Photo of Azim ChowdhuryPhoto of Adam Susser

On August 2, 2018, just over one year since FDA announced its “Comprehensive Plan for Tobacco and Nicotine Regulation”[1] (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.[2]  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.”[3]

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.”[4]  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therapy products, including, among other things, by establishing a Nicotine Steering Committee and issuing a draft guidance related to the nonclinical testing of orally inhaled nicotine-containing drug products.[5]

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.”[6] 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.[7]  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.[8]  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[9]; sent warning letters to retailers for selling JUUL e-cigarettes to youth[10]; and worked with eBay to remove internet listings for JUUL.[11]

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.”[12]  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.[13]  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.[14]

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.

[1] 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.

[2] 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/.

[3] Id.

[4] Id.

[5] 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?

utm_campaign=08032018_Statement_FDA%20statement%20on%20developing%20new%20nicotine%20replacement%20drug%20therapies&utm_medium=email&utm_source=Eloqua.

[6] Id.

[7] FDA Website, Tobacco Product Application Review – A Public Meeting (Oct. 22-23, 2018), https://www.fda.gov/TobaccoProducts/NewsEvents/ucm615443.htm.

[8] 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).

[9] 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.

[10] 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.

[11] 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).

[12] Id.  

[13] Id.

[14] Id.

Photo of Azim ChowdhuryPhoto of Eric GottingPhoto of John Gustafson

On March 27, 2018, a coalition of public health organizations including the Campaign for Tobacco-Free Kids, the Truth Initiative, the American Cancer Society and the American Academy of Pediatrics, among others, as well as several individual physicians (collectively the “NGOs”) filed a lawsuit in the United States District Court for the District of Maryland challenging the Food and Drug Administration’s (“FDA’s”) ability to extend the compliance policy deadlines for premarket authorization applications for deemed tobacco products (Case No. 8:18-cv-00883). On July 10, 2018, the NGOs filed a motion for summary judgment, available here.

The case challenges FDA’s August 2017 Guidance Document, Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule (the “Guidance”) which, among other things: (1) extended the deadlines for premarket applications for deemed tobacco products, such as e-liquids and vapor products, as well as cigars, hookah, and pipe tobacco; and (2) ended the one-year “sunset provision” in the initial compliance policy, permitting manufacturers to continue marketing deemed products that are the subject of timely filed premarket applications that have been accepted by FDA for scientific review.

The NGOs make three main arguments: (1) the Guidance unlawfully authorizes manufacturers to continue marketing newly-deemed tobacco products without obtaining the required FDA marketing order, contrary to the requirements of the Family Smoking Prevention and Tobacco Control Act (“TCA”); (2) the Guidance is an administrative “rule” and FDA issued it without providing the public notice and an opportunity to comment in violation of the Administrative Procedure Act (“APA”);[1] and (3) the Guidance is arbitrary and capricious because it provided inadequate justification for suspending premarket review and did not account for the public health cost of the continued marketing of unreviewed new tobacco products. The NGOs seek to have the Guidance vacated, which could prove disastrous for the vapor industry.

We summarize the NGO’s motion in more detail below.

Background on Premarket Authorization and FDA Compliance Policy for Deemed Tobacco Products

When the “Deeming Rule” became effective on August 8, 2016, the FDA extended its tobacco product authority to previously unregulated categories of products including, but not limited to, e-liquids and vapor products, as well as cigars, hookah, pipe tobacco and heat-not-burn products.[2] Deemed tobacco products are now subject to the Federal Food, Drug and Cosmetic Act (“FDCA”), as amended by the TCA, including, most critically, the requirement that all new tobacco products obtain FDA premarket authorization. A new tobacco product is any product introduced or modified after the February 15, 2007 “grandfather date”. Because there are no known grandfathered e-liquids or vapor products, all such products, including those that have been on the market for years, are required to obtain FDA marketing authorization through the onerous Premarket Tobacco Product Application (“PMTA”) process, which is separately being challenged by the vapor industry.[3]

In the preamble to the Deeming Rule, although it chose not to amend the grandfather date for deemed products, FDA included a “compliance policy” which effectively created marketing grace periods for newly deemed, finished tobacco products that do not have FDA premarket authorization.[4] Pursuant to the compliance policy, manufacturers were permitted to continue marketing e-liquids and vapor products in the U.S. that were on the market on August 8, 2016 until the end of the compliance period, at which time a PMTA would be due. Initially, this compliance period was only 24 months after the effective date of the rule, meaning PMTAs would have been due by August 8, 2018 for all vapor products.[5]

Further, the initial compliance policy created a marketing sunset period that permitted manufacturers of products for which premarket applications were submitted to continue sales for only an additional 12 months, pending FDA review of the applications. After that, if FDA had not yet ruled on an application, it would “consider, on a case-by-case basis, whether to defer enforcement of the premarket authorization requirements for a reasonable time period.”[6]  In other words, companies that submitted PMTAs for vapor products by August 8, 2018 would only be permitted to continue marketing the subject products until August 8, 2019, after which they would have to remove the products from the market while FDA reviewed the applications, no matter how long that would take, unless the Agency granted an exception.

However, in July 2017, FDA announced a new “comprehensive regulatory plan to shift the trajectory of tobacco-related disease, death” that, among other things, extended the premarket application compliance period for non-combustibles, including e-liquids and vapor products, until August 8, 2022. In other words, those products on the market as of August 8, 2016 can now remain on the market at least until August 8, 2022; after that date, only products that are the subject of PMTAs that have been accepted for review can remain on the market. FDA also eliminated the 12-month sunset period, allowing companies to continue marketing products while FDA reviews the PMTAs. FDA formalized the new deadlines in its August 2017 Guidance.

Argument No. 1: The Guidance’s authorization to continue marketing newly-deemed tobacco products without the required FDA marketing order is contrary to the requirements of the TCA.

