What happened
Original notice title
Center for Wellness and Integrative Medicine MARCS-CMS 608693, June 30, 2020
From the archived source record
Based on our review, these products are unapproved new drugs 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, these products are misbranded drugs 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 such unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19. Some examples of the claims on your website that establish the intended use of your products and misleadingly represent them as safe and/or effective for the treatment or prevention of COVID-19 include: On a webpage titled “COVID Household Value Pack,” you represent the following: “I recommend each and every family purchase the ‘4 Horsemen’ to outrun the tide of COVID. . . . Currently, IV Vitamin C is under clinical trials in Shanghai for COVID hospitalized patients.” “Vitamin D3 . . . I’m recommending individuals which [sic] chronic immune debility use this for 3-4 months during the oncoming tide of COVID infections.” From a March 22, 2020 post: “#1 Easiest way to prevent Coronavirus exposure from developing into severe COVID infection: Vitamin C.” You should take immediate action to correct the violations cited in this letter. This letter is not meant to be an all-inclusive list of violations that 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-CDER@fda.hhs.gov describing the specific steps you have taken to correct these violations.
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
- Historical warning letter; closeout not established by annual index
- Source checked
- Jul 16, 2026
- Record revision
- 09ae1b9ce156
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 →