Tobacco | Approvals

Although the Food and Drug Administration (FDA) does not directly approve tobacco or tobacco products for distribution in the U.S., FDA was granted authority under the Family Smoking Prevention and Tobacco Control Act of 2009 (TCA) to set standards regarding tar and nicotine levels, restrict the use of flavors, ingredients and additives in tobacco products, and control the labeling for cigarettes and other tobacco-related products. Therefore, through its regulatory authority, FDA now has the power to set the standards, require submission of reports, and inspect facilities in the tobacco industry to ensure its new regulatory standards are being met. In addition, new tobacco products may be subject to a “premarket review” by FDA, which will likely amount to a pre-approval of tobacco products once implemented by FDA.

This very broad regulatory power includes FDA’s new authority to inspect tobacco product manufacturers, packagers, distributors, and importers. However, even in the permitting process, tobacco companies should expect that an Alcohol and Tobacco Tax and Trade Bureau (TTB) officer may inquire or investigate to verify information contained in an application for a TTB permit is correct before issuing a permit to distribute or import tobacco or tobacco products.

Though not approvals, strictly speaking, these new regulatory powers granted to federal agencies will often feel like an approval process.

FDAImports.com, LLC can assist your company in preparing for FDA inspections or TTB inquiries regarding your tobacco or tobacco product manufacturing, warehousing, distribution or importation. In addition, FDAImports.com, LLC can assist you in obtaining the required and necessary permits and in submitting the required Ingredients Reports and Nicotine Reports to the government agencies.