CO: Fort Collins Couple Sentenced to Federal Prison for Illegally Selling Unapproved Drugs

The United States Attorney’s Office for the District of Colorado announces Mark Godding and Linda Godding have each been sentenced to six months in federal prison for selling unapproved new and misbranded drugs to treat serious medical conditions through their online business.

According to the plea agreement, in December of 2016, the couple purchased the business Mighty Stacks, LLC. In January 2017, Mighty Stacks, LLC, did business through Blue Brain Boost and sold products through the website bluebrainboost.com. The business sold products identified by the Food and Drug Administration (FDA) as misbranded and unapproved new drugs, including Tianeptine Sodium Powder, a dangerous unapproved drug that the FDA has warned is linked with risk of abuse, particularly in those with a history of opioid use disorder and overdose. Some people have turned to tianeptine as an opioid alternative, or to self-treat anxiety or depression. The Goddings also illegally sold multiple other unapproved and misbranded drugs, including adrafinil crystalline powder, aniracetam crystalline powder nicotine solution, IDRA-21, methylene blue solution, noopept crystalline powder, oxiracetam, phenibut hydrocholoride crystalline powder, coluracetam chrystalline powder, phenylpiracetam crystalline powder, pramiracetam, and sunifiram. The Blue Brain Boost website identified its products as “nootropics,” a term widely used to market unapproved products as “smart drugs” and “cognitive enhancers.” The defendants purchased these drugs from China and repackaged and distributed them for consumer use.

The defendants fraudulently misled customers by advertising that their products were tested by independent labs and asserted that they were “compulsive” about quality control. In fact, they rarely tested any of their products before selling them to consumers, even after receiving complaints of side effects. One customer wrote to the company: “The batch I just received I am getting multiple reports from my clients that it causes vomiting.” Another customer wrote in, “After administering a single dose, he noticed a rapid heart rate, a pressure in brain and rapid breathing. The customer vomited out the product. He noted the smell and flavor were not quite right.”

The FDA has identified many nootropics as unapproved new drugs and has issued numerous warning letters and online advisory letters emphasizing that such products have not been proven safe and/or effective and could potentially prevent a person from seeking medical help for a serious medical condition.

Mark Godding pleaded guilty on January 26, 2022, before United States District Court Chief Judge Philip A. Brimmer, who sentenced him to six months in federal prison on May 20, 2022. Linda Godding pleaded guilty on January 27, 2022, before Judge Brimmer. He sentenced her to six months in federal prison on June 10, 2022.

“The defendants knowingly, intentionally, and repeatedly placed customers at risk, and they undermined and evaded the extensive regulations put in place to protect those consumers,” said U.S. Attorney Cole Finegan. “Their sentences should send a message to other businesses that we will hold you accountable if you disregard the law and threaten public health.”

“Prescription drugs that are smuggled from overseas and are outside the secure supply chain can present a serious health risk to those who use them. The drugs may contain unknown or dangerous ingredients and are manufactured under unknown or unregulated conditions,” said Special Agent in Charge Charles L. Grinstead, FDA Office of Criminal Investigations Kansas City Field Office. “We will continue to investigate and bring to justice those who traffic in illegal prescription drugs.”

This case was investigated by the FDA Office of Criminal Investigations.

Case Number: 21-cr-000345

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National Association of Drug Diversion Investigators Federal Tax ID: 52-1660752 / DUNS Number: 073539913

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