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FDA Label & Claims Reviews Attorney In California - MY FDA Lawyers. Learning these terms will help you understand labels and claims. Label –The written, printed, or graphic material on the package (the immediate container, not including liners). Labeling –The written, printed, or graphic material on the product, its container, wrappers, or accompanying a product (an insert or rack card). Misbranded – There is a problem with the product label.
It means that the label or labeling violates FDA law because it has false or misleading statements, or otherwise lacks required label or labeling statements. FTC – The Federal Trade Commission, which is tasked with regulating advertising, among other things. NAD – The National Advertising Division of the Better Business Bureau, which purports to be a private self-regulatory body. Class Action – A lawsuit where there are numerous plaintiffs represented by a member of the group. Navigating FDA Regulations: Your Guide to Food Export Certificates and FDA Registrations. OTC & Homeopathic Drug Consultation Services In California - MY FDA Lawyers. Learning these terms will help you understand drugs as the FDA does. OTC –Over-the-counter, meaning that the drug can be purchased without a prescription from a doctor.
Monograph – An FDA-created regulation that outlines the formula and labeling required to market a particular drug without approval and without a prescription. See the FDA monographs here. HPUS – The Homeopathic Pharmacopoeia of the United States, which is the official compendium of homeopathic drugs in the U.S. HPUS is issued by the Homeopathic Pharmacopoeia Convention of the United States (HPCUS), which is a non-government agency that advocates for and helps to systematize the industry. Homeopathic Monograph – HPCUS-issued descriptions of homeopathic active ingredients.
Drug Facility Registration – A registration for drug facilities. Drug Listing –Each drug that a drug facility manufactures, repacks, relabels, or salvages for commercial distribution. 21 C.F.R. § 207.41.