Dozens of FDA employees have left the agency for the tobacco and vaping industry

An investigation conducted by The Examination[1] has revealed the backgrounds of several lawyers and employees of the US Food and Drug Administration (FDA) who left their posts to work with the tobacco and vaping industry. The latter is looking for people who have insider knowledge of the workings of the agency, with, in some cases, the possibility of dismantling or weakening regulations.

Over the past 15 years, more than two dozen FDA lawyers have left the agency and its Center for Tobacco Products to advise, advocate for or work with the tobacco and vaping industry, according to an investigation by The Examination that analyzed biographies, court documents, published works, company websites and federal government records.

The FDA's Office of the Chief Counsel has about 160 attorneys. That number does not include dozens of other legal advisers who don't litigate but work for other divisions of the agency, including the Center for Tobacco Products.

Former FDA employees now advise tobacco industry

In 2023, Perham Gorji, who had a career as a government lawyer helping lead the U.S. Food and Drug Administration’s battle against tobacco and vaping products, left the agency for a large law firm (DLA Piper) that represents the interests of the tobacco and vaping industries. One of DLA Piper’s new clients is Philip Morris International, which is seeking FDA approval for its latest version of the IQOS. In an interview, Gorji said he didn’t see himself "not to join the other side." He told The Examination that Philip Morris International was at " the forefront of efforts to help people quit smoking" with IQOS.

Most recently, Varrone joined the law firm Sidley Austin, whose clients include Juul Labs and now Global Action To End Smoking, an organization funded for years by Philip Morris International that promotes new tobacco and nicotine products like heated tobacco, vaping products and nicotine pouches. Two other former FDA attorneys are part of the legal team now representing e-cigarette maker Wages and White Lion Investments in a lawsuit challenging the FDA’s review of e-cigarette applications — a case currently pending before the Supreme Court.

Jessica Tierney’s background is another illustration. She joined the FDA’s Center for Tobacco Products in 2011, after graduating. She was part of a unit that sent warning letters to manufacturers and retailers accused of illegally making and selling tobacco and vaping products. In 2021, Tierney took a job at Thompson Hine, one of several law firms that defend e-cigarette makers. “I look forward to helping my clients comply with FDA regulations and demystifying the agency, its policies and procedures,” she said in a press release. She was later named co-counsel on a legal team representing e-cigarette makers Pop Vapor, Wages and White Lion, Avail Vapor, and Magellan Technology, among others, according to court records. Tierney and lead attorney Eric Heyer sued the FDA on behalf of Wages and White Lion, arguing that the agency made a “surprise reversal” by imposing “new requirements” on the vaping company without proper notice. The company then challenged the FDA’s marketing denial orders, but the Fifth Circuit denied their petition for review and upheld the FDA’s decisions. The companies then petitioned the Fifth Circuit for a new en banc hearing, and on Jan. 3, 2024, the en banc panel reversed the decision, with the judges finding that the FDA had acted “arbitrarily and capriciously,” in violation of a federal law called the Administrative Procedure Act (APA). That means the FDA must conduct a full regulatory review of the petitioners' applications. In July, the Solicitor General's office petitioned the Supreme Court, which has agreed to hear the case; oral arguments are scheduled for December 2, 2024.

Tierney has since joined the Washington office of Jones Day, one of the nation's largest law firms, whose major clients include RJ Reynolds. She states on her profile that she “regularly advises its clients on the marketing of new food, tobacco and vaping products, medical devices and drugs”.

Conflicts of Interest That Are Not Prohibited by the FDA

At the Center for Tobacco Products, some attorneys have raised internal concerns about conflicts of interest among former employees who worked on tobacco and vaping issues at the FDA and who later represented the tobacco and vaping industry when they left the agency. In interviews, these former FDA attorneys indicated that they continue to maintain relationships with their former agency colleagues and are informed of internal issues and litigation strategies that support the tobacco and vaping industry’s positions.

