2FIRSTS Exclusive - At the end of 2023, media outlets including Reuters and The New York Times published multiple stories on the new tobacco industry; shortly thereafter, there was a visible surge in attention from the U.S. political sphere towards e-cigarette regulation. The concept of "illegal e-cigarettes from China" has been repeatedly raised in public forums. Publicly available information shows that in compliance inspections of online and offline tobacco product retailers in the United States, the vast majority of commercial entities fined in the batch dated April 23rd were involved in selling "ELFBAR" brand products.
Moreover, following the implementation of new e-cigarette restrictions in the UK and Australia, U.S. Senator Whip Dick Durbin wrote to the FDA at the end of January this year, criticizing its lack of enforcement and stating that the FDA's review of pre-market tobacco product applications (PMTA) for e-cigarette manufacturers was "long-overdue," calling on the FDA to take action to protect American children.
How will the pressure from public opinion be transmitted to policy formulation and enforcement in regulation? Will FDA compliance inspections become increasingly intensive and stringent? To address this, 2FIRSTS interviewed the U.S. Food and Drug Administration (FDA). FDA Press Officer Jim McKinney granted feedback.
Regarding Senator Durbin's Letter
Durbin stated on his website that the FDA's review of pre-market tobacco product applications (PMTA) is long overdue. The federal court's deadline was September 9, 2021, and as of January 2024, the FDA has missed the court-imposed deadline by 28 months. He has already contacted the FDA on this issue.
Regarding Senator Durbin's letter to the FDA, the FDA confirmed receipt of the letter and will respond directly to the senator.
Nearly 60,000 Inspections in the Last 8 Months
As for the warning letters to online retailers, 2FIRSTS inquired about the details of compliance inspections of online and offline tobacco product retailers in the United States.
McKinney pointed out during the interview that the FDA takes a comprehensive approach to compliance and enforcement of tobacco products, including taking action against violators throughout the supply chain, including manufacturers, importers, distributors, and retailers, both online and offline.
The FDA has conducted a total of 57,191 inspections of commercial entities involved in tobacco-related businesses across the United States in the latest fiscal year (October 2023 to present): 48,353 were found to be compliant, a total of 6,556 warning letters were issued, 2,280 civil fines were imposed, and one tobacco sales ban was issued.
Furthermore, on May 1st, the FDA issued warning letters to 14 online retailers selling unauthorized e-cigarettes (see details at https://www.fda.gov/tobacco-products/ctp-newsroom/fda-issues-warning-letters-14-online-retailers-selling-unauthorized-e-cigarettes-0).
Over Half Reported Using ELFBAR; Esco Bar Holds over 20% Market Share
McKinney stated that according to the announcement issued by the FDA on May 1st, the 2023 national youth tobacco survey showed that among the surveyed, over 2.1 million American youth currently using e-cigarettes, over 50% reported using Elf Bar products, and over 20% reported using Esco Bar products. After reviewing retail sales data and new internal data obtained from a survey of teenagers, additional brands included in these warning letters were identified, believed to be popular or attractive to teenagers.
As early as May 2023, the FDA issued an "Import Alert 98-06," with most of the companies highlighted in red including manufacturers, transporters, and distributors of ELFBAR, EBDESIGN, and Esco Bar brands.
McKinney mentioned that after this alert, the FDA could effectively detain new tobacco products without market authorization without testing, thus calling on industry practitioners to "promptly and fully correct all violations and ensure compliance with all applicable laws and regulations."
Over 670 Warning letters Issued for New Tobacco Products
When asked about current enforcement efforts, McKinney cited FDA data, stating that as of May 1st, the FDA had issued over 670 warning letters to manufacturers, importers, and distributors of unauthorized new tobacco products (including e-cigarettes); over 550 warning letters were issued to retailers selling unauthorized tobacco products; civil fine lawsuits were filed against 55 manufacturers and over 100 retailers producing and/or selling unauthorized tobacco products; and in cooperation with the Department of Justice (DOJ), injunctions were sought against 7 unauthorized e-cigarette manufacturers, with over $700,000 worth of unauthorized e-cigarette products seized in collaboration with the DOJ.
Warning Letters may be Followed by Civil Fines or Tobacco Sale Bans
When 2FIRSTS inquired about the compliance inspection process, McKinney responded that when the FDA first identifies violations of federal tobacco laws and regulations in compliance inspections, warning letters are sent to traditional "brick-and-mortar" retailers nationwide, as well as online retailers and manufacturers.
McKinney emphasized that failure to promptly and fully correct all violations and ensure compliance with all applicable laws and regulations could result in further FDA and other related enforcement actions, including civil fines or tobacco sale bans.
2FIRSTS will continue to monitor developments in the U.S. market and related legislation and enforcement actions.
Related Reading：
FDA CTP Director Brian King: Submitting PMTA is No Equivalent to Legal Sale
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