The FDA’s Proposed Deeming Regulation Marks a Step toward Regulating E-Cigarettes

Jesse Longbrake, NAGTRI Visiting Counsel

Jesse Longbrake, NAGTRI  Visiting Counsel

Electronic cigarettes, known as e-cigarettes, are growing in popularity in the United States.[1] An e-cigarette is a non-combustible tobacco product. It mimics cigarettes in that it delivers nicotine to its user, but rather than being inhaled through cigarette smoke, the nicotine is contained in a solution that is heated and turned to vapor, which is then inhaled by the “smoker.” This process is known as “vaping,” and, unlike conventional cigarettes, does not involve burning tobacco.

Since e-cigarettes were introduced into the U.S. market around 2007,[2] there have been claims that they provide actual or potential health benefits. For example, some claim that e-cigarettes may be a stepping-stone to quitting smoking, while others claim that they are a safer alternative to conventional cigarettes for satisfying a nicotine habit.[3] However, since their introduction, e-cigarettes have been largely unregulated.

Amid growing concerns over the potential immediate and long-term public health consequences of their consumption, the U.S. Food and Drug Administration (FDA) has been attempting to bring e-cigarettes under its regulatory authority since 2009.[4] In particular, the FDA has been concerned that e-cigarettes may increase nicotine addiction among young people, potentially leading them to try conventional cigarettes, which are known to cause disease and premature death.[5] Further, because e-cigarettes are not currently subject to FDA regulation, their manufacturers are not obligated to disclose their ingredients, giving rise to concerns that e-cigarettes may contain ingredients that are known to be toxic.[6] There has also been concern that smokers may use e-cigarettes as a “bridge” product, using them only when they are unable to smoke a cigarette because of smoke-free laws or other reasons, thereby maintaining their addiction instead of attempting to quit smoking. Because of these concerns, on Sept. 24, 2013, 40 attorneys general signed a NAAG letter to FDA Commissioner Margaret Hamburg urging her to promptly “issue proposed regulations that will address the advertising, ingredients, and sale to minors of electronic cigarettes.”[7]

On April 25, the FDA issued a notice of proposed rulemaking (NPRM) that would deem certain tobacco products—e-cigarettes included—to be subject to regulation under the Federal Food, Drug, and Cosmetic Act as amended by the Family Smoking Prevention and Tobacco Control Act.[8] The NPRM of the so-called “Deeming Regulation” is the first step in an administrative process to bring e-cigarettes and other tobacco products under the FDA’s jurisdiction. Before delving into the details of the Deeming Regulation, a brief note on the history of the FDA’s regulation of tobacco products is necessary.

A Brief History of the FDA’s Regulation of Tobacco Products

The FDA’s jurisdiction over tobacco products is a relatively recent development. Originally passed in 1938, the Federal Food, Drug, and Cosmetic Act (FDCA) gave the FDA regulatory authority to oversee the safety of food, drugs, and cosmetics.[9] Delineating the full scope of the FDA’s authority under the FDCA is beyond the scope of this article; it suffices to say it is broad in the covered areas. However, the FDCA did not, on its face, originally apply to tobacco products.[10]

In 1996, the FDA attempted to exercise jurisdiction over certain tobacco products under the FDCA. The FDA reasoned that, under the language of the FDCA, nicotine is a “drug” and cigarettes and smokeless tobacco are “devices” that deliver nicotine to the body, thus subjecting them to the FDCA’s regulatory provisions.[11] Four years later, in FDA v. Brown & Williamson Tobacco Corp., the U.S. Supreme Court rejected the FDA’s assertions.[12] The Court concluded that the legislative history of both the FDCA and subsequent statutes governing the tobacco industry indicated that Congress had not intended to give the FDA jurisdiction over tobacco products in the FDCA.[13] Further, the Court considered it significant that prior to 1996 the FDA had consistently stated that it lacked jurisdiction to regulate tobacco.[14] The Brown & Williamson decision prevented FDA from regulating tobacco for nearly a decade.

