Articles Posted in Tobacco Products

Thumbnail image for Thumbnail image for 120px-Components_of_a_MiniCiggy_e-cigarette.jpgThe Food and Drug Administration introduced a proposed rule yesterday that would extend its existing authority over certain tobacco products. Under the proposed rule, FDA would now oversee electronic/e-cigarettes, cigars, pipe tobacco, nicotine gels, waterpipe/hookah tobacco, and dissolvables. These products would be added to the ones already under FDA’s authority–cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.

In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act, which gave FDA the authority to regulate the manufacture, distribution, and marketing of “tobacco products” to protect public health. The statute defines “tobacco products” as “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).” The Act specifically delineated cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco as products over which FDA had authority. But Congress also provided that FDA had authority over “any other tobacco product that the Secretary by regulation deems to be subject to this chapter.” Accordingly, through this proposed rule, FDA is “deeming” electronic/e-cigarettes, cigars, pipe tobacco, nicotine gels, waterpipe/hookah tobacco, and dissolvables to be “tobacco products” subject to FDA regulation. Under the rule, any future products that meet the statutory definition of “tobacco product” would also be deemed to be subject to FDA’s authority.
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newport.jpgOn October 17, 2013, concurring with the end to the government shutdown, FDA responded to a Citizen Petition filed by Lorillard Tobacco Company, Inc. (“Lorillard”). The Petition requested that FDA exercise enforcement discretion to allow the marketing of new tobacco products introduced after March 22, 2011 that are the subject of reports intended to demonstrate substantial equivalence and compliance with the Federal Food, Drug & Cosmetic Act (“FD&C Act”) Section 906(j)(1)(A)(i) (“SE Report”). Lorillard specifically asked that FDA exercise enforcement for two of its tobacco products that were the source of SE Reports and for similarly-situated tobacco products where the SE Report had been submitted at least 90 days prior to introduction in the market. As a preliminary matter, FDA said that requesting enforcement discretion in a citizen petition is not “within the scope of the FDA’s citizen petition procedures,” yet FDA elected to address the concerns underlying the request for a policy of enforcement discretion. FDA also indicated that it had issued orders for both Lorillard products, SE0003730 and SE0003731.

Lorillard had submitted SE Reports for its two new products, non-menthol versions of its 2007 Newport Lights Menthol, in October 2011. FDA indicated it its Technical Project Lead Memoranda for the products that both products had amendments and responses to deficiencies, with the most recent response dated February 8, 2013, and FDA’s response dated June 25, 2013. The new products differed from the grandfathered predicate products by: 1) absence of menthol, 20 presence of fire standard compliant cigarette paper, and 3) changes to design features to maintain consistency of smoke delivery. FDA’s reviews included chemistry, engineering, toxicology, social science, addiction, and an environmental assessment. FDA found the two new products to be substantially equivalent because: 1) the exclusion of menthol would not adversely impact initiation, dependence, or cessation of use, 2) the depth of inhalation would be equivalent and not raise different questions of public health, and 3) constituents in smoke delivered from the comparison products maintains an equivalent risk to the user and does not raise different questions of public health.

FDA agreed with Lorillard’s assertion that the FD&C Act did not mandate a timeframe for FDA’s response to an SE Report. FDA said that it has been “working diligently” to provide feedback to parties to address filing deficiencies, which have been significant and omnipresent, as well as “working expeditiously” to review SE Reports. FDA further intends to “establish performance measures” to include specific timeframes for SE Report review phases. In addition, FDA has conducted and webinars to provide information concerning observed deficiencies to the tobacco product industry to help to improve future submissions and reduce the number of review cycles. FDA described the SE Report review process as “can be complex” with “a wide range in the quality and completeness,” which further requires a review of the product to determine if it complies with the FD&C Act.

