Health Groups Sue FDA Over Deeming Rule Implementation Delay

Current Guidance Document Would Push Back Review of Some Tobacco Products to 2022

April 16, 2018, 03:56 pm Michael Devitt – Short of not smoking in the first place, there's little the average person can do to combat the sheer financial strength and influence of the tobacco industry. Unfortunately, the one government agency that can do something about the industry and its products — the FDA — seems to be dragging its feet on the matter.

Apparently, some groups have finally had enough of the agency's lack of action.

That's the gist of a lawsuit filed March 27 against the FDA, HHS and the individual heads of those agencies. In response to continued delays in implementing a rule regarding the regulation of new tobacco products, a group of public health organizations and physicians led by the American Academy of Pediatrics (AAP) is claiming that an FDA decision to push back product reviews of e-cigarettes and cigars is unlawful and constitutes a severe threat to public health.

"Our concern is that we can't leave our kids vulnerable while FDA waits for e-cig manufacturers to apply," said Matthew Myers, president of the Campaign for Tobacco-Free Kids, in an interview with CNBC last month. The campaign is one of the organizations named as co-plaintiffs in the suit.

"From our perspective, the use of e-cigs by kids is such a serious problem, we think urgent action is needed to curtail it," he added.

The lawsuit comes amid mounting evidence of a dramatic rise in use of e-cigarettes among youth and young adults. A 2016 surgeon general's report, for example, estimated that e-cigarette use among high-school students increased 900 percent between 2011 and 2015. More recently, a report published by the National Academies of Science, Engineering and Medicine in January found "substantial evidence" that e-cigarette use by adolescents and young adults increases the risk of ever using traditional cigarettes. The CDC, meanwhile, has stated that e-cigarettes "are now the most commonly used tobacco product among youth" in the United States.

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Statutory, Regulatory Background

In 2009, Congress enacted the Family Smoking Prevention and Tobacco Control Act (TCA). The TCA amended the Federal Food, Drug, and Cosmetic Act to give the FDA primary regulatory authority over tobacco products, including the power to standardize the manufacture of these products, limit levels of harmful ingredients in them and require manufacturers of the products to disclose information about their health effects.

Although the TCA granted the FDA immediate authority to regulate combustible cigarettes, cigarette tobacco, smokeless tobacco and roll-your-own tobacco, it did not give the FDA explicit authority over all types of tobacco products -- including those that had not yet been invented or were not yet popular. That's where the TCA's "deeming rule" language comes into play. Simply put, that portion of the act authorizes the FDA to "deem" currently unregulated products, such as e-cigarettes, cigars and pipe tobacco, as meeting the TCA's statutory definition of a tobacco product, thus subjecting them to FDA authority.

The TCA also mandated that all "new" tobacco products (i.e., any product not on the market as of Feb. 15, 2007) undergo a premarket authorization process before they could be sold in the United States.

The FDA issued its proposed deeming rule in April 2014, which, in addition to explicitly adding previously unregulated products to the list of those meeting the TCA's definition of tobacco product, also stated that any newly deemed products would become subject to the premarket authorization process.

As a strong proponent of the deeming rule, the AAFP submitted a letter to the FDA in June 2014, "wholeheartedly" supporting the agency's assertion of authority over "all nicotine delivery devices."

Furthermore, in letters to Congress in June 2014, February 2015 and December 2015 the Academy sought to block efforts to exempt cigars and/or other tobacco products from FDA regulation and voiced its support for additional legislation to strengthen oversight of e-cigarettes.

On May 10, 2016, the FDA published the final version of the deeming rule, slated go into effect 90 days later on Aug. 8. The rule gave the agency clear authority to regulate electronic nicotine-delivery devices such as e-cigarettes, along with cigars and other tobacco products that were not previously regulated by the agency, while also announcing a revised policy that staggered the compliance periods to obtain premarketing approval for certain newly deemed tobacco products.

Almost immediately, more than 20 tobacco manufacturers, industry trade groups and e-cigarette companies filed legal challenges, alleging that the FDA had exceeded its authority and seeking injunctions to set aside enforcement of the final rule.

On May 3, 2017, the FDA announced that it would defer enforcement of all future compliance deadlines for e-cigarettes, cigars and other products affected by the deeming rule for three months to "allow new leadership at the FDA and the Department of Health and Human Services additional time to more fully consider issues raised by the final rule that are now the subject of multiple lawsuits in federal court." At the same time, the FDA announced its intention to "issue guidance describing its position in the near future."

