FDA Draft Records Access Guidance:
Several statutes (e.g., Trade Secrets Act (18 U.S.C. 1905), Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(j)), and Freedom of Information Act, (5 U.S.C. 552) and the agency's information disclosure regulations at 21 CFR Parts 20 and 21 govern the agency's disclosure of information to the public.
FDA personnel will comply with all applicable protections, procedures, and legal requirements against the unauthorized disclosure of non-public information, such as any trade secret or confidential commercial information.