On May 10, the U.S. District Court for the Eastern District of Texas issued an order in the case of R.J. Reynolds Tobacco Co. et al. v. United States Food and Drug Administration et al., No. 6:20-cv-00176 to postpone the effective date of the “Required Warnings for Cigarette Packages and Advertisements” final rule.
The new effective date of the final rule is July 8, 2023. Pursuant to the court order, any obligation to comply with a deadline tied to the effective date is similarly postponed. For example, the FDA strongly encourages entities to submit cigarette plans as soon as possible but no later than Sept. 8, 2022.
This is not the first time the new health warnings have been delayed. The rule was most recently delayed to April 9, 2023, after being postponed multiple times before this over the past few years. The rule was originally supposed to go into effect in 2021.
Additional details on the rule, as well as the new effective date and recommended date for submission of cigarette plans, can be found on the FDA’s website.
The ban on menthol cigarettes is closer to becoming a reality. After years of discussion, the U.S. Food and Drug Administration has instituted a proposed rule to place a ban on menthol combustible cigarettes and flavored cigars. Whether the menthol ban will also cover next-generation tobacco products, such as e-cigarettes, has not yet been clarified.
“The authority to adopt tobacco product standards is one of the most powerful tools Congress gave the FDA and the actions we are proposing can help significantly reduce youth initiation and increase the chances that current smokers quit. It is clear that these efforts will help save lives,” said FDA Commissioner Robert M. Califf. “Through the rulemaking process, there’s an important opportunity for the public to make their voices heard and help shape the FDA’s ongoing efforts to improve public health.”
When finalized, the FDA states that the proposed menthol product standard will:
reduce the appeal of cigarettes, particularly to youth and young adults, decreasing the likelihood that nonusers who would otherwise experiment with menthol cigarettes would progress to regular smoking; and
improve the health and reduce the mortality risk of current menthol cigarette smokers by decreasing cigarette consumption and increasing the likelihood of cessation.
According to the FDA, the proposed product standards are based on clear science and evidence establishing the addictiveness and harm of the products. Many organizations were quick to condemn the regulatory agency for proposing the rule that is opposed by all major law enforcement, civil rights and criminal justice reform organizations. Opponents of the menthol ban say that banning menthol products will do nothing to reduce combustible cigarette smoking rates but will lead to an increase in people purchasing products on the black market.
“This misguided proposal will have disastrous impacts on public health and public safety. It will do nothing to reduce smoking rates and instead make the United States less safe.” said Tim Andrews, director of Consumer Issues for Americans for Tax Reform (ATR). “It is unfortunate that as violent crime rates rise across the country, the FDA chooses to divert valuable police resources to pursue an unnecessary ban on menthol products.”
Andrews argues that a menthol ban exposes “vulnerable members of minority communities to conflict with law enforcement, and their purchases could also fund sophisticated international criminal syndicates.” According to the U.S. Department of State, illicit tobacco’s links to funding terrorist organizations already present a “serious threat” to national security. “This policy would worsen the problem while also depriving state governments of excise revenue, putting state government programs at risk,” says Andrews.
Richard Marianos, a senior law enforcement consultant who has served more than 27 years at the U.S. Bureau of Alcohol, Tobacco, Firearms and Explosives and who is now a consultant and adjunct lecturer at Georgetown University, says that in many markets, such as Asia, companies are creating products to make mentholated cigarettes, because those types of products are not covered by the rule.
“They flavor packets you just slide into a pack of cigarettes. You buy your cigarettes, you put that in there and by the time you get home, the whole pack is mentholated. They also have these– it’s like a little Tic Tac box with a round, small, little mint … but what it does is you put it into the filter, shake, crush and now it’s a menthol cigarette,” said Marianos. “Are we eventually going to be asking border protection to now start looking for minty flavor packets or Tic Tac boxes when they have to concentrate on biological and nuclear threats? When you overlook public safety surrounding this matter, you’re creating an unhealthy situation, not just for smokers, but anybody who’s out there.”
Marianos says that a menthol ban will create a greater level of diversion and criminal activity with high-value targets overseas, it’ll bring more organized crime into the United States. It’ll also create a greater market for border countries to begin manufacturing menthol and bring it into the United States.
“There was one investigation in particular, I remember, where the individual said on a wire that once they banned menthol cigarettes in the United States, you can pave the roads in gold because of the boost in sales of black market and DIY menthol cigarettes,” he said. “Prohibition doesn’t work. Your quality of police work goes down; they can’t concentrate on violent crime as much and it creates a greater wedge between themselves and the community.”
