Azim Chowdhury and Adam Susser have been published in the Washington Legal Foundation’s Critical Legal Issues Working Paper Series, Number 210, October 2018 edition. In the paper, Implementing the Continuum of Risk: Modified Risk Tobacco Products, Azim and Adam address how the Food and Drug Administration (FDA) can better implement the Tobacco Control Act’s Modified Risk Tobacco Product (MRTP) provisions to benefit the public health. To read the full article, click here.
Adam Susser is an associate in the food and drug and tobacco and e-vapor practices at Keller and Heckman. He advises clients on regulatory and compliance matters in industries overseen by the U.S. Food and Drug Administration (FDA), including the pharmaceutical, medical device, food, dietary supplement, and tobacco industries.
Mr. Susser is frequently asked to present on FDA regulations at industry conferences hosted by the Food and Drug Law Institute (FDLI) and publishes FDA related articles in various forums including FDLI’s Update Magazine.
Mr. Susser graduated with honors from the University of Chicago Law School where he received the Burton and Adrienne Glazov Academic Merit Scholarship. In addition, he devotes his time to many pro bono and community service projects including the D.C. Bar’s Landlord-Tenant Resource Center. Mr. Susser has a background in political science and, while in law school, worked as a legal intern for the Transportation Security Administration (TSA) within the Department of Homeland Security.
On September 11, 2018, Nicopure Labs, LLC and the Right to be Smoke-Free Coalition (the “Appellants”) appeared for oral argument before a three-judge panel in the United States Court of Appeals for the District of Columbia Circuit to appeal a decision issued last year by the U.S. District Court for the District of Columbia, which ruled in favor of the U.S. Food and Drug Administration (“FDA”) in the first lawsuit challenging various provisions of the Family Smoking Prevention and Tobacco Control Act (“TCA” or “Act”) and FDA’s Deeming Rule as they are being applied to the vapor industry.
During oral argument, the Appellants argued that the Modified Risk Tobacco Product (“MRTP”) preclearance requirement imposed by Section 911 of the TCA violates the First Amendment as applied to vapor products. In addition, the Appellants argued that application of the Act’s free sample ban to vapor products violates the First Amendment, and that FDA failed to tailor the Premarket Tobacco Application (“PMTA”) requirements to ensure the continued availability of vapor products. Below, we provide a brief overview of the issues discussed at the oral argument. The recording of the hearing is available here. For background on the appeal, see our previous blog posts, including copies of the legal briefs, available here and here.
Modified Risk Claims
Appellants argued that the dichotomy in the current law – that manufacturers are legally permitted to sell vapor products for recreational purposes, but not allowed to make objectively truthful statements about those products (e.g., that they do not contain or produce tar, ash, or smoke, among other harmful chemicals found in cigarette smoke), or simply repeat FDA’s and various public health organizations’ statements that vapor products pose less risk than cigarettes – runs afoul of the First Amendment, which protects commercial speech. Indeed, Appellants stated that the requirement to ask permission is a First Amendment injury itself. Further, the Appellants contended that under current law, even if every federal judge in the country found a vapor company’s statements about its products to be true, if FDA determines that such a statement does not benefit public health, it would still be prohibited.
Appellants also discussed application of the Supreme Court’s intermediate scrutiny test to the MRTP provision. Under that approach, restrictions on commercial speech are judged under the four-pronged Central Hudson test, in which Courts ask whether: (1) the speech concerns a lawful activity and is not misleading; (2) the asserted government interest is “substantial”; (3) the restriction directly and materially advances the governmental interest; and (4) the restriction is no more extensive than is necessary to serve that interest. As to the third prong, Appellants maintained that the MRTP provision does not directly and materially advance the government’s interest because others can make similar public statements without any preclearance approval.
The Appellants also noted that the clear trajectory of modern U.S. Supreme Court First Amendment jurisprudence requires that, under the fourth prong of Central Hudson, if the government can achieve its interest in a way that is less restrictive than a prior restraint, it must do so. For example, FDA could rely on non-speech alternatives standing alone or in combination with each other to prevent potentially misleading modified risk claims, such as enforcing the TCA’s misbranding and adulteration provisions, requiring manufacturers to maintain records substantiating such claims, requiring the use of disclaimers, and conducting post-market surveillance.
Free Sample Ban & PMTA Tailoring
Appellants also argued that under the Supreme Court’s decision in Tex. v. Johnson free samples are protected under the First Amendment.  Under that case, whether conduct is “sufficiently imbued with elements of communication” to warrant First Amendment protection depends on whether there is “an intent to convey a particularized message” and “the likelihood [is] great that the message [will] be understood by those who view it.” Here, vapor companies intend to send a message to consumers through their distribution of free samples; thus sampling is a form of protected speech. Appellants argued that it is not enough for vapor companies to simply state that their e-liquid tastes better than a conventional cigarette, for example, but instead the only way to convey this information – the personalized experience of vaping a particular flavor – is through providing a sample. This is expressive conduct. Appellants also maintained that the ban on free samples violates the third and fourth prongs of Central Hudson. For instance, neither Congress nor FDA produced any evidence that minors are, in fact, obtaining access to vapor products through free samples, and there are ample non-speech restrictions that could limit access by youth, such as enhanced enforcement initiatives and minimum age verification at retailers.
In addition, Appellants argued that the PMTA requirements were insufficiently tailored to ensure the continued availability of vapor products. Specifically, given that FDA determined that the vast majority of manufacturers will exit the market before filing PMTAs due to the high cost of long-term, product-specific studies (for more on this see here), Appellants maintained that FDA should have considered accepting for scientific review PMTAs for vapor products that do not contain such studies but otherwise comply with the PMTA informational requirements. FDA could still do a complete review of those PMTAs, which would include a scientific literature review of the population effects of vapor products as such evidence exists in 2022, when PMTAs are expected to be filed under FDA’s current compliance policy for products on the market as of August 8, 2016.
One day after the oral argument, FDA submitted a letter to the D.C. Circuit Clerk of the Court, informing the court that, on September 12, 2018, FDA announced significant new actions, including enforcement initiatives, to address an alleged “epidemic of e-cigarette use among teenagers.” We previously blogged about FDA’s enforcement “blitz” here. The letter notes that “FDA is reconsidering the extended compliance dates for the submission of new product applications when it is apparent that there is widespread youth use of the product, and is also considering a policy change that would lead to the immediate removal of flavored e-cigarette products from the market.”
Indeed, in letters to several large manufacturers of cartridge-based e-cigarettes, FDA threatened to revisit the August 8, 2022 PMTA compliance date (for those companies’ and potentially similar products), if the targeted companies failed to submit within 60 days comprehensive plans to address sales of their products to minors.
On September 17, 2018, Appellants submitted a response to the FDA’s letter, arguing that it “provides no new authorities [as required by Federal Rule 28(j)] and instead describes enforcement actions that have nothing to do with appellants and target a portion of the e-cigarette industry.” Appellants point out that FDA’s enforcement actions, which ostensibly target 97 percent of the e-cigarette market – actually only address the “cartridge-based” e-cigarette market, which is only a portion of the overall vapor products market. Indeed, FDA Commissioner Dr. Scott Gottlieb pointed out that sales of open-tank vaping products, which Appellants primarily market, do not appear to be driving the government’s claimed increase in underage use. Regardless, Appellants maintained that FDA’s recent enforcement actions prove their point: if FDA is concerned about purchases by or marketing of vapor products to youth, it can and should advance that interest through actions targeted at that problem (e.g., warning letters to retailers), not through a blanket prohibition on all truthful, non-misleading speech by manufacturers to adults.
While it is impossible to state with certainty when the D.C. Circuit will rule on the case, we believe it is reasonable to expect a decision sometime in early 2019. We will keep readers of this blog updated on the outcome of the case.
 At the hearing, Miguel Estrada of Gibson, Dunn & Crutcher represented Nicopure Labs, and Eric Gotting of Keller and Heckman represented both Nicopure Labs and the Right to be Smoke-Free Coalition.
 Lorillard Tobacco Co. v. Reilly, 533 U.S. 525, 554-55 (2001) (summarizing test outlined in Cent. Hudson Gas & Elec. Corp. v. Pub. Serv. Comm’n of N.Y., 447 U.S. 557 (1980)).
 See Tex. v. Johnson, 491 U.S. 397 (1989).
 Id. at 404 (citations and internal quotations omitted).
 See Letter from Tyce R. Walters to Mr. Mark Langer, Clerk of the Court re: Nicopure Labs, LLC v. FDA, No. 17-5196 (oral argument heard Sept. 11, 2018); See also U.S. Food & Drug Admin., FDA News Release, FDA Takes New Steps to Address Epidemic of Youth E-Cigarette Use, Including a Historic Action Against More Than 1,300 Retailers and 5 Major Manufacturers for Their Roles Perpetuating Youth Access (Sept. 12, 2018), https://tinyurl.com/y9gh3dyg; U.S. Food & Drug Admin., FDA Statement, Statement From FDA Commissioner Scott Gottlieb, M.D., on New Steps to Address Epidemic of Youth E-Cigarette Use (Sept. 12, 2018), https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm620185.htm.