The NGOs argue first that the Guidance is contrary to the mandates of the TCA.  They emphasize that the TCA directs that an FDA order authorizing a manufacturer to sell a new tobacco product “is required” before that product “may be introduced or delivered for introduction into interstate commerce.”[7] Therefore, the NGOs argue, both the Guidance’s extension of PMTA deadlines and its compliance policy effectively grant permission to market new tobacco products before FDA authorizes their sale, contrary to the TCA’s requirements.

The NGOs further note that the TCA requires that, “as promptly as possible, but in no event later than 180 days after receipt of a PMTA,” FDA “shall” issue an order that the new product may or may not be introduced.[8] The NGOs argue that this requirement renders the Guidance’s revised compliance policy unlawful because the policy permits the indefinite sale of new tobacco products without FDA ever having to complete premarket review.

The NGOs also address a defense likely to be invoked by FDA—that of “enforcement discretion,” the principle that, in the absence of statutory text to the contrary, executive agencies prioritize their own obligations, thereby reserving to their discretion the ability to effectively delay enforcement. The NGOs argue that the TCA does not grant FDA discretion to delay and that publishing a new policy that authorizes conduct Congress made unlawful is not within an agency’s enforcement discretion as the term is understood by courts.

Argument No. 2: The Guidance is a “rule” and FDA issued it without providing the public notice and an opportunity to comment in violation of the APA. 

Second, the NGOs contend that the Guidance is effectively a final rule and thus must undergo the procedural requirements of a rule, including the obligation to give the public notice of the proposed rule and an opportunity to make comments.[9]

The NGOs argue that the Guidance is a “rule” within the meaning of the APA because it affects the “rights and obligations” of stakeholders and “constrains the agency’s discretion.”[10] According to the NGOs, the Guidance creates a “right” to market products for several years without a marketing order from FDA and constrains FDA to engage in a premarket review or to bring enforcement actions against manufacturers marketing new products without first obtaining an order. The NGOs dismiss the Guidance’s disclaimer language that it is not “binding” by citing to case law stating that courts look at the “actual function and effect” of guidance over how it labels itself.

Argument No. 3: The Guidance is arbitrary and capricious because it provided inadequate justification for suspending premarket review and did not account for the public health cost of the continued marketing of unreviewed new tobacco products.

Continuing under the premise that the Guidance is a “rule” and thus a “final agency action” as those terms are defined by APA case law, the NGOs argue that the Guidance must be struck down because it is “arbitrary and capricious.”[11] An agency action is arbitrary and capricious under the APA if it is not the product of reasoned agency decision-making.

The NGOs maintain that FDA did not advance an explanation for the Guidance. Agencies must consider factors considered important by Congress when passing the law and other important aspects of the problem addressed by the statute (the TCA in this case).[12] Further, an agency must show that there are good reasons for a change in policy.[13] FDA published a press release before the Guidance explaining industry’s need for more time to comply with PMTA deadlines,[14] but the NGOs allege that the press release’s reasoning is vague and insufficient and therefore not persuasive.

Finally, the NGOs argue that the Guidance’s effect ultimately has a detrimental impact on public health, particularly youth. The NGOs assert that the detrimental effect to public health outweighs any advantage gained by the Guidance’s effects.

Potential Impact on the Vapor Industry

If successful, the NGO’s lawsuit, which paints an unfavorable, and inaccurate, portrait of a vapor industry bent on targeting and addicting minors could have a devasting impact for vapor companies. If the Guidance is vacated, for example, and the original compliance policy reinstated, vapor products without grandfathered status or premarket authorization, of which there are none, may have to be immediately removed from the market. This would not only be potentially devasting to the public health, as millions of vapers may go back to smoking cigarettes, but it would also put thousands of small companies out of business.

The case has been assigned to Judge Paul Grimm of the United States District Court for the District of Maryland. FDA’s response to the motion is due August 7, 2018. We will continue to monitor the progress of this lawsuit and will provide a summary of FDA’s response.

____________________________________________________________________

[1] 5 U.S.C. § 551 et seq.; 5 U.S.C. § 553.

[2] 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. 28,974 (May 10, 2016).

[3] Alternative premarket authorization pathways exist through submission of Substantial Equivalence (“SE”) Reports and SE Exemption Requests, but those pathways require reference to a grandfathered or predicate tobacco product, and thus are not available for the e-liquids and vapor products.

[4] 81 Fed. Reg. at 28,978.

[5] 81 Fed. Reg. at 28,978.

[6] 81 Fed. Reg. at 28,978.

[7] 21 U.S.C. §§ 387j(a)(2), (c)(1)(A)(i).

[8] 21 U.S.C. § 387j(c)(1)(A).

[9] N.C. Growers’ Ass’n, Inc. v. UFW, 702 F.3d 755, 764 (4th Cir. 2012).

[10] Chrysler Corp. v. Brown, 441 U.S. 281, 302 (1979) (internal quotation omitted); McLouth Steel Prods. Corp. v. Thomas, 838 F.2d 1317, 1320 (D.C. Cir. 1988).

[11] 5 U.S.C. § 706(2)(A).

[12] Motor Vehicle Mfrs. Ass’n of US., Inc. v. State Farm Mut. Auto Ins. Co., 463 U.S. 29, 43 (1983).

[13] FCC v. Fox Television Stations, Inc., 556 U.S. 502, 515 (2009).

[14] FDA News Release, “Protecting American Families: Comprehensive Approach to Nicotine and Tobacco,” https://www.fda.gov/NewsEvents/Speeches/ucm569024.htm (July 18, 2017) (last accessed: 08/02/18).

