Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy Concerning Certain Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Enforcement Policy Concerning Certain Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco." This guidance document discusses FDA's intended enforcement policies with respect to two provisions of the final regulations restricting the sale and distribution of cigarettes and smokeless tobacco to protect children and adolescents. One provision restricts the use of a trade or brand name of a nontobacco product as the trade or brand name for a cigarette or smokeless tobacco product. 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. This guidance document will be implemented immediately, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).