An FDA-approved veterinary product (COMPONENT TE-200 with TYLAN, a combination ear implant containing trenbolone acetate, estradiol and tylosin tartrate) is approved for increased rate of weight gain and improved feed efficiency in steers and heifers fed in confinement for slaughter. Its labeling states the product is "for use in animals only - not for human use," and its approved route is subcutaneous ear implantation, not injection. This approval cannot support a claim that injectable trenbolone is approved for humans.[4]
- Jurisdiction
- United States
- Product
- COMPONENT TE-200 with TYLAN veterinary ear implant
- Indication
- Weight gain and feed efficiency in steers/heifers fed in confinement for slaughter; animal use only
- Record date
- 2026-09-08 · Approved 2007-01-26
- Historical named veterinary product; no human pharmacokinetic estimate or approval of research-market injections follows.
- The approved route (subcutaneous ear implant) differs entirely from the intramuscular injection route used in non-veterinary contexts.
Inspection history
Clinical review: not reviewed by a qualified clinician.
· Independent source inspection; applicability narrowed and inherited assertions excluded where unsupported. No qualified clinical review.
· Freshly reopened the complete FDA summary and added the verbatim "not for human use" label quotation and the route distinction. Independent editorial review pending; no qualified clinical review.
· Currency check for the regulatory-currency batch. The cited approval summary is a fixed 2007 document, so whether the approval still stands was checked separately in the live Animal Drugs@FDA application record, which lists this application as Approved with no voluntary-withdrawal date. The recorded date, the claim text and the sources are unchanged. Independent editorial review pending; no qualified clinical review.