Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1FDA confirmed through laboratory analysis that samples of your products, Etumax Royal Honey for Him and Dose Vital Honey for Men, contain the undeclared active pharmaceutical ingredient tadalafil, and your product, Secret Miracle Royal Honey for Her, contains the undeclared active pharmaceutical ingredient sildenafil, both of which are phosphodiesterase type-5 (PDE-5) inhibitors. Tadalafil and sildenafil are the active ingredients in the FDA-approved prescription drugs Cialis and Viagra, respectively, used to treat erectile dysfunction (ED). These undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
Passage 2FDA reviewed your websites at www.thirstyrun.com and www.usroyalhoney.com in June 2022 and determined you take orders there for the products Etumax Royal Honey for Him, Dose Vital Honey for Men, and Secret Miracle Royal Honey for Her. In addition to being foods of which the introduction or delivery for introduction into interstate commerce is prohibited under section 301(ll) of the FD&C Act, these products are drugs under section 201(g)(1) of the FD&C Act [21 U.S.C. 321(g)(1)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the FD&C Act.
Passage 3Your Etumax Royal Honey for Him, Dose Vital Honey for Men, and Secret Miracle Royal Honey for Her products are not generally recognized as safe and effective for the above-referenced uses and, therefore, the products are “new drugs” under section 201(p) of the FD&C Act [21 U.S.C. 321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)].
Passage 4You market Secret Miracle Royal Honey for Her as a dietary supplement. For example, the webpages for this product on your websites display a product label image with “dietary supplement” on them. However, this product cannot be a dietary supplement because it does not meet the definition of a dietary supplement under section 201(ff) of the FD&C Act [21 U.S.C. 321(ff)]. FDA has concluded, based on available evidence, that sildenafil products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, [21 U.S.C. 321(ff)(3)(B)(i) and (ii)].