The majority of dietary supplement facilities tested were found noncompliant with good manufacturing practices guidelines.
Dangers of Dietary Supplement Deregulation
Below is an approximation of this video’s audio content. To see any graphs, charts, graphics, images, and quotes to which Dr. Greger may be referring, watch the above video.
“The U.S. public is not well protected” by current dietary supplement recommendations. Sometimes, there too little of whatever’s supposed to be in the bottle, and sometimes, there’s too much. Hundreds of people suffering from acute selenium toxicity, thanks to an “employee error” at one of the suppliers. Months later, many continued to suffer. Had the company been following good manufacturing practices, such as testing their ingredients, this may not have happened. In 2007, the FDA urged companies to adhere to such guidelines, but seven years later, the majority of dietary supplement facilities remained “noncompliant” with current good manufacturing practices guidelines.
What are the consequences of this ineffective regulation of dietary supplements? 50,000 Americans harmed every year. Of course, prescription drugs don’t just harm, but actually kill 100,000 Americans every year—and, that’s just in the hospital. Drugs prescribed by doctors outside of hospital settings may kill another 200,000 people every year. But, this doesn’t make it any less tragic for the thousands sickened by supplements.
Sometimes, the supplements may contain drugs. Not only do a substantial proportion of dietary supplements have “quality problem[s];” the “FDA has identified hundreds of dietary supplements…that have been adulterated with prescription medications.” Or, even worse, designer drugs that haven’t even been tested—like tweaked Viagra compounds. About half of the most serious drug recalls in the U.S. aren’t for drugs, but for supplements—yet two-thirds were still found on store shelves six months later.
Then, there’s inadvertent contamination with “potentially hazardous contaminant[s]”, such as heavy metals and pesticides, in 90% of herbal supplements tested. And mycotoxins—potentially carcinogenic fungal toxins, like aflatoxin—in 96% of herbal supplements. Milk thistle supplements were the worst, with most having more than a dozen different mycotoxins. This is thought to be because the plant is harvested specifically when it’s wet; and so, it can get moldy easily. And so, you have these people taking milk thistle to support their livers, and end up getting exposed to “immunotoxic, genotoxic, and hepatotoxic”—meaning liver-toxic—contaminants.
How is this kind of thing even legal? It wasn’t, until 1994, with the passage of the Dietary Supplement Health and Education Act. Before that, supplements were regulated like food additives. You had to show that they were safe before being brought to the market. What a concept. But, not anymore. Most people are unaware that supplements no longer have to be approved first, or that supplement ads don’t have to be vetted first. “This misunderstanding may provide some patients with a false sense of security regarding [the] safety and efficacy of these products.”
This deregulation led to an explosion in dietary supplements from around 4,000, when the law came into effect, to now more than 90,000 different supplements on the market—which are all now presumed innocent until proven guilty, presumed safe until they hurt enough people. “In other words, consumers must suffer harm…before the FDA begins the slow process towards restricting [the] product from the market.”
Take ephedra, for example. Hundreds of poison control center complaints starting back in 1999, increasing to thousands—including reports of “strokes, seizures, and deaths.” Yet, it took seven years for the FDA to pull it off store shelves, thanks to millions from the industry spent on lobbying.
What did the companies have to say for themselves? Metabolife swore that they had “never received” a single report of a single adverse effect from any customer. “According to the company, Metabolife had a [so-called] ‘claims-free history.'” Whereas, in fact, they had gotten 14,000 complaints from customers, but covered them up.
Basically, “dietary supplement manufacturers have no realistic accountability for the safety of their products,” and the industry trade organizations have been accused of responding to legitimate concerns with “bluster and denial.”
Yeah, but are these criticisms of dietary supplements just a Big Pharma conspiracy to maintain their monopoly? No. Big Pharma loves dietary supplements, because Big Pharma owns dietary supplement companies—to dip into the tens of billions in annual sales.
Please consider volunteering to help out on the site.
- Marcus DM, Grollman AP. Correcting the record on dietary supplement regulation--reply. JAMA Intern Med. 2013 Jan 28;173(2):166-7.
