Right to be Smoke-Free

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On September 11, 2018, Nicopure Labs, LLC and the Right to be Smoke-Free Coalition (the “Appellants”) appeared for oral argument before a three-judge panel in the United States Court of Appeals for the District of Columbia Circuit to appeal a decision issued last year by the U.S. District Court for the District of Columbia, which ruled in favor of the U.S. Food and Drug Administration (“FDA”) in the first lawsuit challenging various provisions of the Family Smoking Prevention and Tobacco Control Act (“TCA” or “Act”) and FDA’s Deeming Rule as they are being applied to the vapor industry.[1]

During oral argument, the Appellants argued that the Modified Risk Tobacco Product (“MRTP”) preclearance requirement imposed by Section 911 of the TCA violates the First Amendment as applied to vapor products. In addition, the Appellants argued that application of the Act’s free sample ban to vapor products violates the First Amendment, and that FDA failed to tailor the Premarket Tobacco Application (“PMTA”) requirements to ensure the continued availability of vapor products.  Below, we provide a brief overview of the issues discussed at the oral argument. The recording of the hearing is available here.[2]  For background on the appeal, see our previous blog posts, including copies of the legal briefs, available here and here.

Modified Risk Claims

Appellants argued that the dichotomy in the current law – that manufacturers are legally permitted to sell vapor products for recreational purposes, but not allowed to make objectively truthful statements about those products (e.g., that they do not contain or produce tar, ash, or smoke, among other harmful chemicals found in cigarette smoke), or simply repeat FDA’s and various public health organizations’ statements that vapor products pose less risk than cigarettes – runs afoul of the First Amendment, which protects commercial speech. Indeed, Appellants stated that the requirement to ask permission is a First Amendment injury itself. Further, the Appellants contended that under current law, even if every federal judge in the country found a vapor company’s statements about its products to be true, if FDA determines that such a statement does not benefit public health, it would still be prohibited.

Appellants also discussed application of the Supreme Court’s intermediate scrutiny test to the MRTP provision. Under that approach, restrictions on commercial speech are judged under the four-pronged Central Hudson test, in which Courts ask whether: (1) the speech concerns a lawful activity and is not misleading; (2) the asserted government interest is “substantial”; (3) the restriction directly and materially advances the governmental interest; and (4) the restriction is no more extensive than is necessary to serve that interest.[3] As to the third prong, Appellants maintained that the MRTP provision does not directly and materially advance the government’s interest because others can make similar public statements without any preclearance approval.

The Appellants also noted that the clear trajectory of modern U.S. Supreme Court First Amendment jurisprudence requires that, under the fourth prong of Central Hudson, if the government can achieve its interest in a way that is less restrictive than a prior restraint, it must do so. For example, FDA could rely on non-speech alternatives standing alone or in combination with each other to prevent potentially misleading modified risk claims, such as enforcing the TCA’s misbranding and adulteration provisions, requiring manufacturers to maintain records substantiating such claims, requiring the use of disclaimers, and conducting post-market surveillance.

Free Sample Ban & PMTA Tailoring

Appellants also argued that under the Supreme Court’s decision in Tex. v. Johnson free samples are protected under the First Amendment. [4] Under that case, whether conduct is “sufficiently imbued with elements of communication” to warrant First Amendment protection depends on whether there is “an intent to convey a particularized message” and “the likelihood [is] great that the message [will] be understood by those who view it.”[5] Here, vapor companies intend to send a message to consumers through their distribution of free samples; thus sampling is a form of protected speech. Appellants argued that it is not enough for vapor companies to simply state that their e-liquid tastes better than a conventional cigarette, for example, but instead the only way to convey this information – the personalized experience of vaping a particular flavor – is through providing a sample. This is expressive conduct. Appellants also maintained that the ban on free samples violates the third and fourth prongs of Central Hudson. For instance, neither Congress nor FDA produced any evidence that minors are, in fact, obtaining access to vapor products through free samples, and there are ample non-speech restrictions that could limit access by youth, such as enhanced enforcement initiatives and minimum age verification at retailers.

In addition, Appellants argued that the PMTA requirements were insufficiently tailored to ensure the continued availability of vapor products. Specifically, given that FDA determined that the vast majority of manufacturers will exit the market before filing PMTAs due to the high cost of long-term, product-specific studies (for more on this see here), Appellants maintained that FDA should have considered accepting for scientific review PMTAs for vapor products that do not contain such studies but otherwise comply with the PMTA informational requirements. FDA could still do a complete review of those PMTAs, which would include a scientific literature review of the population effects of vapor products as such evidence exists in 2022, when PMTAs are expected to be filed under FDA’s current compliance policy for products on the market as of August 8, 2016.