On June 22, 2009, nine years after the Brown & Williamson decision, Congress amended the FDCA by passing the Family Smoking Prevention and Tobacco Control Act (TCA Amendment).[15] The TCA Amendment immediately placed cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco products under the jurisdiction of the FDA and established a detailed regulatory framework for those products as a new chapter IX of the FDCA.[16] It also authorized the FDA to extend FDCA coverage via administrative rulemaking to any product made or “derived from” tobacco that is intended for human consumption.[17]

Prior to passage of the TCA Amendment, in 2008-2009, the FDA attempted to exercise regulatory authority over e-cigarettes under the same “drug” and “device” provisions of the FDCA that it had attempted to use to regulate conventional cigarettes and smokeless tobacco in 1996.[18] Its efforts were again rejected by the courts. In Sottera, Inc. v. FDA, which was decided after enactment of the TCA Amendment, the D.C. Circuit Court of Appeals relied on Brown & Williamson in holding that e-cigarettes could not be regulated under the FDCA’s medical “drug” and “device” provisions unless they were marketed for therapeutic purposes.[19] The court further held that customarily marketed e-cigarettes and other tobacco products not already covered by the amended FDCA could be reached by that statute only through the administrative rulemaking procedure set up in the TCA Amendment.[20]

Following the Sottera decision, the FDA announced its intent to exercise jurisdiction over e-cigarettes and other tobacco products not specifically covered in the TCA Amendment.[21] In an April 25, 2011 letter to stakeholders, the FDA promised action to “ensure that appropriate regulatory mechanisms govern all ‘tobacco products’ and all other products made or derived from tobacco after the Sottera decision.”[22] However, that action was delayed for several years.[23]

Claiming Jurisdiction over E-Cigarettes: The Deeming Regulation

Three years to the day after announcing its intent to regulate e-cigarettes and other tobacco products not specifically covered in the TCA Amendment, the FDA published a notice of proposed rulemaking for an expansive “Deeming Regulation.” If ultimately implemented, the regulation would deem all products meeting the statutory definition of “tobacco product” to be subject to the FDCA.[24] That definition includes any product “made or derived from tobacco that is intended for human consumption.”[25] Practically speaking, the products to be deemed subject to the FDCA would include e-cigarettes, cigars, pipe tobacco, waterpipe tobacco (also known as hookah), and dissolvable tobacco products.[26]

Once these products are deemed subject to the FDCA, the next question is what the FDA will do with that regulatory authority. The Deeming Regulation states that the deemed products will automatically be subject to the FDCA provisions currently applicable to cigarettes, roll-your-own tobacco, and smokeless tobacco with respect to the following: enforcement action against products determined to be adulterated and misbranded; required submission of ingredient listing and reporting of harmful and potentially harmful constituents; required registration and product listing; prohibition against the use of modified risk descriptors and claims (e.g., “light,” “low,” and “mild” descriptors), unless the FDA issues an order permitting their use; prohibition on the distribution of free samples; and premarket review requirements.[27]

The Deeming Regulation also proposes placing additional restrictions on the deemed products pursuant to the FDA’s TCA Amendment authority.[28] These additional restrictions would prohibit sales of the deemed products to minors; prohibit vending machine sales except in facilities that prohibit entry by minors; and require health warnings for product packages and advertisements.[29] With respect to the latter provision, the FDA’s proposed health warning would state “WARNING: This product contains nicotine derived from tobacco. Nicotine is an addictive chemical.”[30]

The Deeming Regulation would not, however, subject the deemed products to certain restrictions applicable to cigarettes and smokeless tobacco under the TCA Amendment, including the ban on characterizing flavors in cigarettes and the FDA’s 2010 regulations restricting the sale and distribution of cigarettes and smokeless tobacco in several respects to protect children and adolescents (other than those regulations’ restriction on sales to minors and their ban on free samples). Moreover, the Deeming Regulation does not address the subject of the promotion and sale of the deemed products on the Internet, a matter within the FDA’s authority under the TCA Amendment.

