What happened
Original notice title
MKS Enterprise, LLC MARCS-CMS 624478, July 01, 2022
From the archived source record
Based on our review of your website and laboratory analysis of your product, FDA has identified serious violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Prohibited Act under Section 301(ll) FDA confirmed through laboratory analysis that a sample of your Vital Honey contains the undeclared active pharmaceutical ingredient tadalafil, which is a phosphodiesterase type-5 (PDE-5) inhibitor. This undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Unapproved New Drug FDA reviewed your website at www.wholesaleonline1.com in June 2022 and determined you take orders there for the product Vital Honey. Misbranded Drug Your product Vital Honey is intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Accordingly, Vital Honey fails to bear adequate directions for its intended use and, therefore, the product is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of this misbranded drug violates section 301(a) of the Act [21 U.S.C. 331(a)]. This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction. It is your responsibility under the FD&C Act to ensure that products marketed by your firm do not contain undeclared ingredients and comply with all requirements of federal law.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- FDA closeout listed
- Source checked
- Jul 16, 2026
- Record revision
- 86be9d412c5a
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
Sources, dates, and coverage →