FDA WARNING_LETTER - DIY Vapor Supply LLC - April 27, 2021
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The FDA's Center for Tobacco Products issued a Warning Letter to Jamie Webb of DIY Vapor Supply on April 23, 2021, following a review of their website, diyvaporsupply.com. The FDA determined that e-liquid products manufactured and sold by the company are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA regulation.
The primary violation identified is the marketing of a "new tobacco product," Black River Tank Scarlet Ivy e-liquid, without the required premarket authorization order. This product was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the lack of required information under section 905(j).
The letter emphasizes the firm's responsibility, as a registered manufacturer with over 73,300 listed products, to ensure compliance with the FD&C Act and FDA regulations (21 C.F.R. Parts 1140, 1141, and 1143). Failure to correct these violations may result in regulatory actions, including civil money penalties, seizure, and/or injunction. The company is required
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