 See September 17, 2018 letter from Miguel A. Estrada and Eric P. Gotting to Mr. Mark Langer, Clerk of the Court re: Nicopure Labs, LLC v. FDA, No. 17-5196 (oral argument heard Sept. 11, 2018).
 Id.; See also Thompson v. W. States Med. Ctr., 535 U.S. 357, 371 (2002) (“[I]f the Government could achieve its interests in a manner that does not restrict speech, or that restricts less speech, the Government must do so.”) (emphasis added).
On September 12, 2018, in a self-described “blitz”, FDA announced a deluge of enforcement actions, including more than 1,300 warning letters and fines to retailers aimed at addressing youth use of e-cigarettes, which FDA asserts has reached “epidemic” proportions, based on new, not-yet-released survey data. FDA also requested manufacturers of five “national brands,” whose cartridge (pod) based e-cigarettes the Agency claimed make up 97% of the “current e-cigarette market” (but apparently excluding the open-system vapor products market), and allegedly represent the majority of e-cigarettes sold to minors, to provide detailed plans to curtail youth use of their products. FDA also threatened drastic action that could impact the entire vapor industry, and millions of former smokers that rely on a variety of vapor products, if adequate responses are not received.
Addressing Increase in Underage E-Cigarette Use; Stopping Access at the Retail Level
In its press release, FDA clarified that these enforcement actions were part of a “large-scale, undercover nationwide” crack down on the sale of e-cigarettes to minors at both brick-and-mortar and online retailers. FDA Commissioner Dr. Scott Gottlieb further stated that FDA had failed “to predict what [he] now believe[s] is an epidemic of e-cigarette use among teenagers.” While he reiterated that FDA is “fully committed to the concept that products that deliver nicotine exist on a continuum of risk, with combustible products representing the highest risk, and [e-cigarettes] perhaps presenting an alternative for adult smokers who still seek access to satisfying levels of nicotine, but without all of the harmful effects that come from combustion,” he was unequivocal with respect to underage use, emphasizing FDA’s Youth Tobacco Prevention Plan launched earlier this year, and stating that he “won’t tolerate a whole generation of young people becoming addicted to nicotine as a tradeoff for enabling adults to have unfettered access to these same products.” On September 18, 2018, FDA issued another press release announcing that it would be advancing “The Real Cost” Youth E-Cigarette Prevention Campaign to educate teens about the dangers of using e-cigarettes.
Notably, all of the cartridge-based e-cigarettes now being targeted by FDA (and the Big Tobacco brands in particular) are sold primarily in convenience stores, gas stations and similar outlets (along with cigarettes and other tobacco products), and appear to be the main source of youth access, as well as the focus of FDA’s retailer enforcement efforts. Indeed, the vast majority of the 1,300 warning letters and civil monetary penalties were sent to these types of retailers, rather than to vape shops dedicated to open-system vapor products. While dozens of vape shops and online vape retailers have also been cited by FDA for selling products to minors, those instances appear to represent just a fraction of the millions of transactions that occur annually in the 10,000+ dedicated vape shops across the country.
FDA Focuses on JUUL and JUUL-Like E-Cigarettes; Distinguishes Youth Concerns Between Closed and Open System Vapor Products
Although FDA’s recent announcement refers simply to the “e-cigarette market”, the vapor industry is actually very diverse and complex. Closed-system and cartridge-based e-cigarettes (like JUUL), the adolescent use of which FDA has made clear is its primary public health concern, is only a portion of the overall U.S. vapor products market, along with open-system vapor products (e.g., tanks, mods, e-liquids, etc.).
Indeed, FDA has been focusing on youth-use of cartridge-based e-cigarettes, and JUUL in particular, for several months, as stories about rampant teenage use have been heavily reported in the media, and the focus of Congressional inquiries.
Back on April 24, 2018, FDA announced its first set of 40 warning letters to retailers for underage sales of JUUL e-cigarettes and that it was examining the youth appeal of these products in an effort to end their sale to minors. FDA used its authority under Section 904(b) of the Family Smoking Prevention and Tobacco Control Act (TCA) to request JUUL Labs submit information regarding its marketing and research studies, and any other information it had on how certain product features might appeal to different age groups. Subsequently, in May 2018 FDA sent a second set of requests to several manufacturers seeking information on their JUUL-like products, including information on product marketing and design (as it may relate to the appeal or addictive potential for youth and youth-related adverse experiences), and consumer complaints, among other things.
FDA has now announced that it is targeting five national brands that dominate the closed-system e-cigarette market – JUUL and four other cartridge-based e-cigarettes, all of which are marketed by large tobacco companies: Vuse (Reynolds American), MarkTen XL (Altria), blu e-cigs (Fontem Ventures), and Logic (Japan Tobacco International, USA). Importantly, Gottlieb indicated that these specific e-cigarettes make up “the majority of products sold to minors,” while noting that “the biggest youth use seems to be among cartridge-based e-cigarettes, and not open-tank vaping products.” (Emphasis added.)
The Agency has requested these five manufacturers submit within 60 days detailed plans describing how they will address and mitigate widespread youth use of their products. For example, the FDA stated that such a plan may include:
- Discontinuing sales to retail establishments that have been subject to an FDA civil monetary penalty for sale of tobacco products to minors within the prior 12 months;
- Developing or strengthening any internal program in place to check on retailers, and reporting to FDA the name and address of retailers that have sold products to minors;
- Eliminating online sales, whether through Internet storefronts controlled by the company or other retailers, or providing evidence to demonstrate that the company’s online sales practices do not contribute to youth use of e-cigarette products;
- Revising current marketing practices to help prevent use by minors; and
- Removing flavored products from the market until those products can be reviewed by FDA as part of a PMTA.
The requests that the companies eliminate all online sales and remove flavored products from the market are extremely onerous and effectively require the companies to cease sales of legal products. FDA further noted that these actions are only examples of things the manufacturers might do to demonstrate FDA should continue to defer enforcement of the premarket review requirement with respect to their products, as discussed below, and encouraged the companies to “provide additional youth use prevention tools” for the Agency’s consideration.
Warning Letters to E-Liquid Manufacturers
Beyond illegal underage sales at the retail level, open-system vapor products have not been free from FDA scrutiny. In May 2018, FDA and the Federal Trade Commission (FTC) issued 17 warning letters to e-liquid manufacturers for marketing products the agencies claimed were both misbranded under Sections 903(a)(1) and 903(a)(7) of the FDCA and false and misleading under Section 5 of the FTC Act, for being packaged and/or labeled in a manner that imitated “kid-friendly” foods such as apple juice, candy, whipped cream and cereal. On August 23, 2018, FDA announced that all 17 companies that were warned have cooperated and have ceased all sales of the offending products. FDA has now issued 12 additional warning letters to retailers for continuing to sell those e-liquids, making clear that any existing inventory of the misbranded products must be removed from commerce.
Drastic Action by FDA Could Destroy the Vapor Industry
a. Premarket Compliance Policy
Commissioner Gottlieb has made clear that the recent increase in youth use may force FDA to revisit its premarket review compliance policy, pursuant to which manufacturers of deemed noncombustible tobacco products (such as vapor products) that were on the market as of August 8, 2016, when the Deeming Rule went into effect, have until August 8, 2022 to submit PMTAs, and can remain on the market through that date. Moreover, under this compliance policy, if an application is timely submitted and accepted for scientific review, the subject product is permitted to remain on the market pending FDA review. This compliance policy was first announced in July 2017 as part of the Agency’s comprehensive plan for tobacco and nicotine regulation, and extended the original compliance policy in the Deeming Rule, which only gave e-cigarette manufacturers until August 8, 2018 to submit PMTAs for their existing products.
As noted, FDA’s letter to JUUL and the other large manufacturers indicates that it is seriously reconsidering its compliance policy, at least for cartridge-based e-cigarettes, due to widespread youth use (emphasis added):
To fulfill our public health mandate to address youth addiction to nicotine, FDA is reconsidering its compliance policy for submission of PMTAs for [the JUUL e-cigarette] and other similar products that were illegally sold by retailers during this blitz, including whether earlier enforcement of the premarket review provision might be warranted.
FDA further noted it is “seriously considering a policy change that would lead to the immediate removal of these flavored products from the market.”
Critically, Commissioner Gottlieb stated that if the five companies referenced above do not submit plans to combat youth use of their products, or if those plans are insufficient to address the problem, the companies “face a potential decision by FDA to reconsider extending the compliance dates for submission of premarket applications.”
If FDA does decide to modify the compliance policy for cartridge-based e-cigarettes because of their apparent unique impact on youth compared to other types of vapor products, such action does have precedent. In its comprehensive plan, for example, FDA required deemed combustible products, such as cigars and hookah, on the market as of August 8, 2016 to submit premarket review applications by August 8, 2021, because of the known-health risks of combustible tobacco.