Post-Argument Activity

One day after the oral argument, FDA submitted a letter to the D.C. Circuit Clerk of the Court, informing the court that, on September 12, 2018, FDA announced significant new actions, including enforcement initiatives, to address an alleged “epidemic of e-cigarette use among teenagers.”[6] We previously blogged about FDA’s enforcement “blitz” here.  The letter notes that “FDA is reconsidering the extended compliance dates for the submission of new product applications when it is apparent that there is widespread youth use of the product, and is also considering a policy change that would lead to the immediate removal of flavored e-cigarette products from the market.”

Indeed, in letters to several large manufacturers of cartridge-based e-cigarettes, FDA threatened to revisit the August 8, 2022 PMTA compliance date (for those companies’ and potentially similar products), if the targeted companies failed to submit within 60 days comprehensive plans to address sales of their products to minors.

On September 17, 2018, Appellants submitted a response to the FDA’s letter, arguing that it “provides no new authorities [as required by Federal Rule 28(j)] and instead describes enforcement actions that have nothing to do with appellants and target a portion of the e-cigarette industry.”[7] Appellants point out that FDA’s enforcement actions, which ostensibly target 97 percent of the e-cigarette market – actually only address the “cartridge-based” e-cigarette market, which is only a portion of the overall vapor products market. Indeed, FDA Commissioner Dr. Scott Gottlieb pointed out that sales of open-tank vaping products, which Appellants primarily market, do not appear to be driving the government’s claimed increase in underage use. Regardless, Appellants maintained that FDA’s recent enforcement actions prove their point: if FDA is concerned about purchases by or marketing of vapor products to youth, it can and should advance that interest through actions targeted at that problem (e.g., warning letters to retailers), not through a blanket prohibition on all truthful, non-misleading speech by manufacturers to adults.[8]

Next Steps

While it is impossible to state with certainty when the D.C. Circuit will rule on the case, we believe it is reasonable to expect a decision sometime in early 2019. We will keep readers of this blog updated on the outcome of the case.

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[1] At the hearing, Miguel Estrada of Gibson, Dunn & Crutcher represented Nicopure Labs, and Eric Gotting of Keller and Heckman represented both Nicopure Labs and the Right to be Smoke-Free Coalition.

[2] Oral argument, Nicopure Labs et al. v. FDA, Case No. 15-5196 (D.C. Cir. Sept. 12, 2018), recording available at https://tinyurl.com/y8xzmsr4.

[3] Lorillard Tobacco Co. v. Reilly, 533 U.S. 525, 554-55 (2001) (summarizing test outlined in Cent. Hudson Gas & Elec. Corp. v. Pub. Serv. Comm’n of N.Y., 447 U.S. 557 (1980)).

[4] See Tex. v. Johnson, 491 U.S. 397 (1989).

[5] Id. at 404 (citations and internal quotations omitted).

[6] See Letter from Tyce R. Walters to Mr. Mark Langer, Clerk of the Court re: Nicopure Labs, LLC v. FDA, No. 17-5196 (oral argument heard Sept. 11, 2018);  See also U.S. Food & Drug Admin., FDA News Release, FDA Takes New Steps to Address Epidemic of Youth E-Cigarette Use, Including a Historic Action Against More Than 1,300 Retailers and 5 Major Manufacturers for Their Roles Perpetuating Youth Access (Sept. 12, 2018), https://tinyurl.com/y9gh3dyg; U.S. Food & Drug Admin., FDA Statement, Statement From FDA Commissioner Scott Gottlieb, M.D., on New Steps to Address Epidemic of Youth E-Cigarette Use (Sept. 12, 2018), https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm620185.htm.

[7] See September 17, 2018 letter from Miguel A. Estrada and Eric P. Gotting to Mr. Mark Langer, Clerk of the Court re: Nicopure Labs, LLC v. FDA, No. 17-5196 (oral argument heard Sept. 11, 2018).

[8] Id.; See also Thompson v. W. States Med. Ctr., 535 U.S. 357, 371 (2002) (“[I]f the Government could achieve its interests in a manner that does not restrict speech, or that restricts less speech, the Government must do so.”) (emphasis added).

