The U.S. Food and Drug Administration recently seized 3 million illegal e-cigarette products worth $76 million, its largest enforcement action to date. Conducted in coordination with U.S. Customs and Border Protection, the operation marks an escalation in efforts to block unauthorized vaping products from entering the American market. In light of recent enforcement actions, 2Firsts spoke with Tom Beaudet, CEO of Accorto, to understand the shifting regulatory landscape facing the e-cigarette industry.
In previous discussions with Tom Beaudet, including an interview and his participation in the "U.S. NGPs Regulatory Policy and Compliance Development Workshop" hosted by 2Firsts in Shenzhen in August this year, he warned that FDA scrutiny of e-cigarettes, especially flavoured products, was intensifying. He predicted that companies that do not meet the strict PMTA standards will face major hurdles and that non-compliant products could be withdrawn. The FDA's recent seizure of illegal e-cigarette products confirms his predictions. (Read More: CEO Talks | U.S. Compliance Rush: E-cigarette Compliance Experts Unveil Inner Workings of FDA Review)
This time, Tom Beaudet highlights several important points about the FDA's recent actions and the broader regulatory landscape:
- Increased enforcement: The FDA's collaboration with agencies such as CBP sets a new standard for tracking and removing non-compliant products from the market.
- Importance of PMTA compliance: Companies must submit robust and fully compliant PMTA applications if they wish to remain in the market, as enforcement actions are expected to intensify.
- Cost reduction through bridging: Companies can reduce the cost of PMTA compliance by "bridging" their applications to previously approved products, which can eliminate the need for expensive long-term studies such as pharmacokinetics (PK) and switching efficacy.
- Cross-border trade compliance challenges: New compliance requirements from the FDA and CBP present significant challenges for international companies, making it essential to stay up to date and adapt quickly to avoid non-compliance.
- PMTA compliance focus areas: Key compliance processes include chemical analysis, toxicological risk assessment, long-term stability testing and lifetime cancer risk assessment.
- Preparing for ongoing enforcement: As regulatory scrutiny increases, companies must establish robust compliance management systems to avoid costly penalties and market exclusion.
Here is a lightly edited transcript of the conversation:
2Firsts: How do you view the compliance background of this joint seizure action by the FDA and CBP? Does this indicate that the e-cigarette industry will face stricter regulation and enforcement in terms of compliance in the future?
Tom Beaudet: As we presented in our interview with 2 Firsts in August, there have been a series of actions by the FDA in the past year that have been leading up to their ability to enforce products off of the market that do not have compliant PMTA applications in the system. These actions are as follows:
- March 15, 2024 Dr Brian King addressed the Food and Drug Law Institute and stated that all products except the 23 approved are illegal and that FDA is committed to removing these products from the market. (this number is now 34)
- June 10, 2024 – FDA and DOJ announced a joint agency task force to combat the illegal distribution and sale of e-cigarettes.
- August 16, 2024 FDA issued the proposed Rule for registering STN numbers on each shipment.
The Director of the FDA Center for Tobacco Products, Dr Brian King, stated that the actions taken this week are a result of the new joint task force announced on June 10. He also stated that this is the beginning of an increased level of enforcement aimed at eliminating illegal and illicit products from the market. The coordination of the FDA, the Department of Justice, UC Customs and Border Protection, the US Marshal Service and the US Postal Service has significantly improved the ability to track shipments into the country and to identify which products are legal.
Manufacturers should expect that this is becoming the new standard. Companies who want to remain on the market should submit robust and fully compliant PMTA applications. The good news is that the return on investment for companies who invest in these applications will be significant due to the reduction of illicit products on the market.
2Firsts: In dealing with unauthorized e-cigarette products, what new compliance challenges does the cooperation between the FDA and CBP bring to cross-border trade companies?
Tom Beaudet: The proposed rule, first issued on August 16, 2024, is designed to facilitate rapid and accurate coordination between multiple US agencies in order to stop all illegal vaping products from entering the country. The recent actions are evidence that this new coordinated approach is very effective. The implementation of the new requirements around submitting your STN at the time of shipment will make it even easier for US Customs to determine which products are legal and which are not.
However, there is still uncertainty around what criteria the FDA will use to decide which products are approved for import. If they adopt the strictest approach, only the 34 products that have received market Granted Orders will be allowed to enter the U.S. market.
