Daily Archives: October 21, 2019

2 posts

News Digest on the E-Cigarette Industry

Niusha Tavassoli, CLS ’21

In the past several weeks, there have been many headlines about vaping-induced hospitalizations. When looking at who to blame for this pandemic, there has been a lot of finger pointing from state and federal government officials. Earlier this week, Acting Chief of the FDA, Ned Sharpless, expressed that he felt the FDA should have acted sooner and is now playing a game of catch up to regulate the vaping industry.[1] At the center of this controversy is Juul Labs, a Silicon Valley based e-cigarette start-up that has been valued at $35 billion.[2]

In the past two years, there has been an uptick in vaping and e-cigarette usage. This uptick is especially startling when looking at teen e-cigarette usage. According to a statistic provided by the FDA, from 2017 to 2018, the number of high school students who reported current e-cigarette use within the last 30 days increased 78% to include a total of approximately 3.05 million American high school students.[3]

E-cigarette companies, and predominantly Juul Labs, have been criticized by government officials for targeting their products to the younger populations due to the style of their advertising and the use of flavored products. Public health officials have stated that studies show that e-cigarette flavors encourage youth use of e-cigarettes and can in turn lead youth to become tobacco users.[4] Additionally, the fact that the Juul vaporizer does not resemble traditional e-cigarettes is another factor that is attributed to its success amongst youth. However, Juul spokespersons stand by their products being an alternative for those trying to quit smoking.

“In 2016, FDA finalized a rule extending CTP’s regulatory authority to cover all tobacco products, including electronic nicotine delivery systems (ENDS) that meet the definition of a tobacco product. FDA regulates the manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution of ENDS, including components and parts of ENDS but excluding accessories.”[5] However, this rule has clearly not been utilized to control the current epidemic.

The Trump Administration has recently announced that there will be a forthcoming ban on all fruit-flavored e-cigarette products, unless approved by the FDA.[6][7] Amidst the controversy, the CEO of Juul Labs, Kevin Burns, has resigned and the company has agreed to halt lobbying efforts against the ban.[8]

However, as the Federal government has been slow to act, local governments have taken matters into their own hands. Out of frustration, many cities, including San Francisco where Juul is headquartered, have extended their own local bans on flavored tobacco products to temporarily ban the sale of e-cigarettes entirely beginning in 2020.[9] Many other cities and states, such as Michigan, are following San Francisco’s suit.[10] In fact, Massachusetts has taken the strongest stance against vaping, becoming the first state to place a temporary 4-month ban on e-cigarettes after the vaping-induced deaths of 9 individuals.[11]

The regulations being implemented now are an attempt to clean up the mess that has been created by the lack of regulatory oversight. However, this raises the question of whether these regulations will now do more harm than good. While states are proposing banning e-cigarettes, they are still selling cigarettes and other tobacco products. It is important to consider whether these regulations will encourage the adults using e-cigarettes as a smoking aid and the youth who are now addicted, to turn to other tobacco products with known and serious harms. These realizations are crucial, especially in light of the fact that there is no specific vape product that has been linked to the vaping-induced hospitalizations.[12] Furthermore, many states have regulations banning tobacco sales to individuals under the age of 21.[13] Effective enforcement of the regulations already in place could counteract the allure of the flavored pods. All in all, the implications of regulating the industry are important considerations and will have lasting consequences.

 

[1]Thomas M. Burton, FDA’s Acting Chief Says Agency Acted Too Slowly to Avoid Vaping Crisis, Wall St. J. (Sept. 25, 2019), https://www.wsj.com/articles/fdas-acting-chief-says-agency-acted-too-slowly-to-avoid-vaping-crisis-11569433928?mod=searchresults&page=1&pos=7.

[2]Angelica LaVito, Tobacco giant Altria takes 35% stake in Juul, valuing e-cigarette company at $38 billion, CNBC (Dec. 20, 2018), https://www.cnbc.com/2018/12/20/altria-takes-stake-in-juul-a-pivotal-moment-for-the-e-cigarette-maker.html.

[3]2018 NYTS Data: A Startling Rise in Youth E-cigarette Use, FDA (Feb. 06, 2019), https://www.fda.gov/tobacco-products/youth-and-tobacco/2018-nyts-data-startling-rise-youth-e-cigarette-use.

[4]2018 NYTS Data: A Startling Rise in Youth E-cigarette Use, FDA (Feb. 06, 2019), https://www.fda.gov/tobacco-products/youth-and-tobacco/2018-nyts-data-startling-rise-youth-e-cigarette-use.

[5]Vaporizers, E-Cigarettes, and other Electronic Nicotine Delivery Systems (ENDS), FDA (Sept. 12, 2019), https://www.fda.gov/tobacco-products/products-ingredients-components/vaporizers-e-cigarettes-and-other-electronic-nicotine-delivery-systems-ends.

