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Code of Federal Regulations Title 21. Food and Drugs § 21.1100.5 Exclusion from tobacco regulation

Current as of October 02, 2022 | Updated by FindLaw Staff

If a product made or derived from tobacco that is intended for human consumption is intended for use for any of the purposes described in paragraph (a) or (b) of this section, the product is not a tobacco product as defined in section 201(rr) of the Federal Food, Drug, and Cosmetic Act and will be subject to regulation as a drug, device, or combination product.

(a) The product is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, including use in the cure or treatment of nicotine addiction (e.g., smoking cessation), relapse prevention, or relief of nicotine withdrawal symptoms;

(b) The product is intended to affect the structure or any function of the body in any way that is different from effects related to nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000.

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Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.1100.5 Exclusion from tobacco regulation - last updated October 02, 2022 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-1100-5/

Read this complete Code of Federal Regulations Title 21. Food and Drugs § 21.1100.5 Exclusion from tobacco regulation on Westlaw

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