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  2. Food-grade lubricant - Wikipedia

    en.wikipedia.org/wiki/Food-grade_lubricant

    There is a 10 parts per million (ppm) limit for lubricant base oils (e.g., mineral oil) that can be present in food if incidental contact occurs. To get new food contact substances (FCSs) approved by the FDA, manufacturers must either submit a Food Contact Notification (FCN) filing or apply for a Threshold of Regulation (TOR) exemption.

  3. Center for Food Safety and Applied Nutrition - Wikipedia

    en.wikipedia.org/wiki/Center_for_Food_Safety_and...

    The Center for Food Safety and Applied Nutrition (CFSAN (/ ˈ s ɪ f ˌ s æ n / SIF-san)) is the branch of the United States Food and Drug Administration (FDA) that regulates food, dietary supplements, and cosmetics, as opposed to drugs, biologics, medical devices, and radiological products, which also fall under the purview of the FDA. [3]

  4. Food contact materials - Wikipedia

    en.wikipedia.org/wiki/Food_contact_materials

    Indirect food additives – substances that may come into contact with food as part of packaging or processing equipment, but are not intended to be added directly to food; The food contact materials are described in the Code of Federal Legislation (CFR): 21 CFR 174 – 21 CFR 190. Important starting points are:

  5. Good automated manufacturing practice - Wikipedia

    en.wikipedia.org/wiki/Good_Automated...

    ISPE has published a series of good practice guides for the industry on several topics involved in drug manufacturing. The most well-known is The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture. The second edition (GAMP5) was released in July 2022. [2]

  6. Regulation of food and dietary supplements by the U.S. Food ...

    en.wikipedia.org/wiki/Regulation_of_food_and...

    However, if a store happens to be selling both a food and a book which makes false claims about that food, and is selling the items separately, then no misbranding occurs. This is so even if the book and the food are both produced by the same company, and even if the maker of the food encourages the seller to carry the book. [23]

  7. Food safety in the United States - Wikipedia

    en.wikipedia.org/wiki/Food_safety_in_the_United...

    Food safety in the United States relates to the processing, packaging, and storage of food in a way that prevents food-borne illness within the United States. [1] The beginning of regulation on food safety in the United States started in the early 1900s, when several outbreaks sparked the need for litigation managing food in the food industry.

  8. Food Chemicals Codex - Wikipedia

    en.wikipedia.org/wiki/Food_Chemicals_Codex

    The FCC has been published since 1966. Before 1960s, although the federal Food and Drug Administration (FDA) had by regulations and informal statements defined in general terms quality requirements for food chemicals generally recognized as safe (), these requirements were not published in the official regulations or designed to be sufficiently specific, therefore their use for general ...

  9. Drug Price Competition and Patent Term Restoration Act

    en.wikipedia.org/wiki/Drug_Price_Competition_and...

    Hatch-Waxman amended the Federal Food, Drug, and Cosmetic Act. Section 505(j) of the Act, codified as 21 U.S.C. § 355(j), outlines the process for pharmaceutical manufacturers to file an Abbreviated New Drug Application (ANDA) for approval of a generic drug by the Food and Drug Administration (FDA). [4]