Category: Regulation

  • FDA: 99 Percent of Applications Decided

    FDA: 99 Percent of Applications Decided

    Image: manonteravest | Adobe Stock

    In an update, the U.S. Food and Drug Administration said it has made determinations on more than 99 percent of the nearly 26 million deemed products for which applications were submitted. To date, the agency has authorized 23 new e-cigarette products.

    This includes determination on applications for nearly 6.7 million products received by the Sept. 9, 2020, deadline, more than 18 million products received after the Sept. 9 deadline, and applications for nearly 1 million nontobacco nicotine products submitted by May 14, 2022, in accordance with the new federal law passed in April 2022.

    Under a federal court order, manufacturers of deemed new tobacco products that were on the market as of the deeming rule’s effective date (Aug. 8, 2016) were required to submit premarket review applications by Sept. 9, 2020.

    On Feb. 21, 2023, the FDA issued a refuse-to-accept (RTA) letter to one applicant notifying the company that their premarket tobacco product applications, which are associated with approximately 17 million individual tobacco products, do not meet the acceptance requirements outlined in the FDA’s regulations. The applications were for a grouped submission of e-liquids in varying size, nicotine strength and flavor combinations, each of which was treated as an individual product application according to existing premarket review processes.

    During the acceptance phase of application review, the FDA reviews applications to ensure they meet a minimum threshold for acceptability for FDA scientific review. If required contents for acceptance are missing, the FDA refuses to accept the application. This company was issued an RTA letter because the company’s applications for these products lacked required environmental assessments. The company may submit a new application for these products at any time; however, the products may not be marketed unless the FDA reviews the applications and determines that marketing of the products is appropriate for the protection of the public health.

    The latest updates on actions taken on these applications can be viewed on the FDA’s tobacco products marketing orders page.

  • Hearing on FDA Manufacturing Rules

    Hearing on FDA Manufacturing Rules

    Photo: BAT

    Registration is open for U.S. Food and Drug Administration’s upcoming public oral hearing on April 12, 2023, from 9:30 a.m. to 5 p.m.

    The hearing is an opportunity for the public to verbally comment on the agency’s proposed rule Requirements for Tobacco Product Manufacturing Practice. The FDA is proposing new requirements for tobacco product manufacturers regarding the manufacture, design, packing and storage of their products. Registration also includes a “listen-only” option for those who want to attend the session but do not want to request to speak.

    Speaking spots are limited, and the FDA says it cannot guarantee that it will be able to accommodate all requests. Groups and organizations should select a single spokesperson to help the agency hear as many different perspectives as possible. While speaking spots are limited, listening spots are unlimited. Registration to provide oral comments will close on March 31, 2023.

    The oral session will be recorded, and a transcript will be added to the docket of the proposed rule.

  • Dutch Lawmakers Want ‘Boring’ Vapes

    Dutch Lawmakers Want ‘Boring’ Vapes

    Photo: pathdoc

    Dutch parliamentarians want e-cigarettes and other vaping products to have a uniform appearance, reports RTL Nieuws.

    According to the D66, which will submit the proposal in parliament today, the new rules will make vaping less attractive to teenagers. A majority in parliament supports the plan, RTL Nieuws reports.

    “Young people now think it’s cool to have such an accessory with glitter while vaping is extremely unhealthy,” D66 parliamentarian Jeanet van der Laan told the broadcaster. “The vapes resemble a lip gloss or a marker. They are often colorful, and there are vapes full of glitter. Parents often have no idea exactly what the young people are carrying. Super worrying.”

    There are even e-cigarettes in circulations that look like airpods, Van der Laan said. “That makes it look like a glamor accessory, while it is just smoking and therefore harmful to health. And young people are tempted by all those frills to start smoking.”

    “E-cigarettes should look as neutral and uniform as possible. Preferably they should resemble regular cigarettes. Or else just white or black. Because it’s just smoking,” D66’s MP said. She believes a more boring appearance will make vaping less attractive to young people.

    The lower house of the Dutch parliament is discussing smoking on Wednesday. D66’s proposal seems to have majority support, according to RTL.

    The Netherlands previously announced a ban on flavored e-liquids.

