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).

Under federal law, a “modified risk tobacco product” is a product whose label or advertising represents that the product presents lower risk of tobacco-related disease or is less harmful than other commercially-available products. 21 USC 387k. In order to legally market a product as a modified risk tobacco product (MRTP), an order must first be issued by the FDA permitting the marketing as a MRTP. To date, FDA has not issued a single MRTP order.

According to the FDA’s Warning Letter, found here, JUUL representatives allegedly made statements suggesting its products were safe and were safer than cigarettes. If made, these statements would cause JUUL’s products to be marketed as MRTPs, in violation of federal laws and FDA requirements. As with all warning letters issued by the FDA, the Company has 15 business days to respond to the allegations.

The FDA regulates tobacco products under the Family Smoking Prevention and Tobacco Control Act (Act), which was signed into law by President Obama in 2009. The Act grants FDA the authority to regulate various tobacco products, including electronic delivery nicotine systems or “ENDS”, like JUUL products. ENDS and all covered tobacco products must meet FDA requirements, including labeling and marketing requirements and in many cases premarket notification or authorization requirements. If you have questions about marketing tobacco products, please contact us at contact@sglawfl.com.

Similar to tobacco products previously regulated by the FDA, the new regulations would require product manufacturers and marketers, including marketers of e-cigarettes, to follow certain guidelines, such as the following:

• FDA registration and reporting of product information
• Certain new tobacco products can only be marketed after a full FDA review
• Free samples cannot be distributed
• Only scientifically proven, direct claims of a decreased health risk, i.e., “smoking e-cigarettes is safer than traditional cigarettes”,  can be made where the FDA is able to verify that the evidence meets a certain level of scientific support

Additionally, the new proposed rules will include certain restrictions on newly-regulated tobacco related products, including e-cigarettes, that apply to marketing and sale of previously-regulated tobacco products, such as the following:

• Product packaging must list health warnings
• Identification and minimum age requirements in order to prevent underage purchases
• Products cannot be sold in vending machines unless the machine is located in a facility does not allow underage youths

The full text of the proposed regulations may be accessed here.

Although new tobacco products like e-cigarettes are not subject to current, final regulations pertaining to other tobacco products, the agency is working hard to gain control over these items, as illustrated through the proposed rule. If and when the regulations pertaining to e-cigarettes and other new tobacco products are finalized, importers and marketers of these products will be required to comply with the various requirements in order to ensure that their products may be marketed in a manner consistent with federal law. Accordingly, product registration and changes in marketing, including revisions to current labeling for e-cigarettes and the like, may be necessary in order to continue doing business in the United States.

If you have any questions about the FDA’s proposed tobacco product regulations or how you can maintain compliance with FDA regulations, please contact us at contact@sglawfl.com.

The FDA has authority to regulate tobacco products pursuant to the Federal Food, Drug, and Cosmetic Act (FDCA), as amended by the Family Smoking Prevention and Tobacco Control Act (FSPTCA) of 2009. The use of menthol in cigarettes, however, is currently exempt from restrictions applicable to other flavors in cigarettes. For example, menthol is an exception under Section 907(a)(1)(A) of the FDCA, which otherwise prohibits the marketing and sale of cigarettes that contain a characterizing flavor as a constituent or additive.

As the FDA explains, prospective regulatory options include establishing tobacco product standards, restricting the sale and distribution of menthol cigarettes, and any other appropriate actions. Particularly, the FDCA provides the FDA with authority to establish a tobacco product standard, amend an existing product standard, or restrict the sale and distribution of a tobacco product if it is appropriate for the protection of public health.

The agency will consider all comments, data, research, and other information submitted in response to the ANPRM, available for public comment until September 23, 2013, in making its decision. The FDA will also look to scientific studies, including its “Preliminary Scientific Evaluation of the Possible Public Health Effects of Menthol Versus Nonmenthol Cigarettes,” which is provided for comment here. The preliminary evaluation is the FDA’s independent analysis of the association between menthol cigarettes and various outcomes including initiation, addiction, and cessation.

In sum, if the FDA does decide to issue a rule, the next step will be a Notice of Proposed Rulemaking. If you have any questions about the FDA’s regulation of tobacco products or the rulemaking process, please contact us at: contact@sglawfl.com.

Pursuant to section 910 of the Federal Food, Drug, and Cosmetic Act (FDCA), as amended by the FSPTCA, a manufacturer who wants to marketnew tobacco products must receive a written marketing order from the FDA under one of three pathways: premarket tobacco application, substantial equivalence, or an exemption from substantial equivalence. In particular, to receive an SE marketing order, the new product must be in compliance with FDCA requirements and either have the same characteristic as a predicate product that is already marketed in interstate commerce or have different characteristics but not raise different questions of public health.

