tobacco product fda consultant

On June 21, 2012 the FDA unveiled new graphic warning labels for cigarette packages and ads.  Cigarette packages will now be required to have one color image and one warning about the consequences of smoking. Since September 2012, tobacco makers have been required to put the warning on all cigarette packs and advertisements. To learn more about new cigarette warning labels, visit the FDA web page.

As the area of FDA tobacco regulation continues to change, our FDA consultants are staying up to date on the most recent developments and can help you adapt as quickly and effectively as possible, avoiding costly missteps. 

Other recent FDA 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. Contact our FDA Tobacco Product Consultants today for an initial consultation.