Guy Bentley
Guy Bentley, director of Consumer Freedom Research for the Reason Foundation, said that similar bans have had minimal effects on tobacco consumption in other countries such as Canada and the U.K., adding that a menthol ban is likely to lead to more policing in minority communities, more incarceration, boost black market sales and undermine criminal justice reforms in the U.S.
Bentley explained that a recent study funded by the Norwegian Cancer Society in partnership with the Polish Health Ministry found that in Poland – the EU state with the largest pre-ban menthol share – found “mixed evidence” that the ban is working as intended.
Bentley argues the FDA and Biden administration should apply a harm reduction model, educating the public about safer alternatives to conventional cigarettes and the latest smoking cessation options. Andrews concurs with Bentley, adding that the proposed rulemaking will inevitably lead to further growth of illicit markets, put members of minority communities in danger and divert law enforcement resources away from real crime.
“It ignores best practice expert recommendations on how to reduce smoking rates through proven harm reduction technologies, is a disaster for public health, and will make all Americans less safe,” Andrews said. “If the Biden Administration truly cared about the American people, they would junk this anti-science and genuinely harmful proposal immediately.”
Beginning May 4, 2022, the public can provide comments on these proposed rules, which the FDA will review as it considers future action. The agency also will convene public listening sessions on June 13 and June 15 to expand direct engagement with the public, including affected communities.
The public will have the opportunity to submit either electronic or written comments directly to the dockets on the proposed rules through July 5, 2022. Once all the comments have been reviewed and considered, the FDA will decide whether to issue final product standards.
The FDA also states that it cannot and will not enforce against individual consumers for possession or use of menthol cigarettes or flavored cigars. If the proposed rules are finalized and implemented, FDA enforcement will only address manufacturers, distributors, wholesalers, importers and retailers who violate the rules.
The U.S. Food and Drug Administration has issued a “refuse to file” (RTF) letter to JD Nova Group. The letter notifies the company that the premarket tobacco product applications (PMTAs) it submitted for approximately 4.5 million of its products do not meet the filing requirements for a new tobacco product seeking a marketing order.
As a result of this RTF action, JD Nova Group must remove approximately 4.5 million products from the market or risk enforcement action by the FDA. The company may resubmit a complete application for these products at any time. However, the products may not be marketed unless they receive a marketing granted order.
The FDA’s action affects a significant share of PMTAs under review. The agency has received applications for more than 6.5 million products from over 500 companies.
According to the FDA, JD Nova was issued the RTF letter because the company’s applications for these products lacked an adequate environmental assessment. Under the FDA’s regulations implementing the National Environmental Policy Act, an environmental assessment must be prepared for each proposed authorization.
This RTF does not apply to all product applications submitted by JD Nova. The remaining product applications the company submitted by the Sept. 9, 2020, deadline are still moving through the review process, according to the FDA.
A coalition of 23 organizations has asked the U.S. Food and Drug Administration to follow the recommendations of the Small Business Administration (SBA). Earlier this year, the SBA urged the FDA to allow nicotine products to remain on the market for another year after the current Sept. 9, 2021, deadline while their premarket reviews are in progress.
Due to the large volume of PMTAs submitted—the FDA says it received more than 6 million applications—the FDA will unlikely be able to process all submissions before manufacturers are required to pull their products off the market, according to the SBA.
In a letter to the FDA prepared by the Americans for Tax Reform (ATR), the 23 organizations say that the FDA’s promise to exercise discretion in its enforcement provides insufficient certainty for businesses who have complied with all relevant regulations and have not received authorization due to processing delays by the FDA.
If an extension is not granted, the letter cautions, there could be devastating consequences for businesses, particularly small businesses. Furthermore, any potential reduction in the supply of safe alternatives to tobacco could have a negative impact on public health across the United States and lead to an increase in tobacco-related mortality, according to the authors.
The letter also argues that “millions of consumers who depend on ENDS products for their health and thousands of businesses who depend on these products for their livelihood are threatened by this needless bureaucratic uncertainty.” The only way to avert such an adverse outcome for businesses and consumers is for the FDA to obtain a court order allowing it to extend the existing moratorium on enforcement by another year, according to the letter writers.
“The vaping industry, unlike many others, was created by small businesses, and these same small businesses continue to drive innovation in the market,” the coalition letter states. “Without these entrepreneurs, the vape industry will be consolidated into a few large corporations, causing prices to rise and consumer choice to decrease.”
The FDA gifted you a PMTA deficiency letter … what’s your strategy?
By Willie McKinney and Cheryl K. Olson
“I read it. And I thought it was over.”