  • FDA Proposes New Rules for Manufacturing

    FDA Proposes New Rules for Manufacturing

    Photo: Tobacco Reporter archive

    The U.S. Food and Drug Administration is proposing new requirements for tobacco product manufacturers regarding the manufacture, design, packing and storage of all tobacco products.

    The proposed requirements would help protect public health by, among other things, minimizing or preventing contamination and limiting additional risks by ensuring product consistency, according to an FDA statement.

    “While no tobacco product is safe, this proposed rule is intended to minimize or prevent additional risks associated with these products,”

    Brian King / Credit: FDA

    said Brian King, director of the FDA’s Center for Tobacco Products. “Once finalized, it would establish requirements for tobacco product manufacturers that will help protect public health.”

    The proposed new requirements would help manufacturers comply with the Federal Food, Drug, and Cosmetic Act by helping minimize or prevent the manufacture and distribution of tobacco products contaminated with foreign substances—such as metal, glass, and plastics—which have been found in tobacco products. T

    The proposed rule would also help address issues related to inconsistencies between e-liquid product labeling and the actual concentrations in e-liquids, “Such variability can be misleading to consumers, potentially intensifying addiction and exposure to toxins,” the agency states.

    The proposed rule would also establish several requirements related to the identification, tracing and corrective actions for tobacco products that don’t meet specifications or are contaminated, including for tobacco products that have already been distributed.

    In the event of an issue, these requirements would require manufacturers to take corrective actions, which may include conducting a recall.

    The proposed requirements apply to manufacturers of finished and bulk vaping and other tobacco products. As laid out in the proposed rule, a finished tobacco product is a tobacco product, including any component or part, sealed in final packaging; for example, an e-cigarette, a pack of cigarettes or a can of moist snuff.

    A bulk tobacco product is a tobacco product that isn’t sealed in final packaging, but is otherwise suitable for consumer use. 

    The proposed rule establishes a framework for manufacturers to adhere to, including: 

    • establishing tobacco product design and development controls;
    • ensuring that finished and bulk tobacco products are manufactured according to established specifications; 
    • minimizing the manufacture and distribution of tobacco products that don’t meet specifications;
    • requiring manufacturers to take appropriate measures to prevent contamination of tobacco products; 
    • requiring investigation and identification of products that don’t meet specifications to institute appropriate corrective actions, such as a recall; and
    • establishing the ability to trace all components or parts, ingredients, additives and materials, as well as each batch of finished or bulk tobacco product, to aid in investigations of those that don’t meet specifications. 

    The FDA will hold a public oral hearing on April 12 to gather additional comments from stakeholders, including industry, the scientific community, advocacy groups, and the public.

    The proposed rule also will be available for public comment for 180 days. The agency will review all comments as part of the rulemaking process for this foundational rule.

    “We remain committed to transparency and stakeholder engagement, including providing clarity to industry so that they are equipped to comply with the law,” said King. “We encourage all interested individuals and organizations to participate in the rulemaking process. When the public submits a comment based on sound grounds, that can make an important difference in the agency’s decision-making.”    

    The FDA will also hold a meeting of the Tobacco Products Scientific Advisory Committee (TPSAC) on May 18 to seek recommendations from the agency’s outside panel of experts on the requirements laid out in the proposed rule. As part of the TPSAC meeting, the public will have an opportunity to make oral presentations. The FDA intends to make TPSAC meeting materials available on its website no later than 48 hours before the meeting. 

  • Webinar on FDA Warning Letters

    Webinar on FDA Warning Letters

    Photo: Song_about_summer

    The U.S. Food and Drug Administration has posted a new webinar to help manufacturers and vape shop owners respond to warning letters from the agency’s Center for Tobacco Products (CTP).

    The webinar outlines the appropriate items for a response to a warning letter, which should be received by FDA within 15 business days. The webinar also includes an explanation of proper documentation concerning corrective actions that entities have taken.

    In the webinar, participants will learn about:

    • Preparation for a response to CTP
    • Important items to include in a response
    • Additional compliance resources
  • Malaysia PM Urges Regulation E-liquids

    Malaysia PM Urges Regulation E-liquids

    Photo: Max

    The government of Malaysia wants to regulate and tax nicotine liquids, reports New Straits Times, citing Prime Minister Anwar Ibrahim.

