Dangers of Dietary Supplement Deregulation

Dangers of Dietary Supplement Deregulation
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The majority of dietary supplement facilities tested were found noncompliant with good manufacturing practices guidelines.

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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.

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.

Image credit: Paolo Gamba via flickr. Image has been modified.

Doctor's Note

Isn’t the supplement issue insane? For more, check out:

More than a hundred thousand people are killed every year by pharmaceuticals? Learn more:

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