- Linos E. Balancing the risks and benefits of rituximab. JAMA Intern Med. 2013 May 27;173(10):926.
- Wallace TC. Twenty Years of the Dietary Supplement Health and Education Act--How Should Dietary Supplements Be Regulated? J Nutr. 2015 Aug;145(8):1683-6.
- Cohen PA, Maller G, DeSouza R, Neal-Kababick J. Presence of banned drugs in dietary supplements following FDA recalls. JAMA. 2014 Oct 22-29;312(16):1691-3.
- Pray WS. Orrin hatch and the dietary supplement health and education act: Pandora's Box revisited. J Child Neurol. 2012 May;27(5):561-3.
- Marcus DM, Grollman AP. The consequences of ineffective regulation of dietary supplements. Arch Intern Med. 2012 Jul 9;172(13):1035-6.
- Coates PM, Thomas PR. Dietary supplements. World Rev Nutr Diet. 2015;111:58-63.
- Cohen PA. A false sense of security? The U.S. Food and Drug Administration's framework for evaluating new supplement ingredients. Antioxid Redox Signal. 2012 Mar 1;16(5):458-60.
- Veprikova Z, Zachariasova M, Dzuman Z, Zachariasova A, Fenclova M, Slavikova P, Vaclavikova M, Mastovska K, Hengst D, Hajslova J. Mycotoxins in Plant-Based Dietary Supplements: Hidden Health Risk for Consumers. J Agric Food Chem. 2015 Jul 29;63(29):6633-43.
- Starr RR. Too little, too late: ineffective regulation of dietary supplements in the United States. Am J Public Health. 2015 Mar;105(3):478-85.
- MacKay D. Regarding the Regulation of Dietary Supplements. Am J Public Health. 2015 Jul;105(7):e3.
- Newmaster SG, Grguric M, Shanmughanandhan D, Ramalingam S, Ragupathy S. DNA barcoding detects contamination and substitution in North American herbal products. BMC Med. 2013 Oct 11;11:222.
- Kutz GD. Herbal Dietary Supplements Examples of Deceptive or Questionable Marketing Practices and Potentially Dangerous Advice Statement of Gregory D. Kutz, Managing Director Forensic Audits and Special Investigations. GAO Testimony before the Special Committee on Aging, U.S. Senate.
- Cohen PA. Assessing supplement safety--the FDA's controversial proposal. N Engl J Med. 2012 Feb 2;366(5):389-91.
- Quinones RL, Winsor RD, Patino A, Hoffman P. The Regulation of Dietary Supplements Within the United States: Flawed Attempts at Mending a Defective Consumer Safety Mechanism. J Consum Aff, 47: 328–357.
- MacFarquhar JK, Broussard DL, Melstrom P, Hutchinson R, Wolkin A, Martin C, Burk RF, Dunn JR, Green AL, Hammond R, Schaffner W, Jones TF. Acute selenium toxicity associated with a dietary supplement. Arch Intern Med. 2010 Feb 8;170(3):256-61.
- Ashar BH, Miller RG, Pichard CP, Levine R, Wright SM. Patients' understanding of the regulation of dietary supplements. J Community Health. 2008 Feb;33(1):22-30.
- Weingart SN, McL Wilson R, Gibberd RW, Harrison B. Epidemiology of medical error. West J Med. 2000 Jun;172(6):390-3.
- Lazarou J, Pomeranz BH, Corey PN. Incidence of Adverse Drug Reactions in Hospitalized PatientsA Meta-analysis of Prospective Studies. JAMA. 1998;279(15):1200-1205.
Image credit: Paolo Gamba via flickr. Image has been modified.
Below is an approximation of this video’s audio content. To see any graphs, charts, graphics, images, and quotes to which Dr. Greger may be referring, watch the above video.
“The U.S. public is not well protected” by current dietary supplement recommendations. Sometimes, there too little of whatever’s supposed to be in the bottle, and sometimes, there’s too much. Hundreds of people suffering from acute selenium toxicity, thanks to an “employee error” at one of the suppliers. Months later, many continued to suffer. Had the company been following good manufacturing practices, such as testing their ingredients, this may not have happened. In 2007, the FDA urged companies to adhere to such guidelines, but seven years later, the majority of dietary supplement facilities remained “noncompliant” with current good manufacturing practices guidelines.