    Speaking during the presentation of the government’s 2023 buget, Anwar said that although vape with nicotine is illegal, the product is still being sold widely with an estimated market size of more than MYR2 billion. “Would it not be great if it is monitored and taxed to discourage the usage of vape,” asked Anwar, who is also the finance minister.

    While welcoming the proposal to introduce a regulatory and taxation framework for e-cigarettes, industry groups insisted on consultations. “Regulations and tax rates need to be balanced given it will impact local industry players,” said The Malaysian Vape Chamber of Commerce.

    In his presentation, Anwar also expressed support for the Generational Endgame (GEG) bill, which would make it illegal for people born after 2007 to buy tobacco products, including e-cigarettes.

    The Advanced Centre for Addiction Treatment Advocacy (ACATA) said the government must conduct more studies on the GEG proposal before making any decision.

    While ACATA is encouraged by the government is taking steps to regulate vape, the agency said prohibition was likely to backfire. “There is substantial and credible evidence to prove that vape products are less harmful than smoking cigarettes,” the organization stated. It also cited evidence showing that vaping is effective in helping smokers to quit smoking cigarettes without attracting many never-smokers. ACATA cited a 2020 study, which found that only 0.6 percent of Malaysian nonsmokers vape.

    The Malaysian Vapers Alliance, meanwhile, expressed disappointment that the government supported the GEG proposal, saying that cigarettes and vapor products should be treated differently, given the vast difference in risk they present.

  • CTP Outlines Responses to Reagan-Udall Report

    CTP Outlines Responses to Reagan-Udall Report

    Photo: Tada Images

    The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) on Feb. 24 outlined the steps it plans to take in response to an external evaluation of its operations conducted by evaluators working through the Reagan-Udall Foundation.

    The expert panel issued its final report on Dec. 19, 2022, and included 15 recommendations across a number of areas.

    To address concerns raised in the report about transparency, the CTP said it would appoint internal transparency liaisons within each CTP Office, who will be responsible for objectively identifying areas for transparency enhancement. The center will also create a new webpage to feature its responses to citizen petitions and will resume posting scientific policy memos and reviewer guides “when appropriate.”

    To enhance efficiency of its premarket tobacco product application review process, the CTP said it has started developing a more efficient framework for high-quality reviews. The center said it aims to better communicate on scientific issues and practices; hire additional staff and increase internal communication to improve scientific engagement and deliberation. Among other activities, the CTP said it will resume posting of scientific policy memos and reviewer guides, along with communication through public events, such as workshops and listening sessions.

    The CTP also expressed its intention to hold more frequent meeting of the Tobacco Products Scientific Advisory Committee to obtain input on scientific issues.

    To improve its operations in the areas of regulations and guidance, the CTP said it will create a new policy unit within the Office of the Center Director that would be responsible for providing overall policy coordination across the CTP.

    The FDA has advocated for the authority to collect user fees from e-cigarette companies, which currently do not pay user fees despite the enormous workload to review and make decisions regarding these products.

    Robert Califf, Commissioner, FDA

    Recognizing opportunities to enhance its compliance and enforcement work, the CTP said it will convene a summit related to enforcement with senior officials from the Department of Health and Human Services, the FDA, and the Department of Justice (DOJ). The CTP will consider whether statutory changes are needed to assist the center in enforcing the law. It will also explore approaches to achieve compliance outside of judicial enforcement actions through DOJ.

    The CTP said it plans to create a comprehensive webpage for all enforcement activities for products that are illegally marketed without FDA authorization; routinely reach out to industry stakeholders to keep them apprised of new enforcement priorities and updates; and enhance the FDA’s tobacco product marketing order webpage. Planning has already begun for development of a searchable public database of all tobacco products that have an FDA marketing order, according to the center.

    To improve engagement on its public education campaigns, the CTP said it will develop, publish and promote resources that describe the mechanisms it currently uses to solicit and consider public input on its campaigns. It will also explore new ways for soliciting and considering public input on its campaign program.