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On June 18, 2018, U.S. Food and Drug Administration (FDA) Commissioner Dr. Scott Gottlieb delivered remarks on “FDA’s Nicotine and Tobacco Regulation and the Key Role of Regulatory Science” at the Tobacco Regulatory Science Program Meeting.[1] While addressing the importance of regulatory science to inform FDA’s Center for Tobacco Products (CTP) regulatory efforts, Commissioner Gottlieb focused a portion of his remarks on the use of Electronic Nicotine Delivery Systems (ENDS) as tobacco harm reduction or smoking cessation tools and FDA’s role in their regulation.

“Preservation of E-Cigarettes”

According to Commissioner Gottlieb, utilizing scientific evidence and supporting new research to inform tobacco regulatory actions that protect public health is one of the primary missions of FDA’s CTP. Utilizing regulatory science to better understand e-cigarettes, Commissioner Gottlieb confirmed again that not all tobacco products are equally harmful, but that a “continuum of risk” exists, stating, “[w]e believe in the concept of a continuum of risk related to tobacco products, and we believe there is a role for modified risk products. Further, we want to preserve e-cigs as one among a number of possible options for adult smokers and believe that fully transitioning smokers to ENDS can reduce the morbidity and mortality associated with tobacco use.” Preservation of e-cigs as a possible option for adult smokers entails better understanding “the potential benefits of electronic nicotine products as smoking cessation tools.”

In his remarks, the Commissioner highlighted a recent report by the National Academies of Sciences (NAS), entitled “Public Health Consequences of E-Cigarettes.” You can read a summary of that report in a previous blog post here. Commissioned by FDA, the report makes clear, among other things, the reduced harm of e-cigarettes compared to smoking cigarettes and that completely switching from regular use of combustible cigarettes to e-cigarettes results in reduced short-term adverse health outcomes in several organ systems.[2]

Acknowledging those findings, Commissioner Gottlieb noted, “[p]otentially less harmful products – including the wide diversity of ENDS and other novel tobacco products – must be put through an appropriate series of regulatory gates to fully evaluate their risks and maximize their potential benefits.”

The Commissioner’s praise of vapor products as a potential reduced harm alternative for smokers, however, apparently does not apply to adolescents, for whom FDA maintains there is never a good reason to use any tobacco product, reduced harm or not – a position that has been criticized in some public health circles.

“Appropriate Series of Regulatory Gates” in the Context of the Deeming Rule Appeal

The Commissioner’s remarks on e-cigarettes were delivered in the midst of a lawsuit filed by Nicopure Labs, LLC and the Right to be Smoke-Free Coalition (appellants) challenging aspects of the Tobacco Control Act (TCA) and FDA’s Deeming Rule now pending before the U.S. Court of Appeals for the D.C. Circuit. This blog has been closely following the litigation, previously summarizing Appellants’ opening brief, as well as FDA’s brief and appellants reply brief. A list of all briefs can be found at the end of this blog post.

The Commissioner’s June 18 remarks, acknowledging the benefits of e-cigarettes as tools for adult smoking cessation, follow previous statements by Commissioner Gottlieb, the agency itself, the American Cancer Society (ACS), and an FDA-commissioned report acknowledging the lower risk associated with e-cigarettes in comparison to combustible tobacco and e-cigarettes’ potential public health benefits. As set forth at the outset of appellants’ final reply brief in the Deeming Rule appeal, those statements and findings include:

  • FDA stated numerous times during the rulemaking that vapor products are less harmful than traditional cigarettes.[3]
  • In announcing its Comprehensive Plan for regulating tobacco and nicotine, FDA recognized it must “strik[e] an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes.”[4]
  • FDA Commissioner Gottlieb and Mitch Zeller, Director of FDA’s Center for Tobacco Products, wrote in the New England Journal of Medicine that vapor products, when combined with measures to reduce nicotine levels in cigarettes, “represent[] a promising foundation for a comprehensive approach to tobacco harm reduction.”[5]
  • One of FDA’s supporting amici, the ACS, recently determined, “[b]ased on currently available evidence, using current generation e-cigarettes is less harmful than smoking cigarettes,” and concluded “switching to the exclusive use of e-cigarettes is preferable to continuing to smoke combustible products.”[6]
  • A recent NAS report commissioned by FDA, which the Commissioner mentioned in his June 18 remarks, confirms vaping is less risky than smoking.  The report, which is based on a review of over 800 articles, found: (i) conclusive evidence that completely substituting vaping with smoking reduces exposure to numerous toxicants and carcinogens; (ii) current evidence shows vapor products are less harmful than cigarettes; (iii) substituting vaping for smoking significantly reduces levels of biomarkers of exposure to toxicants; and (iv) vaping exclusively might be useful as a cessation aid in smokers.”[7]

Despite these recent statements, FDA continues to take a hard line in the pending appeal, where the agency argues: (1) the Modified Risk Tobacco Product (MRTP) provision in Section 911 of the TCA does not violate the First Amendment of the U.S. Constitution; (2) the free sample ban is a “price regulation,” so it is not subject to First Amendment protections; and (3) the Premarket Tobacco Application (PMTA) process was statutorily required and did not authorize nor require FDA to modify those requirements for vapor products. Each of these positions, as explained by appellants in the appeal, work against promoting continuum of risk and achieving risk reduction:

  1. Modified Risk Tobacco Product (MRTP) Claims: FDA’s defense of the MRTP provision will ultimately prevent vapor companies from making truthful statements and conveying information that would help adult consumers make informed decisions regarding vaping. As set out in appellants’ briefs, the incredibly onerous and expensive MRTP authorization process, which no company has been able to achieve yet, is ultimately a restriction on the First Amendment rights of consumers in the marketplace to obtain product-related information so they can make educated decisions.
  2. Free Sample Ban: Similarly, FDA downplays free samples as a mere “price regulation,” which are not subject to First Amendment challenge. To the contrary, and as demonstrated by appellants in their briefs, free samples allow manufacturers to pass on product information that adult consumers demand when contemplating a switch from more harmful cigarettes, and are thus protected under the First Amendment.
  3. The Premarket Tobacco Application (PMTA): FDA’s one-size-fits-all PMTA process for vapor products, which involves satisfying all pre-market review requirements for less risky vapor products, will also force the vast majority of vapor companies and less harmful vapor products out of the market absent some tailoring of certain requirements.

