Week of April 7 Regulatory Intelligence Recap

Trade Press and Regulatory Summary:

• FDA to replace laid-off employees with contractors, sources say - CBS News

  • The Food and Drug Administration is finalizing plans to replace some of the employees it laid off with contractors, three FDA officials tell CBS News, after steep cuts to the agency's workforce disrupted drug and food safety inspections.

    "Recent adjustments in staff numbers have created a heightened need for the FDA to be nimble, efficient and respond creatively, in order to continue and maintain FDA's regulatory inspection presence and the gold standard of excellence," agency officials wrote, in emails and draft contracting documents obtained by CBS News.

    The contractors would effectively replace most of the work done by more than 50 laid-off federal employees who handled travel logistics and conducted oversight on spending for the agency's inspectors, said two FDA officials, who spoke on the condition of anonymity. The plan was approved by FDA Commissioner Dr. Marty Makary, one email said.

    The move appears to contradict what laid-off workers supporting FDA's Office of Inspections and Investigations had been told in their layoff notices: that they were being let go because their work was "unnecessary or virtually identical to duties being performed elsewhere in the agency."

• Restoring Trust in FDA: Rooting Out Illicit Products - Guy Bentley Written Testimony - Full Committee on Oversight and Government Reform - April 9, 2025

  • Since 2009, FDA’s Center for Tobacco Products (CTP) has collected $8 billion in user fees but has authorized just eight vaping devices for sale and 34 vaping products in total. Vaping product authorizations account for 0.2% of all approved products compared to 22% for combustible cigarettes, the most dangerous tobacco product. Thanks to the FDA’s regulatory bottlenecks, illicit products have flooded the market to satisfy demand, with almost 90% of e-cigarettes sold being illegal, mainly consisting of disposable products from China. There are around 18 million 4 adult vapers, accounting for a third of all tobacco and nicotine users. Facing few satisfying choices in the legal market, adult vapers are opting to purchase products that are unregulated and unaccountable to the FDA. Streamlining the PMTA process is the safest and most effective way to achieve a coherent marketplace that protects youth while offering adult smokers safer nicotine alternatives and disrupting the illicit market. Application costs should be radically reduced, and reviews must be completed within the statutorily mandated 180 days. These goals can be achieved within the bounds of the TCA as presently structured. The TCA was designed, in part, to create a regulatory regime that facilitates innovation for smoke-free alternatives to cigarettes. In practice, the FDA’s interpretation of its responsibilities under the TCA, particularly concerning the APPH, resulted in a marketplace where most e-cigarette products consumed by adults are illegal, and jobs and manufacturing have been shipped to China. It is within the FDA’s authority to change its approach to help those who wish to quit smoking via a safer nicotine alternative do so with products that are regulated and conform to the highest safety standards. By focusing on product standards, risks relative to cigarettes and illicit e-cigarettes, and responsible marketing practices at the premarket stage, the FDA can authorize a host of products that will displace the illicit market without enticing youth to initiate nicotine use. At the post-market stage, the FDA can quickly identify problematic actors through well-resourced surveillance and intervene when necessary. These changes do not require congressional action and would safeguard public health.

• Mayor Adams, Corporation Counsel Goode-Trufant Announce Lawsuit Against Nine Major National Distributors for Illegally Selling Disposable Flavored E-Cigarettes, Celebrate new Phase of Highly Successful "Operation Padlock to Protect" Initiative - NYC Office of the Mayor New York City

  • Mayor Eric Adams and New York City Corporation Counsel Muriel Goode-Trufant today announced that the City of New York has filed a federal lawsuit against nine of the largest nationwide distributors of disposable e-cigarettes, popularly known as “vapes” — the most popular devices for nicotine use among middle and high school youth. The defendants — all of whom have close relationships with e-cigarette manufacturers in China — are alleged to be distributing e-cigarettes with such youth-attracting flavors as pink lemonade, watermelon, banana ice, lychee ice, and cool mint to sub-distributors in the city that then supply them to retail stores or sell them directly to consumers in New York City and around the country through online sales, violating nearly every applicable federal, New York state, and New York City law governing the sale of e-cigarettes.
    Today's lawsuit seeks to block these so-called “master distributors” from further sales of these illegal items into New York City, seeks both monetary damages and penalties, and marks the continuing effort by the Adams administration to curb illegal sales of flavored e-cigarettes, which are appealing and addictive, especially to teens. (see analysis below)