[6] Sheila Kaplan, Trump Administration Plans to Ban Falvored E-Cigarettes, N. Y. TIMES (Sept. 11, 2019), https://www.nytimes.com/2019/09/11/health/trump-vaping.html.

[7]Richard Harris and Carmel Wroth, FDA To Banish Flavored E-Cigarettes To Combat Youth Vaping, NPR (Sept. 11, 2019), https://www.npr.org/sections/health-shots/2019/09/11/759851853/fda-to-banish-flavored-e-cigarettes-to-combat-youth-vaping.

[8]Bobby Allyn, Juul Accepts Proposed Ban On Flavored Vaping Products As CEO Steps Down, NPR (Sept. 25, 2019), https://www.npr.org/2019/09/25/764201798/juul-will-agree-to-ban-on-flavored-vaping-products-says-its-ceo-is-stepping-down.

[9]Laura Klivans, San Francisco Bans Sale of E-Cigarettes, NPR (Jun. 25, 2019), https://www.npr.org/sections/health-shots/2019/06/25/735714009/san-francisco-poised-to-ban-sales-of-e-cigarettes.

[10]Hannah Knowles, Massachusetts to ban sale of all vaping products for 4 months in toughest state crackdown, Wash. Post (Sept. 24, 2019), https://www.washingtonpost.com/health/2019/09/24/massachusetts-ban-all-vaping-product-sales-months-toughest-state-crackdown/.

[11]Laurie McGinley, Michigan becomes first state to ban flavored e-cigarettes, Wash. Post (Sept. 04, 2019), https://www.washingtonpost.com/health/michigan-becomes-first-state-to-ban-flavored-e-cigarettes/2019/09/03/34f234c6-ce4c-11e9-8c1c-7c8ee785b855_story.html.

[12]Hannah Knowles and Lena H. Sun, What we know about the mysterious vaping-linked illness and deaths, Wash. Post (Sept. 27, 2019), https://www.washingtonpost.com/health/2019/09/07/what-we-know-about-mysterious-vaping-linked-illnesses-deaths/.

[13]Michael Greenwood, Banning tobacco sales to people under age 21 reduces smoking, Yale News (Jul. 26, 2019), https://news.yale.edu/2019/07/26/banning-tobacco-sales-people-under-age-21-reduces-smoking.

Carlson, Postage Stamps, and Hints at the Future of Administrative Law

Samuel E. Weitzman, CLS ’21

In Carlson v. Postal Regulatory Comm’n, recently appointed D.C. Circuit Judge Neomi Rao delivered her first opinion pertaining to administrative law.[1] Judge Rao worked extensively on administrative law issues before ascending the federal bench, both in academia and as the administrator of the Office of Information and Regulatory Affairs.[2] As such, she already has expressed her views on various topics in public. Like Justice Thomas (for whom she clerked)[3] and Justice Scalia (whom she described as a “remarkable man” with whom she agreed “about many matters of legal interpretation”),[4] she is highly critical of congressional delegation to administrative agencies,[5] favors an expansive view of the President’s “sphere of action,”[6] and generally supports deregulation.[7] For the first time, however, legal observers have some sense of how she will rule.

Carlson’s facts were more whimsical than remarkable. The pro se petitioner was Douglas F. Carlson, “a postal customer and watchdog.”[8] Carlson challenged the Postal Regulatory Commission’s (PRC) five-cent increase in the price of “Forever Stamps” (from 50 cents to 55 cents) as arbitrary and capricious under the Administrative Procedure Act.[9] Specifically, Carlson argued that – in promulgating Order 4875 – the PRC failed to (a) consider all of the relevant statutory factors and objectives specified in the Postal Accountability and Enhancement Act (PAEA); (b) explain its justification for the price hike consistent with the requirement of “reasoned decisionmaking”; or (c) respond adequately to public comments, including Carlson’s.[10] The unanimous three-judge panel agreed, opting to vacate the new rates for first-class postage while leaving the rest of Order 4875 in place.[11]

Whether or not the D.C. Circuit was right in its determination is immaterial for present purposes: this blog is about law, not philately. Of greater interest is how Judge Rao reached her conclusion – and what it portends for her jurisprudence. Notably, in distinguishing between rulemaking and adjudication, Judge Rao quoted twice from Justice Scalia’s solo concurrence in Bowen v. Georgetown Univ. Hosp.[12] On the second occasion, she neglected to signal that her citation came from a single jurist rather than a majority of the Supreme Court – perhaps a mere Bluebooking error, but telling nonetheless.[13] The difference between the majority and concurrence’s views in Bowen was subtle yet significant. Speaking through Justice Kennedy, eight members of the Court held that agencies cannot promulgate legislative rules with retroactive effect unless Congress provides for that power using “express terms.”[14] Justice Scalia, meanwhile, maintained that administrative rules could never apply retroactively: for him, rules were exclusively prospective, while adjudications were wholly retroactive.[15] Bowen remains good law, and Justice Scalia’s concurring opinion has received its share of scholarly criticism.[16]

