What happened
Original notice title
PYRLess Group, LLC dba Dr. Fitt MARCS-CMS 611424, January 25, 2021
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 any unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19. Your website [see original source] states that your Buffered C Powder contains vitamin C, your Get Well 2 Day Vit A contains vitamin A, your Get Well 2 Day Vit D3 contains vitamin D3, your OMG Cell Protek contains iodine and iodide, and your Robynzyme “combines hydrochloric acid with digestive enzymes and B vitamins.” Some examples of the claims on your websites 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: “Iodine is also a halogen. If they can’t multiply, they can’t stimulate the immune system response that causes flu symptoms, including death. . . . Fitt Intelligent Designs, LLC on November 7, 2018 for violations regarding products sold on your websites www.drfitt.com, www.drfittinfo.com, [see original source] and [see original source] The letter was posted here, [see original source] You should take immediate action to address 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.
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
- 0ecad022abc6
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 →