Oral arguments in the Deeming Rule appeal have been scheduled for September 11, 2018 before the U.S. Court of Appeals for the D.C. Circuit.

Links to all appeal briefs:

  • February 12, 2018: Appellants Nicopure and Right to be Smoke-Free file opening brief
  • February 20, 2018: Amicus briefs in support of appellants filed by: Washington Legal Foundation, NJOY, State of Iowa and CASAA
  • May 2, 2018: Appellee FDA’s brief filed
  • May 9, 2018: Amicus briefs in support of FDA filed by: Public Citizen, Yale Law School Scholars, Public Health Law Center, and various public health groups (American Academy of Pediatrics, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, American Thoracic Society, Campaign for Tobacco-Free Kids, and Truth Initiative)
  • May 16, 2018: Appellants Nicopure and Right to be Smoke-Free file reply brief
  • June 5, 2018: Appellee FDA files a final copy of its opening brief with updated citations to the administrative record
  • June 6, 2018: Appellants Nicopure and Right to Smoke-Free file final copies of their opening and reply briefs with updated citations to the administrative record

The Right to be Smoke-Free Coalition and Nicopure Labs are represented in the appeal by Keller and Heckman LLP Partners Eric Gotting and Azim Chowdhury. For more information on the lawsuit and to contribute to the appeal efforts, visit www.r2bsmokefree.org.

[1] Gottlieb, S. (2018, June 18). FDA’s Nicotine and Tobacco Regulation and the Key Role of Regulatory Science. Speech presented at Tobacco Regulatory Science Program Meeting, White Oak, MD. Available at https://www.fda.gov/NewsEvents/Speeches/ucm611033.htm.

[2] 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.

[3] Opening brief of appellants at 7. Available at Gottlieb, S. (2018, June 18). FDA’s Nicotine and Tobacco Regulation and the Key Role of Regulatory Science. Speech presented at Tobacco Regulatory Science Program Meeting, White Oak, MD. Retrieved from https://www.fda.gov/NewsEvents/Speeches/ucm611033.htm.

[4] FDA News Release, FDA Announces Comprehensive Regulatory Plan to Shift Trajectory of Tobacco-Related Disease, Death (July 28, 2017), https://tinyurl.com/y7bybf6c.

[5] Scott Gottlieb, et al., Perspective: A Nicotine-Focused Framework for Public Health, New Eng. J. Med. (Sept. 21, 2017), https://tinyurl.com/yatrpq68.

[6] ACS, Position Statement on Electronic Cigarettes (Feb. 15, 2018),  https://tinyurl.com/ybadn9cl; see also a summary of ACS’s most recent position statement in a previous blog post, available at https://www.thecontinuumofrisk.com/2018/06/american-cancer-society-acknowledges-reduced-harm-electronic-nicotine-delivery-systems-warns-dangers-misleading-consumers/.

[7] NAS, PUBLIC HEALTH CONSEQUENCES OF E-CIGARETTES, at S-9, 18-2, 18-13, 1823, https://tinyurl.com/ycxlymgf.

Photo of Azim ChowdhuryPhoto of Benjamin Wolf

 

 

Tobacco product manufacturing establishments in the United States must register with the Food and Drug Administration (FDA) immediately upon beginning manufacturing operations (e.g., the manufacture, preparation, compounding, or processing of a tobacco product).  As part of the registration process, establishment operators must submit a detailed list of products manufactured at the establishment, along with copies of all labeling (see our full summary of the registration requirement here).  This registration must be renewed annually before midnight on December 31 (Eastern time) every year, and product lists must be updated bi-annually: by midnight June 30 and December 31 every year.

This means that operators of manufacturing establishments of newly deemed products (e.g., vapor, cigars, hookah, etc.) on the market as of August 8, 2016 that have made changes to their product offerings must update their product lists with FDA by tomorrow, June 30, 2018, or as soon as possible to avoid FDA enforcement (considering the likelihood that FURLS may crash, the sooner you start this process, the better). Specific examples of changes that need to be updated (in FURLS, if you used that system to register online) include (1) discontinuing products on your product list that you are no longer actively manufacturing, (2) adding new products that are now being manufactured (e.g., co-packers now manufacturing pre-August 8, 2016 products that were not on the co-packers’ initial product list), (3) adding a new manufacturing location for products already listed by another establishment, or (4) labeling changes (including rebranding) of existing products.

Note that if you are planning to update your labels to comply with FDA’s nicotine addiction warning and other labeling requirements (that go into effect on August 10, 2018) after June 30, you have until December 31, 2018 to update your product listing with the revised labels.

If you have any questions about Registration and Product Listing or any of the other Tobacco and Control Act requirements, contact Azim Chowdhury (202.434.4230, chowdhury@khlaw.com) or Ben Wolf (202.434.4103, wolf@khlaw.com). 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.

Photo of Azim Chowdhury

On June 11, 2018, the American Cancer Society (“ACS”) released a statement entitled, “The American Cancer Society Public Health Statement on Eliminating Combustible Tobacco Use in the United States’ (“Statement”).[1] The Statement sets forth the ACS’s goal of eliminating exposure to combustible tobacco smoke and provides three strategies for the ACS to enhance its approach in tobacco prevention and control.

