The U.S. Food and Drug Administration (FDA) has been ramping up their enforcement efforts against tobacco retailers in recent months for compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) by issuing countless tobacco warning letters in connection with tobacco retailer inspection violations. The FDA has the authority to regulate tobacco products under the FD&C Act as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). The Tobacco Control Act, which was enacted on June 22, 2009, amends the FD&C Act and provides FDA with the authority to regulate tobacco products.

The FDA has been aggressively enforcing the Tobacco Control Act, largely against convenience stores and gas stations selling tobacco products in violation of the Tobacco Control Act by issuing tobacco warning letters quite frequently over the past several months. FDA regulations applicable to tobacco retailers prohibit the sale of cigarettes and smokeless tobacco to any person younger than 18 years of age, and impose other restrictions on labeling, marketing, and advertising of cigarettes and smokeless tobacco.

When a FDA compliance inspection reveals a violation, the tobacco retailer first receives a tobacco warning letter. A tobacco warning letter, like other FDA warning letters, contains a list of all of the violations observed during the inspection and directs the tobacco retailer to respond in writing with a plan to correct the observed violation. After receiving a tobacco warning letter, a business must respond to the FDA within 15 working days. The response to the FDA should include an explanation of the steps that the business will take to correct the violations and to prevent future violations, as well as the current contact information for the business.

After the receipt of a tobacco warning letter, if a tobacco retailer fails to correct the violation, it may result in the FDA taking regulatory action without any further notice to the tobacco retailer. Under the FD&C Act, as amended by the Tobacco Control Act, the FDA is authorized to issue a civil money penalty, no-tobacco-sale order, seizure, criminal penalties, and/or an injunction, which would prohibit the business from further tobacco sales.

Tobacco Control Act and Tobacco Retailers

The FDA can issue tobacco warning letters due to a number of different violations of the requirements set forth in the Tobacco Control Act. In particular, the regulations:

• Prohibit the sale or distribution of brand-identified promotional nontobacco items such as hats and tee shirts;
• Prohibit the sponsorship of sporting and other events, or teams;
• Prohibit free samples of cigarettes and restrict distribution of free samples of smokeless tobacco to “qualified adult-only facilities;”
• Require retailers to verify a purchaser’s age by photographic identification.

• Prohibit opening cigarette or smokeless tobacco packages to sell products in smaller amounts;
• Prohibit free samples of cigarettes.

Often, convenience stores and other establishments receive tobacco warning letters in connection with this final requirement – the failure to verify a purchaser’s age, which may also result in Warning letters issued by the FDA for violations of the Tobacco Control Act can be viewed here.

Tobacco Warning Letters: What’s Next?

If your business receives a tobacco warning letter or notice of a tobacco retailer inspection violations, it is extremely important that you take swift action to correct the violations. As stated in all tobacco retailer warning letters, a business only has 15 working days to respond to the FDA. Without a response, the FDA can pursue further legal action against your business with no further notice. 15 days is an extremely short period of time and once a warning letter is received, so swift action must be taken.

We can help you respond to tobacco warning letters and other FDA warning letters by reviewing the legal and regulatory basis for your warning letter, determining the appropriate measures that need to be taken in order to reestablish compliance with federal laws and FDA regulations, if necessary, and drafting a response to your warning letter on your behalf. For more information about hiring a FDA regulatory lawyer to help you respond to FDA warning letters or how you can achieve FDA compliance, please contact us at [email protected].