Judge Rao’s suggestion that, instead, Justice Scalia’s interpretation is the law of the land provides two insights into her approach. First, in adhering to Justice Scalia’s rigid delineations of APA categories, Judge Rao exhibited her formalist predilections. This demonstration was no revelation, following as she does in the footsteps of Justices Scalia and Thomas. Her formalism manifested itself elsewhere in the opinion, too, including through her textualist mode of rejecting the PRC’s interpretation of the PAEA.[17] Second, Judge Rao evinced a willingness to disregard precedent in favor of adopting a position hewing closer to her ideological preferences. She is hardly alone in doing so; jurists often borrow from non-controlling opinions to bolster their rhetoric. And sometimes, the concurrence or dissent really does become the doctrinal standard.[18] Perhaps Judge Rao is just ahead of the curve on rejecting Bowen presumption in favor of a categorical approach. If not, however, she risks wandering into areas unblessed – or even precluded – by prevailing doctrine.

How one feels about these tendencies may depend on how one conceives of the law, and thus one may either welcome or worry about these facets of Judge Rao’s jurisprudence. One thing is certain, however: her implicit rejection of Bowen will be just the first of many contributions Judge Rao makes to administrative law from her new seat on the federal bench.

[1] Carlson v. Postal Regulatory Comm’n, No. 18-1328, 2019 WL 4383260 (D.C. Cir. Sept. 13, 2019). Carlson was Judge Rao’s second opinion authored for the D.C. Circuit. Her first opinion did not involve any issues of administrative law. See Dist. No. 1, Pac. Coast Dist., Marine Eng’rs Beneficial Ass’n, AFL-CIO v. Liberty Mar. Corp., 933 F.3d 751 (D.C. Cir. 2019).

[2] Karen Zraick, Neomi Rao Will Replace Brett Kavanaugh on Key Appeals Court, N.Y. Times (Mar. 13, 2019), https://www.nytimes.com/2019/03/13/us/politics/neomi-rao-confirmed.html.

[3] Id.

[4] Remembering Justice Antonin Scalia, Antonin Scalia L. Sch. (last visited Sept. 25, 2019), https://www.law.gmu.edu/news/2016/scalia_tribute.

[5] See Neomi Rao, Administrative Collusion: How Delegation Diminishes the Collective Congress, 90 N.Y.U. L. Rev. 1463 (2015).

[6] See Neomi Rao, The President’s Sphere of Action, 45 Willamette L. Rev. 527 (2009). See also Neomi Rao, Removal: Necessary and Sufficient for Presidential Control, 65 Ala. L. Rev. 1205 (2014).

[7] See Neomi Rao, The Trump Administration’s Deregulation Efforts are Saving Billions of Dollars, Wash. Post. (Oct. 17, 2018), https://www.washingtonpost.com/opinions/the-trump-administration-is-deregulating-at-breakneck-speed/2018/10/17/09bd0b4c-d194-11e8-83d6-291fcead2ab1_story.html.

[8] Carlson, 2019 WL 4383260, at *3. Carlson has also been described as “sort of a Ralph Nader of the mail.” See Carl Nolte, Stamping Out Mail Problems: Civilian Advocate Addresses Service at the U.S. Postal Service, S.F. Chron. (Sept. 4, 2001), https://www.sfchronicle.com/bayarea/article/PROFILE-Doug-Carlson-Stamping-out-mail-2882873.php.

[9] Carlson, 2019 WL 4383260, at *4.

[10] Id. at *4.

[11] Id.

[12] Id. at *1–2 (quoting Bowen v. Georgetown Univ. Hosp., 488 U.S. 204, 219 (1988) (Scalia, J., concurring)).

[13] Id. at *2 (quoting Bowen, 488 U.S. at 218 (Scalia, J., concurring)).

[14] Bowen, 488 U.S. at 208.

[15] Id. at 216–25 (Scalia, J., concurring).

[16] See, e.g., Ronald M. Levin, The Case for (Finally) Fixing the APA’s Definition of “Rule,” 56 Admin L. Rev. 1077, 1085–88 (2004); William F. Luneberg, Retroactivity and Administrative Rulemaking, 1991 Duke. L.J. 106, 143–47 (1991); Frederick Schauer, A Brief Note on the Logic of Rules, with Special Reference to Bowen v. Georgetown University Hospital, 42 Admin L. Rev. 447, 449–55 (1990). One author recently claimed that “Justice Scalia’s concurrence is frequently referred to as an explanation of the law.” However, the author provided no evidence for this bare assertion. See William C. Neer, Discerning the Retroactive Policymaking Powers of the United States Patent and Trademark Office, 71 Admin. L. Rev. 413, 426 (2019).

[17] Carlson, 2019 WL 4383260, at *8–10.

[18] See, e.g., Youngstown Sheet & Tube Co. v. Sawyer, 343 U.S. 579, 634–55 (1952) (Jackson, J., concurring).