Under Section 603 of what is now Public Law 116-94 (“Law”), Congress set forth sweeping changes to federal tobacco laws, which will serve to bring quick change to daily sales practices. To fully understand the breadth of the changes, it helps to look at the previous state of the law and the amendments that were enacted.

Unlike the original Family Smoking Prevention and Tobacco Control Act (“Act”), the changes to the law are self-executing, meaning that further FDA action is not required in order to implement the change. Namely, the original law permitted FDA to enact minimum age restrictions while limiting the Agency to enacting a minimum age no higher than 18.[1] FDA then promulgating regulations establishing 18 as the minimum age for tobacco sales. 21 CFR part 1140. With the most recent law, Congress has effectively taken FDA’s ability to set the minimum age requirements for tobacco sales and has inserted minimum age restrictions into the law. Language was added to establish a minimum age for the sale of tobacco products within the law itself, reading:  

It shall be unlawful for any retailer to sell tobacco to any person younger than 21 years of age.

Public Law 116-94, Section 603(a)(2).

In addition to inserting a federally mandated minimum age restriction into the law, Congress also made key changes that extend existing penalties for violations of the newly established minimum age requirement. Public Law 116-94, Section 603(d). Accordingly, any violation of the new minimum age restriction may result in civil money penalties, tobacco-no-sale orders, and misbranding charges.

As explained above, no further changes must be made by FDA in order to bring the congressionally mandated minimum age into effect. However, FDA will need to change its regulations in order to conform with the federal law. In addition to changing references from 18 to 21, Congress is also requiring FDA to update its regulations to require age verification for all individuals under the age of 30.[2] Currently, 21 CFR 11.40.14 provides that no verification is required for persons over 26.

Although the law does not require further action from FDA in order to implement minimum age requirements or associated penalties, it is unclear when FDA will begin enforcement of these new restrictions, if they have not already. As of December 31, 2019, FDA’s website notes that the Agency “will provide additional details on this issue as they become available.” For now, we will have to wait to see what the New Year brings with respect to FDA tobacco enforcement.

[1] Act at Section 906 (2009).

[2] Public Law 116-94, Section 603(b).

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 contact@sglawfl.com.