Anne* held the letter she’d just pulled from the brown and white UPS Express envelope marked U.S. Food and Drug Administration. She recalled last September’s frantic scramble to submit a premarket tobacco product application (PMTA) to keep her specialty vape product on the market. Her little team did the best they could to meet the deadline; she knew there were gaps.
Now the FDA’s review of her product had reached a new milestone, marked by the small all-caps header at the top of the letter: DEFICIENCY. “Additional information is needed for FDA to make a determination,” it said.
She stared, speechless, at the 25 pages of highly technical questions—what was HPHC? Puff topography? Abuse liability?—that she had 90 days to answer.
Hundreds of companies, big and small, submitted PMTAs to comply with a court-ordered Sept. 9, 2020, deadline and to keep their novel tobacco products on the market. At a June 11 virtual meeting with the FDA’s Center for Tobacco Products (CTP) Office of Science, we learned that PMTAs for 6.5 million products from over 500 companies have been processed, with more awaiting attention. Given this crush, there are many people waiting and worrying, with the future of their businesses at stake.
This article will help you get your bearings in this confusing review process. We’ll explain how to read and interpret a deficiency letter and how to develop a response strategy. Also, you don’t have to wait for that letter; there are things you could do now to prepare.
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So what is a deficiency letter?
Let’s step back and review what happens after you submit your PMTA. First comes an acceptance review, typically a low administrative bar to clear. Does the product fall under the CTP jurisdiction? Is your application in English? Does it contain an Environmental Assessment? If it’s all yes, you’ll get an acceptance letter.
Then comes filing. This involves a preliminary scientific review that ensures the application contains all the items under section 910(b)1 of the Family Smoking Prevention Tobacco Control Act. If it does, you’ll get a filing letter. Your application will move into phase three: substantive review. A team of specialists evaluates the scientific information and data in your application. If there are gaps or questions, the FDA can ask for more information to help them make a marketing authorization decision. That request comes in the form of a deficiency letter.
Not everyone gets one. But at the June 11 meeting, Office of Science director Matt Holman said the FDA has issued “many” deficiency letters.
Should I feel happy or panicked?
If you, like Anne, have a deficiency letter in hand, the answer is both. You should feel excited because you’re well on your way; the FDA has given your application a pretty through review. You should feel nervous because you have 90 days to respond. You’ve got to get cracking!
How you feel will also depend on what they’re asking you. If, whether by strategy or necessity, your application was light on data, you may get 25 or 30 technical questions. FDA staff need all of that information to finish their evaluation of your application. If you don’t supply it, their decision is easy.
Many companies were brand new to this regulatory process and invested just enough in their PMTAs to pass the first two phases of review. If that was your strategy, it may not have been a bad one.
Some people in the tobacco products industry felt the FDA did not want any of these products on the market. They believed the PMTA process was designed for failure. If that’s your fear, and you have a lump sum you’ve made sitting in the bank … do you spend it on expensive tests and studies for an unknown process with an agency that may not like you? Or do you just dip a toe in and see what the response is?
One client we know said, “I’m not in this for the money. I was a smoker.” The vape product he developed changed his life and the lives of friends and neighbors in his town. So he concluded the PMTA was worth the investment on principle despite the uncertain return.
But as Anne found, when you get that deficiency letter, there’s no way you can respond on your own. This is a communication from a team of FDA experts, saying what they need from a scientific perspective. You have to decide whether to invest in your own team of experts to address these questions or to say, “I had a good run,” pack up and be done.
The key point is that you will have 90 days to respond. The FDA has made it clear that during this crunch time, they will send only one deficiency letter. Ninety days is not a lot of time, especially if the letter is requesting additional data—that means new studies and tests.
Can you get an extension? Maybe. It’s at the FDA’s discretion whether to grant one. It is likely that your odds get better if you can give a rationale for the extension by explaining in detail the work you’re doing to fill those gaps.
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What’s the best way to answer questions raised in my deficiency letter?
Both what you say and how you say it are important. First, your narrative. A PMTA is an opportunity to explain to the FDA why having your product on the market is appropriate for the protection of public health (APPH); it’s essentially storytelling supported by data.
Don’t just contact a lab, get pages of numbers and toss them at the FDA, saying, “We include the data you requested.” You need to understand what data you need, what it shows and how it supports your APPH story. For example, highly variable product data could suggest that you don’t have control of your manufacturing process.
Second, set the right tone. As the CEO at a company one of us worked for told the FDA, “We may disagree. However, we will not be disagreeable.” That helped build rapport.
FDA staff deserve respect for their expertise and dedication. But they are human too. They may make a statement about your product that is wrong (especially given the plethora of PMTAs received). Respectfully making them aware of their error is perfectly acceptable.
Do I have to wait for my letter, or can I respond proactively?