This Statement follows its earlier “Position Statement on Electronic Cigarettes,” released on February 15, 2018, which acknowledged, for the first time, that e-cigarettes, also known as Electronic Nicotine Delivery Systems (ENDS), play an important role in helping certain smokers quit.[2] In that prior position, ACS suggested that physicians should encourage individuals that will not use FDA-approved cessation medicines to switch to using ENDS.[3] This latest Statement takes that position further, as the ACS commits to joining in on efforts to better understand how or whether ENDS might be integrated into evidence-based cessation options, and the organization also warns about the misinformation given to consumers about those products.

 “Rapidly Changing Tobacco Marketplace” and the Consumer Misperception about ENDS

The ACS’s stated highest priority is to eliminate cancer caused by tobacco use as cigarette smoking is the leading cause of mortality in the U.S.[4] Placing its Statement in the context of what is calls, “the rapidly changing tobacco marketplace today,” the ACS acknowledges that tobacco control has increasingly become a social justice issue, as the percentage of smokers at the greatest risk (e.g. because of their low socioeconomic status, lower educational attainment, etc.) has risen markedly.[5]

Given today’s landscape, the Statement highlights the need for consumers to receive accurate information about different tobacco products and the role that nicotine plays in disease.[6] Citing numerous studies and reports, the Statement posits that although the “current generation ENDS are markedly less harmful than combustible tobacco products,”[7] “[m]any adults believe, erroneously, that ENDS are as harmful as combustible tobacco products, and the level of public understanding has deteriorated overtime.”[8] The Statements cites the Monitoring the Future study, which reported that as of 2017, “e-cigarettes have one of the lowest levels of perceived risk for regular use of all drugs, including alcohol,” among adolescents.[9] And to contrast e-cigarette use with combustible (burned) tobacco products, the Statement notes that while ENDS delivers nicotine, flavor additives and other chemicals, they do not actually burn tobacco – a process that yields an estimated 7000 chemicals, including at least 70 carcinogens.[10]

Three Strategies to Eliminate All Combustible Tobacco Use: Lending Support to Further Utilizing ENDS for Tobacco Cessation

The Statement outlines three separate strategies to eliminate all combustible tobacco use-all of which involve some component linked to ENDS.

  • Promote Increased Access and Utilization of Cessation Options for Smokers, With an Emphasis on Preventing Dual Use

As part of its first strategic effort, the ACS will work to promote tobacco-cessation strategies and develop health care provider and consumer-facing materials with information on the risks associated with tobacco products and cessation treatment options.[11] As a part of this communications strategy, the ACS notes that it intends to communicate to consumers that current-generation ENDS are less harmful than combustible tobacco products, and it provides that the ACS will contribute to research to determine how or whether ENDS might be integrated into evidence-based cessation options.[12]

  • Prevent Initiation of ENDS by Youth and Other High-Risk Demographic Groups

Despite noting the lesser risks associated with ENDS relative to combustible tobacco use, the Statement still holds that protecting youth from cigarette smoking and the use of novel tobacco products remains a priority.[13] The ACS will advocate for tobacco-free policies, including ENDS in all cases, as well as for policies to raise the minimum age for sale of all tobacco products, including ENDS.[14] The ACS makes clear that it will continue to oppose what it calls, “the widespread exposure of youth to e-cigarette advertising.”[15]

  • Promote and Support a Comprehensive Tobacco and Nicotine Regulatory Framework

As part of its broader regulatory strategy, the Statement describes a “continuum of risk” for tobacco products, noting that while science is mixed, ENDS are likely to be much less harmful that combustible tobacco products.[16] Among other proposals, the Statement again commits to conduct further scientific research, including research related to the short-term and long-term risks of using ENDS and the impact of ENDS on tobacco use behavior.[17]

Conclusion

Taking its February 15, 2018 statement on electronic cigarettes one step further, this latest announcement by the ACS makes clear that the organization intends to contribute to further research on whether e-cigarettes may be utilized for tobacco cessation strategies. However, the ACS continues to advocate for tobacco-free policies, which include the use of ENDS, and the organization remains concerned about preventing youth initiation of ENDS, which has fallen dramatically since 2015, along with all tobacco use.

[1] The American Cancer Society Public Health Statement on Eliminating Combustible Tobacco Use in the United States (Clifford E. Douglas, et al., 2018) available at https://onlinelibrary.wiley.com/doi/full/10.3322/caac.21455 (hereinafter, referred to as the “Statement”).

[2] American Cancer Society Position Statement on Electronic Cigarettes (2018) available at https://www.cancer.org/healthy/stay-away-from-tobacco/e-cigarette-position-statement.html.

[3] Id.

[4] Statement, supra n.1. at 1.

[5] Id., supra n.1. at 5.

[6] Id., supra n.1. at 2.

[7] Id., supra n.1. at 4.

[8] Id., supra n.1. at 1.

[9] Johnston LD, Miech RA, O’Malley PM, Bachman JG, Schulenberg JE, Patrick ME. Monitoring the Future: National Survey Results on Drug Use, 1975‐2017. Overview, Key Findings on Adolescent Drug Use. Ann Arbor, MI: Institute for Social Research, The University of Michigan; 2018. monitoringthefuture.org/pubs/monographs/mtf‐overview2017.pdf.

[10] Id., supra n.1. at 1.

[11] Id., supra n.1. at 2-3.

[12] Id., supra n.1. at 3.

[13] Id., supra n.1. at 3.

[14] Id., supra n.1. at 4.

[15] Id., supra n.1. at 4.

[16] Id., supra n.1. at 4.

[17] Id., supra n.1. at 5.

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On May 1, 2018 the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued 13 warning letters to companies that they claim misleadingly labeled or advertised nicotine-containing e-liquids as kid-friendly food products such as juice boxes, candies, and cookies.  Warning letters were issued to manufacturers, distributors, and retailers of eight products.