    Consistent with the Reagan-Udall report recommendation, the CTP is also engaging with relevant entities within FDA, the Department of Health and Human Services, and the Office of Personnel Management to identify solutions to facilitate more timely and efficient hiring of professionals that match CTP’s needs.

    To achieve its goals, the CPT stressed the importance of having appropriate resources, which it suggested could be raised through additional user fees for regulated products, including e-cigarettes. “Since the agency’s fiscal year 2020 budget request, the FDA has advocated for the authority to collect user fees from e-cigarette companies, which currently do not pay user fees despite the enormous workload to review and make decisions regarding these products,” said FDA Commissioner Robert Califf in a statement.

    A detailed description of the CTP’s plan for addressing the Reagan-Udall recommendations is available at the center’s new website.

  • Health Advocates Urge FDA to Ban Flavors

    Health Advocates Urge FDA to Ban Flavors

    Image: chocolatefather | Adobe Stock

    Health advocates are urging the U.S. Food and Drug Administration to ban menthol cigarettes and flavored cigars, reports WGBO. The FDA issued draft measures to ban menthol in April 2022. Final regulations are expected later this year.

    “Menthol is an analgesic; it numbs the throat, so it lets the poison go down easier,” said Carol McGruder, co-chair of the African American Tobacco Control Leadership Council. “It dilates the alveoli in the lungs, the little sacs in your lungs, and so it allows the toxins to stay longer and deeper in the lungs.”

    Lincoln Mondy made a documentary called Black Lives/Black Lungs about the marketing of menthol cigarettes to Black communities, something many have pointed out as a trend in tobacco marketing.

    “We say predatory because it was indeed predatory; they went in neighborhoods like Detroit and New York and majority Black neighborhoods and gave out free cigarettes. They just handed out free cigarettes; they drove up in Newport vans and Kool vans and handed out free cigarettes,” Mondy said.

    As a result of this “predatory” marketing, 85 percent of Black smokers smoke menthol cigarettes. Some states like California passed laws banning flavors. However, McGruder says that the industry is still finding ways around such bans.

    “They’ve already introduced new products that have some chemicals in there that mimic menthol, but they’re not menthol, and they’re actually on the market right now in California, and so now we have to deal with that, and so, the industry will never stop. They are going to continue to recruit their new smokers to replace the folks who are dying,” McGruder said.

  • CTP Hires New Office of Science Director

    CTP Hires New Office of Science Director

    Matthew Farrelly (Credit: RTI International)

    The new director of the U.S. Food and Drug Administration’s tobacco science division is Matthew Farrelly, former chief scientist and director of the Center for Health Analytics, Media, and Policy for RTI International.

    In an announcement, the FDA’s Center of Tobacco Products (CTP) stated that Farrelly’s extensive work in the field of tobacco and nicotine science for more than 25 years, and being recognized internationally as an expert with proven leadership and organizational management skills will help him succeed as the director of the CTP’s Office of Science.

    “He has led or been involved with numerous scientific endeavors related to tobacco control policies and regulatory approaches, including those related to graphic health warning labels, excise taxes, smoke-free policies, quitlines, state tobacco control programs, retail advertising, and flavored tobacco products,” the release states. “He has also extensively researched the influence of mass reach health campaigns, including FDA’s The Real Cost.”

    Farrelly also has authored or co-authored over 120 articles in peer-reviewed scientific literature, according to the release. He earned his Ph.D. in Economics from the University of Maryland at College Park.

    Farrelly joins the CTP as the agency faces a series of major tobacco-related decisions, including a potential ban on menthol cigarettes, lowering nicotine levels, and the next step in its ongoing attempt to regulate Juul and other electronic cigarettes.

    Farrelly will replace Matt Holman, who left the position last year to join Philip Morris International. Holman was hired in 2017 and took over for David Ashley.

  • A Teaching Moment

    A Teaching Moment

    Photo: Darren415

    Nicotine’s lessons for cannabis regulation

    By Cheryl K. Olson and Willie McKinney

    From the industry perspective, regulation of tobacco products by the U.S. Food and Drug Administration went from impatient foot-tapping to a lurching roller-coaster ride. The recently released “operational evaluation” of the FDA’s tobacco program, requested by Commissioner Robert Califf, lays out in sedate but clear terms some causes of industry’s frustrated exhaustion: years of delay in establishing requirements. Sudden major shifts in policy. Cycles of litigation and reprieve.