However, open-system vapor product manufacturers should be aware that Gottlieb did note in his statement that FDA’s “policy reconsiderations apply to the entire category” and that FDA is “also re-examining the enforcement discretion we currently exercise for other e-cig products currently on the market without authorization.”
While it remains unclear what, if anything, FDA might do with respect to its current compliance policy, any move to shorten the PMTA grace period for the vapor industry at-large will have devastating consequences not only for thousands of small businesses that would effectively be banned, but also for the public health. These impacts were recently summarized in an amicus brief submitted by the Right to be Smoke-Free Coalition in the federal lawsuit filed by the public health groups challenging FDA’s compliance policy. You can read about that lawsuit and the amicus brief, which makes clear that the vapor industry needs at least until August 2022 to prepare applications given the need for long-term clinical data, on our previous blog post here.
b. Flavored Products
Also of concern for the vapor industry is the potential targeting of flavored products, which the industry has argued are, in fact, appropriate for the protection of the public health (see here). It is important to first recognize that there is no such thing as an unflavored e-cigarette or vapor product. Unlike combustible cigarettes or other tobacco-containing products, there is simply no “natural” tobacco or other flavors inherent to e-liquids. Rather, all flavors for these products are chemically synthesized and added to the base propylene glycol/vegetable glycerin solution. Thus, unlike cigarettes, a ban on characterizing flavors would effectively result in a ban of all vapor products.
Moreover, numerous published studies demonstrate, and FDA has acknowledged, that flavored vapor products and e-liquids can help adult smokers reduce their cigarette use and/or switch completely to vapor products. For example, a recently-released survey of almost 70,000 U.S. vapers found that 87.3% of respondents who quit smoking with e-cigarettes said that flavors were “extremely” or “very” important to their quit attempts.
Remaining Compliant in a Rapidly Changing Regulatory Landscape
The new FDA enforcement actions and broader threats against the industry raise the possibility of dramatically altering the regulatory landscape for e-cigarettes and other vapor products. FDA’s September 12 letters to the large manufacturers of cartridge-based e-cigarettes threaten to potentially end the premarket review compliance policy for those types of products, but it is not clear if FDA would extend this to all vapor product manufacturers. Indeed, the stock market appears to have recognized this possibility, as legacy tobacco stocks rallied after FDA’s announcement. Apparently, the markets have concluded that if adults are not going to be permitted to vape, they could return to traditional combustible tobacco cigarettes – the most harmful nicotine delivery system. From our vantage point, and to the detriment of public health, it is hard to argue with this conclusion.
Accordingly, in view of FDA’s enforcement blitz and the Agency’s current focus on manufacturer advertising, marketing, and manufacturing practices, we recommend vapor product companies:
- Start preparing premarket applications (including PMTAs) sooner rather than later (and attend FDA’s public hearing on October 22-23, 2018).
- Work with retailers (both brick-and-mortar and online) that have age and photo-ID verification procedures that comply with requirements applicable to tobacco retailers, including requirements that:
- the retailer checks the photo ID of everyone under age 27 who attempts to purchase any tobacco product;
- the retailer only sells tobacco products to customers age 18 or older (consider whether age-gating may be appropriate for online retailers); and
- the retailer does not sell tobacco products in vending machines unless in an adult-only facility.
- Work with legal counsel to ensure that your product labeling and marketing would not cause the product to be misbranded or misleading (i.e., by imitating potentially “kid-appealing” foods).
- Make sure your advertising and product labeling fully comply with the nicotine addiction warning (and other labeling requirements).
- Comply with TCA requirements, including registration and listing for U.S. establishments, ingredient listing, and health document disclosures.
- Do not introduce new products after August 8, 2016 without receiving FDA premarket authorization.
- Comply with all sales and marketing restrictions, including use of any modified risk claims and the ban on free samples.
- Prepare to be inspected by FDA and other authorities (sign up for our audit and inspection program here).
- Consider developing an internal audit program to evaluate the procedures used by retail partners to avoid youth-access to your products.
If you have any questions about FDA’s announcements contact Azim Chowdhury (202.434.4230, firstname.lastname@example.org). For more information on our Tobacco and E-vapor Practice in general, visit www.khlaw.com/evapor. Follow Keller and Heckman Tobacco and E-Vapor Partner Azim Chowdhury on Twitter.
 See U.S. Food & Drug Admin., FDA News Release, FDA Takes New Steps to Address Epidemic of Youth E-Cigarette Use, Including a Historic Action Against More Than 1,300 Retailers and 5 Major Manufacturers for Their Roles Perpetuating Youth Access (Sept. 12, 2018).
 Christopher Groskopf, What Yelp Data Reveal About the Sudden Rise of Vape Shops in America, Quartz, (Feb. 10, 2016), https://qz.com/608469/what-yelp-data-tells-us-about-vaping/.
 The first set of letters were sent on May 17, 2018 to J Well, of Paris, France, for Bo Starter Kit; YGT Investment LLC and 7 Daze LLC, of Baldwin Park, California, for Zoor Kit; Liquid Filling Solutions LLC, of King of Prussia, Pennsylvania, for Myle Products; and SVR Inc., of Las Vegas, for SMPO Kit. Subsequently, in late May additional letters were sent to Myle Vape Inc. regarding Myle Products, and to MMS ECVD LLC regarding the Bo Starter Kit, to reflect additional relevant companies in the manufacturing and distribution chain.
 Guidance for Industry: Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule (Revised) (August 2017), available at: https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM557716.pdf.
 The original Deeming Rule compliance policy also had a sunset period that only permitted manufacturers who submitted timely PMTAs to continue to market those products for an additional year, i.e., until August 8, 2019. Unless an application was authorized during that year, it would have to be removed from the market at that time, and could only be re-introduced if it received FDA authorization.
 Konstantinos F., M.D., MPH, et al., Patterns of flavored e-cigarette use among adult vapers in the United States: an internet survey (2018), at 6, 20.
On September 6, 2018, a coalition of vapor industry trade associations and businesses – specifically the Smoke-Free Alternatives Trade Association (SFATA), the American E-Liquid Manufacturing Standards Association (AEMSA), the American Vapor Association (AVA), and SV3, LLC (collectively, the “Vapor Coalition”) – submitted comments to the U.S. Trade Representative (USTR) arguing against the Trump Administration’s additional proposed tariffs that would apply to certain vapor products imported from China (see Docket No. USTR-2018-0026).
The Vapor Coalition’s comments strenuously oppose the tariffs, and describe in detail the potentially disastrous economic and public health consequences that would result if the tariffs are imposed. The comment also describes how FDA’s current regulatory framework makes it effectively impossible for American companies to now start manufacturing vapor devices domestically – forcing U.S. businesses to rely on Chinese manufactured products.
At issue in this docket is the “Third Tranche” of tariffs proposed by the Trump Administration which apply to a number of Harmonized Tariff Schedule (HTS) codes used to import a variety of vapor products and components, parts and accessories from China:
|HTS Code||Product Description|
|85126.96.36.199||Personal electric or electronic vaporizing devices with substances containing nicotine.|
|85188.8.131.52||Other personal electric or electronic vaporizing devices.|
|2403.19.20.20||Mixture containing tobacco mixed with glycerol or other ingredients|
|2905.31.00.00||Ethylene Glycol (without nicotine or flavoring added)|
|2905.32.00.00||Propylene Glycol (without nicotine or flavoring added)|
|38184.108.40.206||Mixtures of a kind containing nicotine used in personal electric or electronic vaporizing devices|
|3923.30.00.00||Carboys, bottles, flasks and similar articles for the conveyance or packing of goods, of plastics.|
|4202.92.00.00||Product with outer surface of sheeting of plastics or of textile materials|
|4819.20.00.00||Folding cartons, boxes and cases of non-corrugated paper or paperboard.|
|4821.10.00.00||Printed paper and paperboard labels of all kinds|
|8506.10.00||Manganese dioxide primary cells and primary batteries|
|8506.30.10||Mercuric oxide primary cells and primary batteries having an external volume not exceeding 300 cubic cm.|
|8506.80.00||Primary cells and primary batteries, nesoi.|
|8507.40.80||Nickel-iron storage batteries, other than of a kind used as the primary source of power for electric vehicles.|
|8507.50.00||Nickel-metal hydride batteries.|
The USTR has already imposed tariffs on vapor products imported under HTS subheading 8543.70.99 including, in particular, 85220.127.116.11, 8518.104.22.168, and 8522.214.171.124 (Final Second Tranche, August 7, 2018). Although not the subject of this docket, the Vapor Coalition noted its opposition to such action and urged the USTR to reconsider and remove these subheadings from its Final Second Tranche.
You can download the Vapor Coalition’s comments to the USTR here.
 See USTR Finalizes Second Tranche of Tariffs on Chinese Products in Response to China’s Unfair Trade Practices, available at: https://ustr.gov/about-us/policy-offices/press-office/press-releases/2018/august/ustr-finalizes-second-tranche.
