FDA Finds Widespread and Serious Violations of Safety and Quality Control Regulations for Dietary Supplements

Despite the possibility that some dietary supplements could have real health benefits, there are many reasons to be skeptical of the safety and value of most supplements on the market. Most have not been tested scientifically to an extent that marketing claims made about them are truly legitimate. Unfortunately the legal framework for regulating these products almost guarantees that most never will be adequately tested. Thanks to the politicking that has led to the Dietary Supplement Health and Education Act (DSHEA), this “travesty of a mockery of a sham” masquerading as public health regulation makes it possible for the multibillion dollar industry that is Big Supplement to profit from selling supplements without ever having to prove they do what the companies claims, so long as the claims are sufficiently vague and the Quack Miranda Warning is appended I small print at the bottom of the page. As a consequence, the supplement industry can make a sizeable sum of money without having to turn around and invest much of that in research or quality control.

The supplement industry is known to spend a far smaller share of its profits on research that the larger, and much more closely watched, pharmaceutical industry, since the law requires little evidence of safety and efficacy for its products. However, even DSHEA requires some minimal quality control standards for herbal remedies and dietary supplements as well as placing some limits on the marketing claims that can be made. The GAO has previously reported that, despite this, contamination with dangerous substances and illegal marketing practices are common in the herbal medicine industry.

And now FDA inspection reports have shown that the dietary supplement industry also has serious and widespread problems with quality control, safety, and regulatory compliance.

The Chicago Tribune has published an article detailing the failings of the supplement industry to meet even its minimal obligations under DSHEA. Here are some examples: 

  • The FDA has found violations in nearly half of the 450 firms it has inspected.
  • 1 in 4 supplement companies have been issued a formal warning letter for violations, a significant enforcement action under the limitations placed on FDA by DSHEA.
  • Violations of good manufacturing practices were found in nearly two-thirds of 204 inspections conducted this year alone.
  • About 1 in 4 products the company tests have a significant problem, said Tod Cooperman, president of ConsumerLab.com. Some contain significantly less of an ingredient than is promised on the label, some far more. Sometimes the product contains contaminants, like lead. Some are rancid. Some have the correct ingredients but are “bedpan bullets” — incorrectly formulated pills that won’t break up in the body.

There is a huge body of evidence showing that inadequately tested supplements and an insufficiently regulated supplement industry can not only fail to help but can actively harm people (see below). And the limited evidence from the veterinary field is certainly no better than that for the human supplement market.

There is a dangerous double standard that requires chemicals called drugs to be extensively and expensively tested (which isn’t always sufficient to prevent harm even with great efforts) and yet chemicals called “herbs” or “supplements” can essentially avoid any testing of safety or efficacy. Even attempts to require basic accuracy in labeling, quality control in manufacturing, or honesty in advertising are routinely ignored by this industry. Without more serious efforts to control the supplement companies, people will continue to waste their money, and even sometimes damage their health, by using these unproven and uncontrolled products. 

Some of the Harm Caused by Vitamins, Supplements, and Herbal Remedies
Vitamin C can interfere with chemotherapy.

Vitamin E can increase cancer risk

.Vitamin E not useful for prevention for prostate cancer and can increase risk of congestive heart failure.

Vitamin E supplements increase risk of hemorrhagic stroke

Vitamin E supplements may increase risk of heart attacks and stroke

Vitamin E increases risk of prostate cancer

Vitamin supplements may associated with overall increase in mortality and no benefit in preventing gastrointestinal cancer.

Omega-3 Fatty Acids may increase risk in ventilator patients with acute lung injury

Mursu J, et al. Dietary supplements and mortality rate in older women: The Iowa Women’s Health Study. Archives of Internal Medicine. 2011;17(18):1625-33.

Widespread Failures in Quality Control of Dietary Supplements Herbal Preparations, Including Ayurvedic and Traditional Chinese Medicine (TCM) Herbs:

Aliye Uc, MD, Warren P. Bishop, MD, and Kathleen D. Sanders, MD, Camphor hepatoxicity. South Med J 93(6):596-598, 2000,

Angers RC, Seward TS, Napier D, Green M, Hoover E, Spraker T, O’Rourke K, Balachandran A, Telling GC. Chronic wasting disease prions in elk antler velvet. Emerg Infect Dis. 2009 May;15(5):696-703.

Angkana R, Lurslurcharchai L, Halm E, Xiu-Min L, Leventhal H, et al. Use of herbal remedies and adherence to inhaled corticosteroids among inner-city asthmatic patients. Annal Allerg Asthma Immunol 2010:104(2);132-138.

Berberine. Inbaraj JJ, Kukielczak BM, Bilski P, Sandvik SL, Chignell CF. Photochemistry and photocytotoxicity of alkaloids from Goldenseal (Hydrastis canadensis L.) Chem Res Toxicol 2001 Nov;14(11):1529-34

Booth JN 3rd, McGwin G. The association between self-reported cataracts and St. John’s Wort. Curr Eye Res. 2009 Oct;34(10):863-6.

Burkhard PR, Burkhardt K, Haenggeli CA, Landis T.Plant-induced seizures: reappearance of an old problem. J Neurol 1999 Aug;246(8):667-70

Chung-Hsin Chen,Kathleen G. Dickman,Masaaki Moriya, Jiri Zavadil, Viktoriya S. Sidorenko, Karen L. Edwards,Dmitri V. Gnatenko, Lin Wu, Robert J. Turesky, Xue-Ru Wu, Yeong-Shiau Pu, Arthur P. Grollman. Aristolochic acid-associated urothelial cancer in Taiwan. Proceedings National Academy of Sciences, April 2012.