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Defendant U.S. Food and Drug Administration (FDA) and the Right to Be Smoke-Free Coalition (RSF) recently submitted briefs to the federal district court of Maryland opposing a motion for summary judgment filed by various public health NGOs in American Academy of Pediatrics v. FDA.[1] The NGOs are challenging various extensions to premarket application compliance deadlines for deemed tobacco products that were announced as part of FDA’s new comprehensive tobacco and nicotine regulatory plan, and finalized in its August 2017 Guidance Document, Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule (the “Guidance”). This includes the August 8, 2022 compliance deadline for filing vapor product Premarket Tobacco Applications (PMTAs), which was extended from the original August 8, 2018 cutoff for products on the market on August 8, 2016, as initially set forth in the Deeming Rule. RSF is not a party to the lawsuit, but filed an amicus (or “friend of the court”) brief defending the compliance period so that vapor product manufacturers have adequate time to prepare compliant applications. We provide background on the case and the NGOs’ opening positions in our August 2, 2018 post, linked here, and highlight below key points from FDA’s and RSF’s briefs.

FDA Argues that the Court Lacks Jurisdiction to Hear the Case or, In the Alternative, the NGOs’ Motion for Summary Judgment Fails on the Merits

In its opposition brief (available here), FDA begins by arguing that the Court does not have jurisdiction to even hear the dispute.

First, FDA maintains that the NGOs lack “standing” – i.e., that the NGOs do not have a sufficient connection to the PMTA issue to bring the lawsuit.[2] In essence, FDA claims that the NGOs will not suffer a concrete and redressable injury if the August 8, 2022 compliance date is upheld. The NGOs complain that if PMTAs are not filed until that date then they will not be able to educate the public in the near-term about information that would otherwise be contained in the PMTAs. But as FDA points out, this argument was soundly rejected by another federal court in Cigar Ass’n of Am. v. FDA after the NGOs tried to intervene in that lawsuit challenging aspects of the Deeming Rule filed by the cigar and pipe tobacco industries.[3] In that case, it was not enough for the NGOs – who are not subject to the PMTA requirements themselves – to rely on generalized and speculative allegations that it might somehow be more difficult or costly to disseminate information to the public in the absence of PMTAs. According to FDA, the same holds true here. Moreover, FDA argues that the NGOs fail to cite any authority that gives them a legal right to the type of information, whether now or at a later date, contained in a PMTA.

Second, FDA claims that the Court lacks jurisdiction because the agency was simply exercising its enforcement discretion not to require PMTAs for a specified period of time, the type of decision that typically is not subject to review by federal courts. Not only is the revised compliance period limited in duration, it is also part of a broader comprehensive policy to address tobacco-related issues and ensure that high-quality applications are filed, which will include upcoming efforts by FDA to further delineate through guidance and rulemaking what information must be included in PMTAs. For support, the agency cites to Supreme Court case law that reserves to agencies the discretion to prioritize their activities, allocate resources, and adopt overall policies – including those involving enforcement – in the absence of statutory mandates to the contrary.[4] FDA concludes that the Tobacco Control Act (TCA)[5] does not prohibit the agency from establishing reasonable compliance deadlines.

Finally, the agency relies on long-standing law that guidance documents are typically not subject to review by federal courts under the Administrative Procedure Act (APA).[6] Unlike a formal rule, guidance does not impose obligations on the agency or legal duties on regulated entities; rather, guidance only represents an agency’s current thinking, which in this case is that FDA does not intend to enforce the PMTA requirements until August 8, 2022 for products that were already on the market when the Deeming Rule went into effect on August 8, 2016. In other words, the Guidance does not have the finality of a regulation – it merely summarizes FDA’s exercise of discretion – that would lend itself to judicial review.

FDA further maintains that, even if the Court has jurisdiction to hear the case, the NGOs’ motion should be denied on the merits. The agency first argues that the Guidance does not conflict with the TCA’s PMTA provisions[7] because it does not modify any statutory requirements.[8] Manufacturers are still required to submit PMTAs. The Guidance merely describes FDA’s intention not to enforce the PMTA requirements for a limited period of time, which is a discretionary determination reserved to the agency. In fact, FDA notes that the NGOs submitted comments during the rulemaking acknowledging that the agency has discretion to establish a compliance period for new tobacco products. Moreover, FDA points to more practical reasons for setting an August 8, 2022 filing deadline, all of which are consistent with the TCA, including the agency’s need to more efficiently manage those PMTAs that are eventually filed and to ensure high-quality submissions.