Today, August 10, 2018, is the compliance date for the health warnings contained in the FDA’s Deeming Rule and codified in 21 C.F.R. Part 1143. In particular, as of today, roll-your-own (RYO) tobacco, cigarette tobacco, or covered tobacco products (except cigars and pipe tobacco) such as e-liquids that contain tobacco-derived nicotine manufactured, packaged, sold, offered for sale, distributed, or imported for sale or distribution within the United States must bear the required warning statement (i.e., “WARNING: This product contains nicotine. Nicotine is an addictive chemical.”) on the package label, per 21 C.F.R. § 1143.3(a)(1). This warning statement requirement also applies to advertising (including websites and social media) for RYO tobacco, cigarette tobacco, and covered tobacco products (except cigars and pipe tobacco).
The warning statement must also comply with certain requirements, with respect to font, text, size, placement, and formatting of the warning statement on the package labels. Indeed, the regulation requires that the required warning statement “appear directly on the package” and “be clearly visible underneath any cellophane or other clear wrapping as follows”:
- Be located in a conspicuous and prominent place on the two “principal display panels” of the package;
- Comprise at least 30 percent of each of the principal display panels;
- Be printed in at least 12-point font size and must occupy the greatest possible proportion of the warning label area set aside for the required text;
- Be printed in conspicuous and legible Helvetica bold or Arial bold type or other similar sans serif fonts and in black text on a white background or white text on a black background in a manner that contrasts by typography, layout, or color, with all other printed material on the package;
- Be capitalized and punctuated as indicated in 21 CFR § 1143.3(a)(1); and
- Be centered in the warning area in which the text is required to be printed and positioned such that the text of the required warning statement and the other information on the principal display panels have the same orientation.
For covered tobacco products (other than cigars), cigarette tobacco products, and RYO tobacco products that are too small or otherwise unable to accommodate a label with sufficient space to bear the required warning statement, the required warning statement must appear on one of the following: carton, outer container, wrapper, or tag firmly and permanently affixed to the tobacco product package.
Compliance Policy and Safe Harbor for Retailers
FDA created a compliance policy for the 21 C.F.R. § 1143.3 nicotine addiction warning in its Guidance Document, Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule, which provides (on page 5):
The Deeming Rule also contains a retailer safe harbor, which provides that a retailer of cigarette tobacco, RYO tobacco, or covered tobacco products (other than cigars) will not be in violation of 21 C.F.R. § 1143.3 for packaging that: (i) contains a health warning; (ii) is supplied to the retailer by the tobacco product manufacturer, importer, or distributor, who has the required state, local, or Alcohol and Tobacco Tax and Trade Bureau (TTB)-issued license or permit, if applicable; and (iii) is not altered by the retailer in a material way.
If you have questions about the compliance policy or the retailer safe harbor, please let us know.
Alternative Required Warning Statement for Zero Nicotine Products
For products that do not contain nicotine, but that are made or derived from tobacco, a tobacco product manufacturer is permitted to display an alternative statement (i.e., “This product is made from tobacco”) on all packages and advertisements in accordance with the requirements of 21 C.F.R. § 1143.3. An example of such a product would be a zero-nicotine e-liquid that contains tobacco-derived flavors or extracts. To be permitted to make such a statement, manufacturers are required to submit a confirmation statement to FDA certifying to be true that the product does not contain nicotine and that the tobacco product manufacturer has data to support that assertion. If you would like to submit such a self-certification to FDA, let us know.
A zero-nicotine e-liquid that does not contain any other tobacco-derived ingredients is not a covered tobacco product subject to either the nicotine addiction warning or alternative statement.
Effect of Injunction in Cigar Association of America v. FDA
Importantly, due to a recent decision by the United States District Court for the District of Columbia, the warnings set forth in 21 C.F.R. §§ 1143.3 and 1143.5 are not applicable to cigars and pipe tobacco until 60 days after final disposition of the plaintiffs’ appeal of the courts’ order on the health warning requirements. FDA has stated that the Agency intends to comply with the court’s order in Cigar Association of America. Further, FDA explained that the Agency does not intend to enforce the labeling requirements under sections 903(a)(2) (i.e., requirement that label contain the name and place of business of the tobacco product manufacturer, packer, or distributor; an accurate statement of the quantity of contents in terms of weight, measure, or numerical count; and an accurate statement of the percentage of domestically grown vs. foreign grown tobacco) and 920(a)(1) (i.e., requirement to bear “Sale only allowed in the United States” statement) for cigars and pipe tobacco while the injunction is in effect so that firms are able to make required label changes at one time.
Notably, the court’s order does not enjoin FDA from enforcing the health warning requirements for other product categories, including electronic nicotine delivery systems (ENDS) products, hookah tobacco, and cigarette tobacco and RYO tobacco.
Other Labeling Requirements
The Deeming Rule also imposed additional labeling requirements on newly deemed products. For example, tobacco products deemed under the Deeming Rule to be subject to FDA’s authority, if in package form, are required to bear a label containing:
- the name and place of business of the tobacco product manufacturer, packer, or distributor;
- an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; and
- the statement “Sale only allowed in the United States” on labels, packaging, and shipping containers pursuant to Section 920(a) of the Federal Food, Drug, and Cosmetic Act (FDCA).
In addition, pursuant to Section 903(a)(2)(C) of the FDCA, a tobacco product in package form is misbranded if its label does not include an accurate statement of the percentage of foreign and domestic grown tobacco used in the product. However, in a draft guidance document entitled, “Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops,” FDA stated that, at this time, it does not intend to enforce this requirement for products made or derived from tobacco, such as tobacco-derived liquid nicotine and e-liquid made or derived from tobacco. FDA explained that it provided this compliance policy “because it recognizes the current difficulty, in many circumstances, qualifying the percentage of foreign and domestic grown tobacco used in these products.”
If you have any questions about warning requirements for product labels and advertisements or any of the other Tobacco and Control Act requirements, contact Azim Chowdhury, Partner (202) 434.4230, (email@example.com). For more information on our Tobacco and E-Vapor Practice in general, visit www.khlaw.com/evapor. You can also follow Azim Chowdhury on Twitter for updates.
 21 C.F.R. § 1143.3(a)(2).
 21 C.F.R. § 1143.3(a)(3).
 21 C.F.R. § 1143.3(c).
 See Order, Cigar Ass’n of Am. v. U.S. Food & Drug Admin., No. 1:16-cv-01460 (D.D.C. July 5, 2018).
 See FDA, “Covered” Tobacco products and Roll-Your-Own Cigarette Tobacco Labeling and Warning Statement Requirements, https://www.fda.gov/TobaccoProducts/Labeling/Labeling/ucm524470.htm?utm_source=CTPTwitter&utm_medium=social&utm_campaign=ctp-warninglabel.
 See 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; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products, 81 Fed. Reg. 28974, 29006 (noting that the compliance date for the 903(a)(2) and 920(a)91) requirements is intended to match the date for health warnings).
 FDA, Draft Guidance for Industry: Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops (Jan. 2017), https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM536997.pdf .
 Id., at 5-6.
On August 2, 2018, just over one year since FDA announced its “Comprehensive Plan for Tobacco and Nicotine Regulation” (hereinafter, the “Comprehensive Plan”), FDA Commissioner, Scott Gottlieb, M.D., and Center for Tobacco Products (CTP) Director, Mitch Zeller, J.D., authored a post on the Agency’s FDA Voice blog, which reviewed the progress made to date and outlined several new initiatives related to the Comprehensive Plan. Among other things, these initiatives included a potential e-cigarette product standard and also proposed foundational rules on various topics related to premarket applications. The authors note that the Comprehensive Plan is a multi-year roadmap for the future of tobacco regulation and “provides a framework for regulating nicotine and tobacco.”
Recent Actions Implementing FDA’s Comprehensive Plan
The FDA Voice blog post recounts the FDA’s actions over the first year of the Comprehensive Plan. For instance, the authors note that FDA recently issued three advanced notices of proposed rulemaking (ANPRMs) that have the “potential to reframe the tobacco landscape.” These ANRPMs focus on: (i) the potential development of a product standard to lower nicotine in cigarettes to minimally or no-addictive levels; (ii) the role that flavors – including menthol – play in initiation, use and cessation of tobacco products; (iii) the patterns of use and resulting public health impacts from “premium” cigars. While the comment period for each of these ANPRMs has closed, FDA is currently in the process of reviewing the comments that the Agency has received. In addition, the authors note the Agency’s efforts to re-evaluate and modernize its approach to the development of nicotine replacement therapy products, including, among other things, by establishing a Nicotine Steering Committee and issuing a draft guidance related to the nonclinical testing of orally inhaled nicotine-containing drug products.