In this case, the FDA determined that the new tobacco products were substantially equivalent because although they had different characteristics than the predicate products, they did not raise different questions of public health. A marketing order does not mean, however, that the new product is safe or approved by the FDA and the tobacco companies are not allowed to say that their products are FDA approved.

To be eligible to obtain an SE marketing order, the manufacturer must submit a substantial equivalence report under FDCA section 905(j). More information about the requirements for tobacco marketing orders can be found here. If you have any questions about marketing a new tobacco product or complying with FDA regulations, please contact us at: contact@sglawfl.com.

In the warning letters, the FDA explains that the companies are required to immediately correct the violations. Also, they have 15 working days from the date that they received the warning letters to submit a written response to the agency. The response must describe all corrective actions that the company has taken to bring their cigarette products and advertisements into compliance with the FDCA and accompanying FDA regulations, especially the Family Smoking Prevention and Tobacco Control Act (FSPTCA), which gives the FDA jurisdiction over the manufacturing, distribution, and marketing of tobacco products.

In particular, after reviewing the companies’ websites, the FDA found that several cigarette products were adulterated under section 902(8) of the FDCA because they are were marketed as modified risk tobacco products without FDA approval. According to section 911(b)(2)(A), a product is considered a modified risk tobacco product if its labeling or advertising represents that the product contains a reduced level of a substance or uses the descriptors light, mild, or low. For example, certain cigarettes were labeled as containing reduced levels of tar and nicotine. A modified risk tobacco product cannot be marketed without an FDA order pursuant to section 911(g). Otherwise, it is adulterated in violation of the FDCA.

Additionally, the FDA notes that many of the cigarettes are either adulterated or misbranded because they are marketed as flavored cigarettes in violation of the FDCA as amended by the FSPTCA. Under section 907(a)(1)(A), a cigarette or any of its components shall not contain a natural or artificial flavor, other than tobacco or menthol, as a constituent or additive that is a characterizing flavor. Cigarettes marketed and sold in violation of this provision are considered adulterated.  Otherwise, if the cigarettes do not actually contain a characterizing flavor, they are misbranded as their labeling or advertising is false or misleading.

More information about the requirements for selling a modified risk tobacco product can be found here. If you have any questions about FDA regulations regarding the marketing of tobacco products or need a FDA attorney to help you respond properly to warning letters, please contact us at contact@sglawfl.com.

In the warning letters, these firms were strongly advised to correct marketing practices on specific products immediately and to submit a response to the warning letters with a specific plan to get their marketing practices in line with the requirements of the Federal Food, Drug and Cosmetic Act (“FDCA”). These warning letters can be read in their entirety by clicking here and here. Under the terms of the warning letters, the companies were also directed to submit a written response within 15 business days from the receipt of the warning that details the corrective actions they have taken to become compliant with the FDCA and FDA regulations.

The violations these companies have been targeted for fall into two general categories. Marketing cigarettes as “light”, or “ultra-light”, and marketing flavored cigarettes. The FDA does regular compliance checks to make sure tobacco retailers are in compliance with FDA regulations, the FDCA and its various amendments, including the Family Smoking Prevention and Tobacco Control Act. This Act, which was signed into law by President Barack Obama in 2009, gives the FDA the power to regulate the manufacture, distribution, and marketing of the tobacco industry.

Provisions of the Family Smoking Prevention and Tobacco Control Act require placement of new warnings and labeling statements on tobacco products and specifically ban flavored cigarettes. The Act also requires FDA approval to use marketing terms such as “mild”, “light”, or “low” that can give a false impression that the product poses less of a health risk than a conventional tobacco product. The ban on flavored cigarettes is an attempt by the federal government to discourage young people from taking up the habit, as it is the government’s stance that these flavors particularly appeal to younger consumers. More information about FDA guidelines for marketing tobacco products can be accessed here.

Failure to comply with federal law and accompanying FDA regulations can result in serious consequences. While warning letters are typically the FDA’s first course of action against companies for alleged non-compliance with the FDCA and/or FDA regulations, failure to resolve the issues cited therein may result in more stringent action. Because appropriate corrective measures may often preclude further enforcement measures, it is critical to be vigilant when mounting a response to perceived deficiencies in compliance and doing so may help a company remain in business without further problem.

For questions about FDA regulations regarding the manufacturing, distribution, and marketing of tobacco products or how you can effectively respond to an FDA warning letter, please contact us at contact@sglawfl.com.