FDA Guidance on Enforcement of Regulations Restricting Sale and Distribution of Cigarettes & Smokeless Tobacco
This post was written by Paul Sheives.
FDA has issued a guidance document entitled “Enforcement Policy Concerning Certain Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco.” The purpose of the guidance document is to announce the agency’s views on the enforcement of two provisions in its final regulations restricting the sale and distribution of cigarettes and smokeless tobacco to protect children and adolescents. The first provision prohibits the use of trade names for tobacco products on non-tobacco products. FDA is exercising enforcement discretion to stay enforcement of this provision where (1) the trade name of the tobacco product was registered, or the product was marketed, in the U.S. on or before June 22, 2009; or (2) the initial marketing or registration of the tobacco product occurred prior to the same for the non-tobacco product not marketed or registered by the same company or an affiliate. The second provision requires that labeling or print advertisements appear in a black-and white text only format, except in certain “adult only” locations or in publications that do not have significant readership by children and adolescents under the age of 18. Although the guidance document is in effect, FDA is accepting written comments at any time.
