Wednesday, October 16, 2013

What's Really in Your Pre-Workout Supplement? It Might Be Methamphetamine . . .

Over the past 15 to 25 years, the sports supplement market has exploded. When I was a wee lad, there was a limited selection of supplements, mainly dessicated liver tablets, Joe Weider Mega Mass 4000 (and other similar buckets of sugar), some amino acids, and a faith in drinking glasses of raw eggs.


Now there are supplements for everything - pre-workout, poist-workout, A.M, P.M., fat loss, energy, focus, better pumps, test boosters, anti-estrogens, and an assortment of proteins, creatine mixtures, and other crap.

One of the areas that has exploded in recent years is the pre-workout segment of the market. Back 15 years, it was common to take 20 mg ephedra, 200 mg caffeine, and 200 mg of aspirin (the ECA stack), but when the FDA banned ephedra because a handful of idiots took 3 or 4 times the recommended dosage and did not eat, then had heart attacks or fainted, the market blew up with companies trying to concoct an equally effective supplement.

During this same period, several companies promoting testosterone boosting supplements got nailed when athletes using the products failed drug tests for anabolic steroids. No wonder they worked!

The practice among the shady companies was to come out with a new product making extraordinary claims - claims any close look at the ingredients listed on the label could not support. Yet users would post rave reviews on message boards about gaining 10 lbs of muscle in just two weeks or losing 4% bodyfat in a week, or whatever. And they did - because the supplement contained banned substances. Once the hype had built around the product, the manufacturer could remove the illegal substances before the FDA caught on and still sell tons of the product to undiscerning people who believed the hype. [T-Nation did an excellent story on this back in the day.]

Turns out the practice is still occurring, with a slight tweak. Now they avoid the actually illegal substances but instead they include analogs, substances that are chemically similar but are not listed as illegal yet (this is especially true in the pro-hormone market, where many products can be found online that are actual steroids, but are not on the controlled substances lists).

A new study found that the popular pre-workout supplement Craze contains an analog of methamphetamine, you now, crystal meth. The FDA has cracked down on them, and they have removed the product from the market - Gaspari Nutrition, a company generally thought reputable, also had a product with this substance, and they have also removed it from the shelves.

 

Here is the summary of the research study from Medical News Today, followed by an article from USA Today about this whole mess.

Muscles and meth: Drug analog identified in 'Craze' workout supplement

An international team of scientists have identified potentially dangerous amounts of methamphetamine analog in the workout supplement Craze, a product widely sold across the U.S. and online. The study, published in Drug Testing and Analysis, was prompted by a spate of failed athletic drug tests. The results reveal the presence of methamphetamine analog N,α- DEPEA, which has not been safely tested for human consumption, in three samples.

"In recent years banned and untested drugs have been found in hundreds of dietary supplements. We began our study of Craze after several athletes failed urine drug tests because of a new methamphetamine analog," said lead author Dr. Pieter Cohen, of Harvard Medical School, U.S.A.

A workout supplement marketed as a 'performance fuel', Craze is manufactured by Driven Sports, Inc., and is sold in stores across the United States and internationally via body supplement websites.

The supplement is labeled as containing the compound N,N-diethyl-phenylethylamine (N,N-DEPEA), claiming it is derived from endangered dendrobium orchids. However, while there is no proof that this compound is found within orchids, it is also structurally similar to the methamphetamine analog N,α-diethylphenylethylamine (N,α-DEPEA), a banned substance.

The team analyzed three samples of Craze for traces of N,α-DEPEA. The first sample was brought from a mainstream retailer in the U.S., while the second and third samples were ordered from online retailers in the U.S. and Holland.

The team used ultra-high performance liquid chromatography to detect the presence of N,α-DEPEA. The first two samples were analyzed by NSF International, while the third was tested at the Netherland's National Institute for Public Health. The findings were independently corroborated by the Korean Forensic Service, which confirmed the presence of N,α-DEPEA in two further samples of Craze in a parallel investigation.

"We identified a potentially dangerous designer drug in three separate samples of this widely available dietary supplement," said Cohen. "The tests revealed quantities of N,α-DEPEA of over 20mg per serving, which strongly suggests that this is not an accidental contamination from the manufacturing process."

As a structural analog of methamphetamine, N,α-DEPEA , may have stimulant and addictive qualities; however, it has never been studied in humans and its adverse effects remain unknown.

The product labeling claims that Craze contains several organic compounds, known as phenylethylamines. However, phenylethylamines are a very broad category of chemicals which range from harmless compounds found in chocolate to synthetically produced illegal drugs.

"The phenylethylamine we identified in Craze, N,α-DEPEA, is not listed on the labeling and it has not been previously identified as a derivative of dendrobium orchids," said Cohen.

"If these findings are confirmed by regulatory authorities, the FDA (The U.S. Food and Drug Administration) must take action to warn consumers and to remove supplements containing N,α-DEPEA from sale," concluded Cohen. "Our fear is that the federal shutdown may delay this, resulting in potentially dangerous supplements remaining widely available."

Full Citation:
Pieter A. Cohen, John C. Travis, Bastiaan J. Venhuis. (2013, Oct 14), A methamphetamine analog (N,α-diethyl-phenylethylamine) identified in a mainstream dietary supplement. Drug Testing and Analysis: Article first published online: 14 OCT 2013 - DOI: 10.1002/dta.1578

Here is the USA Today article:

Maker of Craze suspends production of sports supplement

Alison Young, USA TODAY, October 15, 2013

Driven Sports, maker of the pre-workout supplement Craze, announced Tuesday that it has suspended all production and sales of the product in the wake of tests finding amphetamine-like ingredients.