    Based on feedback from FDA employees, and people from industry and public health, the independent Reagan-Udall Foundation for the FDA made recommendations to start repairing the regulatory mess. After “observ[ing] that CTP [Center for Tobacco Products] has been forced to operate primarily in a reactive mode, moving from one challenge to the next,” the first recommendation to the agency is to get proactive. The Reagan-Udall panel encouraged the CTP to make time now to “think strategically about where it is today and where it needs to go in the next several years.”

    This advice might apply equally to whatever future the FDA faces with regulation of cannabis products. The FDA has authority over cannabis and its dozens of biologically active chemical compounds, including CBD and THC. Although marijuana falls under the federal Controlled Substances Act, the 2018 Farm Bill removed hemp (a low-THC cannabis plant and its derivatives) from that definition.

    Principal Deputy Commissioner Janet Woodcock recently announced in a press release that existing regulatory frameworks for food and supplements are not appropriate for CBD. “The agency is prepared to work with Congress” on a new pathway, she stated.

    What might we take from the U.S. tobacco experience to ease headaches for future cannabis regulation? Below are some points to ponder in three areas: regulatory structure, medical versus recreational use, and the effects of misinformation on regulation.

    What Should a New Structure Look Like?

    First, what regulatory structure makes sense: Should the FDA create an all new one for cannabis products, or should it employ some existing channels? Consider the tobacco parallel.

    “Safe and effective” is the FDA’s traditional standard for evaluating drugs and medical products. In the 1990s, then Commissioner David Kessler tried to assert the FDA’s authority to regulate nicotine as a drug—intended by industry to affect the body’s structure or function—and cigarettes as delivery devices. A 2000 Supreme Court ruling found that the “s and e” standard left no room for regulation of tobacco.

    In 2009, when Congress chose to place tobacco under FDA jurisdiction, a novel department was created. But this promising, fresh science-based regulatory approach for tobacco faced headwinds. This Center for Tobacco Products was largely staffed by people rotated from elsewhere in the FDA. The “appropriate for the protection of public health” (APPH) tobacco standard was a difficult departure from their accustomed ways and views. The combination of suspicion from past industry misbehavior and the political uproar over youth vaping fostered an “us versus them” mindset. The founding legislation’s focus on cigarettes, the most deadly of tobacco products, affected attitudes toward emerging alternative nicotine products with the potential to greatly reduce disease risks for people who smoke.

    Perhaps there is light at the end of the tunnel. The FDA appears to recognize that shoehorning cannabis into existing structures has its own problems. Each type of intended use must find a fit in an existing department, such as human food, veterinary products, cosmetics or drugs. Under the Federal Food, Drug and Cosmetic Act, a drug is any product (including marijuana or hemp) intended to affect the structure or function of the body or intended to diagnose, cure, mitigate, treat or prevent disease.

    What factors will influence staff mindset about cannabis in these various departments? How will that affect regulation?

    Medical vs. Recreational Pathways

    Another issue: How best to regulate cannabis for medical versus recreational use? Like tobacco, cannabis has been used historically for medical purposes, such as treating pain. Both nicotine and cannabis are reportedly used to self-medicate for mental health disorders. Use of marijuana to manage mood disorders is reportedly higher in states with medical marijuana laws. But there currently is no such thing as “medical” marijuana. (This is not unlike the confusion over what constitutes “natural” food.) The FDA drug pathway would create medical cannabis. A standardized product would be evaluated for quality, safety and efficacy for a particular medical indication.

    We lack randomized, controlled clinical trial data on whether cannabis effectively treats disorders such as depression. However, such studies could be done by industry and submitted to the FDA’s Center for Drug Evaluation and Research. Several specialty products containing THC or CBD (e.g., for chemotherapy-related nausea or severe forms of epilepsy) have emerged from this path.

    But what regulatory pathway might recreational cannabis take? And what complications arise from product format and route of administration: smoked, vaped, applied to skin or eaten? Where would combusted flower fit?

