Allovate Illegally Marketing Allerdent, FDA Says

FDA says its review of a brochure posted on a Web site maintained by Allovate Therapeutics in New York, NY, found that it describes Allerdent, an allergenic toothpaste available for home delivery. A 9/30 Warning Letter says the product is an unapproved new drug and an unlicensed biological product that is not being legally marketed. The letter cites information reviewed by FDA that establishes that the toothpaste 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.

One claim repeated in the letter is that those brushing their teeth with Allerdent can experience allergy immunotherapy known as oral mucosal immunotherapy.

Allovate was told to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with documentation of each step and a schedule for completing the corrections.