The Office of Compliance and Biologics Quality (OCBQ) in the Food and Drug Administration's (FDA's) Center for Biologics Evaluation and Research (CBER) has reviewed a Product Fact Sheet entitled “SparVax™ – Recombinant Protective Antigen (rPA) Anthrax Vaccine-Novel Second Generation Vaccine Technology” for your investigational product Bacillus anthracis Recombinant Protective Antigen 102 (rPA; E. Coli) (anthrax) vaccine -b(4)---. The product fact sheet contains false or misleading statements that represent your product as safe and effective for the purposes for which it is being investigated. This is problematic from a public health perspective because it suggests that SparVax is safe and effective when the product has not yet been approved by FDA and the promotional claims have yet to be demonstrated by substantial evidence or substantial clinical experience. As a result, these materials misbrand your investigational product in violation of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 352(a)&(n), and 321(n), and FDA’s implementing regulations. (See 21 CFR 312.7(......."