Second, FDA rebuts the NGOs’ claim that the agency, before it extended the compliance period, failed under the APA to provide notice to the public, and solicit and accept comments on the Guidance.[9] Underpinning the NGOs’ argument, however, is the premise that the Guidance is a formal rule and thus subject to the APA’s notice and comment requirements. But a rule has the force of law and imposes legal rights and obligations, which contrasts with a guidance document that merely advises the public on how the agency intends to assert its discretionary power.[10] As FDA points out, the Guidance does nothing more than simply indicate when it will exercise its enforcement discretion as to the filing of premarket applications for deemed tobacco products.

Finally, FDA maintains that it sufficiently justified the extension, contrary to the NGOs’ claims.  Under the APA, agencies must explain their actions and engage in reasoned decision-making.[11] In support, FDA explicitly cited to arguments made by RSF in Nicopure, et al. v. FDA – that the original August 8, 2018 deadline was not sufficient and that the judge in that case indicated that other filing deadlines may have been reasonable.[12] The agency then noted that the new compliance period is part of an overarching comprehensive plan to regulate nicotine and tobacco, and that the extension will allow the agency to provide further direction to industry through guidance and rulemaking on how the PMTA process will work.[13] As characterized by the agency, the plan is intended “to make certain that the FDA is striking an appropriate balance between regulation and encouraging the development of innovative tobacco products that may be less dangerous than cigarettes,” such as vapor products.[14]

RSF Argues that the Original PMTA Deadlines in the Deeming Rule Were Unattainable and that Vacating the Guidance Would Virtually Ban the Industry and Deprive the Public of the Health Benefits Provided by Vapor Products 

To provide the vapor industry perspective, RSF filed an amicus brief in support of the extended compliance deadline (available here). RSF makes two arguments in favor of the new PMTA filing date: (1) that no vapor company could have met the initial two-year deadline because industry would not have had sufficient time to complete the burdensome applications, including the long-term, product-specific clinical/epidemiological studies that FDA will likely require; and (2) that the two-year deadline, were it reinstated by setting aside the Guidance and granting the NGOs’ motion, would effectively ban vapor products, which provide an important public health benefit to transitioning smokers.

Vapor product manufacturers could not have met the original August 8, 2018 deadline because of the tremendous expectations set forth by FDA in its 2016 draft guidance for PMTA submissions for Electronic Nicotine Delivery Systems (PMTA draft guidance).[15] Among other things, the PMTA draft guidance states that:

  • Manufacturers should file a separate PMTA for each “finished tobacco product”;
  • Components should be tested for each device in which they could reasonably be used;
  • The relative health risks of each new e-liquid or device should be compared to the anticipated risks of other tobacco products on the market;
  • Literature relevant to each product should be thoroughly reviewed and the findings included in any PMTA submission; and
  • Manufacturers should test each product for a broad range of characteristics, including chemical identity, constituent composition, aerosol emissions under a range of operating conditions, toxicological and pharmacological profiles, storage and stability profiles, environmental effects, and use patterns at different nicotine levels.

The most significant concern, however, is that under the PMTA draft guidance manufacturers will likely be expected to conduct exceedingly expensive and long-term clinical/epidemiological studies. In its brief, RSF presents publicly available evidence from long-term studies recently funded by the federal government showing that this type of research, on average, takes at least two years, and in many circumstances far longer. In fact, RSF points out that FDA’s own long-term epidemiological study (called the Population Assessment of Tobacco and Health or “PATH” study) on tobacco products, including e-liquids and devices, has already taken seven years and is still on-going. As such, it was completely unrealistic for FDA to expect that industry would have been able to file compliant applications by the original August 2018 deadline[16] and, as a consequence, the vast majority of manufacturers would have had to leave the marketplace after that compliance period expired.

In its brief, RSF also notes that such a large-scale market exit could have a significant adverse impact on the public health. RSF demonstrates, in particular, that having access to a large variety of products and e-liquid flavors is often a key component in any individual’s attempt to switch away from cigarettes and transition to less risky vapor products. As Julie T. Woessner, National Policy Director for the Consumer Advocates for Smoke-free Alternatives Association (CASAA), explains in an accompanying affidavit filed with the court, “a significant number of our members use more than one flavor or brand of e-liquid . . . we find those making a complete transition from smoking to vaping most often report that finding a non-tobacco flavor was instrumental in helping them distance themselves from their smoking habit, and sampling a variety of different flavors actually served to make vaping more enjoyable than smoking.”