All of the warning letters included allegations of misbranding under Sections 903(a)(1) and 903(a)(7) of the Food, Drug, and Cosmetic Act (FDCA) – both of which relate to labeling or advertising that is misleading or untrue in any particular – and Section 5 of the FTC Act for unfair or deceptive advertising.  Both the FDA and FTC alleged violations are based on the risk of confusion, especially by children, between the e-liquid products and foods that are marketed toward, or appealing to, children.

In some of the warning letters issued to distributors and retailers, FDA added allegations that the e-liquids were sold to minors in violation of Section 903(a)(7)(B) of the FDCA.  In one instance, FDA alleged that the company violated Section 201(rr)(4) of the FDCA – which bars the marketing of a tobacco product “in combination with any other article or product regulated” by FDA – because a combination pack of candy and e-liquid were offered together.  The warning letters also highlighted the potential harm that could result if nicotine-containing e-liquids are ingested by children, although the number of poison center calls regarding e-liquids has fallen dramatically since the Children’s Nicotine Poisoning Prevention Act went into effect in 2016.  That law requires “liquid nicotine containers” use child-resistant packaging just like prescription drugs, some over-the-counter (OTC) drugs, and other potentially hazardous products found in the home, pursuant to the Poison Packaging Prevention Act.

The issuance of the 13 warning letters comes about a week after FDA Commissioner Gottlieb announced that FDA (1) recently issued warning letters to 40 retailers for underage sales of JUUL products, (2) was in the midst of a “new blitz of retail establishments targeting youth sale violations”, (3) is seeking to end sale of JUUL products to minors, and (4) would examine the youth appeal of JUUL products.  FDA also requested JUUL Labs submit information regarding, among other things, its marketing, research studies, and how certain product features might appeal to different age groups.  While some have argued that the panic over JUUL, which appears to be based on anecdotal evidence and media reports, could actually adversely impact the public health, there is no doubt that FDA is committed to cracking down on underage sales and reducing youth appeal of tobacco products, including vapor products.

In light of the warning letters issued on April 24 and May 1 and the Agency’s interest in tobacco product flavors, it appears that FDA may be setting its sights on the elimination of flavored e-liquids, which have also been shown to help adult smokers transition to less harmful vaping alternatives, as part of its effort to curb the use of vapor products by youth. Of note, a recent study evaluating how young people use vapor products in the United Kingdom, where the products are actively promoted by the government as less harmful than cigarettes and as a way to quit smoking, found that most product experimentation does not turn into regular use, and that regular use of vapor products in young people who have never smoked remains very low.

Industry and other stakeholders interested in maintaining the availability in the U.S. of flavored e-liquids have until June 19, 2018 to submit comments to FDA’s Advanced Notice of Proposed Rulemaking.

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The new European Union (EU) General Data Protection Regulation (GDPR) replaces the Data Protection Directive on May 25, 2018 and will directly impact all companies, including vapor product retailers and businesses, that market and sell products to consumers in the EU and/or employ residents of the EU. The reforms will give European consumers new rights and control over the personal data collected from and about them, and impose new obligations on businesses within and outside of the EU that collect personal information from EU citizens, regardless of where they reside, or from individuals who reside in the EU, regardless of their nationality.  Given the magnitude of potential penalties for violations of the GDPR (supervisory authorities are authorized to impose fines of up to 4% of global annual turnover for serious infringements and 2% for less serious infringements), it is imperative that vapor product retailers and others selling into the EU or handling data about Europe-based individuals ensure they are GDPR-ready.

The new rules empower individuals by, among other things, (1) providing easier access to personal data and more information on how data is processed, (2) facilitating data portability, or transfers of personal data between service providers, (3) clarifying the fundamental “right to be forgotten” for individuals who no longer wish for their data to be processed, and (4) requiring expedited notifications to the national supervisory authority by companies that experience a data breach affecting personal data.

Most companies operate with multiple streams of data, such as HR data, consumer data, vendor/supplier data, and the like. A good starting point is for businesses to assess their current data collection practices and identify gaps, and use that to map out a step-by-step compliance plan specific to their data collection practices that fully prepares them for the new GDPR world.

We provide below a summary of the key requirements in the GDPR and a compliance checklist for businesses. Please note that the summary and checklist are provided for informational purposes only, and do not constitute legal advice regarding specific facts or circumstances.

GDPR KEY REQUIREMENTS
Personal Data The term “personal data” means “any information concerning an identified or identifiable natural person.” An identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, identification number, location data, online identifier or to one or more factors specific to the individual’s physical, physiological, genetic, mental, economic, cultural or social identity.
Extraterritorial Effect The Regulation applies not only to the processing of personal data by controllers and processors in the EU, but also the processing of personal data of data subjects who are in the EU by a controller or a processor not established in the EU, if the processing activities are related to offering goods or services to the data subjects or monitoring their behavior within the EU.
Lawfulness of Processing To be lawful, at least one of the following must apply:

