21 C.F.R. § 720.1
Who should file
Either the manufacturer, packer, or distributor of a cosmetic product is requested to file Form FDA 2512 (“Cosmetic Product Ingredient Statement”), whether or not the cosmetic product enters interstate commerce. This request extends to any foreign manufacturer, packer, or distributor of a cosmetic product exported for sale in any State as defined in section 201(a)(1) of the Federal Food, Drug, and Cosmetic Act. No filing fee is required.
Notes of Decisions
Cited in 2
cases, 1978–1980 · leading case: Zotos Int'l, Inc. v. Kennedy, 460 F. Supp. 268 (D.D.C. 1978).
Zotos Int'l, Inc. v. Kennedy, 460 F. Supp. 268 (D.D.C. 1978). “21 C.F.R. § 720.1 et seq. In 1974 the FDA issued a comprehensive regulation designed to implement the Freedom of Information Act for all phases of the agency’s jurisdiction — including food, drugs, additives and cosmetics.”
Del Labs., Inc. v. United States, 86 F.R.D. 676 (D.D.C. 1980). “FDA’s determination of trade se *678 cret status is based on an evaluation of the manufacturer’s voluntary submission of a Cosmetic Product Ingredient Statement (Form FD-1513), 21 CFR § 720.1 , the request for confidentiality, material submitted in support thereof, and publicly…”
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