For FDA to determine that a new tobacco product is substantially equivalent to a predicate product, the manufacturer of the new tobacco product must submit a substantial equivalence report. One of the three pathways to market for tobacco products is the substantial equivalence pathway. Report Potential Tobacco Product Violations to FDAīefore a new tobacco product may be introduced into interstate commerce for commercial distribution in the United States, generally the new tobacco product must undergo premarket review by FDA.Notifications of NSE Tobacco Products Found in Retail Stores.Marketed Tobacco Products that Receive an NSE Order.
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