The Unregulated Sale of Dangerous, Lab-Made Synthetic Drugs Masquerading as Natural, Safe Substances Hurts Americans and Fuels For-Profit Addiction Across the Country
WASHINGTON, D.C. — The Stop Gas Station Heroin coalition today applauded the U.S. Food and Drug Administration (FDA) for issuing a far-reaching and forceful warning letter to Hydroxie, LLC, a California-based seller of synthetic, high-potency, novel opioid drugs like “7” and “Pseudo,” which are deceptively marketed as dietary supplements and food items such as drink mixes. The Coalition praised the move as a critical step in addressing the explosion of Gas Station Heroin.
The proliferation of synthetic opioids “7”, “Pseudo,” and their analogues in the marketplace has been extensively researched by Dr. C. Michael White, Pharm.D. In his recent publication, Dr. White found many of these products are frequently sold as dietary supplements, featuring added flavors or scents, bright packaging, and labels with food pictures or cartoon mascots. As such, he concluded that these dangerous, unapproved new drugs would appeal to children.
“This warning letter marks a major turning point in the government’s fight to crack down on the escalating Gas Station Heroin crisis,” said Matthew Lowe, Executive Director of Stop Gas Station Heroin, echoing the warnings voiced by many scientific experts. “These lab-made, chemically altered substances are cleverly disguised to evade regulatory scrutiny and confuse consumers, all while imitating copycat snacks, knockoff prescription opioids, natural supplements, and other novelty products.”
“We are witnessing a turning point,” Lowe continued. “This action shows that these illegal businesses’ intentional misdirection has not been missed by the authorities and should result in a torrent of warnings to other 7 makers and beyond.” Gas Station Heroin refers to a range of lab-made, chemically altered substances including tianeptine, synthetic isolate alkaloids like 7-hydroxymitragynine (7-OH), high-concentration extracts, intoxicating hemp products, and nitrous oxide. These products or their precursors are lab-manufactured, primarily in China and India, and illegally imported into American communities through cash-based retailers operating under false pretenses as part of a coordinated, multi-billion-dollar syndicate. Despite being marketed as such, these are not dietary supplements, nor traditional botanicals. They are unapproved new drugs.
In its June 25, 2025, letter, the FDA pointed to the proliferation of products like “7” and “Pseudo” and outlined its concerns. Namely, despite being novel opioids for which the intended use is chronic pain and opioid use disorder treatment, they have not been approved as new drugs by the FDA, and the agency is receiving reports of adverse events.
“The FDA has now made it abundantly clear: Products like Hydroxie’s — which are made up of synthetically boosted and highly concentrated levels of 7-OH and other unknown chemical entities — are illegal,” Lowe said. “Natural botanical products have been used safely for centuries and have inherent consumer trust. We must put an end to the serial bad actors isolating single compounds from natural plants and chemically altering them in labs to create hyper-concentrated drugs that are poisoning consumers. In the case of products like Hydroxie, the result is unfettered access to an opioid that is 22 times more potent than morphine and available at smoke shops and independent convenience stores for $6 a pill.”
The FDA’s warning letter must be the first of many actions aimed at extinguishing Gas Station Heroin. Without continued enforcement, the same tactics used to disguise synthetic drugs as safe will continue to drive sales of other Gas Station Heroin products deceptively branded as legal, natural, and safe.
Smart regulation that distinguishes between legitimate, natural botanicals and dangerous, synthetic drugs, combined with enforcement of current federal laws around unapproved drugs, is the path forward.
That is how we can finally Stop Gas Station Heroin.
To learn more about Stop Gas Station Heroin and its mission, navigate to stopgasstationheroin.com.
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