Reviewed August 2026 by the Corydalis Labs Technical Team. How we research and review.
Why this matters more than people think
Two reasons, and both are concrete.
First, claims are what enforcement actually targets. Where agencies have acted against botanical products in adjacent categories, the cited material has overwhelmingly been marketing language — claims that a product treats a named condition, relieves withdrawal, substitutes for medication, or helps with dependence. Those citations rest on the product being marketed as an unapproved drug, which is a claims problem rather than an ingredient problem.
Second, marketing conduct feeds the analogue analysis. The analogue provision looks at what a substance is represented to do, and directs attention to marketing, advertising, and labelling. A compound with a clean structural position can be dragged toward a worse one by a brand that markets it as a substitute for something controlled. The regulatory summary explains this.
Never say these
Claims that create liability
- That a product treats, cures, prevents, or diagnoses any condition — named or implied.
- Anything referencing withdrawal, dependence, addiction, or getting off a medication.
- That a product replaces or substitutes for a pharmaceutical.
- Comparisons to controlled substances, by name or by euphemism.
- Language implying intoxication, or how "high" a product makes someone.
- Unsupported superlatives about strength or potency relative to controlled substances.
- Testimonials that make any of the above claims. A customer review on your own site is your marketing.
This applies everywhere, not just on the label — website copy, social posts, influencer briefs, wholesale sell sheets, customer service replies, and the answers your sales team gives on the phone. Enforcement does not distinguish between a claim on a package and the same claim in a caption.
What you can say
The framework that keeps you on the right side is structure and function, not disease. Language about how an ingredient affects normal function is a different category from language about treating illness. Regulators publish examples of the permitted form — statements along the lines of "calcium builds strong bones" or "fibre maintains bowel regularity."
Where a product qualifies to make such claims, the accompanying disclaimer is required: that the statement has not been evaluated by the Food and Drug Administration and that the product is not intended to diagnose, treat, cure, or prevent any disease.
An important complication, stated honestly
The structure/function framework belongs to lawful dietary supplements. Whether a given novel botanical ingredient qualifies as a lawful dietary ingredient is a separate and genuinely unsettled question that depends on the ingredient and on facts specific to it. Do not assume the safe harbour is available to you. This is precisely the kind of question to put to your counsel before your copy is written, rather than after a letter arrives.
The safest register — and the most persuasive
Our own approach, which we would suggest for anyone in this category: describe what an ingredient does in a formulation, not what it does to a person.
Avoid
- "Takes away the nausea"
- "Stronger euphoria than anything else out there"
- "The legal alternative to [controlled substance]"
- "Helps you get through the day without your prescription"
Prefer
- "Formulated to reduce the sensory harshness common in mitragynine-forward products"
- "A fuller profile at a lower mitragynine inclusion"
- "A corydalis-derived alkaloid, not a kratom alkaloid"
- "Standardised, assayed, and shipped with a certificate of analysis"
The second column is not merely safer. To a buyer who knows the category, it reads as a company that understands its own product — which is a stronger commercial position than the first column achieves anyway.
A practical checklist
- 21+ positioning across the product, the site, and the advertising.
- Declare actives accurately with per-serving amounts. Vague proprietary blends invite exactly the scrutiny this category does not need.
- Carry the disclaimer wherever it belongs, and do not undercut it verbally elsewhere.
- Brief your influencers in writing. Their claims become your claims, and "we did not tell them to say that" is not a defence if you never told them not to.
- Moderate your own reviews and comments. A disease claim in a testimonial on your site is your problem.
- Train customer service. The riskiest claims in this category are made verbally, one customer at a time.
- Have counsel review copy before launch, not after. It is dramatically cheaper.
Common questions
Be careful. A factual statement about scheduling status — that a specific compound does not appear on the federal schedules — is different from a broad claim that a finished product is "legal," which is a claim about every applicable body of law in every market you sell into. The broader the claim, the more you have to substantiate.
Factual comparisons about composition and regulatory status are one thing. Implying that your product reproduces the experience of a substance under federal scheduling action is another, and it is exactly the representation that draws attention. We would not do it.
Testimonials on your own channels are your marketing and are held to the same standard. A review claiming your product treated a condition is a disease claim you published. Moderate accordingly.
Business-to-business materials get somewhat different treatment from consumer advertising, but they are not a free space — and in practice sell sheets get photographed and posted. Write them as though a regulator will read them, because one might.
We are happy to flag things that look obviously risky to us, and we do this for customers regularly. We are not lawyers and our comments are not legal advice — get counsel to review before you launch.