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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 ChowdhuryPhoto of Eric Gotting

On May 2, 2018, the U.S. Food and Drug Administration (FDA) filed its brief in response to Appellants Nicopure and Right to be Smoke-Free Coalition’s appeal in the lawsuit challenging aspects of the Tobacco Control Act (TCA) and the Deeming Rule now pending before the U.S. Court of Appeals for the D.C. Circuit. FDA’s brief was supported by amici briefs filed by several NGOs and public health groups (who recently dropped their motion to intervene as actual parties to the appeal). Appellants filed their reply brief on May 16, 2018. (Links to all the appeal briefs are below.)

Issues on Appeal

In their opening brief, which was supported by a number of amici (Washington Legal Foundation, NJOY, CASAA, the State of Iowa, and Clive Bates et al.), appellants argue that (1) FDA was obligated to consider a less burdensome Premarket Tobacco Product Application (PMTA) process for vapor products while still protecting the public health, (2) the Modified Risk Tobacco Product (MRTP) provision of the TCA as it is being applied to vapor products violates the First Amendment of the U.S. Constitution, and (3) the ban on free samples of vapor products also violates the First Amendment.  We summarize FDA’s response to the appeal, and appellants counter-arguments below.

The Premarket Tobacco Application (PMTA)

With respect to the PMTA, FDA predictably argues that, once deemed, vapor products are tobacco products subject to all the requirements in the TCA, including premarket review. According to the agency, FDA has no choice but to apply the statutory requirements established by Congress, and that the decision not to tailor such requirements for vapor products was not arbitrary and capricious. Appellants, however, counter that they are not actually seeking a complete exemption from the PMTA or the “population effects” (public health) standard, but rather are only arguing FDA either was required to, or arbitrarily and capriciously failed to, tailor how the vapor industry demonstrates compliance with this standard. Such tailoring is necessary because requiring randomized, controlled trials or long-term epidemiological studies for each e-liquid and device would, by FDA’s own admission, eliminate up to 97% of manufacturers and the vast majority of products on the market – which flies in the face of the TCA’s clear intent to ensure that adults continue to have access to less harmful tobacco products.

While FDA maintains it will consider this option on a case-by-case basis, that is simply not enough when entire categories of vapor products could be effectively banned before PMTAs are even submitted. FDA must allow vapor companies on an industry-wide basis to file PMTAs that rely on information and data alternatives to satisfy the public health standard without having to conduct prohibitively expensive, long-term studies for each product before submitting an application. At a minimum, it was arbitrary and capricious for FDA not to adopt this option or adequately consider it during the rulemaking.

Modified Risk Tobacco Product (MRTP) Claims

FDA argues that the requirement that the agency conduct a “premarket review” of modified risk tobacco products is not a regulation of commercial speech subject to First Amendment protection (just like FDA’s review of new drug products) and that, even if it were, the requirement is narrowly tailored to further the government’s substantial interest, as required to meet the “intermediate scrutiny” standard for government limitations on commercial speech. FDA points to Congress’s extensive findings concerning Big Tobacco’s long history of marketing light, mild and low tar cigarettes as safer than regular cigarettes, and the resulting public health consequences.

But appellants argue that modified risk designation of tobacco products does not rely on a manufacturer’s intent (unlike new drugs), and so MRTP claims are protected by the First Amendment. Moreover, FDA cites nothing in either the TCA or the administrative record showing that the agency gave any consideration, as the Administrative Procedure Act requires, to how plainly truthful claims about vapor products (e.g., “no tar,” “no combustible smoke,” “no ash,” “no diacetyl”), which are designed to help smokers move away from cigarettes, might actually be interpreted by consumers. Insisting that, because of Big Tobacco’s past indiscretions, it is the vapor industry’s duty – not the government’s – to demonstrate in the first instance that entirely truthful statements are not potentially misleading puts the cart-before-the-horse.

Free Sample Ban

FDA argues that the ban on the distribution of free vapor product samples (1) does not implicate the First Amendment because it is effectively a price regulation focused on conduct that regulates economic activity rather than expression and that, (2) even if the prohibition were viewed as a speech restriction, it would withstand review under the intermediate scrutiny standard because it is narrowly tailored to further the government’s substantial interest in preventing youth access to tobacco products.

