The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), signed into law on June 22, 2009, establishes specific guidelines on the marketing of tobacco products and gives the FDA authority to regulate manufacturing, distribution, and marketing in the interest of public health.

1. Premarket Tobacco Product Application (PMTA): This is a technical demonstration that your new tobacco product meets the standards established by the FDA in Section 910 of the Federal Food, Drug and Cosmetics Act and that your product is appropriate for the protection of the public health (APPH). Any “new tobacco product,” meaning anything marketed after February 15, 2007, or products modified after February 15, 2007, is subject to a pre-market review to ensure manufacturers understand their products’ ingredients and interactions, have solid manufacturing processes, meet tobacco product standards, have appropriate labeling, and ensure that the product is not being marketed to minors.
2. Substantial Equivalence Report (SE): Applicants who pass this stage have demonstrated that their product has either the same characteristics of a predicate tobacco product (something that was commercially marketed in the USA as of February 15, 2007) or has different characteristics than the predicate product, but does not raise new or different questions of public health.
3. Substantial Equivalence Exemption (SEE): This designation may apply to tobacco products that are modified by adding or deleting a tobacco additive, increasing or decreasing the quantity of an existing tobacco additive, or have undergone other minor modifications.
4. Pre-Existing tobacco product: This applies to any pre-existing tobacco product that was commercially marketed in the United States as of February 15, 2007. While these products do not need to go through the PMTA process to be marketed legally, manufacturers should submit a pre-existing status determination request from the FDA. This includes a description of the product as well as a statement and dated evidence that the product was commercially marketed as of February 15, 2007.

Under Section 910 of the FD&C Act, anyone wanting to market a new tobacco product (one that was not commercially marketed in the United States on or before February 15, 2007), or any modified tobacco product that was commercially marketed after February 15, 2007, are subject to pre-market review and must first obtain a marketing order from the FDA. This includes products covered under the 2016 deeming rule.

The FDA’s Center for Tobacco Products (CTP) Deeming Rule is a regulatory framework introduced by the FDA to extend its authority over previously unregulated tobacco products. The rule, implemented in August 2016, grants the FDA regulatory oversight over electronic cigarettes, cigars, pipe tobacco, and other tobacco products that were not previously subject to FDA regulation.

Under the FDA Deeming Rule, these newly regulated products must comply with various provisions, including pre-market review requirements, ingredients listings, health warning labels, and advertising and marketing practices and restrictions. The rule aims to address the public health concerns associated with the use of these tobacco products, particularly among youth, and to ensure that they are manufactured, marketed, and sold in a manner that protects public health.

By extending its authority to these previously unregulated tobacco products, the FDA seeks to evaluate their risks and potential benefits, implement appropriate regulations, and take necessary actions to protect public health. The agency can now assess these products’ ingredients, manufacturing processes, and potential health effects and impose restrictions or requirements to mitigate any identified risks.

The FDA Deeming Rule represents a significant step in the agency’s efforts to regulate tobacco products’ evolving landscape and address emerging public health challenges. By subjecting electronic cigarettes, cigars, and other tobacco products to FDA oversight, the rule aims to promote transparency, encourage product improvements, and ultimately reduce the adverse health effects associated with tobacco product use.

Effective from April 14, 2022, the Consolidated Appropriations Act of 2022 (Pub. L. 117-103) brought about significant changes to the definition of a “tobacco product” in section 201(rr) of the FD&C Act. These changes broaden the definition to include products containing nicotine from any source while excluding articles classified as foods under section 201(f) of the FD&C Act if they have no nicotine or only trace amounts of naturally occurring nicotine.

Furthermore, the Appropriations Act amended section 901(b) of the FD&C Act (21 U.S.C. 387a(b)), which pertains to FDA authority over tobacco products. The amendment explicitly states that Chapter IX of the FD&C Act applies to any tobacco product containing nicotine that is not derived from tobacco, thus extending FDA regulations to encompass such products.

Consequently, starting April 14, 2022, tobacco products that contain non-tobacco nicotine (NTN), including synthetic nicotine, are now subject to the regulatory provisions that apply to tobacco products in the FDA’s regulations.

In section 910(b)(1) of the Federal Food, Drug and Cosmetics (FD&C) Act, FDA stipulates the application requirements, which must include:

• the manufacturers’ understanding of the health risks of its new tobacco product and that it presents less risk than other currently marketed tobacco products.
• components, ingredients, additives, properties and the principle(s) of operation.
• methods used in, and the facilities and controls used for, the manufacture, processing, packing and installation of your product.
• reference to an applicable tobacco product standard from Section 907 of the FD&C Act and adequate information to show that aspect of your tobacco product fully meets tobacco product standards or adequate information to justify any deviation from the standards.
• product samples of the product and associated components.
• proposed product packaging samples.
• any other information relevant to the focus of your product, as requested by the Secretary.

Our team will ensure that your PMTA contains all required and relevant information for the FDA to determine if your product is appropriate for the protection of public health (APPH) and help and help create a supporting narrative for each point that is supported by science and information.