Establishing a Rigorous, Science-Based Framework for Premarket Review of Tobacco Products
The FDA also announced that a key part of its Comprehensive Plan involves issuing foundational rules and guidance to help industry better understand what is required to submit premarket applications. Indeed, “[e]stablishing a rigorous, predictable, science-based framework for the premarket review of tobacco products is a key element of [FDA’s] program.” With that in mind, the FDA announced several steps to achieve these goals. First, the Agency announced that it plans to propose new rules in the coming months to aid industry on topics including Substantial Equivalence, Premarket Tobacco Product Applications, Modified Risk Tobacco Product Applications, and Tobacco Product Manufacturing Practices. Second, FDA plans to hold a public meeting on the premarket application and review process on October 22-33, 2018. Third, FDA plans to explore opportunities for premarket review efficiencies through rulemaking and guidance as well as new administrative steps to modernize and improve the review process.
FDA did not mention whether it might consider further extending its compliance policy deadlines, which are currently being challenged by several public health groups, that permit deemed tobacco products on the market as of August 8, 2016 (the effective date of the Deeming Rule) to remain on the market until applications are due by August 8, 2021 (for combustible products) or August 8, 2022 (for non-combustibles). Considering that FDA is only now, exactly two years after the Deeming Rule went into effect, announcing potential new guidance documents, rulemakings and public hearings “within the coming months,” additional time for industry to comply would seem warranted.
New Initiatives to Address Youth Use of Tobacco Products
The FDA Voice blog post elucidates a bedrock principle: No kids should be using any tobacco or nicotine-containing products, including e-cigarettes. With that in mind, the authors summarize FDA’s recent actions aimed at addressing youth use of nicotine, and e-cigarettes specifically. Among other things, the FDA has recently sent warning letters to companies for selling e-liquids resembling juice boxes, candies, and cookies; sent warning letters to retailers for selling JUUL e-cigarettes to youth; and worked with eBay to remove internet listings for JUUL.
However, the blog post also outlines three additional new initiatives to address these concerns. Among other things, the FDA Voice blog post announced that FDA has “begun exploring a product standard for e-cigarettes.” As part of this standard, the FDA plans to consider, among other things, levels of toxicants and impurities in propylene glycol, glycerin, and nicotine in e-liquids. Additionally, FDA announced that it plans to expedite the Agency’s review and analysis of comments on the flavors ANPRM so that the Agency can pursue policy solutions, should the science support further action. Lastly, the FDA explained that it is exploring ways that FDA can act more efficiently when the Agency becomes aware of violations affecting youth use of e-cigarettes, such as illegal product marketing to youth.
Enforcement of New Products Without Premarket Authorization
While deemed tobacco products on the market as of August 8, 2016 can take advantage of the premarket application compliance policy noted above, new products intended to be introduced for the first time after August 8, 2016 must first obtain FDA premarket authorization. Regarding new products that have allegedly been introduced without such authorization, the blog authors note: “We’ve also become aware of reports that some companies may be marketing new products that were introduced after the FDA’s compliance period and have not gone through premarket review. These products are being marketed both in violation of the law and outside of the FDA’s announced compliance policies. We take these reports very seriously. Companies should know that the FDA is watching and we will take swift action wherever appropriate.”
Potential Impact on Vapor Industry
While the FDA Voice blog post largely outlines previously known regulatory initiatives, the Agency’s discussion of FDA initiatives to address youth use of tobacco products outlines several new proposals of interest to the vapor industry. Indeed, an e-cigarette product standard could dramatically impact the design and production of future e-cigarettes. Likewise, any action regulating the marketing of flavored tobacco products, including flavored e-cigarettes and e-liquids, could shape the vapor industry for years to come. From an administrative perspective, the FDA’s initiatives to propose foundational rules, hold a public meeting on premarket review, and explore opportunities for premarket review efficiencies, offer the potential to greatly improve the premarket review process, if companies are given enough time to comply.
Looking back, the FDA’s Comprehensive Plan brought a much-needed revamp to the Agency’s approach to tobacco and nicotine regulation. Only time will tell whether the Agency is able to translate its regulatory plan into effective regulatory policy.
 FDA News Release, FDA Announces Comprehensive Regulatory Plan to Shift Trajectory of Tobacco-Related Disease and Death (July 28, 2017),
 FDA Voice Blog, Advancing Tobacco Regulation to Protect Children and Families: Updates and New Initiatives from the FDA on the Anniversary of the Tobacco Control Act and FDA’s Comprehensive Plan for Nicotine (Aug. 2, 2018), https://blogs.fda.gov/fdavoice/index.php/2018/08/advancing-tobacco-regulation-to-protect-children-and-families-updates-and-new-initiatives-from-the-fda-on-the-anniversary-of-the-tobacco-control-act-and-fdas-comprehensive-plan-for-nicotine/.
 FDA Statement, Statement from FDA Commissioner Scott Gottlieb, M.D., on New Steps the Agency is Taking to Support the Development of Novel Nicotine Replacement Drug Therapies to Help Smokers Quit Cigarettes (Aug. 3, 2018), https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm615740.htm?
 FDA Website, Tobacco Product Application Review – A Public Meeting (Oct. 22-23, 2018), https://www.fda.gov/TobaccoProducts/NewsEvents/ucm615443.htm.
 FDA Voice Blog, Advancing Tobacco Regulation to Protect Children and Families: Updates and New Initiatives from the FDA on the Anniversary of the Tobacco Control Act and FDA’s Comprehensive Plan for Nicotine (Aug. 2, 2018).
 FDA News Release, FDA, FTC Take Action Against Companies Misleading Kids with E-Liquids That Resemble Children’s Juice Boxes, Candies, and Cookies (May 1, 2018), https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm605507.htm.
 FDA Statement, Statement from FDA Commissioner Scott Gottlieb, M.D., on New Enforcement Actions and a Youth Tobacco Prevention Plan to Stop Youth Use of, and Access to, JUUL and Other E-Cigarettes (Apr. 24, 2018), https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm605432.htm.
 FDA Voice Blog, Advancing Tobacco Regulation to Protect Children and Families: Updates and New Initiatives from the FDA on the Anniversary of the Tobacco Control Act and FDA’s Comprehensive Plan for Nicotine (Aug. 2, 2018).
In FDA’s latest effort to implement its comprehensive plan for tobacco and nicotine regulation, the Agency published two additional advanced notice of proposed rulemakings (ANPRMs) concerning regulation of premium cigars and tobacco product flavors. Specifically, on March 21, 2018, the FDA published an ANPRM, “Regulation of Flavors in Tobacco Products,” which solicited comments on, among things, the role of flavors (other than tobacco) (hereinafter, “flavors”) on initiation and patterns of tobacco product use and on transitioning combustible to non-combustible tobacco product use. The next week, on March 26, 2018, the FDA published another ANPRM, “Regulation of Premium Cigars,” which requested input on the definition and use patterns of premium cigars as well as public health considerations associated with premium cigars. While these regulatory actions were initially promised in FDA’s July 28, 2017 comprehensive plan for tobacco and nicotine regulation, publication of the ANPRMs in the Federal Register provide an indication of the Agency’s regulatory priorities going forward. 
Flavored Tobacco Products ANPRM
In the ANPRM regarding regulation of tobacco product flavors, FDA requests comments on, among other topics, the following:
- The Role of Flavors (other than tobacco) in Tobacco Products: FDA requested studies or information regarding the role of flavors generally in tobacco products, as well as the appropriateness of extrapolating research from other areas (e.g., consumer products) to the tobacco space.
- Flavors (other than tobacco) and Initiation and Patterns of Tobacco Product Use, Particularly Among Youth and Young Adults: FDA requested studies or information regarding the role of flavors in: (1) initiation and/or patterns of use of combusted and non-combusted tobacco products among youth and young adults; (2) in non-combusted tobacco products on initiation of tobacco product use or progression to use of other tobacco products among youth and young adults.
- Flavors (other than tobacco) and cessation, dual use, and relapse among current and former tobacco product users: FDA requested information on the role of flavors in helping adult cigarette smokers reduce cigarette use and/or switch to potentially less harmful tobacco products. Further, FDA requested studies or information concerning the role of flavors in non-combusted tobacco products on the likelihood of: (i) cessation of combusted tobacco product use; (ii) cessation of all tobacco product use; and (iii) uptake of dual use of combusted and non-combusted tobacco products among current and former tobacco product users.” FDA also requested information on the role of flavors in combusted products on the likelihood of: (1) delayed or impeded cessation among users who would have otherwise quit combusted tobacco product use; or (2) delayed or impeded cessation among users who would have otherwise quit all tobacco product use. FDA also solicited studies or information regarding the role of flavors in non-combusted tobacco on the likelihood that former combusted tobacco product users relapse.
- Additional Public Health Considerations: FDA requested studies or information regarding (1) the potential toxicity or adverse health effects to the user or others from any flavors (e.g., flavor additives, compounds or ingredients) in tobacco products; (2) the impact of public health efforts by local jurisdictions, States, and members of the international community to impose restrictions on the manufacture, marketing, sale or distribution of all or a subset of tobacco products with flavors, including but not limited to, cigars, ENDS, menthol cigarettes, and smokeless tobacco products; (3) consumer perceptions of the health risk of tobacco products with flavors when compared to other tobacco products both with and without flavors; (4) consumer perceptions, if any, of the addictiveness of tobacco products with flavors.