Ms. Woessner then articulates the public health benefit that could be lost: “[I]f consumers do not have access to these products, there is a substantial risk that they will return to their old smoking habits or feel forced to rely on do-it-yourself (“DIY”) activities or an unregulated black market for e-liquids and devices. This is not merely a theoretical concern. . . [w]hen asked what they would do in response to a total ban on all vapor products – the entire product category – 93% of the CASAA [Member] Survey respondents indicated that they would continue to use the products they enjoy by either purchasing them from overseas or a domestic black market, or by engaging in DIY activities.”

The Right to be Smoke-Free Coalition is represented by Keller and Heckman Partners Azim Chowdhury and Eric Gotting. We will continue to monitor the progress of this lawsuit and will provide a summary of the court’s decision on the NGOs’ motion for summary judgment.

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[1] Case No. 8:18-cv-00883 (D. Md.)  It bears noting that an amicus brief in support of Plaintiff NGOs was filed on July 17, 2018 on behalf of the American Thoracic Society and other public health organizations. The brief, which is available here, addresses the health effects of all products newly-deemed by the Deeming Rule, including combustible tobacco products, like cigars. The brief does not address legal arguments in the case, nor does it address the potential public health benefits of newly available, non-combustible products for longtime smokers.

[2] See, e.g., Lujan v. Defenders of Wildlife, 504 U.S. 555, 560 (1992).

[3] Cigar Ass’n of America v. FDA, 323 F.R.D. 54 (D.D.C 2017).

[4] Heckler v. Chaney, 480 U.S. 821 (1985).

[5] 21 U.S.C. §§ 387 et seq.

[6] Bennett v. Spear, 520 U.S. 154, 177–79 (1997); Am. Tort Reform Ass’n v. Occupational Safety & Health Admin., 738 F.3d 387, 395 (D.C. Cir. 2013).

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

[8]  As detailed in the Nicopure v. FDA litigation (Case No. 17-5196) (D.C. Cir.), RSF maintains that FDA had a statutory obligation to tailor the PMTA process to less risky vapor products and allow the vapor industry to submit PMTAs that do not include product-specific long-term clinical/epidemiological studies; instead, industry could rely on an existing scientific literature review showing that vapor products present substantially less risk than cigarettes on the whole and are thus appropriate for the public health.  Indeed, Congress gave FDA such authority within the PMTA provision itself, only requiring clinical studies “when appropriate” and permitting use of other “valid scientific evidence.”  21 U.S.C. § 387j(c)(5).  Unfortunately, FDA rejected this approach during the rulemaking.  See 81 Fed. Reg. at 28,997.

[9] 5 U.S.C. § 551 et seq.; 5 U.S.C. § 553.

[10] See Bennett, 520 U.S. at 178.

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

[12] Nicopure Labs, LLC v. FDA, 266 F. Supp. 3d 360, 399–400 (D.D.C. 2017).  That case is now on appeal before the U.S. Court of Appeals for the District of Columbia Circuit, with oral arguments scheduled for September 11, 2018.  See Update on Deeming Rule Appeal available at https://www.thecontinuumofrisk.com/2018/07/fda-commissioner-dr-scott-gottliebs-recent-remarks-vapor-products-continuum-risk-update-deeming-rule-appeal/.

[13] 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: 08/21/18).

[14] Id.

[15] FDA, Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems: Guidance for Industry (Draft Guidance) (May 2016).

[16] Indeed, as summarized previously on this blog here, on August 2, 2018, just before the initial PMTA deadline would have expired, FDA announced it would soon be issuing additional guidance, holding a public hearing and begin a new rulemaking regarding the PMTA process.  See FDA, Advancing Tobacco Regulation to Protect Children and Families: Updates and New Initiatives, https://tinyurl.com/y8wked2z.  As such, it is not clear how manufacturers would have been able to submit complete applications by the original cutoff if FDA itself is still in the process of finalizing the PMTA framework.

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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.

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On February 20, 2018 several organizations filed amicus (“friend of the court”) briefs in support of Plaintiff-Appellants Nicopure Labs’ and the Right to be Smoke-Free Coalition’s appeal in the Deeming Rule challenge now pending in the U.S. Court of Appeals for the D.C. Circuit.

