Earlier this month, FDA issued advance notice of proposed rulemaking (ANPRM) to obtain information related to the regulation of non-face-to-face sale and distribution of tobacco products and the advertising, promotion, and marketing of tobacco products. Under the Tobacco Control Act (TCA), FDA is required to issue regulations by October 1, 2011 regarding the sale and distribution of tobacco products through non-face-to-face transactions, such as Internet and mail order sales.  Similarly, the TCA requires FDA to issue regulations by April 1, 2012 addressing the promotion and marketing of tobacco products that are sold or distributed through a non-face-to-face exchange.  The stated justification for these new regulations is to prevent the sale and distribution of tobacco products to minors.

In the ANPRM, FDA admits that the PACT Act, which became law before FDA could issue the above regulations, governs the same subject matter for which FDA is to issue regulations.   In light of the overlap between the PACT Act and the proposed regulations, FDA is requesting additional information, including comments, data, and research, prior to issuing the proposed regulations.  Just a few of the specific questions posed by FDA in the ANPRM are:

  •  Since the enactment of the PACT Act, have minors found alternative methods to purchase and/or acquire cigarettes or smokeless tobacco products by a means other than a face-to-face exchange? If so, what are they?
  • What are current technologies, procedures, or other methods used to ensure that the purchaser of a tobacco product through a non-face-to-face exchange is an adult, including age and ID verification?
  • How are the Internet, e-mail, direct mail, telephone, smartphones, and other communication technologies used to direct tobacco product advertising, marketing, and promotion messages to specific recipients?

FDA’s questions appear to be geared toward determining how effective the PACT Act has been at curbing youth access to tobacco products.

For questions and/or comments, please contact Bryan Haynes, at 804.697.1420 or by email.