In September, Accortor’s Chief Science Officer, Dr. Vince Angelico, and I met with leaders at the FDA’s Center for Tobacco Products (CTP). We argued that the FDA should also allow companies that have submitted high-quality PMTA applications to sell their products while they complete the long-term studies required for final approval.
“It is important for companies who have invested millions of dollars completing high quality applications are allowed to begin selling their products as soon as possible to generate the revenue to pay for this very expensive process. Companies cannot spend millions of dollars then wait for years for FDA to make a final decision. Companies who have submitted complete / compliant applications along with completed tox risk assessments and product HPHC screening to demonstrate that their products do not pose any health risks should be allowed to legally market their products under a temporary marketing order while long term stability, PK and Switching Efficacy studies are completed.”
2Firsts: Regarding imported e-cigarette products, how can U.S. companies ensure that their products comply with the FDA’s PMTA requirements? What key compliance processes should they particularly focus on?
Tom Beaudet: The PMTA standard is the most complex in the world. It involves a comprehensive review of all aspects of a product—chemical, toxicological, manufacturing, environmental, and consumer impact—to ensure that everything about your product is appropriate for the protection of public health (APPH). Here are the key areas companies need to focus on:
- Chemical Analysis of HPHCs (Hazardous or Potentially Hazardous Constituents): This involves identifying and measuring the harmful substances in your product.
- Stability Testing: Long-term studies are needed to show that your product remains chemically safe and stable over its advertised shelf life.
- Toxicological Risk Assessment: A detailed evaluation of the risks associated with all the ingredients (at the CAS level) in your product.
- Leachables and Extractables Testing: This study checks for any chemicals that might be released from the packaging materials or the device itself into the vapor that the user inhales.
- Lifetime Cancer Risk Calculation: Based on the data from the studies above, you’ll need to calculate the potential cancer risk associated with using your product over a lifetime.
- Pharmacokinetics Study: This measures the nicotine uptake rate from your product compared to cigarettes and other products on the market.
- Label Comprehension and Human Factors Studies: These studies evaluate whether consumers understand the product's labeling and whether the design prevents unintended misuse.
- Comparative Efficacy Studies: These studies aim to show that the benefits of your product—like helping adult smokers switch to less harmful alternatives—outweigh the risks, especially to underage users.
Finally, all the manufacturing and quality system documents must be compiled into 6 CMC summaries, which detail how the product is made and ensure it meets FDA standards for safety and quality. Each study's data must then be incorporated into these summaries and cross-referenced with relevant published literature—essentially, information that is "known or should be known" in relation to your product.
The next critical step is creating an integrated summary, which synthesizes the findings from all individual studies. This document weaves together the results to clearly explain why your new tobacco product is appropriate for the protection of public health (APPH).
This requires a team of Chemists, Toxicologists, Psychologists and Regulatory experts who have spent their careers developing strategies, writing protocols, conducting studies and writing final applications for FDA regulated products. For companies who are willing to invest in a proper PMTA application it is strongly recommended that they work with a US regulatory consultant with an experienced team.
2Firsts: For companies involved in international supply chains, how can they establish a robust compliance management system during import and export processes to avoid similar violations?
Tom Beaudet: FDA has issues the proposed TPMP standard. This was based upon the well-established ISO 13485 medical device manufacturing standard. Accorto has a team of TPMP specialists who can help to audit your quality system, assist you in improving your system to comply with the TPMP standard, submit a Tobacco Product Master File (TPMF) and prepare you for your first FDA audit.
2Firsts: Do you think that as regulatory enforcement intensifies, the compliance costs for e-cigarette companies operating in the U.S. market will significantly increase in the future? How should companies prepare in advance?
Tom Beaudet: As FDA has reviewed millions of applications in the years following the issuance of the PMTA final rule in 2020, they continue to learn more and more about these newly regulated products and have continued to refine the science needed for them to make a determination on APPH. Two examples of this are the comparative efficacy studies referenced in the first round of mass RTAs, and more recently, the requirement for a lifetime cancer risk calculation.
The recent approval of the NJOY Menthol flavored pods has helped to set the bar for vaping product PMTAs. As more and more products are approved, the standard FDA process of bridging to predicate (approved) products will help to reduce the cost of conducting compliant PMTA applications by eliminating the need to conduct some of the long term and expensive studies such as PK and Switching Efficacy.
