FDA WARNING_LETTER - MKS Enterprise, LLC - July 12, 2022

The FDA issued a Warning Letter to Mr. Bhatia regarding the product "Dose Vital Royal Honey VIP Honey" (Vital Honey), purchased from www.wholesaleonline1.com. Laboratory analysis confirmed the product contains undeclared tadalafil, a PDE-5 inhibitor and active ingredient in the prescription drug Cialis, used for erectile dysfunction.

This constitutes a prohibited act under Section 301(ll) of the FD&C Act [21 U.S.C. 331(II)], as tadalafil is an FDA-approved drug added to a food. The undeclared ingredient poses a health risk, potentially lowering blood pressure to dangerous levels, especially for individuals taking nitrates.

Furthermore, the product is an unapproved new drug under Section 201(g)(1)(B) of the FD&C Act [21 U.S.C. 321(g)(1)(B)] due to therapeutic claims on the website, such as preventing arthritis, lowering cholesterol, and remedying liver disease. Vital Honey is not generally recognized as safe and effective for these uses, making it a "new drug" under Section 201(p) [21 U.S.C. § 321(p)] requiring prior FDA approval.

The product is also a misbranded drug under Section 502(f)(1) [21 U.S.C.