was not able to identify a single, common source of contaminated kratom. 34
February 6, 2018 A statement from FDA Commissioner Scott Gottlieb, M.D. links 44 deaths to kratom products based on scientific evidence on the presence of opioid compounds found in kratom products, underscoring their potential for abuse. The FDA says the opioid investigation is not related to a separate current investigation of a multi-state Salmonella outbreak. The FDA is overseeing the recall and destruction of a “large volume” of kratom products promoted for relief of chronic pain, including arthritis.35
2017 arthritis supplement recalls & warnings
October 30, 2017 Under the heading Dietary Supplement Recalls and Notifications FDA is advising consumers not to purchase or use the dietary supplement Linsen Double Caulis Plus, a product promoted for joint, gout, and back pain on various websites and possibly retail stores. FDA laboratory analysis confirmed the product illegally contains an undeclared corticosteroid that can cause serious health problems. 22
August 15, 2017 FDA warning letter to Years to Your Health, Inc. following inspection of the company’s website found misbranded products containing drug claims, including Arthritis, Pain Relief, Gout, Inflammation, Gout Tea, Root Beer Tea/Arthritis Tea.14
August 16, 2017 FDA warning letter to Total Nutrition, Inc. following a facilities inspection which found arthritis and pain relief products, Arth-Support, Tart Cherry, Tumeric Curcumin, Napro-Zyn and others to be adulterated and failed quality requirements of cGMP rule. Also cited were misbranded labels and making drug claims..15
2016 arthritis supplement recalls & warnings
July 1, 2016 FDA warning letter to BioGenyx-Basic Reset following a facility inspection which found joint products Ionyte and Aqualyte and others adulterated and failed quality requirements of cGMP rule. In addition, the two above-mentioned supplements were found misbranded and making drug claims.16
October 5, 2016 FTC announced settlement 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 claims the supplement was scientifically proven to provide complete relief from chronic and severe joint pain caused by arthritis and fibromyalgia. The sellers also sponsored an infomercial with one company principal acting as a third party medical expert and another principal acting as a third-party testimonial guest. Settlement includes $150 million judgment, suspended due to the financial status of the company.17
April 8, 2016 FDA warning letter to Salud Natural Entrepreneurs, Inc. following a facility inspection which found more than 20 noni juice products adulterated and failed numerous quality requirements of cGMP guidelines. Products were misbranded and made drug claims. For example, the product Aloe Vera Juice claimed to be anti-inflammatory analgesic and another, Arthritis Formula, made drug claims for osteoarthritis, rheumatism, and other areas of joint pain. FDA also posted warnings on its Health Fraud list.18
May 13, 2016 FDA warning letter to Rocky Fork Formulas, Inc. following a facility inspection which found joint health supplements Arthritis Complex HS, Niacin 500 Time-Released and seven other products misbranded, adulterated and failed quality requirements of cGMP rule. Additionally, the company’s website made drug claims for the two above-mentioned supplements relative to different arthritis types and alleviation of joint pain. FDA also posted warnings on its Health Fraud list.19
2015 arthritis supplement recalls & warnings
June 17, 2015 FDA warning letter to Desert Stream, Inc. following a facility inspection which found the company’s products, including Arthritis Discomforts, adulterated and failed quality requirements of cGMP rule by not conducting a single quality and safety test of raw ingredients. Additionally, FDA said the name Arthritis Discomforts is a drug claim. 20
June 5, 2015 Under the heading Dietary Supplement Recalls and Notifications, FDA warned consumers not to buy or use joint pain supplement Pyrola Advanced Joint Formula found to contain hidden pharmaceuticals. The FDA said the previously recalled product continued sales in some retail stores and various websites, including Amazon.com. Two years prior, on June 13, 2013, FDA announced supplement recalls on Pyrola Advanced Joint Formula capsules by G&C Natural due to hidden drugs. The supplement recalls involved products carrying the brand name(s) Pyrola. 21
May 4, 2015 The FDA, under the heading Dietary Supplement Recalls and Notifications, warned consumers not to buy or use the following supplements promoted for joint or back pain because they were found to contain undeclared drugs during an examination of international mail shipments: Jianbo Hugian Wan; Ginseng She Lian Wan, Asihuri Plus Forte, and Saurean Fong Sep Lin. One of the drugs found in Asihuri Plus Forte was phenylbutazone, a non-steroidal anti-inflammatory drug (NSAID) that was discontinued for human use in the United States due to the risk of serious and life-threatening injuries, including bone marrow toxicity.23,24,25,26
2014 arthritis supplement recalls & warnings
November 20, 2014 FDA under the heading Dietary Supplement Recalls and Notifications warned consumers not to purchase or use the herbal dietary supplement Feng Shi Ling because it was found to contain undeclared drugs. Promoted for arthritic pain associated with rheumatoid arthritis, it is sold on various websites and possibly some retail stores.27
August 24, 2014 FDA warning letter to CreAgri, Inc for drug claims following a website review. Products included joint pain and chronic joint inflammation supplements Olivenol plus Easeflex and Olivenol plus Essence capsules and Olivenol plus Essence Elixer. . FDA also posted warnings August 10, 2016 on its Health Fraud list. 30
February 13, 2014 FDA under the heading Dietary Supplement Recalls and Notifications warned consumers should stop using and throw away or not to purchase or use Arth-Q, a supplement sold for joint, muscle and arthritic pain that contains an undeclared pharmaceutical.28
January 13, 2014 FDA, under the heading Dietary Supplement Recalls and Notifications, warned consumers not to purchase or use joint health supplements, Super ArthGold and Pro Arth-Max, found to contain hidden drugs during a facilities inspection. The manufacturer, West Coast Laboratories, Inc. agreed to a voluntary recall. However, in response to a March 2014 reply from the manufacturer. FDA’s warning letter outlined a list of continued cGMP violations by the firm, including failure to conduct at least one appropriate test to verify the identity of dietary ingredients.29
The FDA and the Federal Trade Commission (FTC) have enforcement programs to protect consumers from false and misleading claims about the safety and benefits of products marketed as dietary supplements. Both agencies have post-market authority over the marketing of these products:3
· The FDA looks at labeling claims, content, purity and safety.
