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Cerenovex - Online Advisory Letter

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Online Advisory Letter Reference #723473


March 17, 2026

Cerenovex
www.cerenovex.com
hello@cerenovex.com

RE: Cerenovex Super Probiotic  

Dear Cerenovex:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at http:// www.cerenovex.com in February 2026 and found that you take orders there for Cerenovex Super Probiotic. Various claims and statements made on your website and/or in other labeling establish that this product is a drug as defined in 21 U.S.C. § 321(g)(1)(B) because it is intended for the treatment, cure, mitigation, or prevention of disease. For example, your website recommends or suggests the use of Cerenovex Super Probiotic to treat or prevent Alzheimer’s disease and Parkinson’s disease. As explained further below, the introduction of this product into interstate commerce for such uses violates the Federal Food, Drug, and Cosmetic Act. 

This product is also a new drug as defined under 21 U.S.C. § 321(p) because it is not generally recognized as safe and effective for the uses recommended or suggested in its 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 product does not have an FDA-approved application as required by 21 U.S.C. § 355.

Your product is also an unlicensed biological product in violation of section 351(a)(1) of the Public Health Service Act (PHS Act), 42 U.S.C. § 262(a)(1). A biological product for which a biologics license application (BLA) has been approved under section 351(a) of the PHS Act is not required to have an approved application under section 505 of the FD&C Act. See 21 U.S.C. § 355; 42 U.S.C. § 262(j). Otherwise, with certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act. Your introduction or delivery for introduction of your product into interstate commerce, or the causing thereof, is prohibited under sections 301(d) of the FD&C Act, 21 U.S.C. § 331(d).

We advise you to review all materials through which you communicate to consumers the intended uses of your product, and to either submit a BLA for your product or, alternatively, remove all statements indicating that your product is intended for use in treating, curing, mitigating, diagnosing, or preventing a disease. 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 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.

For more information on the kinds of claims that establish that a product is intended for use as a drug and biological product, please see 21 CFR 101.93(f)-(g) and https://www.fda.gov/food/food-labeling-nutrition/label-claims-conventional-foods-and-dietary-supplements. 

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,


Health Fraud Inspectorate Branch
Division of Field Enforcement
Office of Inspections and Inspections
U.S. Food and Drug Administration 
FDAAdvisory@fda.hhs.gov

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