  • The data subject consents;
  • Processing is necessary for the performance of a contract to which the data subject is a party;
  • Processing is necessary for compliance with a legal obligation to which the controller is subject (under EU or Member State law);
  • Processing is necessary to protect the vital interests of the data subject or another natural person;
  • Processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller (under EU or Member State law);
  • Processing is necessary for legitimate interests pursued by the controller or a third party, except where such interests are overridden by the interests or fundamental rights and freedoms of the data subject which require protection of personal data, in particular where the data subject is a child.
Consent Consent to processing must be unambiguous, specific, informed, and freely given (for example, checking a box at a website or choosing technical settings). Pre-checked boxes do not constitute consent. For sensitive data (for example, data revealing race or ethnic origin, political opinions, religious or philosophical beliefs, trade union membership, genetic data, biometric data, data concerning health or data concerning a natural person’s sex life or sexual orientation), consent must be explicit. When processing has multiple purposes, consent should be given for all of them. Consent may be withdrawn.
Data Processing Processing of personal data must be lawful, fair, and transparent. Individuals should be made aware of the risks, rules, safeguards and their rights in relation to the processing of personal data. The specific purposes for which personal data are processed should be explicit and legitimate and determined at the time of the collection. Personal data should be adequate, relevant and limited to what is necessary for the purposes for which they are processed. Time limits should be established for erasure or periodic review. Personal data should be processed in a manner that ensures appropriate security and confidentiality.
Right to be Forgotten Individuals have a right to request deletion of data, with some exceptions (for example, if retention is legally required).
Data Portability Individuals have the right to easily transfer personal data between different service providers.
Children Special rules apply to children’s data. Where a child is below age 16, processing is lawful only if parents or guardians consent. Member States may establish a lower age for these purposes, so long as the age is not below age 13.
Controller Responsibility Personal data must be processed under the responsibility and liability of the controller, who must ensure and document compliance for each processing operation. Controllers should only use processors who provide sufficient guarantees in terms of expert knowledge, reliability and resources to implement technical and organizational measures that will meet the requirements of the Regulation. Adherence to an approved code of conduct or certification mechanism may be used to demonstrate compliance. There must be controller-processor agreements in place that describe the subject matter, duration, nature and purposes of the processing, type of personal data, and categories of data subjects. Upon completion of the processing, the processor must, at the controller’s election, return or delete the data, unless the processor is required by law to store it. Joint and several liability for controllers and processors.
Data Protection Impact Assessments

Data controllers must conduct Data Protection Impact Assessments (DPIAs) for “risky” processing. DPIAs should be completed before beginning any type of processing which is “likely to result in a high risk.” This means even though the actual level of risk may not have been assessed, a DPIA may be necessary based on identifying factors that point to the potential for a widespread or serious impact on individuals. Some jurisdictions may impose DPIA requirements on specific types of processing.

 

If the DPIA indicates that processing involves a high risk that cannot be mitigated, controller should consult supervisory authority (DPA) prior to the processing.

Data Protection Officer Organizations must appoint a data protection officer (DPO) in three situations: the processing is carried out by a public authority; the core activities of the controller or processor consist of processing operations which require regular and systematic processing of data subjects on a large scale; or the core activities involve processing sensitive data or criminal convictions on a large scale.
Documentation Controllers and processors must document all processing and make documentation available to DPA on request.
Data Breach Notification Controllers must notify DPA within 72 hours of learning of a breach, where feasible; no notification is required if a breach is unlikely to result in risk to the rights or freedoms of individuals. Controllers must notify data subjects without undue delay, where the breach is likely to result in a high risk to their rights or freedoms. Notifications to data subjects should describe the nature of the breach and recommendations for individuals to mitigate potential adverse effects. Processors must notify controllers.
Streamlined Approvals A single DPA can be designated the lead, enabling multiple DPAs to handle cases in a more streamlined manner.
Codes of Conduct and Certification Codes of conduct are encouraged, and are subject to approval by the Commission, and compliance should be monitored by an appropriate expert, accredited body. Approved codes of conduct will be registered and published. Data protection certification mechanisms, seals and marks are encouraged.
Transfers to Other Countries Transfers to other countries are permitted based on a determination that the country provides adequate protection of privacy; transfers are subject to adequate safeguards (for example, binding corporate rules, standard contractual clauses, an approved code of conduct, approved certification mechanisms, explicit informed consent).
Reduced Notifications Supervisory notifications about data processing are no longer required, but permission is required to process certain categories of data.
Art 29 Working Party (WP29) WP29 will be “upgraded” to an independent European Data Protection Board.
WP29 Guidance WP29 has issued guidance on several aspects of the GDPR that provide clarification and recommendations:

DPA Enforcement DPAs have enhanced enforcement powers, including expanded investigatory authority.
Complaints and Remedies EU citizens can lodge complaints with local DPAs, even where data is processed extra-territorially, and have the right to a judicial remedy against supervisory authorities who fail to act and against controllers and processors.
Penalties DPAs are authorized to impose fines of up to 4% of global annual turnover for certain serious infringements; 2% for less serious infringements.


GDPR Compliance Checklist 

Types of Personal Data Collected
Identify types of data collected
Identify sensitive data
Identify data collected from children/ whether parental consent is required
Data Processing
Appoint data protection officer (DPO)
DPOs must be appointed if:

  • The processing is carried out by a public authority;
  • The core activities of the controller or processor consist of processing operations which require regular and systematic processing of data subjects on a large scale; or
  • The core activities involve processing sensitive data or criminal convictions on a large scale.
  • May also be Operating/established in a jurisdiction (such as Germany) with more stringent requirements.
  • WP29 guidance on DPOs
  • “Core activities”: defined by WP29 as those that are integral to “the controller’s or processor’s activity.”
  • “Large scale”: WP29 recommends that businesses consider the number of data subjects concerned; the volume of data or range of data items; and the duration and the geographical extent of the processing.
  • “Regular and systematic monitoring”: WP29 states this would “include all forms of tracking and profiling on the internet, including for the purposes of behavioral advertising.”
Confirm the lawful basis for the processing:

  • Consent
  • Necessary for compliance with a legal obligation to which the controller is subject
  • Necessary for the performance of a contract to which the data subject is a party
  • Necessary to protect an individual’s vital interest
  • Legitimate interests of the controller (i.e., providing client services or preventing fraud)
  • Transfers of personal data among controllers within an affiliated group for internal administrative purposes
  • Strictly necessary and proportionate for ensuring network and information security
If consent is the basis for the processing:

  • Must be unambiguous, specific, informed, and freely given
  • Must obtain consent for each processing activity/purpose
  • Explicit consent required for sensitive data
Confirm that personal data collected is adequate, relevant and limited to what is necessary for the purpose(s)
Determine whether a data protection impact assessment (DPIA) is required (high-risk processing)