But according to the Appellants, FDA’s position completely ignores the underlying purpose of the commercial speech doctrine, i.e., the free flow of commercial information through advertising, which warrants First Amendment protection so consumers can make intelligent and well-informed purchasing decisions. As Consumer Advocates for Smoke-Free Alternatives Association (CASAA) made clear in its amicus brief in support of the appellants, a substantial amount of information is furnished through free samples regarding e-liquid flavors and device performance that adult consumers require. Record evidence shows that when deciding whether to switch from significantly more harmful cigarettes, consumers must be able to understand how vapor products work, taste various flavors, and experience the sensation and performance levels of different devices. Samples are needed to convey this information – it is not enough for sellers to simply make representations through other channels, such as written materials or retailer demonstrations.

Moreover, requiring companies to charge a fee to sample products will limit the amount of information conveyed through sampling, whether because consumers are price sensitive, reluctant to spend money on an unfamiliar or novel product, or otherwise. Vapers engage in a routine and ongoing sampling process of multiple products as they switch from cigarettes. The act of constantly paying for each sample tested presents an unnecessary hurdle.

FDA also never acknowledges the Supreme Court’s test for determining whether the ability to distribute free samples possesses sufficient communicative elements (i.e., an intent to convey a particularized message) to bring the First Amendment into play. Rather, FDA asserts that it is only regulating conduct, turning a blind eye to the extensive record evidence that manufacturers and retailers not only offer free samples with the specific intent to convey important information to consumers, but also that consumers themselves understand testing free samples will help them make critical choices in the marketplace affecting their health and well-being.

Finally, FDA points to how cigarette manufacturers in the past failed in their efforts to limit youth access (and would distribute cigarettes at youth-oriented events like concerts), and argues that the exception in the TCA permitting free samples of smokeless tobacco in qualified-adult-only-facilities will not work for vapor products. But nowhere in FDA’s brief or the administrative record, according to appellants, is there any evidence – whether through studies, surveys, anecdotal reports, or otherwise – demonstrating that underage individuals are obtaining free samples of vapor products from venues or events only frequented by adults – e.g., vape shops, trade shows, and adult-oriented concerts. In fact, vast swaths of the vapor marketplace – primarily vape shops – are swept-up in the free sample ban when it is pure speculation and conjecture on FDA’s part to conclude that minors have easy access to samples through such channels. This approach is not permitted under the First Amendment.

Rather than a prophylactic ban on free vapor product samples, there are a number of non-speech related alternatives that FDA could implement to restrict youth access to free tobacco product samples, such as:

  1. prohibiting free samples at youth-oriented events;
  2. limiting free samples to adult-only, age-verified facilities where the sample must be used or consumed on-site so as to prevent removal and any access by the general public;
  3. aggressively enforcing minimum age requirements; and
  4. conducting education campaigns aimed at minors.

In short, FDA’s treatment of free vapor product samples fails to balance the government’s interest in preventing youth access with Congress’s stated goal of allowing adults continued access to less harmful tobacco products.

Links to all briefs:

Oral arguments will likely be scheduled in the Fall of 2018. We will keep you updated on the progress of the appeal.

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.

Photo of Azim ChowdhuryPhoto of Adam Susser

 

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.

 

______________________________________________________

[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.

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February 26, 2018 – Keller and Heckman LLP is pleased to announce the introduction of its Audit and Inspection Program (AIP) for Tobacco and Vapor Product Manufacturing Establishments.

The AIP was developed in response to the Food and Drug Administration’s (FDA) inspection authority under the Food, Drug, and Cosmetic Act (FDCA or the Act), as amended by the Tobacco Control Act, which provides that FDA shall inspect each factory, warehouse, establishment, or vehicle in which tobacco products, including deemed tobacco products, are manufactured, processed, packed, or stored.  Pursuant to Sections 704 and 905 of the Act, FDA is directed to inspect every establishment at least once every two years.

Audit and Inspection Program

Keller and Heckman’s experienced team of attorneys and scientists will provide a comprehensive, on-site training and facility auditing program designed to help your company adequately prepare for an FDA inspection.  As part of the AIP, companies can expect:

  • An introductory presentation and memorandum detailing FDA’s inspection authority, what to expect during an inspection, and how to adequately prepare for – and respond to – an FDA inspection;
  • A full facility audit, consisting of a complete mock-inspection; and
  • A written post-inspection report detailing the overall readiness of the facility for an FDA inspection, including a list of specific recommendations and opportunities for improvement*

Keller and Heckman’s AIP program is designed to provide companies that are involved in any aspect of the tobacco or vapor product supply chain with confidence that their facilities are operating in accordance with FDA requirements.  The AIP will consider a broad range of inspection activities, including: recordkeeping, product labeling, product samples, requests for video/audio/photographic recordings, standard operating procedures, cleanliness and sanitation, inventory control, and personnel interviews.