The FDA Center for Tobacco Products (CTP) regulates the manufacturing, distribution and marketing of all tobacco projects, and oversees the PMTA application process. The agency has established completion time targets for various stages of the PMTA process. However, the timing for decisions at each stage of the PMTA process depends on several factors, such as the completeness of the application and the type of new tobacco product to be evaluated. For example, FDA will quickly reject incomplete applications. On the other side of the spectrum, a complete application for an inhaled tobacco product requires more time for FDA to review. Keep in mind, it can take a year or two to generate the data for a complete application. Once the application is submitted, there are several key milestones in the PMTA process:

1. Acceptance of the application, which based on historical data may take several months for the agency to review and notify applicants.
2. Filing the application can take up to a year. Delays can occur with acceptance and filing when applications are missing components, using outdated forms, or the application contains even minor mistakes, in which case the agency provides a “refuse to accept” or “refuse to file” letter.
3. Scientific review timing depends on the complexity and innovative nature of your product, but historically this review phase has taken FDA one or more years.
4. There are several actions that can come from your scientific review:
   • A deficiency letter identifying an area(s) of concern and a request for additional information. You will only have 90 days to address identified deficiencies. We advise using experts that can anticipate deficiencies or perform a gap analysis on pending applications.
   • When a product is deemed not appropriate for the protection of public health (APPH), the agency issues a marketing denial letter (MDO). At this point, we recommend that manufacturers challenge the MDO or remove the product from the market and restart the PMTA process, addressing any gaps FDA have identified.
   • If your product meets the standard of appropriate for the protection of public health, your application will be authorized and you will receive a marketing granted order (MGO).

Hopefully, this gives you a general sense of what you can expect and how your organization can plan accordingly.

The PMTA process is an expensive endeavor and applicants should expect costs to total in the seven-to-eight-figure range. This cost can be spread out over multiple years. Our regulatory filing strategies are based partly on the manufacturer’s risk tolerance. We’ll work with your team to design and oversee the implementation of a bespoke regulatory research program that balances risk tolerance, budget, and regulatory requirements.

Most applicants need help understanding the full scope of what the FDA is asking to be included in their PMTA. We help clients understand the process, outline a plan catered to their risk tolerance and budget, and implement that plan using our team’s vast experience. Based on that experience, we’ve found that most applications get tripped up when the client does not have a clear understanding of the science behind their product, or when the applicant struggles to clearly demonstrate that the product is not being marketed to minors or tobacco non-users.

Ultimately, the purpose of the PMTA process is to demonstrate understanding of your product and intentionality around its marketing. And while the application itself must meet that standard, it helps when you can provide concrete examples of your subject matter or industry expertise. Oftentimes, our clients will demonstrate product knowledge by submitting industry articles or presenting at industry conferences. Our team can work with you to develop content that may be used to showcase your deep knowledge.

The FDA will consider any product in a grouped submission as a separate product application; therefore, manufacturers still need to produce environmental assessments for each product in the group.

Many of our clients come to us after they receive a “refuse to accept” letter. This typically occurs when a client submits the application on their own. Often we find the application is missing components, using outdated forms, or contains minor mistakes. When we work with these clients, we propose a gap analysis to determine what they have already completed and which areas need more work. This ensures we are not duplicating any performed research and helps the client manage overall costs and their timeline.

Deficiency letter recipients are given a 90-day response window, which means timing is critical. We’re practiced in that scramble and can quickly build the right team, develop relationships with your team, and wrap our arms around the challenge. Recently, one of our clients received a deficiency letter on a product that had been on the market for several years and we were able to assemble a team within two days. We allocated a specialist for each section of the letter, and, prior to submission, we gathered the team to ensure the tone remained consistent throughout the response and that we met the standards for completion.

Certain types of tobacco products – such as e-cigarettes, heated tobacco products and herbal products for smoking – are regulated by the European Union Tobacco Products Directive (EU TPD) or in the case of the UK, the Tobacco and Related Products Regulations (TRPR). While specific implementation details differ by county, all countries operate a notification scheme that must be used before marketing a new product. Generally speaking, the process is much simpler and requires a less extensive suite of information than what is needed for a PMTA.

The data requirements for European applications, which they call “notifications”, are simple, and include emissions testing, providing toxicological information for each e-liquid ingredient, and demonstrating the use of compliant packaging, including child resistance. Manufacturers also need to be aware of specific labeling requirements, which can differ from country to country and may depend on the e-liquid ingredients.

The testing requirements regarding emissions from e-cigarettes are fairly limited and include certain types of carbonyls, a small number of metals, and nicotine.

There are some restrictions on the size of the e-liquid container (10ml for refill bottles containing nicotine and 2ml for the e-liquid container in a mod system or for pods). The e-liquid nicotine content is also limited to a maximum of 20mg/ml.

Regulations exhibit significant variations across countries, and McKinney’s team of advisors possesses the expertise to guide clients through the specific regulatory frameworks of any country in which their products can be lawfully marketed.

It is possible to license an e-cigarette as a smoking cessation tool almost anywhere in the world. The pathway is most streamlined in the UK, where the regulator (the Medicines and Healthcare products Regulatory Agency or MHRA) requires a much smaller package of pre-clinical and clinical data than in other countries.