In a contemporaneous statement accompanying the ANPRM, FDA Commissioner Scott Gottlieb, M.D called upon all stakeholders to “share data, research, and information that can inform our process for examining the role that flavors – including menthol – play in initiation, use and cessation of tobacco products. Importantly, the FDA Commissioner also requested “personal stories” from individuals that have been aided by flavors in making the transition between combustible tobacco cigarettes and vaping. As seen in the litigation surrounding the deeming rule, these regulatory comments could be cited in any future litigation regarding either of these issues.
Comments are due on the tobacco product flavors ANPRM by June 19, 2018.
Premium Cigars ANPRM
In the preamble to the ANPRM regarding premium cigars, FDA noted that it received “numerous comments on the deeming proposed rule with respect to premium cigars, both in favor of, and against, regulating these products.” However, FDA explains that there was a lack of data supporting the opinions expressed in the comments received by the Agency regarding the Deeming Rule. For that reason, the ANPRM explains that “FDA is seeking comments, evidence, information, data, and analysis that were not submitted in response to the proposed deeming rule” that could inform FDA’s thinking with respect to regulation of premium cigars.
As an example of the type of information that would be responsive to the ANPRM, FDA cites a PATH Study Paper, which analyzed findings from the 2013-2014 Population Assessment of Tobacco and Health (PATH) Study with a focus on smokers of filtered cigars, cigarillos, and traditional cigars, which were further classified by study authors as either “premium” or “nonpremium.” That study concluded that “use characteristics, cigar smoking patterns, and dual smoking with cigarettes varied by cigar type.”
Specifically, in the ANPRM, FDA requests comments on, among other topics, the following:
- Definition of Premium Cigars: Among other things, FDA requested comments from the public concerning the defining characteristics of premium cigars, which may include: size; tobacco filler type; fermentation type; wrapper and binder composition; where the tobacco used for premium cigar filler or wrappers is grown; presence or absence of a filter or mouthpiece; manufacturing and assembly process; rate of production; presence or absence of flavor imparting compounds, flavor additives, or characterizing flavors other than tobacco; presence or absence of any additives other than cigar glue; nicotine content; tar and carbon monoxide delivery amounts; retail price; frequency with which price changes; packaging quantity and size; any action directed to consumers by a retailer or manufacturer.
- Use Patterns of Premium Cigars: FDA solicited studies or information regarding, among other things, and as compared to other cigars: (1) the potential role of premium cigars on tobacco initiation and progression to use of other tobacco products; (2) behavioral data related to dual use of premium cigars and other tobacco products; (3) the frequency and intensity of premium cigar use; (4) the proportion of premium cigar smokers showing symptoms of dependence; (5) the abuse liability of premium cigars; (6) the impact of premium cigar labeling, advertising, and marketing efforts on patterns of use. Lastly, FDA also requested information on the extent to which users of other tobacco products might switch to premium cigars if FDA were to exempt premium cigars from regulation or regulate premium cigars differently from other cigars.
- Public health considerations associated with premium cigars: FDA requested studies or information regarding, among other things, and as compared to other cigars: (1) nicotine concentrations for premium cigars; (2) the risk of cancer, heart disease, aortic aneurysm, periodontal disease, stroke, and chronic obstructive pulmonary disease associated with premium cigar use; (3) the addictiveness, and consumer perceptions of the addictiveness, of premium cigars; (4) the required warning statements for premium cigars; and (5) the applicable manufacturing, marketing, sale, distribution, advertising, and labeling and/or packaging requirements and restrictions in the FDCA and its implementing regulations and whether they should be applied differently to premium cigars.
Comments are due on the premium cigar ANPRM by June 25, 2018.
An Advanced Notice of Proposed Rulemaking constitutes the earliest (and optional) stage of the administrative process that must be followed before eventually issuing an administrative rule. As such, there is still ample time for efforts to influence the FDA’s regulatory approach to both premium cigars and tobacco product flavors by submitting comments to the administrative docket. Companies or individuals interested in providing such feedback should consult with counsel to determine the best approach to maximize their impact with FDA.
 See FDA, Statement from FDA Commissioner Scott Gottlieb, M.D., on Efforts to Reduce Tobacco Use, Especially Among Youth, by Exploring Options to Address the Role of Flavors – including Menthol – in Tobacco Products, https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM601690.htm?utm_source=CTPEblast&utm_medium=email&utm_term=sro&utm_content=pressrelease&utm_campaign=ctp-flavanprm.
 Regulation of Flavors in Tobacco Products, 83 Fed. Reg. 12294 (Mar. 21, 2018);
 Regulation of Premium Cigars, 83 Fed. Reg. 12901 (Mar. 26, 2018).
 FDA News Release, FDA Announces Comprehensive Regulatory Plan to Shift Trajectory of tobacco-related disease and death (July 28, 2017), https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm568923.htm.
 83 Fed. Reg. 12994, 12998-99 (Mar. 21, 2018).
 83 Fed. Reg. 12999.
 83 Fed. Reg. 12901, 12902 (Mar. 26, 2018).
 83 Fed. Reg. 12902. (emphasis added).
 83 Fed. Reg. 12902-03, citing, Catherine G. Corey, MPSH et al., U.S. Adult Cigar Smoking patterns, Purchasing Behaviors, and Reasons for Use According to Cigar Type: Findings from the Population Assessment of Tobacco and Health (PATH) study, 2013-2014, Nicotine & Tobacco Research (Sept. 15, 2017), available at https://academic.oup.com/ntr/advance-article-abstract/doi/10.1093/ntr/ntx209/4159211?redirectedFrom=fulltext.
 Catherine G. Corey, MPSH et al., U.S. Adult Cigar Smoking patterns, Purchasing Behaviors, and Reasons for Use According to Cigar Type: Findings from the Population Assessment of Tobacco and Health (PATH) study, 2013-2014, Nicotine & Tobacco Research (Sept. 15, 2017), available at https://academic.oup.com/ntr/advance-article-abstract/doi/10.1093/ntr/ntx209/4159211?redirectedFrom=fulltext.
 83 Fed. Reg. 12903.
 83 Fed. Reg. 12904.
In the U.S. Food and Drug Administration’s (FDA’s) latest effort to implement its comprehensive regulatory plan to shift the trajectory of tobacco-related disease and death, the Agency issued, on March 15, 2018, an advanced notice of proposed rulemaking (ANPRM) to obtain information for consideration in developing a tobacco product standard to set a maximum nicotine level for cigarettes. As described in a contemporaneous statement issued by FDA Commissioner Scott Gottlieb, M.D., the ANPRM provides a wide-ranging review of the current scientific understanding about the role nicotine plays in addiction. Moreover, the ANPRM clarifies that FDA is considering “issuance of a product standard to set a maximum nicotine level in cigarettes so that they are minimally addictive or nonaddictive.”
As detailed below, FDA requests in the ANPRM comments on, among other topics, the following:
- Scope: Should the potential maximum nicotine level apply only to cigarettes or should it include other combustible tobacco products as well?
- Maximum Nicotine Level: What is the maximum nicotine level that should be used as the threshold for “minimally addictive” or “non-addictive” levels?
- Implementation: Should the maximum nicotine level for cigarettes propose a single target (where nicotine is reduced all at once or a stepped-down approach (where nicotine is reduced gradually over time through a sequence of incremental levels)? Relatedly, what is the proper timeframe to implement a possible maximum nicotine level?
- Analytical Testing Method: Should FDA specify a method for manufacturers to use to detect the level of nicotine in their products? If so, which method should be used?
Comments are due by June 14, 2018.
Scope of FDA’s Proposed Tobacco Product Standard
In the ANPRM, FDA seeks comments on whether the standard should cover any or all of the following products: combusted cigarettes (which FDA has previously interpreted to include kreteks and bidis), cigarette tobacco, roll-your-own (RYO) tobacco, some or all cigars (e.g., including large and “premium” cigars), pipe tobacco, and waterpipe tobacco. Importantly, the Agency explains that “any nicotine tobacco product standard would cover all brands in a particular product category and, therefore, those products currently on the market and any new tobacco products would be expected to adhere to the standard.” Key questions raised by the ANPRM also include whether so-called “premium” cigars should be regulated differently from other cigars and whether waterpipe tobacco products should be excluded because they are unlikely to be migration substitutes or dual use candidates.