Supplemental Environmental and OSHA Compliance Components

In addition to FDA compliance, the AIP offers companies the option to include supplemental compliance training and auditing focusing on environmental and occupational health and safety regulations and requirements – efficiently leveraging the FDA mock inspection and full facility audit.

  • Environmental: The AIP program will offer companies the opportunity to add an additional training and compliance component focusing on federal and state environmental and waste management regulations. Specifically, nicotine-bearing products may be subject to regulation under the Federal Resource Conservation and Recovery Act (RCRA) when disposed.  State regulations governing dangerous or industrial wastes also could apply.  This component will provide an overview of how nicotine in tobacco-based products are regulated differently than when found in e-cigarettes and other vaping products, and will provide valuable information regarding companies’ obligations in responding to these additional requirements.  For more information on environmental requirements, see here.
  • Occupational Health and Safety: Participants in the AIP program will also have the opportunity to add an additional training and compliance component focusing on federal and state Occupational Safety and Health laws. OSHA recordkeeping requirements apply to all employers, except very small businesses.  Most other OSHA standards apply to all employers, regardless of size.  This component will provide companies with a review of existing policies and practices, and will recommend specific actions designed to bring companies into compliance with regulations in areas relevant to the industry, including: personal protective equipment, emergency plans, fire protection, and hazard communication (g., labeling and safety data sheets).

Pre-Registration

Pre-registration for the AIP is available immediately by filling out the form available here:

Tobacco and Vapor Product Manufacturing Establishment Audit and Mock Inspection Program Pre-Registration Form

The completed pre-registration form can be E-mailed to chowdhury@khlaw.com, faxed to (202) 434-4646, or mailed to:

Keller and Heckman LLP
Attn: Azim Chowdhury
1001 G Street NW, Suite 500 West
Washington, D.C. 20001

Upon receipt of your pre-registration form, Keller and Heckman will provide your company with a formal written proposal and cost-estimate to conduct on-site training and mock inspection at your facility.  Scheduling is generally available on a first-come, first-serve basis.

*The written post-inspection report is covered by any existing attorney-client relationship between Keller and Heckman and the Company, and is generally not subject to discovery.  The recommendations set forth in the post-inspection report are for informational purposes only, and do not constitute any warranties or guarantees regarding the outcome of an actual FDA, EPA or OSHA inspection.  Keller and Heckman’s attorneys remain available and look forward to the opportunity to assist with any post-inspection activities or questions following completion of the written report.

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On February 12, 2018, Nicopure Labs, LLC and the Right to be Smoke-Free Coalition[i] (the Appellants) filed their opening brief in the appeal of last year’s decision from the U.S. District Court for the District of Columbia, which ruled in favor of FDA in the first lawsuit challenging aspects of the Tobacco Control Act (TCA) and the Food and Drug Administration’s (FDA’s) Deeming Rule as they are being applied to the vapor industry. In the brief, the Appellants respectfully disagree with the lower court’s conclusions and believe that both the law and the facts compel a different result.

Specifically, Appellants argue that (1) the Modified Risk Tobacco Product (MRTP) provision of the TCA, as well as the ban on free samples of vapor products, violate the First Amendment of the U.S. Constitution, and (2) FDA was obligated to consider a less burdensome Premarket Tobacco Product Application (PMTA) process for vapor products while still protecting the public health. We summarize these issues in turn below, and you can download the full brief here.

