FDA Approved Supplements: Generally Regarded As Safe And Effective For Intended Use And Produced Under Current Good Manufacturing Practice?

in supplements •  2 years ago 

"The main regulatory standard for ensuring pharmaceutical quality is the Current Good Manufacturing Practice (CGMPs) regulation for human pharmaceuticals. Consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective"
https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturing-practices-cgmps

"Supplement manufacturers are required to seek FDA approval known as Generally Regarded As Safe (GRAS). This approval indicates an ingredient is considered safe to be added to food items."
https://www.advancedliving.com/fda/

"An OTC drug monograph establishes conditions, such as active ingredients, uses (indications), doses, routes of administration, labeling, and testing, under which an OTC drug in a given therapeutic category (e.g., sunscreen, antacid) is generally recognized as safe and effective (GRASE) for its intended use."
https://www.fda.gov/drugs/otc-drug-review-process-otc-drug-monographs

"The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA."
https://cacmap.fda.gov/drugs/types-applications/new-drug-application-nda

"Drug manufacturers may claim that their product will diagnose, cure, mitigate, treat, or prevent a disease. Such claims may not legally be made for dietary supplements."
https://psu.pb.unizin.org/bbh143/chapter/supplements-and-foods-for-health-and-well-being/

"The FDA is particularly concerned that products that claim to cure, treat or prevent serious diseases like COVID-19 may cause consumers to delay or stop appropriate medical treatment, leading to serious and life-threatening harm."
https://www.fda.gov/news-events/press-announcements/coronavirus-update-fda-and-ftc-warn-seven-companies-selling-fraudulent-products-claim-treat-or

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