  • Systems that analyze a person’s economic situation, location, health, personal preferences, reliability or behavior
  • Video surveillance systems
  • Data in large scale filing systems on children, genetic or biometric data
DPIA, if required, should address

  • Contemplated processing and purposes
  • Necessity and proportionality of the processing in relation to the purposes
  • Risks to the rights and freedoms of data subjects
  • Safeguards and security measures to address the risks
If DPIA indicates that processing would result in high risk, then consult DPA prior to processing
Data subjects must be informed about:

  • Identity and contact information for controller and DPO
  • Purposes of the processing and legal basis
  • Recipients/ categories of recipients of personal data
  • Period for which personal data will be stored
  • Right to request access to and correction or erasure of personal data or to restrict processing
  • Right to withdraw consent at any time
  • Right to file complaint with supervisory authority
Review privacy policies and update as necessary
Establish system for documenting processing operations
Amendments to third-party contracts to ensure compliance with GDPR and e-Privacy Directive (and eventually e-Privacy Regulation)
Data Storage
Determine where and how data is stored
Establish limits for erasure of data and periodic reviews
Review data retention policies to ensure data only kept for as long as necessary
Establish and/or review processes for rectifying or deleting inaccurate data
Prepare template responses for data access requests
Data Transfers to Other Countries
Review and analyze global data flows
Assess validity of current mechanisms for transfers of personal data from the EU to the U.S. or other countries, for example:

  • Adequacy determination
  • Binding corporate rules
  • Standard contractual clauses
  • EU–U.S. Privacy Shield
  • Codes of conduct
  • Certification mechanisms
  • Explicit, informed consent in limited circumstances
Assess feasibility/benefits of approved codes of conduct and certification mechanisms
Assess need for controller-controller and/or controller-processor agreements; review content for compliance with new requirements
Data Security
Review technical and organizational measures in place to prevent unlawful destruction, loss, alteration, disclosure of/ access to personal data

  • Pseudonymization and encryption
  • Ability to ensure ongoing confidentiality integrity, availability, and resilience of processing systems and services
  • Ability to restore availability and access to data in timely manner in the event of a physical or technical incident
  • Process for regularly testing, assessing and evaluating the effectiveness of the security measures in place
Ensure that processors are employing adequate technical and organizational measures; address in contracts
Establish and/or update data breach response plan

For more information on the GDPR or other privacy or data security matters, and how they affect businesses involved in e-liquid and vapor products, please contact Tracy Marshall (+1 202.434.4234, marshall@khlaw.com), Azim Chowdhury (+1 202.434.4230, chowdhury@khlaw.com), or Nathan A. Cardon (+1 202.434.4254, cardon@khlaw.com).

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The 2nd Annual Keller and Heckman E-Vapor and Tobacco Law Symposium held on February 6-7, 2018 in Irvine, California was a huge success with over 100 attendees from all over the country and world.  Check out the highlight video below.  We are in the process of securing a location for next year’s symposium and would like your feedback on potential locations (Irvine, Miami, Dallas or Washington, DC).  Please take a moment to complete the brief survey here.

Take a look at highlights from this year’s conference:

Click on the link below to receive updates on the 2019 E-Vapor and Tobacco Law Symposium.

For questions or additional information,  please contact:

Sara A. Woldai

Manager, Marketing Meetings and Events

Keller and Heckman LLP

woldai@khlaw.com

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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.[1]  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.[2]  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. [3]

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.[4]
  • 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.[5]
  • 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.”[6]  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.[7]
  • 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.[1]  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.”[8]  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.[9]

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.”[10]  That study concluded that “use characteristics, cigar smoking patterns, and dual smoking with cigarettes varied by cigar type.”[11]

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.[12]
  • 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.[13]
  • 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.

Summary

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.

[1]              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.

[1]              Regulation of Flavors in Tobacco Products, 83 Fed. Reg. 12294 (Mar. 21, 2018);

[2]              Regulation of Premium Cigars, 83 Fed. Reg. 12901 (Mar. 26, 2018).

[3]              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.

[4]              83 Fed. Reg. 12994, 12998-99 (Mar. 21, 2018).

[5]              83 Fed. Reg. 12999.

[6]              Id.

[7]              Id.

[8]              83 Fed. Reg. 12901, 12902 (Mar. 26, 2018).

[9]              83 Fed. Reg. 12902. (emphasis added).

[10]             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.

[11]             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.

[12]             83 Fed. Reg. 12903.

[13]             83 Fed. Reg. 12904.

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In the U.S. Food and Drug Administration’s (FDA’s) latest effort to implement its comprehensive regulatory plan[1] 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.[2]  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.[3]  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.”[4]

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.[5]  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.”[6]  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.[7]

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.”[8]  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.[9]  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.[10]  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).[11]

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.”[12]  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.[13]  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.[14]  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.[15]  Under the same model, by 2060, it is estimated that a median value of almost 3 million deaths due to tobacco would be avoided.[16]

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.”[17]  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.[18]  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.[19]   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.

 

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[1] 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.

[2] 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.

[3] 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.

[4] Id., at 6

[5] Id., at 7.

[6] Id., at 8.

[7] Id., at 33.

[8] 21 U.S.C. § 387g(d)(3)(B)

[9] Tobacco Product Standard for Nicotine Level of Combusted Cigarettes Advanced Notice of Proposed Rulemaking (ANPRM), at 9.

[10] Id., at 9.

[11] Id., at 9

[12] Id., at 10.

[13] 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.

[14] Id., at 74.

[15] Id., at 75.

[16] Id., at 75.

[17] Id., at 26.

[18] Id., at 69.

[19] Id., at 74.