1. Modified Risk Claims and Free Sample Ban

The MRTP provision in Section 911 of the TCA prohibits vapor companies from, among other things, representing without FDA authorization that their products: (i) present a lower risk of disease or is less harmful than another tobacco product; or (ii) contain a reduced level of, or is free from, a substance, or that exposure to a substance is reduced or eliminated.  In other words, this means that vapor companies require explicit FDA approval to tell adult consumers, for example, that their products do not contain certain substances (“no diacetyl” or “no allergens”), that they are unlike more dangerous cigarettes because they have “no tar” or produce “no combusted smoke,” and they pose less health risk to individuals than smoking cigarettes (as FDA itself has publicly stated numerous times). Obtaining such MRTP authorization is an incredibly onerous and expensive process (which no company has been able to achieve yet) that requires applicants to demonstrate that their product will:

(i) significantly reduce harm and the risk of tobacco-related disease to individual users; and

(ii) 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). As to the latter “population effects” prong of the standard, applicants must establish not only the relative health risks of the subject product, but also the potential impact the product will have on overall tobacco use initiation and cessation. 21 USC § 387k(g)(4).

In reality, this imposes a prophylactic ban on MRTP claims and violates the First Amendment because it effectively prohibits truthful, non-misleading statements by vapor companies that convey information needed by adult consumers to make informed purchasing decisions and switch away from cigarettes to less risky vapor products. The First Amendment protects the rights of consumers in the marketplace to obtain product-related information so they can make educated decisions.

But vapor companies cannot make these claims without prior FDA approval and, in all likelihood, will never be able to because the Agency has never approved a claim under the stringent and cost prohibitive MRTP standard. As such, and as detailed in the brief, the MRTP process fails to meet the “intermediate scrutiny” standard required when the government regulates commercial speech.  Central Hudson Gas & Elec. Corp. v. Pub. Serv. Comm’n of N.Y., 447 U.S. 557 (1980).

Similarly, the free sample ban violates the First Amendment because it prohibits adult consumers from trying different vapor products and obtaining valuable information about a novel product category that will help them transition away from cigarettes. Sampling is an “expressive” act that is protected speech. As FDA conceded, sampling conveys information that allows consumers to make individualized choices and change their purchasing behavior. This is important where, as FDA also acknowledged, smokers may have a better chance of switching to vapor products if they can continually sample a variety of e-liquid flavors. Indeed, numerous consumer surveys and other data indicate that smokers rely heavily on flavor variability and the opportunity to try different e-liquids and devices when considering vaping as a substitute for deadly smoking. But, as set forth in the brief, neither Congress nor FDA demonstrated that the free sample ban survives intermediate scrutiny.

2. PMTA Process

Since the Deeming Rule took effect on August 8, 2016, the restrictions on vapor products have been even more onerous than combustible cigarettes, most of which are grandfathered and exempt from FDA’s premarket review requirements. While FDA’s announcement last year for a “comprehensive regulatory plan to shift trajectory of tobacco-related disease, death” acknowledged, among other things, the tobacco harm reduction potential of vapor products and extended the compliance policy deadline for PMTAs for pre-August 8, 2016 vapor products to August 8, 2022, the reality is that safety advances and innovation have been stifled, and the industry still faces effectively being banned in a few short years.

In this regard, it is critical to recognize that the TCA has an overarching goal of ensuring that adult smokers continue to have access to innovative, less risky tobacco products. Despite this, and even though the Agency acknowledged that forcing vapor products to complete a one-size-fits-all PMTA process would eliminate over 95% of manufacturers (along with product variety those companies supply), FDA failed to tailor the PMTA process to less risky vapor products.  Indeed, to date FDA has only approved one PMTA (which was not for a vapor product) and, as provided in the brief, Deeming Rule commenters submitted compelling evidence showing the PMTA will be time and cost prohibitive. FDA was obligated, therefore, not just to extend the filing deadlines, but to consider a less burdensome PMTA process for vapor products (e.g., one that does not require long-term, clinical or epidemiological studies for each vapor product) while still protecting the public health.

FDA’s reply brief is due by April 18, 2018. We will keep you updated on the progress of the appeal.

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.

[i]  The Right to be Smoke-Free Coalition trade association members supporting the appeal include the American E-Liquid Manufacturing Standards Association (AEMSA), American Vaping Association (AVA), Georgia Smoke Free Association (GSFA), Kentucky Smoke Free Association (KYSFA), Louisiana Vaping Association (LAVA), Maryland Vape Professionals, LLC (MVP), New Jersey Vapor Retailers Association (NJVRA), Ohio Vapor Trade Association (OHVTA), Tennessee Smoke Free Association (TSFA), and the Shenzhen E-Vapor Industry Association (SEVIA).  For a full list of members see www.r2bsmokefree.org.

