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# Untitled Letter on Web Site Product Promotion
- URL: https://www.fdaweb.com/untitled-letter-on-web-site-product-promotion/
- Published: 2018-10-15T12:00:00.000Z
- Updated: 2026-09-15T00:38:04.000Z
- Author: David McFarland
- Tags: Biologics, FDA Policy/General, #legacy-id-D5142585

CBER has sent an [untitled letter](https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/Enforcement/UntitledLetters/UCM623412.pdf?ref=fdaweb.com) to the operator of two Web sites — [http://www.ollereg.com](http://www.ollereg.com/?ref=fdaweb.com) and [http://www.innovativeallergy.com](http://www.innovativeallergy.com/?ref=fdaweb.com) — because they were promoting an unapproved product, Ollereg Oral Immunotherapy. Based on statements and claims appearing on the sites, CBER says it “appears that your product is intended to treat and/or prevent allergies in adults or children, and therefore appears to be a drug under section 201(g) of the Federal Food, Drug, and Cosmetic Act (FFD&C Act) because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man \[21 U.S.C. 321(g)\].” It told the site operator that in order to lawfully market a drug that is also a biological product, a valid biologics license must be approved, and requested a response to the alleged violations.