How the Hell Is This Legal?
The federal loophole letting opioids, brain drugs, and "herbal highs" sit on the same shelf as vitamin C.
Walk into a vape shop after dark and you’ll see it glowing: "ZaZa • Neptune’s Fix • Feel Free." The clerk calls it a natural supplement. The chemistry says otherwise; these compounds hit the same opioid receptors targeted by morphine.
So how the hell is this legal?
The 30-Year-Old Law That Time Forgot
Every pill, powder, and tincture labeled a supplement hides behind the Dietary Supplement Health and Education Act of 1994 (DSHEA), a law older than online shopping.
Under DSHEA, a company can market a "dietary supplement" without pre-approval if the ingredient was sold in the U.S. before 1994. Anything newer must survive the New Dietary Ingredient (NDI) review, where the FDA examines safety data 75 days before launch.
That’s the theory. In practice, manufacturers skip the filing, stamp "plant-based" or "herbal" on the label, and ship it straight to gas stations and vape counters.
The NDI Test and How They All Flunked
The FDA has already ruled on the three marquee offenders: Phenibut, Kratom, and Tianeptine. Each tried or was reviewed under the NDI pathway. Each failed.
Kratom (Mitragyna speciosa)
Six NDI filings since 2014. All rejected. FDA’s verdict: "Inadequate information to provide reasonable assurance of safety." Translation: too risky to count as a supplement.
Phenibut (β-phenyl-GABA)
FDA: "Not a dietary ingredient." It’s a lab-made chemical, not a nutrient or amino acid naturally found in food. Any product claiming otherwise is "misbranded and adulterated."
Tianeptine
FDA again: "Not a dietary ingredient and not generally recognized as safe for use in food." Meaning any capsule or drink containing it is illegal by definition with no loophole, no gray area.
Bottom line: Every legal door to the supplement market has already slammed shut on these three. They aren’t unapproved; they’re explicitly disqualified.
The Enforcement Void
The FDA can issue warnings and reject NDIs, but it has no standing army. Without state or local backup, the same drugs reappear in fresh neon packaging within weeks. Regulators even have a term for it: "label laundering."
- Alabama schedules tianeptine → sales surge across state lines.
- Florida bans it → Georgia stalls under lobbying.
- New brand. New barcode. Same powder.
The Marketing Trick
They don’t change the chemistry—just the vocabulary.
"Herbal Oxycodone" becomes "Mood Booster." "Anxiolytic nootropic" becomes "Focus Fuel."
Bright colors. Wellness fonts. QR codes to nowhere. And thanks to DSHEA, the FDA can’t pull it until after someone overdoses.
What Policymakers Can Do
- Close the NDI Loophole. Amend DSHEA to require pre-market approval for any psychoactive ingredient, not just a notification.
- Empower Boards of Pharmacy. Let states classify these drugs as prescription-only or remove them entirely.
- Regulate signage and age limits. If a store sells kratom, delta-8, or tianeptine, it should follow the same rules as alcohol and tobacco.
- Name the fiction. If a label says "dietary supplement," ask: is this really food, or a drug in drag?
The Bigger Truth
America’s supplement law was written when dial-up was cutting-edge and Gore-Tex meant progress. It never imagined chemical imports posing as tea.
Today, "herbal" sells, "unregulated" protects, and "not yet scheduled" means open season.
Until Congress rewrites DSHEA or the FDA gets power to yank products proactively, the shelves will keep glowing and the poisons will keep finding new names.
Sources & Documentation
- Food and Drug Administration. New Dietary Ingredient Notification Process. 2024.
- FDA. Kratom in Dietary Supplement Products. 2024 — six NDI notifications denied.
- FDA. Phenibut in Dietary Supplements. Constituent Update, 2019.
- FDA. Tianeptine Marketed as Dietary Supplement — Serious Risks. Consumer Update, 2023.
- Cohen PA et al. Unapproved Pharmaceuticals Marketed as Dietary Supplements. JAMA Netw Open. 2021; 4(7): e2113203.