Tobacco Products

We Can Help Make Sense of the new FDA Regulations

In March of 2010, the FDA issued a set of federal regulations intended to limit access to and the appeal of tobacco products to children and adolescents in the United States. The new rules take effect on June 22, 2010 and restrict the sale, marketing and distribution of tobacco products.  As the area of tobacco regulation continues to change, our trade attorneys are staying abreast of the most recent developments and can help you adapt as quickly and effectively as possible, avoiding costly missteps. 

Among other things, the new regulations — entitled Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents — prohibit:  

• The sale of cigarettes or smokeless tobacco to people younger than the age of 18;
• The sale of cigarette packages with fewer than 20 cigarettes;
• Distribution of free samples of cigarettes;
• Tobacco brand name sponsorship of any athletic, musical, or other social or cultural events;
• Restricts distribution of free samples of smokeless tobacco.

Tobacco product manufacturers and importers must submit all documents developed after June 22, 2009 "that relate to health, toxicological, behavioral, or physiologic effects of current or future tobacco products, their constituents (including smoke constituents), ingredients, components, and additives." They also must submit a listing of all ingredients -- including tobacco, substances, compounds, and additives -- that are added to the tobacco product.

All domestic companies that manufacture, prepare, compound or process tobacco must register with the FDA annually.