Panax ginseng: A Systematic Review of Adverse Effects and Drug Interactions. Drug Saf 2002;25(5):323-44 Drug Saf 2002;25(5):323-44

Cupp MJ Herbal remedies: adverse effects and drug interactions. Am Fam Physician 1999 Mar 1;59(5):1239-45

Debelle FD, Vanherweghem JL, Nortier JL.Aristolochic acid nephropathy: a worldwide problem. Kidney Int. 2008 Jul;74(2):158-69. Epub 2008 Apr 16.

Emery DP, Corban JG Camphor toxicity. J Paediatr Child Health 1999 Feb;35(1):105-6

Ernst E Adverse effects of herbal drugs in dermatology. Br J Dermatol 2000 Nov;143(5):923-

Fugh-Berman A Herb-drug interactions. Lancet 2000 Jan 8;355(9198):134-8

Huang WF, Wen KC, Hsiao ML. Adulteration by synthetic therapeutic substances of traditional Chinese medicines in Taiwan. J Clin Pharmacol. 1997 Apr;37(4):344-50

Kutz GD. Herbal dietary supplements: Examples of Deceptive or questionable marketing practices and potentially dangerous advice. General Accounting Office. May 26, 2010.

Lai MN, Lai JN, Chen PC, Tseng WL, Chen YY, Hwang JS, Wang JD. Increased risks of chronic kidney disease associated with prescribed Chinese herbal products suspected to contain aristolochic acid. Nephrology (Carlton). 2009 Apr;14(2):227-34.

Lawrence JD. Potentiation of warfarin by dong quai. Page RL 2nd, Pharmacotherapy 1999 Jul;19(7):870-6

Means C. Selected herbal hazards.Vet Clin North Am Small Anim Pract 2002 Mar;32(2):367-82

Nizsly N, Grizlak B, Zimmerman M, Wallace R. Dietary Supplement Polypharmacy: An Unrecognized Public Health Problem? eCAM 2010 7(1):107-113

Norred CL, Finlayson CA Hemorrhage after the preoperative use of complementary and alternative medicines. AANA J 2000 Jun;68(3):217-20

O’Connor A, Horsley CA. Yates, KM “Herbal Ecstasy”: a case series of adverse reactions. N Z Med J 2000 Jul 28;113(1114):315-7

Pittler MH. Ernst, E Risks associated with herbal medicinal products. Wien Med Wochenschr 2002;152(7-8):183-9

Poppenga RH.Risks associated with the use of herbs and other dietary supplements. Vet Clin North Am Equine Pract. 2001 Dec;17(3):455-77, vi-vii

Pies R Adverse neuropsychiatric reactions to herbal and over-the-counter “antidepressants”. J Clin Psychiatry 2000 Nov;61(11):815-20

Prakash S, Hernandez GT, Dujaili I, Bhalla V. Lead poisoning from an Ayurvedic herbal medicine in a patient with chronic kidney disease. Nat Rev Nephrol. 2009 May;5(5):297-300.

Raman P, Patino LC, Nair MG. Evaluation of metal and microbial contamination in botanical supplements. J Agric Food Chem. 2004 Dec 29;52(26):7822-7

Ruschitzka F, Meier PJ, Turina M, Luscher TF, Noll G Acute heart transplant rejection due to Saint John’s wort. Lancet 2000 Feb 12;355(9203):548-9
aper RB, Phillips RS, Sehgal A, Khouri N, Davis RB, Paquin J, Thuppil V, Kales SN. Lead, mercury, and arsenic in US- and Indian-manufactured Ayurvedic medicines sold via the Internet.JAMA. 2008 Aug 27;300(8):915-23.

Shad JA, Chinn CG, Brann OS Acute hepatitis after ingestion of herbs. South Med J 1999 Nov;92(11):1095-7

Smolinske SC J Am Med Womens Assoc 1999 Fall;54(4):191-2Dietary supplement-drug interactions.

Tachjian A, Maria V, Jahangir A. Use of herbal products and potential interactions in patients with cardiovascular disease. J. Am. Coll. Cardiol. 2010 55: A32

Wang JD, Lo TC, Chen PC. Increased mortality risk for cancers of the kidney and other urinary organs among Chinese herbalists. J Epidemiol. 2009;19(1):17-23. Epub 2009 Jan 22.

Zhang SY, Robertson D. A study of tea tree oil ototoxicity. Audiol Neurootol 2000 Mar-Apr;5(2):64-8

Kidney failure from aristolochia in TCM herbals preparations.Lead, mercury and arsenic in herbal preparations.

Lead in TCM preparations.

Lead in ayurvedic preparations.

Lead in herbal preparations.

Tea Tree Oil Can be toxic to cats.

Toxic metals in Brazilian herbal preparations.

Contamination of herbal products with undisclosed pharmaceuticals.

Widespread contamination of supplements with undisclosed toxins and parmaceuticals

Unpredictable levels of coumarin in cinnamon bark, even within the same tree, pose risk of liver damage


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2 Responses to FDA Finds Widespread and Serious Violations of Safety and Quality Control Regulations for Dietary Supplements

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