Are Vape Shops and Gas Stations Violating Your State’s Food, Drug & Cosmetic Act?

Why tianeptine, phenibut, Amanita mushrooms, and kratom don’t just “slip through the cracks”—they actively break the rules.

Walk into almost any vape shop or gas station today and you’ll find tianeptine (“gas-station heroin”), phenibut, Amanita mushroom gummies, kratom shots, and powders lined up next to energy drinks.

But here’s the real question every parent, pharmacist, and legislator should be asking:

Are these stores violating our state’s Food, Drug, and Cosmetic Act?

In most states, the answer is yes—and not by a little. These products violate multiple sections of nearly every state FD&C Act, the same laws that regulate food, drugs, dietary supplements, cosmetics, and consumer safety.

Below is exactly where the violations occur, why they’re violations, and what states should strengthen to stop the explosion of unregulated psychoactive products being sold to teenagers.

1. Illegal to Sell an “Unapproved Drug”

Most state FD&C Acts adopt the federal definition: any substance intended to affect the body that is not FDA-approved is an unapproved drug.

What this means:

• Tianeptine → a synthetic antidepressant, not FDA-approved
• Phenibut → a GABA-B drug, not FDA-approved
• Amanita muscaria → contains muscimol, a psychoactive drug, not approved
• Kratom (mitragynine/7-OH) → pharmacologically active, not approved

Violation:
Unapproved Drug – State FD&C §§ “New Drug” / “Unapproved Drug” provisions.

Why: These products are sold with effects on mood, pain, sleep, energy, anxiety, or withdrawal—legally categorizing them as drugs. No state has approved them.

2. Illegal to Sell a Product Labeled as a “Dietary Supplement” When the Ingredient Is Not Allowed in Supplements

Most state FD&C Acts adopt DSHEA definitions for dietary ingredients.

Not lawful dietary ingredients:

• Tianeptine
• Phenibut
• Amanita mushrooms (muscimol/ibotenic acid)
• Kratom/mitragynine/7-OH

Violation:
Misbranding – State FD&C §§ “False or Misleading Labeling” and “Improper Dietary Ingredient.”

Why: Selling these as “herbal supplements,” “nootropics,” or “dietary capsules” is flatly illegal. None qualify as lawful ingredients in supplements.

3. Illegal Medical Claims = Classified as a Drug

Most state laws say a product becomes a “drug” if the label or marketing claims:

• Pain relief
• Anxiety relief
• Depression help
• Sleep improvement
• Opioid withdrawal help
• “Energy,” “focus,” “relaxation,” “mood booster”

Violation:
Misbranding as a Drug – State FD&C §§ on “Intended Use” and “Health Claims.”

Why: Vape-shop Kratom and Tianeptine labels commonly claim opioid-like effects. That automatically makes them drugs, and therefore unapproved drugs.

4. Illegal to Sell Adulterated Products

State FD&C laws prohibit contaminants, undeclared ingredients, or unsafe constituents.

What testing shows:

• Synthetic 7-hydroxymitragynine added to kratom
• Undeclared phenibut in “herbal” blends
• Heavy metals (lead, nickel, arsenic)
• Unidentified psychoactive compounds
• Inconsistent potency

Violation:
Adulteration – State FD&C §§ “Adulterated Foods/Drugs.”

Why: These products routinely contain contaminants and undeclared active drugs.

5. Illegal to Fail to Disclose Ingredients

Most state laws require:

• Complete ingredient lists
• Proper weight/volume
• Identity of active constituents
• Accurate potency
• Manufacturer and distributor information

Violation:
Misbranding – State FD&C §§ “Labeling Requirements.”

Why: Vape-shop products frequently omit muscimol, 7-OH, phenibut, or tianeptine concentrations, or list false amounts.

6. Illegal to Sell Psychoactive Products Without Registration or Licensure

State FD&C Acts require:

• Manufacturer registration
• Distributor registration
• Good manufacturing practices
• Facility inspections

Vape-shop “brands” do none of this.

Violation:
Unlicensed Drug Manufacture/Sale – State FD&C §§ “Registration” and “Licensure.”

What You Should Do as a Reader

1. Check your state’s FD&C Act.

Make sure it includes:

• The federal definitions of “drug,” “new drug,” “misbranding,” “adulteration,” and “dietary supplement.”
• Strong enforcement language allowing seizures, injunctions, and criminal charges.
• Explicit bans on unapproved active ingredients in ingestible products.

Most states already have these. Many legislators don’t realize they apply.

2. Push for felony penalties for willful violations.

Most states start with misdemeanors for first offenses. But states can and should upgrade penalties:

Felony triggers should include:

• Repeat violations
• Knowingly selling unapproved drugs
• Intentionally misbranding psychoactive substances
• Selling to minors
• Causing serious injury or death

Gas stations and vape shops making millions selling unapproved drugs should not get a $500 slap on the wrist. They should face felony consequences when violations are willful and repeated.

3. Tell your lawmakers that these products are already illegal under state law.

Legislators often believe they “can’t ban kratom,” or “the FDA hasn’t acted,” or “there are no laws.”

That is false.

These products violate:

• Unapproved drug provisions
• Misbranding sections
• Adulteration sections
• Dietary ingredient rules
• Registration/licensing requirements

The law already exists.
It simply needs to be enforced.

Final Thought

Vape shops and gas stations are selling substances that:

• Act like drugs
• Are labeled like supplements
• Are manufactured like street drugs
• Are regulated like nothing at all

Your state’s FD&C Act was written to prevent exactly this. It’s time for the law to be enforced—and strengthened—before more families learn the hard way how dangerous these products really are.