In a significant development, 78 organizations spanning public health, medical, educational, and political domains have called for stringent federal enforcement against unauthorized flavored vaping products. The letter, addressed to key federal officials including FDA Commissioner Robert Califf, U.S. Attorney General Merrick Garland, and Troy Miller of U.S. Customs and Border Protection, underscores a collective urgency to mitigate the proliferation of nicotine addiction among youth.
The Coalition’s Demands
The coalition, spearheaded by the Campaign for Tobacco-Free Kids, emphasizes the need for the FDA and its enforcement partners to leverage all available tools against entities involved in the manufacture, distribution, and sale of unauthorized e-cigarettes. Despite the FDA issuing over 600 warning letters, the coalition argues that stronger enforcement actions, such as civil monetary penalties, product seizures, and criminal prosecutions, have been underutilized.
Specific Enforcement Actions Requested
- Civil Monetary Penalties (CMPs): The coalition criticizes the FDA for filing CMP complaints against only 55 manufacturers and 108 retailers, deeming this insufficient given the widespread illegal sales.
- No-Tobacco-Sale Orders and Product Seizures: The letter calls for more frequent use of no-tobacco-sale orders and product seizures to disrupt the supply chain of illegal products.
- Import Restrictions and Injunctive Actions: These measures are seen as necessary to prevent unauthorized products from entering the U.S. market.
- Criminal Prosecutions: The coalition urges the FDA to pursue criminal prosecutions to deter repeat offenders.
Industry Perspectives
Interestingly, the letter’s demands align with those of major tobacco companies like R.J. Reynolds and Altria Group. These companies have received FDA marketing permission for some of their vape products and stand to benefit from the removal of unauthorized products from the market. This alignment has led to a peculiar coalition of public health advocates and tobacco giants, all pushing for the same regulatory outcomes.
The FDA’s Role and Challenges
The FDA’s Center for Tobacco Products (CTP), led by Brian King, has not authorized any flavored vape product or bottled e-liquid since his appointment two years ago. The CTP’s enforcement activities are funded through user fees from tobacco companies, primarily generated by cigarette sales. This funding structure has led to criticisms of the CTP’s regulatory actions—or lack thereof.
Historical Context and Previous Collaborations
The Campaign for Tobacco-Free Kids has a history of collaboration with the tobacco industry, notably in the 1998 Master Settlement Agreement and the 2009 Tobacco Control Act. These collaborations have been instrumental in shaping the regulatory landscape for tobacco products, granting the FDA authority over these products.