· The FTC looks at the truth and accuracy of any claims made in dietary supplement advertising and marketing on TV, radio, and in print ads, as well as social media and online marketing.4
FDA lists dietary supplement recalls for undeclared drugs under the Description column on its Drug Recalls page.
FDA also lists some supplement recalls of arthritis-related products on its Tainted Arthritis Pain Products page.
Can your arthritis or gout relief supplement manufacturer answer YES to any of the following questions about their product?
· Are they the best that money can buy?
· Are they organic; or as our recommended company explains, 'beyond organic'?
· Are their ingredients tested for 350 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 contained ingredients and milligram measurements verified to accurately match the product label?
Surprising, for an overwhelming majority of dietary supplements on the market, the answer to many of these questions is a resounding NO.
We recommend from personal use one manufacturer that answers YES to each question, the #1 natural nutrition company in the U.S. For arthritis relief, their "pain trio" of joint and muscle pain relief products are extremely safe, tested and effective.
They operate more like a pharmaceutical manufacturer. They are remarkably different from other supplement makers. The quality and science behind their products are unmatched in the industry. They far exceed the cGMP’s for purity. They’re the only supplement company we’ve heard of that routinely clinically tests their nutritional products for efficacy. In business since 1956, this California-based leader is the gold standard supplement company.
Their motto is The Golden Rule. Their mission is to make each of their products the best that money can buy. Period. Guaranteed. 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. And, you won’t need to worry about supplement recalls.
1 ConsumerLab, Recalls and Warnings Posted March 17, 2017; FDA Finds Problems at 62% of Supplement Manufacturing Sites in U.S. and Abroad; Non Compliance percentages; login required. Accessed June 19, 2018. www.consumerlab.com/recall_detail.asp?recallid=14053
2 Long, Josh, article; FDA Targets High-Risk Firms for Dietary Supplement GMP Reinspections, published Natural Products Insider June 20, 2016. www.naturalproductsinsider.com/blogs/insider-law/2016/06/fda-targets-high-risk-firms-for-dietary-supplemen.aspx
3 Engle, Mary FTC and Tave, Steven FDA. Blog Dietary supplement concerns? Tell the FTC and FDA. Published by FDA Voice, July 25, 2017
4 Weeks, Jennifer. Report: Dietary Supplements—Is regulation of the industry too lax? Published CQ Researcher, October 30, 2015 Vol 25 Issue 38 www.library.cqpress.com/cqresearcher/document.php?id=cqresrre2015103000
5 Lehmann, John; Post: Compliance in Focus: FDA Warning Letters and Form 483—What’s the Difference? Published ImarcResearch. Accessed online May 31, 2018 www.imarcresearch.com/blog/bid/280993/FDA-Warning-Letters-and-Form-483-What-s-the-Difference
6 Article: 26 percent of Arthritis Supplements Fail Testing for Lead Contamination and Label Claims, published by Underground Health Reporter, accessed June 2, 2018 www.undergroundhealthreporter.com/arthritis-supplements-lead-contamination/
7 National Institute of Health (NIH), Office of Dietary Supplements (ODS), Dietary Supplement Health and Education Act (DSHEA) of 1994, Section 9, Good Manufacturing Practices (GMP), Public Law 103-417, 103rd Congress.