Shortly after that announcement, the AAFP joined dozens of other health agencies in a letter to (then) HHS Secretary Tom Price, M.D., expressing concern that federal officials appeared to be reconsidering the deeming rule. The letter also urged against delaying implementation of the rule's key provisions.

The FDA issued its promised guidance in August 2017 in a document titled "Extension of Certain Tobacco Compliance Deadlines Related to the Final Deeming Rule." In it, the agency offered a new list of extended timelines for manufacturers to submit tobacco product review applications. For most cigars, pipe tobacco and hookah tobacco, the premarket compliance deadlines were extended to Aug. 8, 2021; for most newly deemed tobacco products such as e-cigarettes, the deadlines were extended to Aug. 8, 2022. In the meantime, these products can continue to be marketed.

In November 2017, the FDA revised the guidance document to permit additional compliance deadline extensions for certain elements of the regulatory process, although the 2021 and 2022 premarket compliance deadlines for newly deemed tobacco products remained in place.

The FDA provided no explanation for the compliance deadline extensions despite the agency's contention that "the decisions made by FDA in the regulation of tobacco products are grounded in science."

Details on Current Lawsuit

Other litigants in the suit, which was filed in the U.S. District Court for the District of Maryland, include the AAP's Maryland chapter, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, and the Truth Initiative. Five pediatricians with practices in Maryland and Washington, D.C., have also joined the suit as co-plaintiffs.

The complaint is based on statements in the FDA's August 2017 guidance document and provisions in the Administrative Procedure Act, a 1946 law that lays out the method by which federal agencies may propose and establish regulations. The plaintiffs allege in the complaint that the guidance document is "manifestly unlawful" and should be set aside, on three grounds:

First, the plaintiffs claim the guidance document exceeds the FDA's statutory authority and is not in accordance with existing law because it is "an express and deliberate abdication of the FDA's responsibilities" as outlined in the TCA. They assert that the guidance document not only declines to enforce a statutory requirement; it also effectively overturns existing law by exempting, for several years, manufacturers of newly deemed tobacco products from adhering to the premarket review process Congress imposed.
Second, they argue that the guidance document is unlawful because it is a substantive rule that was not implemented in accordance with the notice and comment requirements mandated by the Administrative Procedure Act. Extending the exemption period for submitting review applications substantially alters the rights and responsibilities of manufacturers of newly deemed tobacco products, the plaintiffs claim, and, thus, requires observance of formal notice and comment procedures to ensure adequate public input and sufficient time for the agency to deliberate. Failure to follow the proper procedures, they claim, has "resulted in an ill-advised action that will potentially have devastating and substantial public health effects" for years to come.
Finally, the plaintiffs argue that the guidance is "arbitrary and capricious and not the product of reasoned decision-making." The Administrative Procedure Act requires federal agencies to consider "important aspects" of a problem the agency is trying to solve and to "cogently explain why it has exercised its discretion in a given manner." In the plaintiffs' view, the FDA has "failed to grapple with, much less reasonably explain, how its decision" to extend the premarket compliance deadlines for several years was warranted given previous agency findings and determinations regarding the regulation of tobacco products.

The FDA has not officially responded to the lawsuit. However, in a series of tweets published the same day the complaint was filed, FDA Commissioner Scott Gottlieb, M.D., touted the agency's concern about the hazards of tobacco, particularly among youth, writing that the FDA "shares the belief that tobacco products, including e-cigs, should never be marketed to, sold to, or used by kids" and that the agency "will be taking new steps soon to help keep kids from using tobacco products."

AAFP Perspective

According to Jennifer Frost, M.D., medical director for the Academy's Health of the Public and Science Division, as the use of e-cigarettes among youth has risen, so have concerns about the health effects of these products.

"The AAFP is concerned about the increasing use of e-cigarettes, especially among children and adolescents," Frost told AAFP News. "There has also been a dramatic increase in nicotine-related toxicity and poisoning associated with nicotine refill cartridges."

Recent evidence indicates that teenagers who use e-cigarettes expose themselves to significantly higher levels of volatile compounds than teens who have never used them. Many of these compounds, such as acrylonitrile, propylene oxide and acrylamide, are known or suspected carcinogens.

In addition, Frost suggested a few steps family physicians can take when discussing smoking and e-cigarettes with patients. "The AAFP encourages family physicians to ask their patients about smoking, specifically asking about vaping and the use of electronic cigarettes," she said. "Those patients who use these products should be informed about the potential health risks and also reminded to keep them out of the reach of others, particularly children."

More From AAFP
Policy on Electronic Cigarettes

Tobacco: Preventing and Treating Nicotine Dependence and Tobacco Use (Position Paper)

Tobacco Use