(Photo: Alison Young, USA TODAY)

Story Highlights
  • Driven Sports says it stopped production of Craze "several months" ago after media reports
  • A USA TODAY investigation in July reported that tests had found amphetamine-like compounds in Craze
  • Two scientific journal articles have recently identified a methamphetamine-like compound in Craze
  • FDA and DEA officials could not be reached for comment because of the government shutdown
The maker of the popular sports supplement Craze, which scientists say contains a methamphetamine-like compound, revealed Tuesday that it has suspended all production and sales of the product.

Driven Sports, which has declined USA TODAY's repeated interview requests, posted a statement on its website disclosing that the New York-based company suspended production "several months ago while it investigated the reports in the media regarding the safety of Craze."

In July, a USA TODAY investigation revealed that a top Driven Sports official, Matt Cahill, is a convicted felon who has a history of putting risky products on the market and that tests of Craze by the U.S. Anti-Doping Agency and a lab in Sweden had found amphetamine-like compounds in the pre-workout powder.

On Monday, a team of scientists from the U.S. and the Netherlands published an article in the peer-reviewed scientific journal Drug Testing and Analysis saying they had identified an analog — or chemical cousin — of methamphetamine in samples of Craze. They warned that the chemical has never been studied in humans, that the health risks are unknown and that it is not disclosed on Craze's label.

Driven Sports says that its own studies continue to show Craze is safe "when used responsibly" and that tests it has commissioned "have consistently indicated that Craze does not contain amphetamines or controlled substances." It added "the confidence of our retailers to sell the product and our consumers to buy the product is our primary concern so we will continue the suspension of the production and sale of Craze for the foreseeable future until these issues are resolved."

Walmart.com, Bodybuilding.com and some other online retailers stopped selling Craze earlier this summer in the wake of the USA TODAY investigation, but tubs of the pre-workout powder continued to be available for purchase elsewhere online and in GNC stores. Recently, the product was no longer available on GNC.com and Driven Sports' own website listed Craze as out of stock.

GNC officials have declined to be interviewed. In a statement the retailer said: "With third party products, GNC is simply the retailer and, like all retailers, relies upon the representations and contractual warranties made by the vendor that the products are safe and compliant with all applicable laws and regulations."

In a related development this week, NSF International announced that in separate testing they found the same meth-like compound in the weight-loss supplement Detonate, which is marketed by Gaspari Nutrition. NSF International is a Michigan-based testing organization; one of its scientists co-authored Monday's journal article about Craze.

Gaspari Nutrition officials did not respond to interview requests and as of Tuesday night had removed Detonate from its website's list of products. Detonate was still listed on Gaspari's website as of Oct. 10, according to a version of the page archived by Google that day. Detonate remains available for sale online and in some stores. USA TODAY was able to purchase a bottle of Detonate on Tuesday at a Vitamin Shoppe store in Sterling, Va., but found several GNC and Vitamin Shoppe stores in the Virginia suburbs of Washington, D.C. did not have it in stock.

Driven Sports says it believes that the independent labs and scientists who have found amphetamine-like and methamphetamine-like compounds in Craze may have made a mistake in their tests. Craze's label says it contains dendrobium orchid extract, which the company says has naturally occurring phenylethylamine compounds. The statement says that these other scientists' tests may be mistaking the natural compound for amphetamine-like substances.

Driven Sports says its labs' tests indicate the presence of "n-beta DEPEA" in Craze" and that this compound is "a related but very different substance" from the n,alpha DEPEA identified in Monday's journal article. The company said it is "very difficult to distinguish these two substances unless you know precisely what you are looking for and are using the proper test methodology."

In an e-mailed statement, the journal article's authors said that "their argument holds no merit" and that Driven Sports is "just throwing out new chemical names to try to confuse." The authors said that n-beta DEPEA is "a completely different molecule" and that the differences in the molecule would have made them act differently on two of the three tests they ran.

"We stand 100% behind our results," said the research team: Pieter Cohen of Harvard Medical School; John Travis, a scientist at NSF International; and Bastiaan Venhuis of the National Institute for Public Health and the Environment in the Netherlands.

Another team of scientists based in South Korea found the same methamphetamine-like substance when they tested other samples of Craze. Their findings were published in a forensic toxicology journal in August.

Neither the Food and Drug Administration nor the Drug Enforcement Administration could be reached for comment because of the federal government shutdown.

Amy Eichner, a special advisor on supplements at the U.S. Anti-Doping Agency, noted that both Craze and Detonate have been listed on the nonprofit organization's "high risk" supplement list. "There needs to be a serious examination of the current regulations of supplements," she said, "and changes must be made in order for the FDA to have the necessary tools to effectively regulate the supplement industry."

Although dietary supplements -- such as vitamins, minerals and herbal pills -- are often marketed as health remedies, the FDA does not have the authority to require pre-market testing for safety or effectiveness as it does with medications. Supplement industry officials have said that greater enforcement, not new regulations, are what is needed to address problem products and makers.

Driven Sports and Gaspari Nutrition, the companies marketing Craze and Detonate, are both members of the American Herbal Products Association. The association did not respond to questions or an interview request from USA TODAY about the findings of meth-like compounds in the companies' products.

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