E-Cigarettes Non-Regulation Disappears in Cloud of Smoke

June 3, 2019

On May 15, 2019, Judge Paul W Grimm of the District Court of Maryland rendered a decision that declared the policy of the Food and Drug Administration (FDA) to delay the requirement that current manufacturers and producers of e-cigarettes obtain approval prior to entering the market as unlawful and contrary to their legal duty as established within the Tobacco Control Act.  The action was initiated by several public health organizations, which includes the American Academy of Pediatrics, The American Heart Association, and the Campaign for Tobacco-Free Kids.  The parties asserted standing as public health organizations that were injured by being deprived of access to vital information to their purpose of educating the public and alleged that the guidance the FDA issued in the early months of 2017 exceeded the agency’s discretion and was an abdication of the FDA’s responsibilities according to the Tobacco Control Act.

In 2016, after conducting the notice and comment period mandated by the Administrative Procedure Act, the FDA established a new rule that deemed electronic nicotine device systems (ENDS or e-cigarettes), cigars, and pipe tobacco as “tobacco products,” which rendered them subject to regulatory control under the Tobacco Control Act.  The Deeming Rule, which was published on May 10, 2016, would require manufacturers to be in compliance within 90 days.  This was delayed, however, by the changing of presidential administrations.

In August of 2017, the FDA issued new Guidance, absent a notice and comment period, that altered the 2016 Deeming Rule and deferred enforcement of the Tobacco Control Act against any products already in the market until 2021 (combustible products) or 2022 (e-cigarettes and other noncombustible products).  This new exception meant that existing manufacturers, such as the popular Juul Labs, were able to continue to sell and market their products absent any review or regulation by the FDA.

The Tobacco Control Act requires that all tobacco product manufacturers submit to the FDA an application that contains information on the ingredients, substances, compounds, and additives contained within the product they wish to introduce to the market.  In addition, the application must contain research information and findings on the health effects of the product.  As of this writing, there have not been an extensive amount of studies on the long term health effects of e-cigarettes.  While e-cigarettes do not produce tar or the toxic gases found in cigarettes, the liquid used does contain nicotine and other potentially harmful substances that are still inhaled.  Nicotine has been associated with causing numerous negative health effects such as increased blood pressure and a change to the brain chemistry in young people.  The liquid used within e-cigarettes itself has been found to be a common hazard, causing high numbers of nicotine poisoning in children based on accidental ingestion.

In his decision, Judge Grimm held that the public health organizations did have standing to challenge the FDA’s 2017 Guidance and that it was subject to judicial review.  The FDA was found to have exceeded its legal authority in issuing the 2017 Guidance and that its actions were inconsistent with its duty under the Tobacco Control Act.  Judge Grimm has granted the plaintiffs fourteen days to provide recommendations for remedial action, and fourteen days for the FDA to respond.

There has been a marked push of late for greater regulation of e-cigarettes.  A number of senators have urged the FDA Acting Commissioner Ned Sharpless to take action on regulating e-cigarettes, and legislation has been introduced to raise the minimum age for purchasing tobacco products.  On the same day that the decision from Judge Grimm was issued, the North Carolina Attorney General Joshua Stein filed a lawsuit against Juul Labs, alleging that Juul caused addiction caused addiction in consumers by “deceptively downplaying the potency and danger of the nicotine” and marketed toward people beneath the legal smoking age.  All parties involved in these matters have voiced concern and support to the idea of preventing children from using these products, and it appears as though action is beginning to move forward to cement this commitment.

Image source: REUTERS/Mike Segar

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