The Washington Legal Foundation (WLF) is a nonprofit, public-interest law firm and policy center dedicated to defending and promoting free enterprise, individual rights, limited government, and the rule of law. In particular, WLF has devoted substantial resources over the years to promoting the free-speech rights of consumers and merchants in the marketplace, appearing before many federal courts in raising First Amendment issues. WLF has actively litigated First Amendment limits on the Food and Drug Administration’s (FDA) authority to restrict manufacturer speech.  In its amicus brief, WLF argues that FDA’s regulation of the vapor industry unjustifiably restricts truthful, non-misleading speech in violation of the First Amendment. By requiring vapor product companies to obtain FDA’s preapproval of “modified risk” claims before communicating their products’ uncontested health and related benefits to prospective consumers, the Deeming Rule effectively bans legally protected speech. The Rule will also harm those members of the public trying to quit smoking, who have a right to receive truthful information about comparatively safer alternatives to combustible tobacco.  Download the full brief here.

NJOY develops, imports, and distributes e-cigarettes and other electronic nicotine delivery products, and is committed to helping adult smokers switch completely from combustible cigarettes to e-cigarettes.  Like WLF, NJOY’s amicus brief addresses the First Amendment issue, i.e., “a government-imposed gag order” that blocks NJOY from truthfully describing its products to consumers.  Specifically, NJOY argues that FDA’s MRTP preclearance requirement is an unconstitutional speech-licensing regime that silences e-cigarette manufacturers and perpetuates misinformation about the comparative health risks of e-cigarettes and combustible cigarettes, jeopardizing the health of millions of smokers. Download the full brief here.

The State of Iowa also filed an amicus brief because it felt “compelled to defend its strong interest in reducing the number of Iowans who smoke combustible tobacco products,” noting that Iowa advocates for a harm-reduction approach and that “the difference between combustible cigarettes and non-combustibles, like e-cigarettes, is dramatic”.  Iowa argues that the MRTP process places a roadblock in the path of public health advocates and frustrates harm-reduction objectives by requiring pre-market review of truthful, non-misleading modified risk claims – which are protected by the First Amendment.  While Iowa supports rules that require pre-market review of any modified risk claim offered for a combustible tobacco product, generalized modified risk claims for e-cigarettes are different because they are true – and the MRTP process undermines momentum towards critical harm reduction by effectively silencing them. Download the full brief here.

The Consumer Advocates for Smoke-free Alternatives Association (CASAA), a non-profit 501(c)(4) organization with an all-volunteer board and a grassroots membership, is dedicated to ensuring the availability of reduced harm alternatives to smoking and to providing smokers and non-smokers alike with honest information about those alternatives so that they can make informed choices.  CASAA submitted an amicus brief to provide helpful information to the Court about the importance of flavors and sampling in connection with consumers (a) receiving information about products and (b) making a successful transition from smoking to vaping.  The brief discusses the critical need for consumers to receive truthful information from manufacturers and retailers about the low-risk nature of vapor products.  Download the full brief here.

Last, but certainly not least, Clive Bates, Director of The Counterfactual and former Director of the UK’s primary anti-smoking non-profit Action on Smoking in Health, as well as additional public health advocates Philip Alcabes, Scott Ballin, Konstantinos Farsalinos, Bill Godshall, Jacques Le Houezec, Bernd Mayer, Jeff Nesbit, Joel Nitzkin, Riccardo Polosa, Sally L. Satel, Michael B. Siegel, Jeff Stier, and David Sweanor, submitted an amicus brief because of their concern that excessively burdensome or restrictive regulation of e-cigarettes by FDA will have unintended consequences, effectively protecting the combustible cigarette market, increasing smoking and causing harm to health. The authors argue that vaping is proving highly beneficial to the health of millions of American adults as a low-risk alternative to cigarette smoking – which has fallen rapidly and reached record lows since vaping was introduced.  FDA’s approach to regulating e-cigarettes failed to account for the likelihood of the risks of harmful unintended consequences arising from its own interventions in the e-cigarette market.  Indeed, the authors make clear that the costs of the current regulatory approach are likely to overwhelm the claimed benefits, and a failure to account for them undermines the Deeming Rule.  Download the full brief here.

