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The feds want a West Boylston man to stop selling unapproved drugs to target anxiety

If Chill6’s website is to be believed, the powdered beverage supplement that comes in flavors like pink lemonade can cure almost anything you throw at it — from anxiety to post-traumatic stress disorder and even alcoholism. But the feds say these claims haven’t been tested and want the product gone.

“Within minutes of taking this, I felt an unusual calm come over me. I didn’t feel spaced out, jittery, or any other random, unwanted side effect. I felt, well, at peace,” raved Tammy G., a verified customer, on the testimonials page. “I cannot recommend this product highly enough.”

The product is sold by Daniel Marold of West Boylston, and as of Thursday afternoon, all five of its flavors were listed as “Sold Out.”

That could be because of fans like Tammy, or because the Massachusetts U.S. Attorney’s office has filed for a permanent injunction to prevent Marold from “distributing a product that the government claims is an unapproved new drug and adulterated food under the Federal Food Act, medicines and cosmetics.”

The drug of concern is phenibut, which the Chill6 website describes as having “been used safely in Russia for over 50 years…safely treating hundreds of thousands of people for a variety of disorders including; anxiety, insomnia, mental stress, alcoholism and post-traumatic stress disorder.”

While Chill6 claims it “uses the lowest, effective dose for anxiety relief,” the feds say research has been completed on whether any dose is safe.

According to the complaint, the Food and Drug Administration conducted a search of the available literature and could find no evidence showing that Chill6 is “generally recognized as safe and effective” “for any use.”

A 2001 paper by a Russian scientist published in CNS Drug Reviews describes phenibut as a “tranquilizer and nootropic” that was “discovered and introduced into clinical practice in Russia in the 1960s.”

Author Izyaslav Lapin of the Bekhterev Institute for Psychoneurological Research in St. Petersburg, Russia, says the drug acts as a GABA-mimetic — meaning it mimics gamma-aminobutyric acid, according to the Cleveland Clinic, reducing “the ability of nerve cells to receive, generate, or send messages to others nerve cells” — and also stimulates dopamine receptors in the brain.

This effect has made it “widely used in Russia” to alleviate the same types of disorders that Chill6 claims to alleviate.

The compound is readily available on other nootropic or supplement oriented websites, from NootropicsDepot.com to LifeMode.com, but both of those sites do not make the same claims as the Chill6 website. LiftMode, for example, states that “Phenibut is a chemical compound that has not been approved for food, drug, or veterinary use by any US regulatory agency.”

The FDA sent Marold a warning letter last July, telling him that “failure to correct these violations could result in regulatory action, including seizure and/or prohibition.” It was a tactic that Marold did not respond well to.

“Never, never write me a letter telling me what to do!” Are you even serious!” he was quoted in the complaint as responding to the agency in an email. “This is not even a dietary supplement and nowhere on the site does it claim that … Never, ever waste the taxpayer [sic] money send such nonsense or i will remove you! … If you ever become tyrannical towards me, I will exercise my second amendment rights.”

The Herald could not reach Marold Thursday. As of Thursday evening, Maroldo’s attorney was not listed in the filings.

A screenshot of the Chill6.com website listing additional product facts.  The U.S. Attorney's Office for the District of Massachusetts filed a motion to permanently ban the sale of this product because its medical claims are not supported by federal regulators.  (courtesy / Ministry of Justice)

Courtesy / Ministry of Justice

A screenshot of the Chill6.com website listing additional product facts. The U.S. Attorney’s Office for the District of Massachusetts filed a motion to permanently ban the sale of this product because its medical claims are not supported by federal regulators. (courtesy / Ministry of Justice)

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