'Blue Brain Boost': FDA blocks Colorado couple from importing and reselling drugs from China
A Colorado-based couple, Mark and Linda Godding, received a final debarment order from the FDA, stipulating that they cannot import drugs to the US for the next five years.
The debarment comes as last summer they were each sentenced to six months in federal prison for selling unapproved and misbranded drugs to treat serious medical conditions through their online business, known as “Blue Brain Boost.”
The company’s Twitter profile says it was “Leveraging discoveries in neuroscience to improve cognitive performance.” The most recent post, from August 2019, said they’re offering free shipping.
According to the plea agreement, in December 2016, the couple purchased a business called Mighty Stacks, which did business through Blue Brain Boost and sold products through the website, bluebrainboost.com.
The business sold products identified by the FDA as misbranded and unapproved new drugs, including Tianeptine Sodium Powder, a dangerous unapproved drug that the FDA warned may be abused, particularly in those with a history of opioid use disorder and overdose.
While the Blue Brain Boost website identified its products as “nootropics,” which are essentially unapproved drugs falsely marketed as “smart drugs” and “cognitive enhancers,” in reality, the couple purchased about a dozen drugs from China and repackaged and distributed them for consumer use.
Safety concerns were an issue with the imported drugs, and the FDA noted:
Ms. Godding had no knowledge of these products’ manufacturers’ practices, where or how the products were manufactured, the safety of those products, or that the products were what the suppliers alleged them to be, with the minor exception that Ms. Godding in rare cases had the products tested, sometimes after receiving safety complaints from her customers.
The US attorney’s office said the couple “fraudulently misled customers by advertising that their products were tested by independent labs and asserted that they were ‘compulsive’ about quality control.”
The couple also received numerous violation letters placing holds, noting detentions, or demanding return of nootropic products that were imported to the US.
“Copies of these notices were located in Ms. Godding’s desk during an execution of a search warrant at the Godding’s warehouse,” FDA noted.
The suppliers also shipped their goods to US affiliates before shipping to Godding to try to evade the appearance of imports.
“Godding emailed a testing laboratory representative to let him know that she was sending him 3 grams of tianeptine sodium for testing as she did not want to pay the supplier until she had the test results,” the FDA wrote yesterday in the debarment order. “She noted in her email that the product was coming to the laboratory with a different sender name and not from Blue Brain Boost, and labeled as, ‘Alpha GPC to get it thru customs.’ Ms. Godding also received emails from Chinese suppliers explaining how the suppliers changed the product name for easy shipment and customs clearance.”