What are the consequences of this ineffective regulation of dietary supplements? 50,000 Americans harmed every year. Of course, prescription drugs don’t just harm, but actually kill 100,000 Americans every year—and, that’s just in the hospital. Drugs prescribed by doctors outside of hospital settings may kill another 200,000 people every year. But, this doesn’t make it any less tragic for the thousands sickened by supplements.
Sometimes, the supplements may contain drugs. Not only do a substantial proportion of dietary supplements have “quality problem[s];” the “FDA has identified hundreds of dietary supplements…that have been adulterated with prescription medications.” Or, even worse, designer drugs that haven’t even been tested—like tweaked Viagra compounds. About half of the most serious drug recalls in the U.S. aren’t for drugs, but for supplements—yet two-thirds were still found on store shelves six months later.
Then, there’s inadvertent contamination with “potentially hazardous contaminant[s]”, such as heavy metals and pesticides, in 90% of herbal supplements tested. And mycotoxins—potentially carcinogenic fungal toxins, like aflatoxin—in 96% of herbal supplements. Milk thistle supplements were the worst, with most having more than a dozen different mycotoxins. This is thought to be because the plant is harvested specifically when it’s wet; and so, it can get moldy easily. And so, you have these people taking milk thistle to support their livers, and end up getting exposed to “immunotoxic, genotoxic, and hepatotoxic”—meaning liver-toxic—contaminants.
How is this kind of thing even legal? It wasn’t, until 1994, with the passage of the Dietary Supplement Health and Education Act. Before that, supplements were regulated like food additives. You had to show that they were safe before being brought to the market. What a concept. But, not anymore. Most people are unaware that supplements no longer have to be approved first, or that supplement ads don’t have to be vetted first. “This misunderstanding may provide some patients with a false sense of security regarding [the] safety and efficacy of these products.”
This deregulation led to an explosion in dietary supplements from around 4,000, when the law came into effect, to now more than 90,000 different supplements on the market—which are all now presumed innocent until proven guilty, presumed safe until they hurt enough people. “In other words, consumers must suffer harm…before the FDA begins the slow process towards restricting [the] product from the market.”
Take ephedra, for example. Hundreds of poison control center complaints starting back in 1999, increasing to thousands—including reports of “strokes, seizures, and deaths.” Yet, it took seven years for the FDA to pull it off store shelves, thanks to millions from the industry spent on lobbying.
What did the companies have to say for themselves? Metabolife swore that they had “never received” a single report of a single adverse effect from any customer. “According to the company, Metabolife had a [so-called] ‘claims-free history.'” Whereas, in fact, they had gotten 14,000 complaints from customers, but covered them up.
Basically, “dietary supplement manufacturers have no realistic accountability for the safety of their products,” and the industry trade organizations have been accused of responding to legitimate concerns with “bluster and denial.”
Yeah, but are these criticisms of dietary supplements just a Big Pharma conspiracy to maintain their monopoly? No. Big Pharma loves dietary supplements, because Big Pharma owns dietary supplement companies—to dip into the tens of billions in annual sales.
Please consider volunteering to help out on the site.
- Marcus DM, Grollman AP. Correcting the record on dietary supplement regulation--reply. JAMA Intern Med. 2013 Jan 28;173(2):166-7.
- Linos E. Balancing the risks and benefits of rituximab. JAMA Intern Med. 2013 May 27;173(10):926.
- Wallace TC. Twenty Years of the Dietary Supplement Health and Education Act--How Should Dietary Supplements Be Regulated? J Nutr. 2015 Aug;145(8):1683-6.
- Cohen PA, Maller G, DeSouza R, Neal-Kababick J. Presence of banned drugs in dietary supplements following FDA recalls. JAMA. 2014 Oct 22-29;312(16):1691-3.
- Pray WS. Orrin hatch and the dietary supplement health and education act: Pandora's Box revisited. J Child Neurol. 2012 May;27(5):561-3.
