Thirsty Run LLC / US Royal Honey LLC
FDA issued a warning letter to Thirsty Run LLC / US Royal Honey LLC (Dearborn, MI) after laboratory analysis confirmed that their honey products Etumax Royal Honey for Him and Dose Vital Honey for Men contained undeclared tadalafil, and Secret Miracle Royal Honey for Her contained undeclared sildenafil — both prescription-only PDE-5 inhibitors. The products were marketed with disease-treatment claims on the company's websites, making them unapproved new drugs under the FD&C Act, and their introduction into interstate commerce was also a prohibited act under section 301(ll) for adding approved drug ingredients to food. FDA demanded a written response within 15 working days and warned that failure to comply could result in seizure and injunction.
Flagged claims (2)
Reduces vaginal discharge and protects against bacterial infection
Reproductive System Health - Being a product of nature, royal honey possesses nutrients that decrease the risk of prostate illness and other reproductive system conditions.
Required actions (2)
Please notify FDA in writing, within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to address any violations.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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