Identification and Implementation of Appropriate Maximum Nicotine Level
With respect to nicotine levels in cigarettes, FDA requested comments on a potential maximum nicotine level that would be “minimally addictive” or “non addictive” and appropriate for the protection of public health, recognizing that the Family Smoking Prevention and Tobacco Control Act specifically prohibits FDA from “requiring the reduction of nicotine yields of a tobacco product to zero.” Indeed, FDA is particularly interested in comments concerning the merits of nicotine levels of 0.3, 0.4, and 0.5 mg nicotine/g of tobacco filler. In addition, the ANPRM requests comments on how any potential maximum nicotine level should be measured (e.g., nicotine yield, nicotine in tobacco filler, something else), how the threshold of nicotine addiction should be measured, and whether the product standard should specify a method for manufacturers to use to detect the level of nicotine in their products. Further, FDA requests comments on whether a maximum nicotine level for cigarettes should propose either a single target (where the nicotine is reduced all at once) or a stepped-down approach (where the nicotine is reduced gradually over time through a sequence of incremental levels and implementation dates).
Technical Challenges Associated with Implementation
The ANPRM also acknowledges the technical challenges associated with implementation of a maximum nicotine standard. Indeed, FDA explains that “significant nicotine reductions in cigarettes and other combusted tobacco products can be achieved principally through tobacco blending and cross-breeding plants, genetic engineering, and chemical extraction.” Similarly, FDA notes that “agricultural practices (e.g., controlled growing conditions, fertilization, and harvest) as well as more recent, novel techniques also can help to reduce nicotine levels.” With that in mind, FDA explains that it is considering the proper timeframe to allow adequate time for industry to comply with a possible tobacco product standard setting a maximum nicotine level. Relatedly, the ANPRM requests data and information regarding the potential costs, including the potential costs to farmers, to implement such a standard.
Countervailing Effects of Potential Nicotine Standard
Notably, the ANPRM also outlines several possible countervailing effects of a potential nicotine tobacco product standard, including: (1) continued combustible tobacco product use (e.g., current users switching to, or using simultaneously (i.e., dual use), a different combusted tobacco product to maintain their nicotine dependence; (2) continued very low nicotine cigarette smoking with altered behaviors (e.g., increase in number of cigarettes smoked, increased depth of inhalation); (3) cigarette users adding nicotine in liquid or other form to their combusted tobacco product; and (4) increased illicit trade of tobacco products. FDA plans to consider each of these potential unintended consequences before moving forward with issuing a potential maximum nicotine level for combustible tobacco products.
Projected Health Benefits
As explained in FDA Commissioner Gottlieb’s statement accompanying the ANPRM, new estimates included in the ANPRM and to be published in the New England Journal of Medicine, evaluate a potential policy scenario whereby a maximum nicotine level is implemented. By the year 2100, the median estimate from the model, based on the experts’ estimates of potential initiation rates because of the policy, is that more than 33 million youth and young adults who would have otherwise initiated regular smoking would not start as a result of the hypothetical policy scenario. Further, using expert estimates for the percent of current smokers who would quit smoking after implementation of the policy, approximately 5 million additional smokers are estimated to quit smoking within one year after implementation of the standard. Under the same model, by 2060, it is estimated that a median value of almost 3 million deaths due to tobacco would be avoided.
Impact of Potential Maximum Nicotine Level on Electronic Nicotine Delivery Systems (ENDS)
Of note for the vapor industry, in the Agency’s discussion of the effects of FDA’s potential tobacco product standard establishing a maximum nicotine level for cigarettes, FDA essentially acknowledges, as it has in the past, that ENDS products are less harmful than cigarettes. Indeed, FDA explains “former smokers that choose to switch completely to a potentially less harmful nicotine product (e.g., electronic nicotine delivery systems (ENDS)) to maintain their nicotine dose also would, to the extent that those products result in less harm, significantly reduce their risk of tobacco-related death and disease.” By implication, this statement appears to tacitly accept that current combustible tobacco product users are likely to switch to ENDS products not covered by the potential maximum nicotine level rule.
Indeed, this result was recognized in a 2018 update (discussed in the ANPRM) to a previously published discrete system dynamic population model that compared projected outcomes for a status quo scenario (in which no maximum nicotine level is implemented) with outcomes for a policy scenario in which a hypothetical regulation lowering nicotine in cigarettes and selected other combusted tobacco products, to minimally addictive levels. Importantly, the model of the potential effects of the maximum nicotine level for cigarettes projected a simultaneous reduction in cigarette smoking and an increase in non-combusted tobacco product use. Lastly, in an industry conference call held on March 15, 2018 to announce the ANPRM, Mitch Zeller, the Director of the Center for Tobacco Products, expressly acknowledged the Agency’s obligation under Commissioner Gottlieb’s new comprehensive plan to ensure that nicotine remains on the market in less harmful forms as FDA works to implement a potential maximum nicotine level for combustible cigarettes.
 FDA News Release, FDA Announces Comprehensive Regulatory Plan to Shift Trajectory of tobacco-related disease and death (July 28, 2017), https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm568923.htm.
 FDA, Tobacco Product Standard for Nicotine Level of Combusted Cigarettes Advanced Notice of Proposed Rulemaking (ANPRM), available at https://s3.amazonaws.com/public-inspection.federalregister.gov/2018-05345.pdf (pre-publication copy), at 1.
 FDA Statement, Statement from FDA Commissioner Scott Gottlieb, M.D., on Pivotal Public Health Step to Dramatically Reduce Smoking Rates by Lowering Nicotine in Combustible Cigarettes to Minimally or Non-Additive Levels, https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM601039.htm?utm_campaign=Statement_ANPRM%20to%20reduce%20nicotine%20in%20cigs&utm_medium=email&utm_source=Eloqua.
 Id., at 6
 Id., at 7.
 Id., at 8.
 Id., at 33.
 21 U.S.C. § 387g(d)(3)(B)
 Tobacco Product Standard for Nicotine Level of Combusted Cigarettes Advanced Notice of Proposed Rulemaking (ANPRM), at 9.
 Id., at 9.
 Id., at 9
 Id., at 10.
 Id., at 10-12; See also FDA, Draft Concept Paper, “Illicit Trade in Tobacco Products after Implementation of an FDA Product Standard (Mar. 15, 2018), available at https://www.fda.gov/downloads/tobaccoproducts/newsevents/ucm601047.pdf.
 Id., at 74.
 Id., at 75.
 Id., at 75.
 Id., at 26.
 Id., at 69.
 Id., at 74.
Committee on the Review of the Health Effects of Electronic Nicotine Delivery Systems Releases Report Documenting Massive Review of Existing Scientific Literature
On January 23, 2018, the National Academies of Sciences, Engineering and Medicine (hereinafter referred to as the “National Academies”) Committee on the Review of the Health Effects of Electronic Nicotine Delivery Systems (ENDS) (hereinafter referred to as the “Committee”) released a report entitled, “Public Health Consequences of E-Cigarettes” (hereinafter referred to as the “Report”). The Report, which was the result of the Committee’s review of over 800 articles identified from a massive literature search of six different databases, noted that the Committee found sufficient literature to suggest that, “while there are risks associated with e-cigarettes, compared with combustible tobacco cigarettes, e-cigarettes contain fewer toxicants; can deliver nicotine in a manner similar to combustible tobacco cigarettes; show significantly less biological activity in a number of in vitro, animal, and human systems; and might be useful as a cessation aid in smokers who use e-cigarettes exclusively.” In sum, the Report acknowledges that vaping is significantly less harmful than smoking traditional combustible tobacco cigarettes
Background on the Report
The Consolidated Appropriations Act of 2016 included language directing the Center for Tobacco Products (CTP) of the U.S. Food and Drug Administration (FDA) to “contract with the Institute of Medicine to conduct an in-depth evaluation of available evidence of health effects from e-cigarettes and recommendations for future federally funded research.” CTP contracted with the National Academies to convene an ad-hoc committee to conduct this evaluation, which resulted in the creation of the Committee. The Committee’s literature review included an analysis of data on both short-term and long-term health effects in: (1) users of ENDS, including health effects associated with the use of these devices (e.g., cigalikes, tank systems, mods); (2) vulnerable populations of users (e.g., youth, pregnant women, individuals with underlying medical conditions (e.g., heart disease, pulmonary disease); and (3) non-users of ENDS exposed to second-hand and third-hand aerosol generated by use of these devices.
The Report Concludes That Vapor Products Are Less Harmful Than Combustible Tobacco Cigarettes
Perhaps the most significant aspect of the Report is the Committee’s implicit and explicit conclusion that e-cigarettes are safer than combustible tobacco cigarettes. Although the Report is more cautious than the Royal College of Physicians Report, the Committee nevertheless acknowledged that the “current evidence points to e-cigarettes being less harmful than combustible tobacco cigarettes.”
Moreover, several of the Report’s findings bolster the Committee’s conclusion that e-cigarettes are less harmful than combustible tobacco cigarettes. For example, the Committee found “conclusive evidence that completely substituting e-cigarettes for combustible tobacco cigarettes reduces users’ exposure to numerous toxicants and carcinogens present in combustible tobacco cigarettes.” Indeed, all cross-sectional and longitudinal studies comparing exposure to nicotine and toxicants in smokers who substituted e-cigarettes for their combustible cigarettes, showed that smokers who substitute e-cigarettes for their combustible cigarettes had significantly reduced levels of biomarkers of exposure to potentially toxic chemicals. Similarly, the Committee observed that “although some studies found similar harm from e-cigarettes, no studies found that e-cigarettes were more harmful than combustible tobacco cigarettes among combustible tobacco cigarette smokers who switched to exclusive e-cigarette use.”
