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How dietary supplements evade regulation — with dangerous results

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Some popular dietary supplements contain amphetamine-like chemical stimulants — even though they're marketed as "natural" botanicals. That's the conclusion of new research published in the journal Drug Testing & Analysis. And this isn't the first study to come to such a conclusion.

What's more, the Food and Drug Administration has known about this mislabeling for two years. But the agency has done nothing to get the products off store shelves or to inform consumers that an amphetamine-like drug that has never been tested in humans is lurking in their "natural" pill bottles.

So how could this keep happening?

The truth is that supplements are barely regulated in US. Under current law, supplement manufacturers can make basically any vague health claim about their wares — without needing evidence to back it up. All they're required to do is ensure that what’s listed on the label is actually what’s in the bottle.

But often they don’t even do that, says Pieter Cohen, assistant professor at Harvard Medical School and author of the latest study. "What is astounding," he told Vox, "is that manufacturers have not honored the law, nor has the FDA enforced it." An estimated 70 percent of supplement manufacturers don't follow the most basic labeling requirements.

"The FDA’s own team found a new drug in multiple supplements two years ago," Cohen adds. "Our study demonstrates that the stimulant is now found in even more supplements, and the FDA has yet to warn the public, much less move aggressively against the manufacturers to eliminate this dangerous new drug from supplements altogether."

Health supplements are only very lightly regulated

Dietary supplements are regulated like foods — not like drugs — under the Dietary Supplement Health and Education Act of 1994. Pill-makers can basically put whatever claims they want on their bottles, and consumers swallow them up, spending some $33 billion on the pills each year.

Specifically, supplement manufacturers can make three types of health claims:

The label of a dietary supplement or food product may contain one of three types of claims: a health claim, nutrient content claim, or structure/function claim. Health claims describe a relationship between a food, food component, or dietary supplement ingredient, and reducing risk of a disease or health-related condition. Nutrient content claims describe the relative amount of a nutrient or dietary substance in a product. A structure/function claim is a statement describing how a product may affect the organs or systems of the body and it can not mention any specific disease.

To remove a supplement from the market, the FDA first has to prove that it's not safe. This is basically the opposite of how pharmaceuticals are regulated. Drugmakers need to prove their medicines are safe and effective through high-quality scientific studies before they reach consumers.

Sometimes, the regulatory response to flawed supplements is too slow. Researchers have documented that liver damage and failure has been a problem with some supplements. The Centers for Disease Control and Prevention found that the weight-loss supplement OxyElite Pro caused nearly 100 people in 16 states to develop hepatitis, leading to liver replacements, hospitalization, and even death.

All told, according to the New York Times, there were 2,292 serious illnesses and 33 deaths related to supplements between June 2009 and June 2011. According to an analysis by Consumer Reports, one-third of the more than 50,000 supplements in the Natural Medicines Comprehensive Database have only "some level of safety and effectiveness that is supported by scientific evidence," and 12 percent have been associated with safety or quality concerns.

Congress refuses to crack down on supplement makers

Watch John Oliver explain why supplement regulation is so lax. (Via YouTube)

There's another reason for the lax regulation of this industry: Over the past few decades, fierce lobbying efforts by the industry, coupled with work by a few influential lawmakers, have pushed back bills that would bring supplement regulation closer in line with pharmaceutical regulation.

Journalist Lynn Stuart Parramore detailed the incredible extent of the conflicts of interest here in a piece for Al Jazeera:

Corporate giants in the supplement industry have maintained their free hand by courting select politicians. The Congressional Dietary Supplement Caucus (yes, there is such a thing) boasts power brokers from both parties, such as Sen. Orrin Hatch, R-Utah, and Sen. Tom Harkin, D-Iowa.

Hatch is a hero in Utah County, Utah — a region known as the Silicon Valley of the nutritional supplement industry — for winning a key battle in 1994, when he and Harkin pushed the Dietary Supplement Health and Education Act through Congress. The law allowed supplement manufacturers to test their products on a voluntary basis before selling them and blocked the FDA from regulating them unless there was evidence of harm. Thanks to the senators' efforts, the U.S. population became guinea pigs.

Hatch's industry ties encompass former aides and family members, including his son, a supplement lobbyist in Washington. The pharmaceutical and health-products industry ranks as Hatch's second-biggest financial supporter.

Unsurprisingly, as Parramore points out, the supplement industry has also invested money to counter any regulatory challenges. In some cases, they have help from Big Pharma. Drug companies such as Pfizer, Bayer, and Procter & Gamble own supplement makers.

But there's a push to crack down on supplements

That said, things don't look impossible for people who want to see reforms. In February, an investigation by the New York attorney general's office found that many supplements being sold at Walgreen, Walmart, GNC, and Target don't actually contain the ingredients listed on their labels. (So ginseng or St. John's wort supplements didn’t necessarily contain those ingredients.)

To push the matter along further, 13 attorneys general joined New York’s Eric Schneiderman last week, asking Congress to investigate — and consider clamping down on — the US supplements industry. They want to give the FDA more regulatory power.

"When consumers take an herbal supplement," Schneiderman said in the Wall Street Journal, "they should be able to do so with full knowledge of what is in that product and confidence that every precaution was taken to ensure its authenticity and purity."

That crackdown already appears to be making the industry nervous. Last week, the supplement retailer GNC announced that it would go beyond federal requirements and start expanding safety testing for some of its products.

Still, until there's a more robust regulatory process, it has to be buyer beware. "No consumer product should kill you," said Cohen. "With supplements, we accept that it's okay to take these pills, even if they might lead to a heart attack or stroke. To me it's mind-boggling that we accept this."

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