Prepare in advance and avoid a panicked sprint against that 90-day clock. You may already have a pretty good idea of where your PMTA was lacking. You can check FDA guidance documents for more clues (see “Perception and Intention Studies,” Tobacco Reporter, February 2021, and “Gold Nuggets,” Tobacco Reporter, March 2021). Make sure you’ve done enough to address sensitive issues, such as flavors, youth access, acceptability of ingredients and the ability to switch smokers to your product. Get expert feedback to identify gaps; give priority to filling the ones that take time to address. Then, when your letter comes, the workload will be manageable. And you can get some sleep.
However, there are no guarantees. This is not a check-the-box exercise. The FDA has made it clear that getting authorized depends on both the information in your original PMTA and your response to questions. If you’ve made a solid data-based case that your product is APPH, the agency will probably come to that conclusion too. If you don’t give them what they need to evaluate, they can’t.
As of this writing, everyone is still somewhere in the process; FDA had not issued any marketing authorizations for PMTAs submitted in September 2020. But if you haven’t heard about acceptance of your application soon after you read this (by mid-July to late July), reach out to the CTP for an update.
*A pseudonym
Common PMTA Gaps Raised in Deficiency Letters
As consultants, we’re seeing some patterns in the letters our clients receive. Here’s what your PMTA may be missing:
Behavioral science: Perception and intention studies and actual use studies. Confused about what the FDA wanted, many companies submitted marketing research data, information on their product category (e.g., consumer perceptions of vaping instead of views on their vape) or just skipped these parts.
HPHC(analytical chemistry): A common oversight was testing liquids for toxicants but not testing the aerosol.
Limited toxicology review: Either not enough tests or not good enough explanations to show that it’s OK to inhale the ingredients (e.g., there are no carcinogens, or they’re at very low levels).
Proof of action: Many PMTAs we’ve read talk about great stuff people do to make their product and to keep it out of the hands of youth. But it’s all talk. They provide no certificates of analysis or data to support what they say. You need details and “teeth.” For example, how and when will you monitor youth purchase attempts? And what are the penalties for failure?
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.
Cheryl K. Olson is a California-based public health researcher who specializes in behavioral health issues and consults on tobacco product behaviors. She spent 15 years on the faculty of Harvard Medical School.
The U.S. Food and Drug Administration (FDA) today opened a public comment period on Philip Morris International’s application seeking authorization to market the IQOS 3 electrically heated-tobacco system as a modified-risk tobacco product (MRTP).
PMI’s application requests the same reduced exposure modification orders granted on July 7, 2020, for the IQOS 2.4 system—the first, and only, electronic nicotine product to be granted marketing orders through the FDA’s MRTP process. To authorize MRTP consumer communications, the FDA’s Center for Tobacco Products is required by law to conclude that a product is appropriate to promote the public health.
The IQOS 3 device contains a number of technological advancements compared to the IQOS 2.4 device, including longer battery life and quicker recharge between uses. It was authorized for sale in the U.S. via the FDA’s premarket review process on Dec. 7, 2020, having met the standard that permitting its sale is appropriate to protect public health.
This application underscores PMI’s ongoing commitment to make new innovations available to American adult smokers through the FDA process.
“PMI is fully committed to a smoke-free future, one where we completely replace cigarettes with scientifically substantiated smoke-free alternatives that are a better choice for adults who would otherwise continue smoking,” said PMI CEO Jacek Olczak.
“Our commitment to a science-based future is unmatched, having invested more than $8 billion since 2008 on smoke-free products. This application underscores PMI’s ongoing commitment to make new innovations available to American adult smokers through the FDA process; the confidence we have in our science; and our belief that public scrutiny and open engagement with governments is vital to achieving a smoke-free future.”
The U.S. Food and Drug Administration Center for Tobacco Products (CTP) will host a virtual meeting June 11 from 13:00 to 15:30 Eastern Daylight Time. The meeting will discuss the scientific review of tobacco marketing applications received by Sept. 9, 2020. It will focus on the application intake process, review progress and allocation of review resources. There will be time allotted for audience questions as well.
Matt Holman
The meeting will feature a presentation from CTP Office of Science Director Matt Holman and include a question-and-answer session. Other Office of Science staff participating in the meeting include Todd L. Cecil, deputy director for regulatory management; Crystal Allard, director for the division of regulatory science and informatics; Joanna C. Randazzo, D.C., acting chief for the science policy branch; and Cristi Stark, director of the division of regulatory project management.
The CTP Office of Science is responsible for identifying, developing and enhancing the science related to tobacco products, their use, and the resulting morbidity and mortality so that regulatory decisions will have the greatest impact on improving public health.
