Module 1 2021

Center for Food Safety and Applied Nutrition (CFSAN) Food Product Categories (website: https://www.fda.gov/food • Food • Foods for Special Dietary Uses − Infant formulas, weight loss products • Medical Foods − Specific dietary management of a disease − Nutritionally complete products, oral rehydration formulas • Dietary Supplements − Vitamins, minerals, botanicals • Nutraceuticals * • Functional Foods *

* These terms are widely used in the marketplace. Such foods are regulated by FDA under the authority of the FD&C Act, even though they are not specifically defined by law.

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FDA Regulations & Guidances • Food, Drug, and Cosmetic (FD&C) Act − Federal Law; sets broad legal requirements • Regulations (21 CFR) e-CFR

− Prescribes specific legal requirements; codified in Code of Federal Regulations. The CFR presents the official and complete text of the Agency’s regulations into an organized publication – IND (Title 21 CFR 312) – NDA/BLA (Title 21 CFR 314/601) – ANDA (Title 21 CFR 320) – 505(b)(2) (Title 21 CFR 314.107) – PMA (Title 21 CFR 814) • Guidances − Represent FDA’s current thinking on a given subject E-CFR: https://www.ecfr.gov/cgi-bin/text- idx?SID=3ee286332416f26a91d9e6d786a604ab&mc=true&tpl=/ecfrbrowse/Title21/21tab_02.tpl FDA Guidances: https://www.fda.gov/RegulatoryInformation/Guidances/default.htm

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