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FDA Grants First E‑Cigarette PMTA Authorization

The US Food and Drug Administration recently issued an order authorizing R.J. Reynolds Vapor Co. to market its Vuse Solo electronic nicotine delivery system and corresponding e-liquid pods. These authorizations mark the first...more

FDA Clarifies Premarket Path for Ecigarette Products

The US Food and Drug Administration (FDA or the Agency) on June 11 issued the final guidance: “Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems” (the ENDS Guidance), which is intended to assist...more

Liquid Nicotine—New Warnings and Packaging?

FDA publishes an advance notice of proposed rulemaking for products containing liquid nicotine. On July 1, the Food and Drug Administration (FDA) published an advance notice of proposed rulemaking (ANPRM) to obtain...more

FDA Proposes Tobacco Products Rule; E-Cigarettes, Cigars To Be Regulated

The rule would ban the sale of e-cigarettes, cigars, pipe tobacco, and other products to those under 18; would require warning statements on product packages and in advertisements; and would require manufacturers to register...more

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