Interestingly, FDA’s response to Lorillard’s two referenced SE Reports via the Technical Project Lead Memoranda were just a day short of one year after the Petition was filed. Time will tell whether FDA provides more definitive timeframes for reviewing such SE Reports and how industry addresses the perceived review cycles in terms of filing their SE Reports before intended marketing of the new tobacco products.

ecig.jpgLast week, the European Parliament voted on a draft for the Tobacco Products Directive (TPD) and declined to accept the European Commission’s proposal to regulate electronic cigarettes (“e-cigarettes”) as medicines. The majority of Members of European Parliament (“MEPs”) supported using a mixture of tobacco regulation (e.g., controls on promotion) and medicines-style regulation (e.g., reporting of adverse reactions) for all nicotine products (including medicines), and applying medicines regulation to products that make medicinal claims.

However, just prior to the Parliament’s decision the United Kingdom (“UK”) Medicines and Healthcare Products Regulatory Agency (“MHRA”) had announced that the UK government would regulate e-cigarettes and other nicotine-containing products (“NCPs”) as medicines. After the vote the MHRA stated that it still believed that medicinal regulation of NCPs is in the best interests of the public health, and they will continue to encourage companies voluntarily to seek a medicinal license for their NCPs. Comparable nicotine replacement products (e.g. gums, patches, inhalator), for example, are licensed as medicines.

Earlier the Commission on Human Medicines (“CHM”) working group on NCPs had concluded that the NCPs currently on the market do not meet appropriate standards of safety, quality, and efficacy. Their study found that nicotine levels can vary considerably from the labeled content, and the amount of nicotine per product can differ from batch to batch. Regarding e-cigarettes, which deliver nicotine via a cartridge, there is also no data concerning the manufacture of the cartridge or device to suggest consistent nicotine doses across multiple cartridges or multiple devices. Additionally, the cartridges may contain potentially toxic elements at unexpectedly high doses, which could produce adverse effects, particularly in vulnerable patient groups.
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Thumbnail image for 120px-Components_of_a_MiniCiggy_e-cigarette.jpgOn September 5, the Centers for Disease Control and Prevention (“CDC”) released a Morbidity and Mortality Weekly Report “Electronic Use Among Middle and High School Students – United States, 2011-2012“. According to the Report, electronic cigarette or “e-cigarette” use among middle and high school students doubled in just one year from 4.7 percent in 2011 to 10.0 percent in 2013. In the same period, high school students using e-cigarettes within the last 30 days rose from 1.5 to 2.8 percent. Yet among current e-cigarette users in high school (2012), 80.5% reported current conventional cigarette smoking, and current use of both e-cigarette and conventional cigarettes increased from 1.2% to 2.2%.

E-cigarettes are designed to look and feel like conventional cigarettes but do not ignite tobacco leaf products. Instead, they include a vaporizer or atomizer, powered by a battery and controlled by a sensor and microcomputer chip, which heats and vaporizes fluid in a cartridge containing various chemicals. These chemicals often include liquid nicotine derived from natural tobacco plants. Back in 2011, we blogged on an FDA announcement that the Agency would regulate e-cigarettes as “tobacco products” under Family Smoking Prevention and Tobacco Control Act of 2009. At that time, FDA was reacting to a loss that the Agency had in Sottera, Inc. v. FDA, where FDA first had attempted to regulate e-cigarettes as combination drug/devices. In Sottera, the D.C. Circuit Court of Appeals concluded that unless the e-cigarettes were marketed with therapeutic claims, such as smoking cessation or reduction, FDA had the authority to regulate e-cigarettes as “tobacco products,” because the nicotine used in the products was obtained from tobacco leaves.

