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- W2912845020 abstract "There are many duties that one has an option whether to take on or not and upon taking steps to take on the duty they are obligated to carry out that duty by law. The duty to warn is a duty that any organization that wishes to put their products in the marketplace in the US regardless of which product, food, drugs, biologics, vaccines, animal products, cosmetics, dietary supplements, etc., that is regulated by the Food and Drug Administration (FDA) under the many statutes they are in charge of administering, the duty to warn is a core responsibility for the product manufacturer or sponsor and they do not have an option to chose whether to do so or decline to do so. Likewise, this is a mandatory duty for the FDA as well in terms of protecting the consumers. This paper reviews some of the key regulations since 1902, to current that have been enacted to convey this duty to warn. Along with the specific regulations, some of the common laws interpreting these regulations will be reviewed especially those contributing to the current elements or tests that are used in regards to this duty. Much of the legal casework as well as current requirements share two common terms: 1) misbranded and 2) adulterated. These terms will be reviewed in depth especially in terms of labeling, which is defined by many legal interpretations to be almost anything related to a product and not just the affixed label on the particular product. Finally, the preemption of the federal regulations impact on the common law liability that can and does exist in many jurisdictions will be briefly reviewed." @default.
- W2912845020 created "2019-02-21" @default.
- W2912845020 creator A5014912586 @default.
- W2912845020 date "2010-01-01" @default.
- W2912845020 modified "2023-09-24" @default.
- W2912845020 title "FDA Regulated Products and the Duty to Warn" @default.
- W2912845020 doi "https://doi.org/10.2139/ssrn.1624702" @default.
- W2912845020 hasPublicationYear "2010" @default.
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