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Finally, the Department of Justice and FDA go after unsafe supplements in a big way [Respectful Insolence]
Now that’s what I’m talking about! Yesterday, the Justice Department announced criminal charges and lawsuits against the sellers of several supplements! This is the ort of thing that is long overdue—incredibly so, in fact. Before I get to this specific case, let’s discuss a little background.
One of the regular topics I write about, both on this blog and at my not-so-super-secret other group blog, is how supplement manufacturers take advantage of the lax regulation of dietary supplements in this country. It’s a problem in our laws that we’ve had since the supplement industry and its lapdogs in Congress (Senator Orrin Hatch from Utah, the home of the supplement industry, and Senator Tom Harkin, the man who is, more than anyone else, responsible for the creation of the National Center for Complementary and Integrative Health, formerly known as the National Center for Complementary and Alternative medicine, or NCCAM) managed to persuade Congress to pass the Dietary Supplement Health and Education Act (DSHEA) of 1994. It’s a law that basically regulates dietary supplements as food, rather than drugs, and does not require them to be tested for safety or efficacy before they can be marketed. On the surface, this would make sense if supplement manufacturers stuck to making only nutritional claims for their products, but they don’t.
In fact, the DSHEA, although forbidding supplement manufacturers from making drug claims for their supplements (e.g., the ability to treat or prevent specific diseases), the DSHEA does carve out a separate category of health claims that could be made for supplements, specifically so-called “structure-function” claims; that is, claims that the supplement somehow supports the structure or function of the body in some way—as long as no specific claims about diseases are made. That, of course, is how we got famous claims like, “boosts the immune system” (a meaningless phrase that should start your skeptical antennae twitching whenever you hear it) or “supports prostate health” (whatever that means). In the meantime, supplements can be almost anything the supplement industry wants them to be, from not unreasonable substances like vitamins, minerals, herbs or other botanicals, and amino acids, to other to substances that have little to do with diet. So loose are the rules over what can be a supplement that for a time an antivaccine chemist marketed an industrial chelator as a “dietary supplement.”
It took a case that blatant to motivate the FDA to act. It’s also not been at all uncommon for supplements to be contaminated with heavy metals or even with real pharmaceuticals. Yes, sometimes “herbal Viagra” sometimes contains actual Viagra, and DNA barcoding studies of such supplements find that many of these products don’t even contain the herbs that they are advertised to contain. This latter observation shows how poorly the law enforces the two aspects of the DSHEA that are reasonable: That supplement manufactures use good manufacturing processes and that they be able to certify that their supplements contain what they are advertised to contain. Indeed, the most ironic example of this occurred when über-quack Gary Null overdosed on vitamin D when the manufacturer of one of his supplements put ten times too much vitamin D in it. Meanwhile, a recent study linked dietary supplements to 20,000 visits to the emergency room every year.
Not surprisingly, in the 21 years since the passage of the DSHEA, the supplement industry has really taken off and is estimated to contribute $60 billion to the economy. So powerful is the industry that every effort to tighten up the DSHEA of 1994 has failed, most spectacularly when Senator John McCain, facing a major challenge from his right in the primary, gave up on an attempt to pass a law modifying the DSHEA to tighten regulations and in essence had to grovel to chief supplement industry lapdog Orrin Hatch.
Other good evidence of how much the supplement industry has taken advantage of the DSHEA comes from the press conference yesterday in which the FDA and the Justice Department announced:
The U.S. Food and Drug Administration, in partnership with other government agencies, today announced the results of a yearlong sweep of dietary supplements to identify potentially unsafe or tainted supplements. The sweep resulted in civil injunctions and criminal actions against 117 various manufacturers and/or distributors of dietary supplements and tainted products falsely marketed as dietary supplements. Among the cases announced today is a criminal case charging USPlabs LLC and several of its corporate officers. USPlabs was known for its widely popular workout and weight loss supplements, which it sold under names such as Jack3d and OxyElite Pro.
The investigation involved the FDA, the Department of Justice, the Internal Revenue Service’s Criminal Investigation Division, the Federal Trade Commission, the U.S. Postal Inspection Service, the Department of Defense and the U.S. Anti-Doping Agency and took over a year. Here’s the meat of the indictment:
The indictment alleges that USPlabs engaged in a conspiracy to import ingredients from China using false certificates of analysis and false labeling and then lied about the source and nature of those ingredients after it put them in its products. According to the indictment, USPlabs told some of its retailers and wholesalers that it used natural plant extracts in products called Jack3d and OxyElite Pro, when in fact it was using a synthetic stimulant manufactured in a Chinese chemical factory.
The indictment also alleges that the defendants sold some of their products without determining whether they would be safe to use. To the contrary, as the indictment notes, the defendants knew of studies that linked the products to liver toxicity.
We here this time and time again. Because most herbal remedies and supplements don’t do much of anything—and if they did they would be functioning as drugs—unscrupulous manufacturers sometimes decide to put actual drugs in the supplement. This might just be confirmation bias, but it seems to me that the most common kind of supplement I read about containing drugs are usually dietary supplements containing stimulants. Be that as it may, it gets worse than that.