To date, however, FDA has not issued regulations to expand its jurisdiction for “tobacco products” to include e-cigarettes, and, as a result, FDA has little information to understand the types of components or potentially-harmful ingredients contained therein. According to the CDC’s Press Release covering this topic, FDA’s Director for the Center for Tobacco Products, Mitch Zeller, said reacting to the CDC’s Report, “These data show a dramatic rise in usage of e-cigarettes by youth, and this is cause for great concern as we don’t yet understand the long-term effects of these novel tobacco products. . . . These findings reinforce why the FDA intends to expand its authority over all tobacco products and establish a comprehensive and regulatory framework to reduce disease and death from tobacco use.” So while it remains unclear when FDA will act to regulate e-cigarettes, FDA still seems committed to do so.
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nicotine.jpgOn April 1, FDA provided a combined response to three citizen petitions concerning the regulation of over-the-counter (“OTC”) nicotine replacement therapy (“NRT”) drug products. The petitions were submitted by the Commissioner of Health, New York State Department of Health (Docket No. FDA-2008-P-0116), the Director, Legal Resource Center for Tobacco Regulation, Litigation & Advocacy, University of Maryland Francis King Carey School of Law on behalf of the Association for the Treatment of Tobacco Use and Dependence (“ATTUD”) and the Society for Research on Nicotine and Tobacco (“SRNT”) (FDA Docket No. FDA-2008-P-0116), and four not-for-profit organizations, the American Cancer Society Cancer Action Network, the American Lung Association, the Campaign for Tobacco-Free Kids, and the American Legacy Foundation (FDA Docket No. FDA-2010-P-0454). For additional background on this topic generally, please see an earlier blog that we posted here about a NRT workshop that FDA held in October 2010 addressing the topics in these petitions.

The petitioners asked FDA to consider modifying the labeling of OTC NRTs, certain policy changes, and allowing greater access to the products. While the requests varied, a common theme was that the petitioners wanted consumers to have greater access to NRTs in smaller packages that would permit more flexible use of the products, other than the typical up-to-12-weeks smoking cessation program scenario contemplated by the clinical studies that supported the use of these products. For instance, some of the petitioners suggested that the labeling should include additional risk/benefit information concerning NRTs versus continued cigarette (or other tobacco product) use, including possible concomitant use of cigarettes and NRTs, as well as longer-term NRT use to reduce and perhaps ultimately eliminate an individual’s cigarette use. The not-for-profit petitioners wanted FDA to make the development of NRTs a priority within FDA, including certain collaborations with manufacturers of NRTs, such as the development of appropriate trial designs, and to transfer evaluation of NRTs from FDA’s drug division for addiction drug products to its division for oncology drug products.
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Thumbnail image for Thumbnail image for supremecourt.pngEarlier this week, the U.S. Supreme Court denied GlaxoSmithKline’s certiorari petition in a case that would have helped clarify the scope of 35 U.S.C. § 271(e)’s safe-harbor provision. The issue facing the Court was whether section 271(e)(1) applies to postmarketing activity as well as premarketing activity.

Section 271(e), which states that it is not an act of infringement to make, use, offer to sell, or sell a patented invention “solely for uses reasonably related to the development and submission of information under [federal drug laws],” does not include a time limitation. The question about timing was highlighted in two recent Federal Circuit cases. In Classen Immunotherapies, Inc. v. Biogen Idec, 659 F.3d 1057 (Fed. Cir. 2011), the Federal Circuit explained that “§ 271(e)(1) is directed to premarketing approval of generic counterparts before patent expiration.” Last year, however, a different panel of judges in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., 686 F.3d 1348 (Fed. Cir. 2012) held that post-approval studies performed for the FDA fall within § 271(e)(1)’s safe harbor and explained that Classen held that 271(e)(1) “does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained.”

As previously blogged on here, the Solicitor General had urged the Supreme Court to deny GSK’s petition in the Classen case. Despite a belief that the Federal Circuit erred in Classen, United States Solicitor General Donald Verrilli offered the following reasons why the Supreme Court should deny certiorari: (1) the Federal Circuit’s Momenta decision sufficiently clarified and narrowed the Classen holding; (2) it was unclear whether the safe harbor applied to the types of patents at issue in the Classen case; and (3) the petitioners were not entitled to the safe harbor protection regardless of the Supreme Court’s interpretation of the provision.
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Thumbnail image for Thumbnail image for Thumbnail image for FDA.jpegOn January 2, 2013, barely three months after FDA’s new user fee programs go into effect, certain mandated spending reductions, called sequestration, also may go into effect that could prevent FDA from using the user fees it collects from industry. A Congressional Super Committee failed to find the required $1.2 trillion in cuts over ten years by a November 2011 deadline. The combined effect of lost taxpayer and user fees projected by Maryland-based Alliance for a Stronger FDA, would be an initial $294 million out of a $3.65 billion budget.