8 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
9 Ziv Harel, MD, Shai Harel, MD, et al. Research Letter, The Frequency and Characteristics of Dietary Supplement Recalls in the United States; published JAMA Intern Med, May 27, 2013; 173(10):929-930 doi:10.1001/jamainternmed.2013.379
10 Cohen, PA, MD, 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).
11 Food & Drug Administration (FDA) webpage: FDA 101: Dietary Supplements, accessed June 25, 2018 www.fda.gov/forconsumers/consumerupdates/ucm050803.htm
12 Bradley, J., Content Director & Editor in Chief, Nutrition Business Journal, Article: The U.S. Supplement Industry is 37 billion, June 1, 2015 www.nutraingredients-usa.com/article/2015/06/01/NBJ-the-us-supplement-industry-is-37-billion-not-12-billion
13 Ostroff, Stephen, M.D., Acting Commissioner, U.S. Food & Drug Administration (FDA), blog post, Making Progress in Protecting Consumers from Unsafe Supplements, (200 million supplement users) published online FDA Voice, January 20, 2016 www.blogs.fda.gov/fdavoice/index.php/2016/01/making-progress-in-protecting-consumers-from-unsafe-supplements/
14 Food & Drug Administration (FDA) Warning Letter to Years to Your Health, Inc. August 15, 2017 www.fda.gov/iceci/enforcementactions/warningletters/2017/ucm579558.htm
15 Food & Drug Administration (FDA) Warning Letter to Total Nutrition, Inc August 16, 2017 https://www.fda.gov/iceci/enforcementactions/warningletters/2017/ucm572479.htm
16 Food & Drug Administration (FDA) Warning Letter to BioGenyx-Basic Reset July 1, 2016 www.fda.gov/iceci/enforcementactions/warningletters/2016/ucm509962.htm
17 Federal Trade Commission (FTC), Marketers of Joint Pain Supplement Agree to Settle FTC Charges of Deceptive Advertising, Endorsements. Supple LLC Settles FTC Charges October 5, 2016 www.ftc.gov/news-events/press-releases/2016/10/marketers-joint-pain-supplement-agree-settle-ftc-charges
18 Food & Drug Administration (FDA) Warning Letter to Salud Natural Entrepreneurs, Inc April 8, 2016 www.fda.gov/iceci/enforcementactions/warningletters/2016/ucm519400.htm
19 Food & Drug Administration (FDA) Warning Letter to Rocky Fork Formulas Inc May 13, 2016 www.fda.gov/iceci/enforcementactions/warningletters/2016/ucm501556.htm
20 Food & Drug Administration (FDA) Warning Letter to Desert Stream, Inc May 13, 2016 www.fda.gov/iceci/enforcementactions/warningletters/2015/ucm452294.htm
21 Food & Drug Administration (FDA) Pyrola Advanced Joint Formula, Recall and Public Notification (contains hidden drug ingredients) June 4, 2015 www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/
22 Food & Drug Administration (FDA) Linsen Double Caulis Plus Recall & Public Notice (contains hidden drug ingredients) October 30, 2017 www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/Medication
23 Food & Drug Administration (FDA) Jianbu Hugian Wan Recall & Public Notice (contains hidden drug ingredients) May 4, 2015 www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/
24 Food & Drug Administration (FDA) Ginseng She Lian Wan Recall & Public Notice (contains hidden drug ingredients) May 4, 2015 www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/
25 Food & Drug Administration (FDA) Asihuri Plus Forte Recall & Public Notice (contains hidden drug ingredients) May 4, 2015 www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/
26 Food & Drug Administration (FDA) Saurean Fong Sep Lin Recall & Public Notice (contains hidden drug ingredients) May 4, 2015 www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/
27 Food & Drug Administration (FDA) Feng Shi Ling Recall & Public Notice (contains hidden drug ingredients) November 20, 2014 www.fda.gov/Drugs/DrugSafety/ucm424103.htm
28 Food & Drug Administration (FDA) Arth-Q Recall & Public Notice (contains hidden drug ingredient) February 3, 2014 www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/
29 Food & Drug Administration (FDA) Super Arth-Gold and ProArth Max Recall & Public Notice (contains several hidden drug ingredients) January 15, 2014 www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/
30 Food & Drug Administration (FDA) Warning Letter to Cre-Agri, Inc August 28, 2014 www.fda.gov/iceci/enforcementactions/warningletters/2014/ucm412326.htm
31 Food & Drug Administration (FDA) Badger Botanicals Red Suma, Green Suma, Green Hulu 2 and Red Hulu 2 Kratom Supplements recalled (Salmonella health risk) May 4, 2018 www.fda.gov/Safety/Recalls/ucm606721.htm#recall-photos
32 Food & Drug Administration (FDA) NutriZone LLC Dietary supplement recalls for Pain Out Thai, Pain Out Malay, Nirvanio Green Malay, Pain Out Maena Da for potential Salmonella April 20, 2018 www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/
33 Food & Drug Administration (FDA) Triangle Pharmanaturals LLC FDA orders mandatory recall for 26 Kratom products due to risk of Salmonella after Triangle Pharmanaturals refused to cooperate with FDA despite repeated attempts to encourage voluntary recall., including organic formulas. April 3, 2018 www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm603517.htm
34 Centers for Disease Control and Prevention (CDC) issued a supplement recalls and advice to consumers that Salmonella infections are linked to Kratom. The Notice included an FDA Public Notice of multistate outbreak of Salmonella infections from various products containing Kratom. June 22, 2018. www.cdc.gov/salmonella/kratom-02-18/advice.html
35 Food & Drug Administration (FDA), statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s scientific evidence on the presence of opioid compounds in kratom, underscoring its potential for abuse. February 6, 2018. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm595622.htm
Supplement Recalls Disclaimer: Health statements on this supplement recalls 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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