The Deeming Regulation is a proposed rule, and hence is far from final. It is open to public comment until July 9, 2014 (or later if the comment period is extended). After a final rule is issued, it will be subject to challenge in court. At this point, the FDA is specifically requesting comments and data in 13 major areas.[31] Attorneys general are expected to file comments in several of these areas. The nature of some of the requests suggests a final rule may differ from the current proposed rule in some respects. For instance, the FDA admits a lack of scientific data on the overall public health effects of non-combustible tobacco products such as e-cigarettes.[32] For that reason, the FDA is seeking general comments on how non-combustible products should be regulated and specific data on possible links between the use of e-cigarettes and the use of conventional cigarettes.[33] Further recognizing the distinctions between combustible and non-combustible tobacco products, the FDA is seeking comments and research on whether all tobacco products should be required to carry an addiction warning and, if so, whether different warnings should be placed on different categories of products.[34] It is also seeking comment on whether “premium” cigars should be treated differently from other cigars.[35] Questions of this type suggest that the future of the FDA’s regulation of e-cigarettes is still very much up in the air. Nonetheless, the proposed rulemaking is a concrete step forward for the FDA in establishing jurisdiction in an area that has historically eluded it.



[1] See Toni Clarke, Reports of E-Cigarette Injury Jump Amid Rising Popularity, U.S. Data Show, Reuters (April 17, 2014), http://www.reuters.com/article/2014/04/17/us-usa-health-ecigarettes-idUSBREA3G06N20140417.

[2] Azim Chowdhury, FDA Regulation of Tobacco Products Set to Expand: The Deeming Regulation, Keller and Heckman (Oct. 2013), 31, http://www.khlaw.com/Files/18449_Chowdhury%20-%20FDLI%20Article%20on%20Tobacco%20Deeming%20Regulation.pdf.

[3] See Daniel J. DeNoon, E-Cigarettes Under Fire, WebMD, 2, http://www.webmd.com/smoking-cessation/features/ecigarettes-under-fire (last visited May 12, 2014).

[4] See FDA Warns of Health Risks Posed by E-Cigarettes, Food and Drug Administration (Sept. 17, 2013), http://www.fda.gov/forconsumers/consumerupdates/ucm173401.htm.

[5] Id.

[6] See id.; see also Summary of Results: Laboratory Analysis of Electronic Cigarettes Conducted by FDA, Food and Drug Administration (April 22, 2014),http://www.fda.gov/newsevents/publichealthfocus/ucm173146.htm.

[7] Letter from National Association of Attorneys General to the Honorable Margaret Hamburg, Commissioner, U.S. Food and Drug Administration (Sept. 24, 2013), available at http://www.naag.org/assets/files/pdf/E%20Cigarette%20Final%20Letter%20(5)(1).pdf.

[8] Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products 79 Fed. Reg. 23141; 23149 (April 25, 2014), available at https://www.federalregister.gov/articles/2014/04/25/2014-09491/deeming-tobacco-products-to-be-subject-to-the-federal-food-drug-and-cosmetic-act-as-amended-by-the [hereinafter “Deeming Regulation”].

[9] See 21 U.S.C. ¿¿ 301 et seq.

[10] See FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000).

[11] Brown & Williamson, 529 U.S. at 125.

[12] FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000).

[13] Brown & Williamson, 529 U.S. at 125.

[14] Id.

[15] Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31 (2009).

[16] See Stakeholder Letter: Regulation of E-Cigarettes and Other Tobacco Products, Food and Drug Administration (April 25, 2011), http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm252360.htm.

[17] See id.

[18] See Sottera, Inc. v. FDA, 627 F.3d 891 (D.C. Cir. 2010) (interpreting 21 U.S.C. ¿ 321(rr)).

[19] Sottera, Inc. v. FDA, 627 F.3d at 895.

[20] See Deeming Regulation, supra note 8, at 2314.

[21] See Stakeholder Letter, supra note 16.

[22] Id.

[23] See Chowdhury, supra note 2, at 31.

[24] Deeming Regulation, supra note 8, at 23143.

[25] 21 U.S.C. ¿ 321(rr).

[26] Deeming Regulation, supra note 8, at 23143.

[27] Deeming Regulation, supra note 8, at 23143.

[28] See 21 U.S.C. ¿ 387f(d).

[29] Deeming Regulation, supra note 8, at 23143.

[30] Deeming Regulation, supra note 8, at 23162.

[31] See Deeming Regulation, supra note 8, at 23144-45.

[32] Deeming Regulation, supra note 8, at 23144.

[33] Deeming Regulation, supra note 8, at 23144.

[34] Deeming Regulation, supra note 8, at 23144.

[35] Deeming Regulation, supra note 8, at 23143.

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