The catch comes from a component of FDA’s user fee programs known as the “trigger” that requires a certain baseline of taxpayer funds to go to FDA, so industry user fees supplement rather than fund FDA’s operations. FDA’s projected funding for fiscal year 2013, set at $2.5 billion, would be cut by an across-the-board, 8% cut in federal government, coined as a “fiscal cliff”, imposed to help curb the ever-increasing government debt. While FDA’s cut of about $200 million would not normally hit the trigger to prevent FDA’s use of user fees, Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA, told Anna Edney from Bloomberg that the Obama Administration may still sequester FDA’s user fee funds to help with federal spending reduction goals. The exact trigger levels, moreover, are based on formulas that include consumer inflation and past spending, which so far FDA has declined to comment on.

According to Grossman, if this occurs, about $68 million in drug and device user fees and $40 million in tobacco-company payments would be diverted to a U.S. Treasury Department account that would “reduce government because it would reduce what they can do.” Faced with the sudden loss of these funds, drug industry experts have speculated that FDA would be forced to lay off personnel and take other measures to reduce costs.
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3699948229_d7732f8df0_o.jpgOn April 30, FDA published in the Federal Register final regulations amending the scope of its clinical investigator disqualifications. Now when the Commissioner determines that a clinical investigator is ineligible to receive one kind of test article (drug, device, animal drug), the clinical investigator is also ineligible to conduct any clinical investigation that supports an application for research or marketing for other FDA-regulated products, including foods and tobacco products. FDA amended its regulations “to protect the rights and safety of subjects involved in FDA-regulated investigations, and help[s] to ensure the reliability and integrity of the data used to support the marketing of products regulated by FDA.”

According to FDA, the final rule was based on a recommendation from the General Accounting Office (“GAO”) in September 2009. The GAO Report, Oversight of Clinical Investigators: Action Needed to Improve Timeliness and Enhance Scope of FDA’s Debarment and Disqualification Process for Medical Product Investigators, stated that it was “critical for FDA to take action–and to have the authority to take action–to prevent clinical investigators . . . who engaged in serious misconduct from doing it again, whether in research that involve drugs, biologics, or devices.” FDA is also amending its regulations for informal hearings under 21 C.F.R. Part 16 by changing the scope of certain provisions that were “inadvertently omitted.”

FDA proposed the rule in the Federal Register on April 13, 2011 and received only two comments. FDA, however, managed to convert one of the filed comments to ten points to address in the preamble to the final rule. First, FDA clarified the “repeatedly or deliberately” language in the regulations for when a clinical investigator may be disqualified for repeatedly or deliberately failing to comply with FDA’s applicable clinical investigations regulations or deliberately submitting false information to the sponsor. FDA said “repeatedly” means more than once, which can be more than one time in a single study or in more than one study. “Deliberately” means “willful” conduct or with reckless regard, such as knowingly failing to comply with FDA’s regulations or falsifying data. In another point, FDA clarified that FDA will place no limits on how far back FDA will investigate to find applications or submissions that may have been affected by a disqualified investigator. In yet another point, FDA summarized the notification process for how sponsors become aware of an clinical investigator’s ongoing disqualification process, including redacted letters on FDA’s website. In the final point, FDA indicated how FDA notifies sponsors that clinical investigators have been reinstated–once again, primarily FDA’s website.
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FDLILogo.jpgOn April 24, at the Food and Drug Law Institute’s (“FDLI’s”) 55th Annual Conference 2012, reflecting on history of the FDA and FDLI, FDA Commissioner Margaret A. Hamburg, M.D., noted that dating back to the first FDLI/FDA informal conference back in 1957, FDA continues to regulate an “enormous scope” of products with a continuing need for more resources. Hamburg said that FDA is now at a “turning point”–there is a need to develop medical countermeasures for biological threats either natural- or terrorism-oriented, such as new antibiotics, and there are needs for new product such as treatments for type II diabetes and obesity. At the same time FDA is poised for various riders expected to be added to the four user fee bills presented to Congress. Some of those riders include new provisions for accelerated approval, increased authorities for FDA to regulate products or component of products made overseas (e.g., 85% of the active ingredients are manufactured outside us and 40% drug products are made outside the United States), increased monitoring for drug shortages, and strengthening FDA’s rare disease program. Hoping to create a “brand” for FDA, Hamburg said there is a need for stronger and more sophisticated science to help bolster reliance by the world on FDA’s decision-making as the “gold standard.”