Eric Lindblom, director of the Center for Tobacco Products' Office of Policy from 2011 to 2016, has proposed banning former staffers from working for the tobacco and vaping industry for at least one to two years after leaving the Office of Policy, regardless of the circumstances. "I thought it was really important that we had this independence", said Mr. Lindblom, now a senior fellow at Georgetown University's O'Neill Institute. "I also wanted to do this not only to ensure greater independence, greater freedom from potential industry influence, but also to help screen potential employees who might be interested in working for the industry after the (Center for Tobacco Products) or open to the idea," Mr Lindblom said. The proposal remained a dead letter.

Federal rules regarding post-employment status prohibit former employees from communicating with or lobbying a federal official for two years on behalf of a client or employer. However, employees are allowed to work “behind the scenes” to advise clients, under FDA guidelines for post-employment status.

Defections that have significant consequences for public health

Daniel Aaron, a former FDA attorney, says that lawyers and other employees who have left the agency to work for the tobacco and vaping industries can have far-reaching consequences for what "ends up on store shelves" and public health overall.

Matthew Holman, the FDA’s top tobacco scientist, left to work for Philip Morris in 2022, shortly after it approved an earlier version of the IQOS device, FDA documents show. Former FDA chief of staff Keagan Lenihan, who left the agency in 2021, also joined the tobacco company the following year to oversee U.S. policy and regulatory issues.

These problematic situations are not new: in the 1990s, former FDA Commissioner Charles Edwards testified before the U.S. Senate about the FDA's efforts to regulate tobacco. He said the agency's oversight was unnecessary. But at the time, Edwards was on the payroll of Philip Morris, as noted in a book called "A Question of Intent," written by David Kessler, the FDA commissioner at the time of the hearing.

In 2018, former FDA chief counsel Gerald Masoudi led Juul’s legal defense when the company was under fire for selling e-cigarettes to minors in the United States. Masoudi has since returned to Covington & Burling, a law firm where he previously worked and which has had close ties to the tobacco industry for nearly four decades. Other names that can be cited include former FDA chief counsel Peter Hutt, a longtime Covington partner who also represented the tobacco industry.

FDA's inaction and inexperience on tobacco denounced

When the FDA began regulating tobacco in 2009, it relied on lawyers from other FDA units with little or no tobacco experience, or on young lawyers fresh out of law school, according to former staffers interviewed by The Examination.

Public health advocates helped familiarize agency staff with key tobacco issues, but lawyers were still overwhelmed, as evidenced by a 2012 case when veteran attorneys representing RJReynolds and other tobacco companies torpedoed the FDA’s first major regulation to require larger health warnings on cigarette packages. Since then, “inaction”[2] and the agency’s “caution” is often criticized by public health experts. For example, the agency took more than a decade to advance a rule that would eliminate the sale of menthol cigarettes in the United States, which public health advocates say could save thousands of lives. The FDA issued a proposed rule to ban the products in October 2023, but it was shelved earlier this year by the Biden administration after intense lobbying by tobacco companies and other groups. Public health organizations have filed a lawsuit, and are doubling down on their efforts to establish that the FDA “unduly delayed” adopting a ban on menthol cigarettes.

According to Desmond Jenson of the Public Health Law Center, "The FDA appears to be particularly terrified of lawsuits from tobacco manufacturers."  "This fear is to some extent justified, but it does not justify the lack of action on many important policies," he added.

Tobacco Center director Dr. Brian King declined to comment on the menthol dispute, describing menthol regulation as a "very bureaucratic and tortuous" development process.

©Generation Without Tobacco

AE

[1] Kathryn Kranhold, Former FDA lawyers join tobacco industry in 'epic' fight against the agency, The Examination, published October 21, 2024, accessed October 28, 2024

[2] Tobacco-free generation, United States: FDA called out for inaction on menthol, published March 3, 2021, accessed October 28, 2024