What happened
Original notice title
Todos Medical Ltd aka Todos Medical USA Inc MARCS-CMS 626258, November 07, 2022
From the archived source record
Based on our review, this product is an unapproved new drug sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). Furthermore, this product is a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. § 352. We request that you take immediate action to cease the sale of any unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19. Some examples of the claims on your websites that establish the intended use of your product and misleadingly represent it as safe and/or effective for the treatment or prevention of COVID-19 include: • “3CL Protease Inhibitors: The Potential Key to Combating the SARS-CoV-2 Virus Life Cycle . . . Reese on November 14, 2021 “A 5-day dosing regimen of Tollovid, from all the research I have done on 3CL Protease inhibitors, should keep the [infection] from replicating to the point I need hospitalization. This letter is not meant to be an all-inclusive statement of violations that may exist in connection with your products or operations. We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a COVID-19-related use for which they have not been approved by FDA and that you do not make claims that misbrand the products in violation of the FD&C Act. Within 48 hours, please send an email to COVID-19-Task-Force-CFSAN@fda.hhs.gov describing the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of any violations, as well as copies of related documentation. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- 46c1e0370e12
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 →