One of the supplements, OxyElite Pro, was recalled in 2013 after it was implicated in dozens of cases of acute liver failure due to nonviral hepatitis. Of these cases at least 3 received a liver transplant, and one death was reported. It turns out that OxyElite Pro contained a substance known as aegeline (which appeared as N-[2-hydroxy-2(4-methoxyphenyl) ethyl]-3-phenyl-2-propenamide on the label). Aegeline is extracted from Aegle marmelos (bael), a plant that has a long history of use in Ayurvedic medicine. Unfortunately, it wasn’t long before aegeline was identified as the likely culprit in this outbreak of liver injury. It turns out that the company never told the FDA that it was adding aegeline to its supplement.
But it’s even worse than that, still:
The indictment also alleges that USPlabs and its principals told the FDA in October 2013 that it would stop distribution of OxyElite Pro, once the product had been implicated in an outbreak of liver injuries. The indictment alleges that, despite this promise, USPLabs engaged in a surreptitious, all-hands-on-deck effort to sell as much OxyElite Pro as it could as quickly as possible. It was sold at dietary supplement stores across the nation.
If true, this is pure criminal behavior. Not only did USPlabs allegedly adulterate its supplement, but, when busted after that supplement caused a whole lot of people to have liver failure, the company did its damnedest to make as much money as it could selling its remaining stock. The sheer blatantness of the behavior is shocking and depressing.
Unfortunately, USPlabs and its OxyElite Pro product were not the only culprits. The DOJ filed a complaint in federal court on behalf of the FDA against Bethel Nutritional Consulting, Inc, including the company’s president and vice president. What did they do, allegedly? According to the complaint filed, Bethel distributed adulterated and misbranded supplements and unapproved new drugs, as well as demonstrated major deviations from current good manufacturing practices regulations. Truly, this was an example of scary substances manufactured under scary conditions.
Oh, and Bethel also made medical claims that some of their supplements were able to cure, mitigate, treat, or prevent diseases. It turns out that some of the products marketed as dietary supplements by Bethel contained—you guessed it!—real drugs. These included sibutramine, the active ingredient of Meridia, a drug approved in 1997 to treat obesity that was removed from the market in 2010 because of the risk of serious adverse events, including heart attack and stroke. There was also lorcarserin, the active pharmaceutical in Belviq, a drug approved by the FDA in 2012 for chronic weight management. This is a drug that can also cause significant side effects, including disturbances in attention or memory. It’s also can cause serotonin syndrome, particularly when taken with drugs that impact the serotonin system. The serotonin syndrome is a very serious, life-threatening condition due to elevated serotonin levels and produces a wide variety of symptoms, including: headache, agitation, hypomania, mental confusion, hallucinations, coma, shivering, sweating, hyperthermia, vasoconstriction, tachycardia, nausea, diarrhea, myoclonus (muscle twitching), and hyperreflexia (manifested by clonus), tremor.
Next, showing that it’s all about the money, the FDA’s announcement had a profound effect on stock prices of supplement companies:
Shares of dietary supplement retailers tumbled in heavy trading volume on Tuesday, spurring a surge in options hedging activity for those stocks even though fears they would be mentioned in a U.S. Department of Justice lawsuit did not materialize.
GNC Holdings’ shares tumbled as much as 27.1 percent to hit their lowest in four years, but closed 6.4 percent lower at $29.07. Daily volume was the largest ever according to Reuters data.
Unfortunately, USPlabs and Bethel, the two companies whose officers are facing criminal charges, are not publicly traded.
Finally, I took a brief look across the quackosphere for reactions to this news and was shocked by one of them. Believe it or not, this is Mike Adams:
Believe it or not, I agree that there is a fringe, criminal element in the dietary supplement industry, and this element is engaged in deceptive, dubious practices that put the public at risk.
While most of the dietary supplement industry operates ethically and honestly, a few bad apples are raking in millions of dollars each month in sales of dishonest, chemically-adulterated products that endanger the public.
The DOJ and FDA’s case must be pretty solid if even Mike Adams, master of the conspiracy theory, couldn’t come up with something other than the supplement companies to blame, as in a conspiracy by the government to discredit supplements. Either that, or he maybe he’s in the earliest stages of serotonin syndrome from taking OxyElite Pro. Whatever the reason, it’ll be interesting to see the reactions of quacks over the next few days. Will they emulate Adams and admit that there are criminal companies in the supplement industry and that supplement adulteration is a huge problem, or will they try to defend the indefensible?
The other question is this: When will Congress pass a law to tighten up the regulation of dietary supplements and rectify the deficiencies of the DSHEA? Sadly, given the current Congress and its extreme anti-regulatory bent, I don’t expect anything to happen sometimes soon.
Source: http://scienceblogs.com/insolence/2015/11/18/finally-the-department-of-justice-and-fda-go-after-unsafe-supplements-in-a-big-way/