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

Photo of Azim Chowdhury

This interview originally appeared here: https://www.cyclopsvapor.com/blog/qa-with-azim-chowdhury-pRight to be Smoke-Free artnerfda-group-tobacco-evapor-food-packaging-at-keller-and-heckman-llp/

Azim Chowdhury is nationally recognized as an expert on FDA issues as they relate to the tobacco and e-vapor industries. He represents tobacco, e-cigarette and e-liquid manufacturers, suppliers and trade associations in matters of FDA regulatory and corporate compliance, and spearheaded Keller and Heckman’s FDA tobacco and e-cigarette practice group. Keller and Heckman LLP, founded in 1962, has a broad practice in regulatory law and related litigation and business transactions. Keller and Heckman’s comprehensive and extensive experience dealing with the regulation of food, drugs, medical devices and dietary supplements before the FDA uniquely positions the firm to guide tobacco, e-cigarette and e-liquid companies through the myriad of statutory and regulatory requirements that will soon be applicable to these products.

In the anticipation of Keller and Heckman’s *2018 E-Vapor and Tobacco Law Symposium, spoke with Chowdhury about what to expect at the second annual event.

For our readers who don’t know, can you talk a little bit about how you got into vaping law/education as a specialty?

The first time I came across a vapor product was back in 2009. While shopping at the mall, I came across a kiosk selling Smoking Everywhere cigalikes. I had been practicing law for a few years at that point and was focusing on medical devices and FDA regulations. I was immediately intrigued by the so-called “electronic cigarettes,” and started researching. When and how FDA was going to regulate vapor products was very much uncertain — the Tobacco Control Act had just become law, giving FDA the authority to regulate tobacco products, but the agency had already come out against e-cigarettes (the first time) arguing that they were unauthorized drug delivery devices. I wrote one of the first law articles on what FDA might do and how it would impact the burgeoning vapor industry for the Food and Drug Law Institute’s Update magazine (which you can findhere). I continued to write articles following the Sottera lawsuit, began speaking at conferences and attending vape expos, edited a couple of books, and quickly came to be recognized as a legal expert on vapor products.

In March 2010, I joined Keller and Heckman, a firm best known for its nationally-ranked FDA practice that includes lawyers as well as scientists, and spearheaded the E-Vapor Law Practice here. Now, we represent dozens of vapor businesses in the U.S. and around the world, including trade associations, manufacturers, suppliers, distributors and retailers in matters of federal, state and global regulatory compliance, as well as litigation, business and intellectual property issues.

This year is the second E-Vapor and Tobacco Law Symposium. Can you talk about how this year’s agenda came into play and how it changed from last year’s?

Last year we launched the inaugural E-Vapor and Tobacco Law Symposium from our offices in Washington, D.C. It was an experiment to see how this industry, which is mostly used to vape expos, trade shows and advocacy events, would react to a legal training seminar. Keller and Heckman’s well-established food, packaging and environmental practices have a long history of hosting these types of seminars, so this is right up our alley. Because the Deeming Rule had just become effective, we knew it was the right time to bring this type of event to the vapor industry to help companies understand how to stay in compliance.

With the success of last year’s Symposium, we decided to take the event “on the road” to Irvine, Calif., to reach a broader audience and make it easier for businesses on the West Coast to attend. With all the changes with the new administration, a new FDA commissioner and new policies that seem to indicate a shift in the agency’s view of these products (we hope), we are covering a lot more material at this year’s event. In addition to our Keller and Heckman experts, we are particularly excited for our guest speakers, several coming from overseas, who will be presenting on topics including good manufacturing practices, state laws, EU and UK laws, and vapor device standards.

Stepping further into that, what are some of the biggest challenges that vapers and business owners need to be aware of this year?

Companies must understand that even though the deadline for premarket applications for products on the market today has been delayed until 2022, the Deeming Rule is still in effect, and there are several fast-approaching deadlines for requirements such as ingredient reporting and HPHC testing that companies need to comply with in the meantime. We are expecting FDA to ramp up enforcement and inspections of facilities, so being prepared for that is critical. We will also be addressing the elephant in the room — Premarket Tobacco Product Applications (PMTAs) — and how companies might be able to work together to save money and submit applications to FDA.

Beyond FDA, more states are passing legislation impacting this industry, including new taxes and licensing requirements. Much of this will be covered at the Symposium. We are also seeing more companies get notices from state environmental regulators regarding how they are storing and disposing of nicotine and other hazardous chemicals. We think that is going to be a big issue in 2018 and moving forward.

Finally, if you’re looking to expand your business beyond the U.S. to the EU or Asia, we are going to have a lot of great presentations on how to do that.

Have there been any wins within the law that you’ve seen for our industry?