- Marcus DM, Grollman AP. The consequences of ineffective regulation of dietary supplements. Arch Intern Med. 2012 Jul 9;172(13):1035-6.
- Coates PM, Thomas PR. Dietary supplements. World Rev Nutr Diet. 2015;111:58-63.
- Cohen PA. A false sense of security? The U.S. Food and Drug Administration's framework for evaluating new supplement ingredients. Antioxid Redox Signal. 2012 Mar 1;16(5):458-60.
- Veprikova Z, Zachariasova M, Dzuman Z, Zachariasova A, Fenclova M, Slavikova P, Vaclavikova M, Mastovska K, Hengst D, Hajslova J. Mycotoxins in Plant-Based Dietary Supplements: Hidden Health Risk for Consumers. J Agric Food Chem. 2015 Jul 29;63(29):6633-43.
- Starr RR. Too little, too late: ineffective regulation of dietary supplements in the United States. Am J Public Health. 2015 Mar;105(3):478-85.
- MacKay D. Regarding the Regulation of Dietary Supplements. Am J Public Health. 2015 Jul;105(7):e3.
- Newmaster SG, Grguric M, Shanmughanandhan D, Ramalingam S, Ragupathy S. DNA barcoding detects contamination and substitution in North American herbal products. BMC Med. 2013 Oct 11;11:222.
- Kutz GD. Herbal Dietary Supplements Examples of Deceptive or Questionable Marketing Practices and Potentially Dangerous Advice Statement of Gregory D. Kutz, Managing Director Forensic Audits and Special Investigations. GAO Testimony before the Special Committee on Aging, U.S. Senate.
- Cohen PA. Assessing supplement safety--the FDA's controversial proposal. N Engl J Med. 2012 Feb 2;366(5):389-91.
- Quinones RL, Winsor RD, Patino A, Hoffman P. The Regulation of Dietary Supplements Within the United States: Flawed Attempts at Mending a Defective Consumer Safety Mechanism. J Consum Aff, 47: 328–357.
- MacFarquhar JK, Broussard DL, Melstrom P, Hutchinson R, Wolkin A, Martin C, Burk RF, Dunn JR, Green AL, Hammond R, Schaffner W, Jones TF. Acute selenium toxicity associated with a dietary supplement. Arch Intern Med. 2010 Feb 8;170(3):256-61.
- Ashar BH, Miller RG, Pichard CP, Levine R, Wright SM. Patients' understanding of the regulation of dietary supplements. J Community Health. 2008 Feb;33(1):22-30.
- Weingart SN, McL Wilson R, Gibberd RW, Harrison B. Epidemiology of medical error. West J Med. 2000 Jun;172(6):390-3.
- Lazarou J, Pomeranz BH, Corey PN. Incidence of Adverse Drug Reactions in Hospitalized PatientsA Meta-analysis of Prospective Studies. JAMA. 1998;279(15):1200-1205.
Image credit: Paolo Gamba via flickr. Image has been modified.
Republishing "Dangers of Dietary Supplement Deregulation"
You may republish this material online or in print under our Creative Commons licence. You must attribute the article to NutritionFacts.org with a link back to our website in your republication.
If any changes are made to the original text or video, you must indicate, reasonably, what has changed about the article or video.
You may not use our material for commercial purposes.
You may not apply legal terms or technological measures that restrict others from doing anything permitted here.
If you have any questions, please Contact Us
Dangers of Dietary Supplement Deregulation
LicenseCreative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0)
Content URLDoctor's Note
Isn’t the supplement issue insane? For more, check out:
- Black Raspberry Supplements Put to the Test
- Shark Cartilage Supplements Put to the Test to Cure Cancer
- Lead in Calcium Supplements
- Supplement Regulation and Side Effects: Efforts to Suppress the Truth
More than a hundred thousand people are killed every year by pharmaceuticals? Learn more:
- Why Prevention Is Worth a Ton of Cure
- How Doctors Responded to Being Named a Leading Killer
- Does an Apple a Day Really Keep the Doctor Away?
If you haven't yet, you can subscribe to our free newsletter. With your subscription, you'll also get notifications for just-released blogs and videos. Check out our information page about our translated resources.