Trepanier MacGillis Battina P.A. 8000 Flour Exchange Building 310 Fourth Avenue South Minneapolis, MN 55415 612.455.0500
Trepanier MacGillis Battina P.A. 8000 Flour Exchange Building 310 Fourth Avenue South Minneapolis, MN 55415 612.455.0500

Recent Changes to Federal Tobacco Laws and Regulations

The Federal Age Limit to Purchase Tobacco Products, Cigarettes Increased to 21: Effective Immediately

On December 20, 2019, President Donald J. Trump signed an amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act), Public Law 116-94, which raises the minimum age for the sale of tobacco products from 18 to 21.  The new law – which was included as part of the federal spending package – applies to traditional tobacco products as well as e-cigarettes and vape products. Usually, new legislation does not take effect upon signing. The age change, however, became effective immediately because it was considered only a simple change to preexisting legislation with respect to age vs. a wholesale change to the FD&C Act. As a result, regardless of what the current state law says, the new minimum age to buy cigarettes, cigars, smoking tobacco, e-cigarettes, or vape products is now 21 nationwide.

Tobacco 21 in Minnesota

Prior to the change in federal law, 55 Minnesota cities and counties had already raised the lawful age to purchase tobacco products to 21. Minnesota lawmakers – like a number of lawmakers throughout the country – were also contemplating a similar shift on statewide-level. These changes have been brought about as part of a broader initiative to reduce youth and young adult access to tobacco and vape products after recent reports regarding the increase in youth smoking and vaping, addiction, and its associated health risks.  The underlying thought is that those under 18 have much greater access to young adults between the ages of 18 and 21, than they do to those over 21. As a result, lawmakers hope that an age increase will put tobacco and vape products out of the typical youth’s social circle.

Enforcement of the New Federal Age Increase to Purchase Tobacco

The Food and Drug Administration (“FDA”) has not yet made clear how state and local authorities that enforce tobacco-age laws will react and enforce the new law. Previously, the FDA enforced tobacco laws partly through “spot checks.” If found in violation of the tobacco laws during a spot check, stores could be fined or even barred from selling tobacco for repeated violations. Likewise, the federal government can withhold government funding to states that refuse to comply.

It is more likely, however, that enforcement would be handled on a local-level, especially once local ordinances are amended to be consistent with federal law. The Minnesota Department of Revenue is responsible for monitoring compliance with Minnesota Cigarette and Tobacco Tax laws, and local municipalities regularly conduct their own compliance checks through their police departments. Prior to the age increase, random inspections were regularly used to monitor compliance of retailer’s cigarette and tobacco inventories and ID verification procedures.  During these checks, the retailer’s license to sell cigarette or tobacco supplies may investigated, as are the retailer’s inventory and invoices from cigarette or tobacco suppliers. It is likely that spot checks will increase to ensure prompt compliance with the new age increase.

Several Minnesota municipalities have already notified affected licensees of their expectation for compliance and intention to promptly update local ordinances. Presumably, the state legislature will also proceed with amending Minnesota law to increase the age to 21, consistent with the federal law to avoid conflicting federal and state laws.

Food and Drug Administration Bans Fruit and Mint Flavored E-Cigarette and Vaping Products

In a similar effort to curb youth smoking and vaping, the FDA has taken action to ban fruit and mint-flavored e-cigarette and vaping products.  The 2016 Family Smoking Prevention and Tobacco Control ACT (Tobacco Control Act) granted the FDA the authority to regulate the manufacture, marketing, and distribution of cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco products to protect the public health and reduce tobacco use by minors. As a result, the FDA has authority over the regulation of electronic nicotine delivery systems, cigars, waterpipe (hookah) tobacco, pipe tobacco, nicotine gels, and dissolvables, as well.

On January 2, 2020, the FDA issued a policy under the Tobacco Control Act prioritizing the enforcement against certain unauthorized flavored e-cigarette products that appeal to youth, including fruit and mint flavors.  As a result, companies must cease manufacture, distribution, and/or sale of unauthorized fruit and mint flavored cartridge-based e-cigarettes within 30 days from the publication of the notice of availability of the guidance in the Federal Registrar. If companies fail to comply, they risk FDA enforcement actions.

The FDA’s released guidance indicates that it intends to prioritize enforcement against illegally marketed electronic nicotine delivery system (“ENDS”) products in the following groups:

  • Any flavored, cartridge-based ENDS product (other than tobacco or menthol flavors);
  • All other ENDS products which the manufacturer has failed to take, of is failing to take adequate measures to prevent minors’ access; and
  • Any ENDS product that is targeted to minors or likely to promote use of ENDS by minors.

The ban on fruit and mint-flavored products arises from what the United States is calling an epidemic of youth use of e-cigarettes.  The FDA believes that prioritizing the enforcement against the fruit and mint- flavored products that they believe are most widely used by youth and young adults will benefit public health.

A temporary exception allowing the sale of certain fruit and mint-flavored vape products exists for vape shops. These shops will be allowed to sell fruit and mint-flavorings in stores from tank-based systems, which allow users to mix their own nicotine and vaping juice. This exception was seen as an attempt to find middle ground with adult vape users who use e-cigarettes to provide an alternative from combustible tobacco use or as part of smoking cessation, while also acting to limit youth access to flavored vape products from adult-only vape stores. It is possible, however, that this exception may eventually be removed if vape products remain widely used (or available) to youth and young adults.

Future of ENDS Products

The 2016 legislation granting the FDA authority over e-cigarettes and ENDS products also included the premarket authorization requirements in the FD&C Act. As of 2016, all e-cigarette products and other ENDS products on the market at that time were required to have authorization from the FDA to be legally marketed. As an exercise of its authority, however, the FDA has deferred enforcement of the premarket authorization of ENDS products.  As a result, to date, no ENDS products have been authorized by the FDA – meaning the FDA considers all ENDS products currently on the market to be illegally marketed.

For this reason, according to the FDA’s recent guidance, the deferment will end on May 12, 2020.  At that time, the FDA intends to prioritize enforcement against any ENDS product manufacturer for which the manufacturer has not submitted a premarket application (or after a negative action by the FDA on a timely submitted application).

The FDA will make enforcement decisions on a case-by-case basis, recognizing that as a practical matter, to take enforcement action against every illegally marketed tobacco product will be difficult.

Conclusion

These recent changes affect thousands of tobacco and retail stores and their daily sales. Failure to promptly comply could result in significant problems for unaware tobacco businesses, including fines and suspension or loss of a retail tobacco license.  Ordinarily, there would be a “sunset” period before compliance is expected. Here, tobacco retailers will need to change their procedures, policies, and train staff immediately, and cease the sale or marketing of certain ENDS vape products, or risk adverse action from both a local and federal level.  

If you have questions about compliance, enforcement, or the effect of the new federal tobacco age increase, the ban on fruit and mint-flavored ENDS vape products, or application requirement to market ENDS vape products on your Minnesota tobacco, vape, or CBD business, contact one of the Minneapolis tobacco business attorneys of Trepanier MacGillis Battina P.A.

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About the Author:  Trepanier MacGillis Battina P.A. is a Minnesota business law firm located in Minneapolis, Minnesota. Their attorneys can be reached at 612.455.0500.