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Public Health Advocacy Institute

at Northeastern University School of Law

360 Huntington Avenue, 117CU

Boston, MA 02115

tobacco@tobaccopolicycenter.org

You are here: Home > Tobacco Control > Tobacco Litigation > FDA Deeming Rule

FDA Deeming Rule

In May of 2016, the U.S. Food and Drug Administration published its final “deeming” rule through which the agency extended its regulatory authority to all types of tobacco products, including e-cigarettes, cigars, hookah and others. The FDA may now regulate shisha (hookah tobacco), pipe tobacco, dissolvables, gels, all cigars (including premium cigars) and e-cigarettes. Newly deemed products were subject to certain sales restrictions as of August 8, 2016, while other regulations will be phased in.

As expected, several challenges by tobacco manufacturers and their trade groups were filed in federal courts across the country, alleging in large part that the FDA had exceeded its authority, violated the rulemaking process, and restricted rights protected by the U.S. Constitution. Visit this webpage from our partners at the Public Health Law Center to read more about each case.

Further, several health groups filed suit challenging FDA’s implementation of the deeming rule and seeking to vacate the agency’s 2017 Guidance extending premarket review deadlines for e-cigarette and cigar manufacturers. That case is summarized here: 

American Academy of Pediatrics, et al., v. Food and Drug Administration, et al., 8:18-cv-00883-PWG (D.Md. 2019)

In a May 2019 decision, U.S. District Judge Paul W. Grimm vacated FDA’s 2017 Guidance that indefinitely allowed e-cigarettes on the market without agency pre-approval. The court found that the terms of the Guidance exceeded FDA’s authority under the Tobacco Control Act, and that the Guidance was akin to a rule and must be promulgated through administrative notice and comment procedures. The judge ordered the FDA to prepare to review premarket applications as soon as possible, and the court is reviewing timeline proposals from plaintiff health advocacy groups and defendant FDA.

In March of 2018, six public health groups and four individual doctors filed suit seeking to vacate the 2017 Guidance and compel FDA action consistent with the federal law. These plaintiffs challenged the agency’s decision to indefinitely delay regulation of e-cigarettes, despite in 2016 “deeming” these products as subject to FDA regulatory authority. Federal law technically mandates product manufacturers hold off from putting a new tobacco product on the market until receiving a marketing order from FDA. When e-cigarettes were originally deemed to be tobacco products, FDA set a 2018 deadline for manufacturers to submit “premarket” applications to the agency. However, via the 2017 Guidance, the agency reversed course and allowed e-cigarettes (and other 2016 deemed products) already on the market as of August 8, 2016 to stay on the market through August 8, 2022 without even submitting an application for a marketing order—essentially providing a “five-year compliance safe-harbor.” Further, FDA did not set a deadline for the agency to complete review of premarket applications, thus indefinitely extending the period of “safe-harbor.”

Through their lawsuit, health groups argued that the FDA’s 2017 Guidance extending the compliance deadline violates the Administrative Procedure Act (APA) in three ways: It exceeded the agency’s authority under the Tobacco Control Act; its issuance failed to comply with notice and comment rule-making requirements; and it is “arbitrary and capricious” because the agency did not offer sufficient rationale for reversing its course on requiring e-cigarette manufacturers to submit applications to market new tobacco products.

In the May 2019 decision Judge Grimm concurred that FDA is “abdicating its statutory duty to review new tobacco products in the prompt fashion dictated by Congress” and vacated the 2017 Guidance. The court concluded the 2017 Guidance does not fall within the agency’s enforcement discretion, but rather “[i]ts action is inconsistent with the Tobacco Control Act and in excess of its statutory authority, and it cannot stand.” The court further found the Guidance tantamount to a legislative act and therefore subject to APA notice and comment requirements.

The court expressed the dramatic consequences of FDA exceeding its regulatory authority in issuing the 2017 Guidance, noting: “Arguably, the five-year compliance safe-harbor has allowed the manufacturers enough time to attract new, young users and get them addicted to nicotine before any of their products, labels, or flavors are pulled from the market, at which time the youth are likely to switch to one of the other thousands of tobacco products that are approved – results entirely contrary to the express purpose of the Tobacco Control Act.”

The court sought and received from the parties timeline proposals for the premarket review process. The health groups requested 120 days for manufacturer application submissions, and that FDA review the applications within one year. FDA, on the other hand, requested that the Court go no further than vacating the agency’s 2017 compliance policy, arguing that the agency would be imminently publishing guidance that will partially address the compliance issues. The agency did finalize that guidance, which detailed the information manufacturers will need to include in their premarket applications for e-cigarettes. Judge Grimm then set a deadline of 10 months (or May 11, 2020) by which date FDA shall require manufacturers to submit their applications to the agency. E-cigarettes may remain on the market no more than one year after the application is filed, without being subject to FDA enforcement action, according to the Judge’s order. 

Meanwhile, several major tobacco companies filed motions to intervene for the purpose of addressing the appropriate remedy, arguing substantial economic interest in the remedy (e.g., application timeline). Judge Grimm denied all of these motions. If overturned upon appeal and admitted as intervener parties to the lawsuit, these companies would earn standing to appeal Judge Grimm’s decision, along with the health groups and FDA. This summary will be updated as the case progresses.

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