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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”).[1] 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.”[2] 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.”[3] 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.[4]

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,[5] the Committee nevertheless acknowledged that the “current evidence points to e-cigarettes being less harmful than combustible tobacco cigarettes.”[6]

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.”[7] 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.[8] 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.”[9]

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.”[10] 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.[11] The Report also noted that, “among dual users, e-cigarettes may help maintain smoking reduction.”[12]

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.[13] 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.[14] Indeed, the modified risk standard is so stringent that it is highly unlikely any such claim will ever be approved for a vapor product.[15]

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.[16]

Youth Use of E-Cigarettes
A frequent area of concern for courts[17], 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.[18] 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.”[19] 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.”[20]

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.[21] 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.”[22] 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.”[23] In this regard, we note that the National Youth Tobacco Survey data shows that youth smoking rates have been falling rapidly.[24] 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.

 

___________________________________________

[1] 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”).

[2] Report, supra n.1., at S-9.

[3] Id., supra n.1., at 1-1, 1-2 (Box 1-1 Statement of Task).

[4] Id., supra n.1., at S-9.

[5] 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.”).

[6] Report, supra n.1., at 18-23.

[7] 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).

[8] Id., supra n.1., at 18-13.

[9] Id., supra n.1., at 18-23.

[10] Id., supra n.1, at 18-24.

[11] Id., supra n.1., at 18-28.

[12] Id., supra n.1., at 18-25.

[13] Id., supra n.1., at 18-2.

[14] 21 U.S.C. § 387k.

[15] 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).

[16] 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.

[17] 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.”).

[18] 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.).

[19] Id., supra n.1., at S-1, 2.

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

[21] Id., supra n.1., at 16-3.

[22] Id., supra n.1., at 16-30 (emphasis added).

[23] 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.

[24] 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.

 

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The U.S. Food and Drug Administration’s (FDA’s) “Deeming Regulation” became effective on August 8, 2016, extending the Agency’s regulatory authority over tobacco products beyond traditional cigarettes, smokeless tobacco and roll-your-own tobacco products to include “other” tobacco product categories such as cigars, pipe tobacco, hookah/shisha, electronic vapor and e-liquid products, and components and parts of such products. Now, manufacturers of newly deemed products are subject to the Tobacco Control Act (TCA) requirements, including registering U.S. manufacturing establishments, reporting ingredients and health documents to FDA, and obtaining premarket authorization.

Products made or derived from tobacco usually fall within the meaning of “tobacco products” under the TCA, and are regulated as such by FDA’s Center for Tobacco Products (CTP) unless claims made for the product trigger a different regulatory classification. In FDA’s final rule, “Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ‘Intended Uses,'” published on January 9, 2017, FDA is seeking to clarify when a product made or derived from tobacco would be excluded from the definition of a tobacco product, and instead subject to FDA’s drug, medical device, and combination product (i.e., medical product) authority.  

Determining Intended Use

Determining a product’s intended use is critical to establishing whether a product made or derived from tobacco will be regulated as a medical product. A drug is defined in Section 321(g) of the Food, Drug and Cosmetic Act (FDCA), in pertinent part, as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals” (the “disease” or “therapeutic benefit” prong) or “articles (other than food) intended to affect the structure or function of the body of man or other animals” (the “structure/function” prong).

FDA’s new rule “reiterates” that a product made or derived from tobacco will be subject to FDA’s medical product authority, and not its tobacco authority, (a) if it is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, including use in the cure or treatment of nicotine addiction (e.g., smoking cessation), relapse prevention, or relief of nicotine withdrawal symptoms; or (b) if it is intended to affect the structure or any function of the body in any way that is different from effects related to nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000.  21 C.F.R. § 1100.5.

Medical products cannot be marketed without FDA approval, which requires demonstrating, typically through significant non-clinical and clinical evaluations, that a product is “safe and effective” for its intended use. The process of getting a medical product approved for a particular indication is complicated, takes many years, and costs millions of dollars. New medical products are also approved for a particular indication, virtually always require a prescription (with adequate data and FDA approval, over-the-counter status is possible), and may not be used recreationally, as e-vapor products generally are. Additionally, the Supreme Court has said that because FDA considers tobacco to be inherently unsafe, “if tobacco products were ‘devices’ under the [FDCA], the FDA would be required to remove them from the market,” FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 135 (2000). Although scientific research, both in the United States and abroad, supports that e-vapor products are substantially less hazardous than combustible tobacco products (see, for example, Public Health England’s report finding that e-vapor products are 95% less harmful than traditional cigarettes, which was followed by the Royal College of Physicians’ ground breaking report lauding the public health benefits of e-vapor products), manufacturers should understand how FDA determines a product’s “intended use” and avoid making claims, statements, or taking other actions that might trigger FDA’s medical product authority.

