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There are two kinds of health claims that can be made about foods other than dietary supplements: structure/function claims and disease claims. Structure/function claims are claims that do not suggest that the food can diagnose, treat, or prevent any particular disease, but that it can, for example, maintain, regulate, or promote normal healthy ...
This product is not intended to diagnose, treat, cure, or prevent any disease" if the supplement bears a claim to affect the structure or function of the body (structure/function claim), a claim of general well-being, or a claim of a benefit related to a classical nutrient deficiency disease. [8]
Dietary supplements may make "structure or function" claims but cannot legally claim to cure or prevent disease unless they meet an approved health claim as a food product. CFSAN is also responsible for food labeling , specifically the " Nutrition Facts " panel typically seen on packaged foods.
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...
An example would be "_____ helps maintain healthy joints", but the label must bear a disclaimer that the Food and Drug Administration (FDA) "has not evaluated the claim" and that the dietary supplement product is not intended to "diagnose, treat, cure or prevent any disease", because only a drug can legally make such a claim. [8] The FDA ...
In 2013, the EFSA decided to permit health claims that 200 mg/day of cocoa flavanols "help[s] maintain the elasticity of blood vessels." [32] [33] The FDA followed suit in 2023, stating that there is "supportive, but not conclusive" evidence that 200 mg per day of cocoa flavanols can reduce the risk of cardiovascular disease. This is greater ...
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Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP). [1] It is divided into three chapters: Chapter I — Food and Drug Administration