Further, the Committee concluded that there was “substantial evidence that completely switching from regular use of combustible tobacco cigarettes to e-cigarettes results in reduced short-term adverse health outcomes in several organ systems.” In addition, studies reviewed by the Committee showed that use of an e-cigarette in indoor environments may involuntarily expose non-users to nicotine and particulates, but such exposure is at lower levels compared with exposure to secondhand tobacco smoke from combustible tobacco cigarettes. The Report also noted that, “among dual users, e-cigarettes may help maintain smoking reduction.”
At the same time, the Report notes that “the proportion of U.S. adults who consider [e-cigarettes] to be as harmful as combustible tobacco cigarettes has increased over time,” indicating that the public needs information related to the relative harm of e-cigarette products. However, the “modified risk” provisions of the Tobacco Control Act (the “Act”) prohibit vapor companies from making truthful claims that their products present reduced-risk compared to combustible cigarettes, or even that their products do not contain or produce smoke or tar, without submitting an extensive application and securing FDA’s approval to make such claims. Indeed, the modified risk standard is so stringent that it is highly unlikely any such claim will ever be approved for a vapor product.
Accordingly, an unintended consequence of FDA’s approach to implementing the Act may be the proliferation of misinformation concerning the relative risks of vapor products and combustible tobacco cigarettes.
Youth Use of E-Cigarettes
A frequent area of concern for courts, FDA, and public interest groups involves the use of e-cigarettes among youth. As background, the Committee notes that the “proportion of youth who reported ever using e-cigarettes varies substantially across surveys” from as low as 10.7 percent to as high as 27.1 percent. The Committee indicates that “early results suggest” that e-cigarette use “stabilized or decreased in youth between 2015 and 2016, despite increases between 2011 and 2015 across a range of surveys.” Among those who reported having ever used an e-cigarette, youth most commonly reported using rechargeable/refillable tank-style devices, with more than half (53.4 percent) of middle and high school students reporting using only this kind of device.”
In its consideration of the impact of e-cigarette use on “ever-use” of combustible tobacco products, which critically, is defined as smoking a single cigarette at any point in one’s life, the Report considers two dueling hypotheses (i.e., the diversion hypothesis and the catalyst hypothesis). The Committee explains that e-cigarettes could have a preventive effect if the diversion hypothesis – the hypothesis that because some youth possess an elevated drive to engage in exploratory or risk-taking behavior, the availability of e-cigarettes allows such young people to satisfy their curiosity and drive for novelty without resorting to combustible tobacco cigarettes – is proven. Similarly, if the catalyst hypothesis – the hypothesis that e-cigarettes attract low risk teens who would not otherwise try combustible tobacco cigarettes and, once these teens have tried e-cigarettes, they are more likely to try combustible tobacco cigarettes – holds, e-cigarette use would increase the risk of ever-smoking. Of course, e-cigarette use may also have no effect on combustible tobacco cigarette ever use in adolescents and young adults.
Keeping in mind the definition of “ever-use” noted above (i.e., smoking a single cigarette at some point) the Committee concluded, among other things, that “there is substantial evidence that e-cigarette use increases the risk of ever using combustible tobacco cigarettes among youth and young adults.” While news headlines across the world ran with this conclusion to claim that e-cigarettes “lure” kids into smoking, the Report also observes that “the population-based data broadly show opposing trends in e-cigarette and cigarette use prevalence across time among U.S. youth in recent years and thus do not provide confirmatory evidence of the epidemiologic person-level positive associations of vaping and smoking.” In this regard, we note that the National Youth Tobacco Survey data shows that youth smoking rates have been falling rapidly. Between 2011 and 2016, current use of cigarettes by high school students fell from 15.8 percent to 8.0 percent, and use of cigars and pipes also fell.
Implications of the Report
Ultimately, the Report is the most complete analysis of existing research on the public health consequences of e-cigarettes in the United States. Further, the Report provides the imprimatur of the National Academies on a conclusion long recognized by the vaping community: e-cigarettes are significantly less harmful than combustible tobacco cigarettes.
 National Academies of Science, Engineering and Medicine: Committee on the Review of the Health Effects of Electronic Nicotine Delivery Systems, The Public Health Consequences of E-Cigarettes (eds. Kathleen Stratton et al., 2018), available at https://tinyurl.com/ya4w37kb (hereinafter, referred to as the “Report”).
 Report, supra n.1., at S-9.
 Id., supra n.1., at 1-1, 1-2 (Box 1-1 Statement of Task).
 Id., supra n.1., at S-9.
 Tobacco Advisory Group of the Royal College of Physicians, Nicotine Without Smoke: Tobacco Harm Reduction (2016), at 87, available at https://tinyurl.com/h5ypa7s (stating, “although it is not possible to precisely quantify the long-term health risks associated with e-cigarettes, the available data suggest that they are unlikely to exceed 5% of those associated with smoked tobacco products, and may well be substantially lower than this figure.”).
 Report, supra n.1., at 18-23.
 Id., supra n.1., at 18-13; See also Id., at 5-32 (“Conclusion 5-3. There is substantial evidence that except for nicotine, under typical conditions of use, exposure to potentially toxic substances from e-cigarettes is significantly lower compared with combustible tobacco cigarettes.”) (emphasis in original).
 Id., supra n.1., at 18-13.
 Id., supra n.1., at 18-23.
 Id., supra n.1, at 18-24.
 Id., supra n.1., at 18-28.
 Id., supra n.1., at 18-25.
 Id., supra n.1., at 18-2.
 21 U.S.C. § 387k.
 FDA may issue a modified risk order only after the manufacturer makes numerous showings based on scientific data. Specifically, the applicant must demonstrate that the product will:
- significantly reduce harm and the risk of tobacco-related disease to individual users; and
- benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.
21 USC § 387k(g)(1) (emphasis added). As to the “population effects” prong of the standard, FDA must consider:
- relative health risks of the subject tobacco product;
- likelihood that those who do not use tobacco products will start using the subject product (e., initiation); and
- likelihood that users who would otherwise stop using tobacco products will start using the subject product (e., cessation)
21 USC § 387k(g)(4).
 See Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31, 123 Stat. 1776 (2009) (hereinafter referred to as the “Act”); See also 21 U.S.C. § 387k.
 See e.g., Discount Tobacco City & Lottery, Inc. v. United States, 674 F.3d 509(6th Cir. 2012), (finding a “substantial state interest in curbing juvenile tobacco use that can be directly advanced by imposing limitations on the marketing of tobacco products.”).
 Report, supra n.1., at 1-3 (compare the Population Assessment of Tobacco and Health (PATH) survey (Wave 1 in 2013-2014) finding only 10.7% of youth ages 12-17 reporting ever using an e-cigarette once or twice with the National Youth Tobacco Survey finding that 27.1% of middle and high school students ever used e-cigarettes.).
 Id., supra n.1., at S-1, 2.
 Id., supra n.1., at 1-5.
 Id., supra n.1., at 16-3.
 Id., supra n.1., at 16-30 (emphasis added).
 Id., supra n.1, at 16-28; See also Sheila Kaplan, Vaping Can be Addictive and May Lure Teenagers to Smoking, Science Panel Concludes, The N.Y. Times (Jan. 23, 2018), available at https://tinyurl.com/y86naj7u.
 Jamal A, Gentzke et al. Tobacco Use Among Middle and High School Students — United States, 2011–2016, 66 MMWR Morb Mortal Wkly Rep. No. 23, at 597-603 (June 16, 2017), available at https://tinyurl.com/y8ce2w9a.
Azim Chowdhury and Adam Susser will participate in the FDLI Tobacco Products and Regulation and Policy Conference, which will take place October 26-27, 2017 in Washington, DC.
This KH sponsored event will bring together public health advocates, researchers, manufacturers, lawyers, consumer interests, entrepreneurs, governmental agencies and others to effectively regulate the broad spectrum of tobacco and nicotine products in the US and globally.
Azim will participate on the panel “The Future of Deeming Regulations: Policy and Litigation” which will engage in discussions about the future of the deeming regulations, including issues pertaining to litigation, regulations, legislation, and the pros and cons of extending the implementation dates to 2021 and 2022. Attention will also be given to the appropriate use of flavoring in both e-cigarettes and cigars and how it can be ensured that children and youth are not being encouraged to use these products.
Adam will present on “Overview of Tobacco Law and Regulation” during the Introduction to U.S. Tobacco Law and Regulation seminar which will explore the essentials of tobacco law and regulation including the Deeming Rule, Premarket Tobacco Applications (PMTAs) and Modified Risk Tobacco Product Applications (MRTPAs), advertising and promotion, compliance, enforcement, and related issues.
For more information on this event, click here.