Delivery Method: Via UPS and EMAIL Reference #: CBER 25-708912 Product: Biologics Recipient:

Recipient Name

William Reisacher, MD

Recipient Title

Senior Scientific Advisor and Co-Founder

Allovate Therapeutics, LLC

20 W 125th St #1
New York, NY 10027
United States

wir2011@med.cornell.edu Issuing Office: Center for Biologics Evaluation and Research (CBER)

United States

WARNING LETTER

September 30, 2025

CBER 25-708912

Dear Dr. Reisacher:

The United States Food and Drug Administration (FDA) reviewed your brochure at https://ent.weill.cornell.edu/sites/default/files/lifewithoutallergies.pdf (last visited September 2025), which describes Allerdent, an allergenic toothpaste, which you state “can be sent directly to your home,” (hereafter, “your product”).1 This letter is to advise you that your product is an unapproved new drug in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). 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, 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. The introduction or delivery for introduction of your product into interstate commerce, or the causing thereof, is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. § 331(d).

Unapproved New Drug and Unlicensed Biological Product Violations

Based on information reviewed by FDA, https://ent.weill.cornell.edu/sites/default/files/lifewithoutallergies.pdf (last visited September 2025), your product is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or conditions in humans and/or is intended to affect the structure or function of the body. For example, your brochure states, “With Allerdent you can experience allergy immunotherapy while simply brushing your teeth every day. This is known as oral mucosal immunotherapy, or OMIT”.

Therefore, your product is a drug as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), and a biological product as defined in section 351(i) of the PHS Act, 42 U.S.C. § 262(i).

Subject to certain exceptions not applicable here, to lawfully introduce or deliver for introduction into interstate commerce a drug that is a biological product, a valid BLA must be in effect under section 351(a)(1) of the PHS Act, 42 U.S.C. § 262(a)(1). Such licenses are issued only after showing that the product is safe, pure, and potent. Your product is not the subject of an approved BLA.

Conclusion

This letter is not intended to be an all-inclusive list of deficiencies that may exist in connection with your product. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure full compliance with all applicable requirements in the FD&C Act, PHS Act, and all applicable regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address these matters may result in action without further notice including, without limitation, seizure and/or injunction.

Please submit your response in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to address any violations and prevent their recurrence. Include any documentation necessary to show that the matters have been addressed. If you cannot address these matters within fifteen (15) working days, please explain the reason for your delay and the timeframe for completion. If you do not believe your product is in violation of the FD&C Act, PHS Act, or applicable regulations, include your reasoning and any supporting information for our consideration.

Send your electronic response to CBERDCMRecommendations@fda.hhs.gov. If you have questions regarding this letter, contact the Division of Case Management, CBER at CBERDCMRecommendations@fda.hhs.gov.

Sincerely,
/S/

Melissa J. Mendoza
Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research

________________________

1 We also reviewed the website http://allovate.com, which directs to http://easily healthcare.com (last visited September 2025). The Easily Healthcare website offers Easily Allergy Toothpaste, an allergenic toothpaste, for sale.

Source