There have been a lot of victories at the state level by advocacy organizations such as SFATA, VTA and the Smoke-Free Associations fighting for vaper’s rights. We also had a huge victory last year on behalf of the Right to be Smoke-Free Coalition in Indiana, where we got the Seventh Circuit Court of Appeals to strike down the unconstitutional parts of Indiana’s e-liquid law (seehere). The industry should also consider FDA’s extension of the PMTA deadline as a victory that resulted from everyone’s lobbying efforts, as well as the threat from the lawsuits.

One topic we will be discussing at the Symposium is the appeal of the Nicopure and Right to be Smoke-Free challenge to the Deeming Rule, and how companies can still help with that effort.

The symposium schedule is jam packed and really looks like a must-attend event. Can you talk further about the importance of this two-day event?

I do believe this is a must-attend event for businesses who truly are interested in complying with the law and staying around for the long-term. This will also be a great opportunity to network with Keller and Heckman attorneys and other experts, as well as with other businesses. So far, we have over 100 registered attendees that include some of the biggest names in the industry, but also a lot of smaller companies who are looking to do things the right way.

*Seating is limited, but it is still not too late to register! Keller and Heckman is also exploring options for next year’s Symposium, and may take it to the Midwest or back to the East Coast.

Photo of Azim ChowdhuryPhoto of Eric Gotting

The U.S. Seventh Circuit Court of Appeals ruled in favor of the Right to be Smoke-Free Coalition holding that portions of Indiana’s E-Liquid Law are unconstitutional as applied to out-of-state manufacturers

On January 30, 2017, the U.S. Court of Appeals for the Seventh Circuit issued its decision in Legato Vapors LLC et al. v. David Cook et al., No. 16-3071, striking as unconstitutional portions of Indiana’s Vapor Pens and E-Liquid Act (the Act) as it applies to out-of-state manufacturers.

Among other things, the Act prohibited the sale of “unpermitted” e-liquid products used in refillable open-system e-vapor devices starting June 30, 2016. Actually obtaining a manufacturing permit from the Indiana Alcohol and Tobacco Commission (ATC), however, was effectively impossible for out-of-state companies for several reasons; most critically, e-liquid manufacturers were required to (1) build facilities compliant with the Indiana Commercial Kitchen Code and (2) contract with a qualified third-party security firm to provide certain specific services (such as 24/7 video surveillance). For a security firm to qualify under the law, however, it must have a certified Rolling Steel Fire Door Technician and an Architectural Hardware Consultant under its employ – certifications not common in the security industry. Moreover, those certified employees had to be hired by July 2015, preventing future security companies from ever being able to comply. Indeed, the ATC determined that only one security firm in the country, located in Lafayette, Indiana, qualified under the law.

In September 2015, the Right to be Smoke-Free Coalition (the Coalition), a trade association of e-vapor companies represented by Keller and Heckman Partners Eric Gotting and Azim Chowdhury, intervened in a lawsuit challenging the Act. Among other things, the Coalition argued that the Act violated the dormant Commerce Clause of the United States Constitution, which prohibits extraterritorial legislation, by regulating e-liquid manufacturing activities that occur completely outside of Indiana. After their motions for preliminary injunction and summary judgment were denied by the Southern District of Indiana, the Coalition and co-petitioners Legato Vapors LLC et al. appealed to the Seventh Circuit. Oral arguments were heard in Chicago on December 8, 2016 and the decision issued on January 30, 2017.

Ruling in the Coalition’s favor, the appellate Court declared that the “unprecedented” application of the Act’s security provisions, clean room (kitchen code) requirements, and audit provisions as they relate to facility design and production processes to out-of-state manufacturers was clearly extraterritorial and a violation of the dormant Commerce Clause. Indeed, the Court stated that “with almost two hundred years of precedents to consider, our review of prior dormant Commerce Clause decisions has not revealed a single appellate case permitting any direct regulation of out-of-state manufacturing processes and facilities comparable to the Indiana Act.” The Court also noted that the Act directly regulates production facilities and processes of out-of-state manufacturers and “thus wholly out-of-state transactions.” It also “poses the clear risk of multiple and inconsistent regulations that would unduly burden interstate commerce.”

The Circuit Court reversed the district court’s grant of summary judgment to Indiana and remanded the case to the district court to declare the challenged provisions unenforceable against out-of-state manufacturers and to enjoin their enforcement against the Coalition and co-petitioners.

Co-petitioners Legato Vapors, Rocky Mountain E Cigs and Derb E Cigs were represented by D. Epstein and James A. Tanford of Epstein Cohen Seif & Porter LLP, and J. Gregory Troutman of Troutman Law Office PLLC.