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M83 Ministries LLC - Online Advisory Letter

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Online Advisory Letter Reference #723496


March 5, 2026

Geinel Rodriguez, CEO
M83 Ministries LLC
www.m83heals.com
2402 Warwick Rd
Houston, TX 77093-2426
info@m83ministries.com
geinelrod85@gmail.com

RE: M83, DMSO, CDS, CDS Chloride Dioxide, and P107 Neuroplastic Fuel

Geinel Rodriguez:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites at www.m83ministries.org1 and www.m83heals.com, as well as your social media websites at www.instagram.com/m83healsyou/, www.instagram.com/ggrose85, and www.facebook.com/ggrose8522 in February 2026 and has found that you take orders for M83, DMSO, CDS, CDS Chloride Dioxide, and P107 Neuroplastic Fuel.3 Various claims and statements made on your websites and/or in other labeling establish that these products are drugs as defined in 21 U.S.C. § 321(g)(1)(B) because they are intended for the treatment, cure, mitigation, or prevention of disease. For example, your websites recommend or suggest the use of M83, DMSO, CDS, CDS Chloride Dioxide, and P107 Neuroplastic Fuel to treat or prevent autism, cancer (e.g., bladder, thyroid, leukemia, etc.), COVID-19, dementia, diabetes, HIV/AIDS, seizures, and sexually transmitted diseases. As explained further below, the introduction of these products into interstate commerce for such uses violates the Federal Food, Drug, and Cosmetic Act.

These products are also new drugs as defined under 21 U.S.C. § 321(p) because they are not generally recognized as safe and effective for the uses recommended or suggested in their labeling. Before a new drug may be marketed or otherwise introduced into interstate commerce, it must be approved by FDA on the basis of scientific data demonstrating that the drug is safe and effective under the conditions of use in its labeling. See 21 U.S.C. §§ 355(a) and 331(d). Your drug products do not have FDA-approved applications as required by 21 U.S.C. § 355.

We advise you to review all materials through which you communicate to consumers the intended uses of your products, and to either submit a new drug application (NDA) for products intended for use in treating, curing, mitigating, diagnosing, or preventing a disease or, alternatively, remove all statements indicating that your products are intended for such uses. This would include reviewing your websites, product labels, catalogs, brochures, flyers, package inserts, audio and video, e-commerce and social media accounts you operate (e.g., Amazon, eBay, Facebook, Instagram, and X accounts), as well as any other promotional materials, and removing product claims, consumer testimonials, metatags, and anything else that states or implies that your products are useful in treating, curing, mitigating, diagnosing, or preventing diseases.

Within 30 calendar days of the date of this letter, please correct the violations described in this letter and notify FDA, via electronic mail at FDAadvisory@fda.hhs.gov, that the violations have been corrected. Include the Online Advisory Letter Reference number (located in the upper right portion of this letter) in all your communications to FDA regarding this matter.
After 30 days from the date of this letter, if your websites or other labeling continue to demonstrate that your products are intended to treat, cure, mitigate, or prevent diseases, the name of your firm and this letter will be posted on the FDA webpage for products illegally marketed for serious diseases.
This letter is not intended to be an all-inclusive review of your websites or a list of all violations of law that exist in connection with your products, your websites and other product labeling, or at your facilities. FDA expects you to take the necessary steps to ensure that all your products comply with the laws and regulations enforced by FDA.

Sincerely,


U.S. Food and Drug Administration

  1. 1Your social media websites, https://www.instagram.com/m83healsyou/, www.instagram.com/ggrose85, and www.facebook.com/ggrose85 indicate Geinel Rodriguez is the Chief Executive Officer of M83 Ministries. The www.m83heals.com website refers to “M83 Ministries” in several places. Furthermore, the webpage, https://m83ministries.org/about states Geinel Rodriguez is the “founder,” and the www.m83ministires.org website also sells your products.
  2. 2Your firm’s Facebook social media website (www.facebook.com/ggrose85) directs consumers to your firm’s Instagram www.instagram.com/ggrose85 social media website which directly links to the www.m83heals.com website where products can be purchased.
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