In the preamble to the new rule, FDA sought to clarify when it would consider a manufacturer to have intended to market a tobacco product in a way that satisfied either the structure/function or disease prongs of the drug definition.  According to the FDA and associated court rulings, a manufacturer’s intended use can be determined through “any relevant source.” Common sources could be product labeling, promotional claims, or advertising. FDA has taken the position that when it is seeking to determine whether a product is intended for use as a medical product, it may consider direct and circumstantial evidence, as well as circumstances surrounding distribution of the product.  82 Fed. Reg. 2196. Any representation by a manufacturer in a public forum can provide evidence of intent, including communications and reports to other administrative agencies or a manufacturer’s websites. For example, FDA has previously determined the intended use of a product based on statements made in the manufacturer’s SEC filings or patent filings with the USPTO. Importantly, FDA may also look at how the product is actually being used by consumers as evidence of the manufacturer’s intent.

Disease Claims (Claims of Therapeutic Benefit)

FDA further emphasized that manufacturer claims related to “smoking cessation in the context of curing or treating nicotine addiction and its symptoms” would bring a product within the disease prong of the drug or device definition. This would include claims, for example, that an e-vapor device can help a smoker quit or treat their nicotine addiction. Indeed, FDA is clear that it considers smoking cessation claims to “create a strong suggestion of intended therapeutic benefit” which would be difficult to overcome. Beyond smoking cessation or quit claims, any claims that a product may be used to diagnosis, cure, mitigate, treat or prevent of disease (particularly tobacco-related disease) would cause a product made or derived from tobacco to be a medical product.

Structure/Function Claims

Disease claims are not the only type of claims that might trigger FDA’s medical product authority. Claims that a tobacco product affect the “structure or function” of the body in any way related to the effects of nicotine may as well. FDA’s new rule states that the only nicotine structure/function claims permissible are those that were customarily used by tobacco companies to market cigarettes and smokeless tobacco prior March 21, 2000 – the date of the U.S. Supreme Court decision in FDA v. Brown & Williamson. In other words, claims that were commonly and legally made in the marketing of cigarettes or smokeless tobacco prior to March 21, 2000 will not cause products made or derived from tobacco to be marketed as medical products.

Permissible structure/function claims could relate to satisfaction, pleasure, enjoyment, or refreshment. Additionally, claims that a particular tobacco product will provide the same effects as another tobacco product may be acceptable. FDA offers several examples of such claims, such as “get your nicotine fix” or “provides smokers the same delight, physical and emotional feelings.” 82 Fed. Reg. 2200.

On the other hand, statements that a product can “relieve tension” or “promote weight loss” would be considered structure/function claims that are related to the pharmacological effects of nicotine but that were not commonly and lawfully used prior to March 21, 2000. Absent evidence to the contrary, FDA would likely consider products subject to those claims to be medical products. Even if you had evidence of such claims having been made prior to March 21, 2000, FDA’s position would be that such claims were not lawful.


Other Claims

The new rule also reminds manufacturers that claims that a tobacco product may present reduced risk or harm (compared to other tobacco products) can only be made with FDA’s explicit authorization through the Modified Risk Tobacco Product (MRTP) application process set forth in Section 911 of the FDCA, as amended by the Tobacco Control Act. In addition, false or misleading claims, including unsubstantiated claims, regarding any product regulated by FDA would cause the product to be misbranded and subject manufacturers to enforcement action. 82 Fed. Reg. 2202.

Quick Tips for Compliance

  • Make truthful and substantiated claims, but avoid focusing on any health impact or potential reduced risk compared to other products.
  • Avoid making claims that could be perceived as “smoking cessation” or “quit” claims, or nicotine addiction claims.
  • Claims regarding “enjoyment” or “satisfaction” are permitted. 
  • Claims about e-vapor device functions, features, and e-liquid flavors are permitted.