Questions to work through
Look beyond the small print.
Food and Drug Administration is the agency’s name, shortened to FDA.
In warning letters reviewed September 26, 2026, FDA told particular sellers they may have broken drug laws. FDA said their products were being promoted as treatments for people, despite the research-only labels.
These letters give FDA’s view of what particular sellers did wrong, rather than a court’s decision.
Notice the treatment claims.
A product’s intended purpose can make it a drug under US law; this was the legal position on September 26, 2026. Promises to treat disease or alter the body’s workings are part of that question.
Ask about reviewed patient information.
Approved medicines have pregnancy information in their FDA-reviewed labels. A compounded or other unapproved product has no pregnancy information reviewed by FDA in that way.
A lab report answers a narrower question
If an offer points to a test certificate, ask what was tested, what the result actually means and what question it leaves unanswered. Do not turn a narrow test into a treatment claim.
Ask separately about evidence for your recovery goal and about who would assess you and how the visit would happen.
Bring the wording, not just the product name
Keep a copy of the benefit claim and the research-only statement together. Ask the clinician to explain the mismatch before making a decision.
Notes for this question
FDA: a letter to a seller
This letter records FDA’s concerns about one seller at the time it was written. It supplies no final court ruling on research products as a whole.
Federal rule: intended use
The rule covers evidence of what a product is meant to do.
FDA: limits of review
The pregnancy-information point follows from the absence of product approval and review.