The Office of Science provides the scientific support for regulations and guidance, reviews tobacco product applications, evaluates the knowledge basis for regulatory decisions and carries out research to fill the gaps in scientific knowledge related to tobacco product regulation.
Lawmakers in the U.S. House of Representatives have sent a letter to the head of the U.S. Food and Drug Administration (FDA) urging the agency to remove all flavored vaping products from the market. The 43 House Democrats sent the letter to acting FDA Commissioner Janet Woodcock as the agency continues to review thousands of premarket tobacco product applications (PMTAs).
“Flavored e-cigarettes are putting a new generation of kids at risk of nicotine addiction and the serious health harms that result from tobacco use,” states the letter drafted by Representatives Debbie Wasserman Schultz and Diana DeGette, according to The Hill.
The lawmakers want the FDA to ban all flavored e-cigarettes upon further review and eliminate the exemption the FDA has for menthol and disposable products.
Along with a ban on flavored e-cigarettes, lawmakers want a ban on PMTAs and the marketing of e-cigarettes that target minors. “Today, e-cigarette use by youth remains at what FDA calls ‘epidemic proportions,’ and e-cigarettes have been the most commonly used tobacco products among youth since 2014—and flavors are a key reason why,” the letter states.
The FDA has already put a ban on fruity e-cigarettes. However, brands such as Puff Bar are sidestepping the ban by selling fruit-flavored disposable vaporizers that use synthetic (tobacco-free) nicotine. “We strongly recommend that FDA’s premarket review process require manufacturers to provide convincing evidence that their products do not increase youth use of nicotine and tobacco in ways that increase the risk of abuse and addiction among youth,” the lawmakers stated.
The U.S. Food and Drug Administration (FDA) issued three more warning letters to vapor companies on March 19. The latest announcement brings the count to 69 letters this year for companies selling vapor products without gaining regulatory approval through the agency’s premarket tobacco product application (PMTA) process.
The latest letters were issued to Arizona-based Vapor Outlet, Vapor Tech Hawaii and the Vaporium in Illinois. In its letter to Vaporium, the FDA stated that the company continues to “manufacture, sell and/or distribute to customers in the United States The Vaporium 6 mg Red White and Blue 70/30 30 mL e-liquid product” without a marketing authorization order.
“Your firm is a registered manufacturer with 19,860 products listed with FDA. It is your responsibility to ensure that your tobacco products comply with each applicable provision of the FD&C Act and FDA’s implementing regulations,” the letter states. “Failure to adequately address this matter may lead to regulatory action, including, but not limited to, civil money penalties, seizure and/or injunction.”
Companies that receive warning letters from the FDA have to submit a written response to the letter within 15 working days from the date of receipt describing the company’s corrective actions, including the dates on which it discontinued the violative sale and/or distribution of the products. They also require the company’s plan for maintaining compliance with the FD&C Act in the future.
Many of the FDA’s letters so far have gone to local vape shops that manufacture their own e-liquids in the store. For example, Vapor Tech Hawaii’s letter states that the FDA has determined that it “manufacture[s], sell[s] and/or distribute[s] to customers its Vapor Tech Hawaii Waikikiwi 100 mL 3 mg e-liquid product” without a marketing authorization order.
On March 12, the U.S. FDA sent warning letters to 13 firms that manufacture and sell unauthorized e-liquids.
Thousands of vapor companies submitted premarket tobacco product applications (PMTAs) to the U.S. Food and Drug Administration (FDA) by the Sept. 9, 2020, deadline to keep their products on the U.S. market. But which products exactly are under review and how all those submissions have fared in the process is less clear. A comprehensive list promised by the FDA has yet to materialize.
In the absence of an official database, Tobacco Reporter’s sister publication, Vapor Voice, decided to create its own tracker. As a news outlet, Vapor Voice already receives many press releases relating to PMTA submissions. In addition, its editors continuously monitor corporate websites, social media platforms and other industry sources. Individually, the pieces of information gathered during those endeavors make for interesting news announcements; taken together, they provide a coherent dataset to track PMTAs.
Of course, this approach has its limits. The data is self-reported, and at present, Vapor Voice cannot fully verify the veracity of all claims made in the announcements used to compile the list. The quality of the information that reaches the magazine also varies greatly, from exact counts in all list categories to more general statements on a brand or brand family without further elaboration. As per Vapor Voice’s protocol, these issues are noted in the list.
While the dataset should not be taken as a representative sample, it paints as coherent a picture as possible. Vapor Voice recommends using this tool to gain a directional understanding and as a starting point in a comprehensive due diligence search regarding products.