    Nicotine is regulated by the FDA as a drug and as a recreational product. Two paths for cannabis also make sense. Although there is overlap (to get technical: Gum bases that contain nicotine are regulated as both pharmaceuticals and recreational tobacco products), combusted tobacco products that contain nicotine are only regulated by the Center for Tobacco Products.

    We propose that Congress modify the 2009 Tobacco Control Act to give the CTP authority over combusted and vaped cannabis. Such products are very unlikely to pass the “safe and effective” drug standard, but the APPH standard may be applicable to recreational cannabis. And the CTP has built up expertise in combusted and vaped products.

    Keep Moral Panic Out of Regulation

    A third issue deserving of thought is how to prevent moral panic and misinformation from derailing the potential benefits of cannabis. One lesson from nicotine is how these can fog the ability of regulators, politicians and the public to see data clearly.

    Research shows that youth use of nicotine and cannabis (as well as alcohol and other substances) overlap. A 2022 analysis of Population Assessment of Tobacco and Health study data found that more than half of e-cigarette users aged 15 to 24 had vaped cannabis. At the population level, teen cannabis youth has been fairly stable for the last quarter century. However, there will be concerns that the spread of state laws legalizing cannabis for adults could ease access for youth.

    Once it takes hold, misinformation is hard to uproot. Witness stubborn rates of misbelief that the outbreak of vaping-related lung injuries (e-cigarette or vaping product use-associated lung injury, or EVALI) were caused by e-cigarettes instead of THC vapes adulterated with vitamin E acetate.

    We see signs of a potential moral panic over cannabis. When the Centers for Disease Control and Prevention noted that marijuana vaping was most often linked to EVALI, the Wall Street Journal editorial board decried the “risky social experiment [of] legalizing and especially destigmatizing cannabis”—a drug that “could be damaging young brains for a lifetime.” News reports tout studies suggesting higher potency cannabis could mean higher risks of addiction and health harms.

    Research to clarify the specific nature of cannabis risks to youth is needed. We also need research on the current state of cannabis misinformation, including overly rosy views of risk that could create a backlash when problems are publicized. Using the results of this research for outreach ASAP, before the pot panic gets rolling, could soften the impact.

    Scrutinize and Enforce

    To avoid repeating mistakes of the past, we also need rigorous oversight. The FDA has been criticized for reluctance to use its powers to remove illegal nicotine vapes from the market. Some companies continue to sell despite warning letters. We need to study what cannabis products drive youth use and proactively target those makers and distributors.

    Products likely to attract underage users deserve particular scrutiny. Although no deaths were reported, a study in the journal Pediatrics2 documented a worrisome increase in child poisonings from edible cannabis products. To protect both adult access and child well-being, it’s common sense to require that edibles come in clearly marked, child-resistant packaging with no resemblance to candy.

    We have tools to unmask the bad actors. Youth will tell us in surveys what products they buy. The FDA’s own National Youth Tobacco Survey identified products not legally on the market, such as Puff Bar and Hyde, as favorite brands (Hyde was identified through write-in responses).

    With nicotine, regulatory delays and gray areas (such as regulation of synthetic nicotine) were abused by companies willing to skirt the law for quick profit. We see analogous situations with cannabis. One example is hemp-derived delta-8 THC products, said to produce a milder high similar to that from marijuana-derived delta-9 THC. Sales are rising fast. So are concerns. There are safety risks from impurities created during delta-8 manufacturing. And public confusion over delta-8’s legal status could complicate marijuana legalization efforts.

    The Reagan-Udall Foundation review of the CTP highlighted the need for “truthful and accurate information to help adult consumers make informed decisions about the role of nicotine” and product-specific risks. This applies equally to cannabis.

    Cheryl K. Olson is a California-based public health researcher who specializes in behavioral health issues and consults on tobacco product behaviors via McKinney Regulatory Science Advisors. She spent 15 years on the faculty of Harvard Medical School.
    Willie McKinney is the founder of McKinney Regulatory Science Advisors. He’s held senior regulatory roles at major tobacco product companies and served for three years as the industry representative on the FDA’s Tobacco Products Scientific Advisory Committee.