Following Hamburg, three of FDA’s relatively-new Deputy Commissioners discussed key issues confronting each of them. Michael R. Taylor, Deputy Commissioner for Foods, said that he believes resource allocation is important. Taylor’s key issues include antimicrobial resistance, nutrition labeling, nanotechnology, chemical contaminants, a new strategic plan for foods and veterinary medicine, and executive leadership management–all with a need to involve stakeholders in the process. Stephen P. Spielberg, M.D., Deputy Commissioner for Medical Products and Tobacco, said that he is excited to be working at FDA at a time when the medical community is better understanding the causes of diseases. He is looking at the potential for more synergies between the centers and also looking at his own responsibilities, including how to help prevent children from initiating smoking and becoming addicted to nicotine. Deborah M. Autor, Deputy Commissioner for Global Regulatory Operations and Policy, said she is interested in “leap frogging” and developing an enterprise management where domestic and foreign inspection are handled the same in an increasingly global environment with statutes and regulations drafted with domestic manufacturing primarily in mind. Autor is hoping that manufacturers take a better look at the supply chain and components that go into their products, while developing better risk analytics to maintain quality.

Following a discussion on FDA regulatory science and a lunch session highlighting FDLI’s new upcoming conference in Brazil, each of the FDA centers presented their outlooks for the upcoming year. Presenting for the Center for Drug Evaluation and Research (“CDER”), Deputy Center Director, Douglas C. Throckmorton said that a key priority will be to finalize and implement the requirements of FDA’s requested user fees. CDER plans to fill a number of key senior leadership position: an additional Deputy Center Director and directors for the Office of Generic Drugs, the Office of Biostatistics, the Office of Clinical Pharmacology, and the Office for Surveillance and Epidemiology. In addition,
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FLH Partner Brian Malkin will attend the Food and Drug Law Institute’s (“FDLI’s”) Annual Conference in Washington, D.C. on April 24-25. For 55 years, FDLI’s Annual Conference has been considered the venue for food and drug law lawyers and professionals to hear from FDA and industry about new and emerging topics covering all the products FDA regulates. FDLI has reported that this year’s event is expected to draw more than 600 attendees, who will hear directly from FDA’s key leaders including Commissioner Margaret Hamburg; Deputy Commissioners Deborah Autor, Stephen Spielberg, and Michael Taylor, various representatives from FDA’s six product Centers; newly-appointed Chief Counsel Eliabeth Dickinson, as well as a number of former Chief Counsels. An updated agenda is available here.

FDA Lawyers Blog is a Media Partner of FDLI’s 55th Annual Conference. Prior to FDLI’s Annual Meeting, Mr. Malkin will participate in a FDLI Monograph Committee Meeting on April 23 and will be working out of Frommer Lawrence & Haug LLP’s Washington, D.C. office next week. Mr. Malkin looks forward to seeking you and catching up at FDLI’s Annual Conference this year.