Last month marked a little-known legal anniversary with big-time consequences for Americans’ public health: Back in July 2012, British biopharmaceutical giant GlaxoSmithKline reached a record $3 billion settlement with the Justice Department, pleading guilty to promoting its profitable antidepressants for unapproved uses and distributing phony data to push the drugs on children.
The GlaxoSmithKline case, which resulted in what was until then the largest health care fraud payout in U.S. history, established new standards for the regulation of misleading marketing by drug companies and supercharged skepticism toward the broader pharmaceutical industry.
The extraordinary settlement also helped set the stage for the modern Make America Healthy Again movement, specifically its emphasis on natural medicines and alternative treatments over the prescription pills and Big Pharma products that too many U.S. consumers have come to rely on.
Now, over a dozen years later, it’s only fitting that the nation’s top health agencies — led by the Food and Drug Administration (FDA) — are again rejecting false marketing and half-baked pseudoscience in favor of Mother Nature, galvanizing Americans against a deadly new threat to kids and communities across the country: 7-hydroxymitragynine, also known as 7-OH.
On July 29, Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary formally recommended 7-OH be classified as a Schedule I substance under the Controlled Substances Act — alongside the likes of heroin, ecstasy, and LSD.
7-OH is an oxidative byproduct compound found in trace amounts in dried kratom leaf (<0.01%) and can be mass produced by chemically altering concentrated kratom extracts. These isolated 7-OH derivatives exhibit serious adverse effects, are up to 13 times stronger than morphine, and are illegal on the state and federal levels.
Crucially, the FDA’s recommendation applies only to products containing concentrated, unnatural levels of 7-OH — not those that contain natural kratom leaf, a whole-plant product harvested from the Southeast Asian tropical tree Mitragyna speciosa.
Kratom enjoys inherent consumer trust through centuries of safe use, commonly consumed in forms such as capsules, powders, teas, and liquid suspensions. Concentrated synthetic 7-OH opioid products bear absolutely no resemblance to the natural leaf kratom products that are used by more than 23 million Americans.
In fact, semi-synthetic 7-OH is a particularly pernicious form of Gas Station Heroin, an unregulated category of street drugs encompassing a range of foreign lab-made substances. In addition to 7-OH derivatives such as “7” and analogues like “Pseudo,” other types of Gas Station Heroin include tianeptine, nitrous oxide, and intoxicating hemp products.
Gas Station Heroin is sold alongside everyday bites and beverages, cleverly camouflaged as copycat snacks and supplements to evade regulatory scrutiny and confuse consumers. Misleadingly marketed and often targeted at children, they are advertised in an assortment of flavors and sheathed in colorful packaging.
By recommending 7-OH for Schedule I classification, FDA officials clarified what opponents of Gas Station Heroin products have long known: Illicit synthetic drugs are not the same as natural, plant-based remedies.
Dried kratom leaf products, for example, are made from raw plant material processed solely through mechanical means or standard food-grade sanitation processes. Extracts, concentrates, and synthetic derivatives boost the quantity of the raw plant’s active ingredients beyond that naturally occurring in the botanical.
The FDA’s decision, grounded in commonsense science and deference to Mother Nature, has its fair share of dubious detractors. For example, the Holistic Alternate Recovery Trust (HART) — a trade association representing manufacturers of “7” products — is fighting tooth and nail to keep Gas Station Heroin on convenience store shelves, despite its industry members receiving a series of stern FDA warnings in recent weeks.
But bogus studies cooked up by shady special interest groups haven’t fooled FDA officials, who affirmed once and for all the distinction between natural kratom and street drugs designed to mimic the effects of prescription opioids and other scheduled narcotics.
Going forward, government action aimed at curbing the synthetic drug crisis should follow the FDA’s model of embracing real science over the deception of the global Gas Station Heroin syndicate. By prioritizing common sense and Mother Nature, federal health officials can help regain public trust, protect consumers, and Make America Healthy Again.
