Today, the U.S. Food and Drug Administration (FDA) issued 10 warning letters to retailers and manufacturers who sell, manufacture and/or import unauthorized electronic nicotine delivery system (ENDS) products targeted to youth or likely to promote use by youth.
The warning letters were sent to establishments marketing unauthorized products, such as a backpack and sweatshirt designed with stealth pockets to hold and conceal an e-cigarette, ENDS products that resemble smartwatches, or devices appearing as children’s toys such as a portable video game system or fidget spinner.
Warning letters were also issued to companies marketing e-liquids that imitate packaging for food products that often are marketed and appeal to youth, such as candy, or feature cartoon characters like SpongeBob SquarePants.
“The FDA is focused on manufacturers and retailers that make and sell ENDS products that are targeted to youth and increase their appeal. The public should really be outraged by these products. The FDA is especially disturbed by some of these new products being marketed to children and teens by promoting the ease with which they can be used to conceal product use, which appeals to kids because it allows them to conceal tobacco product use from parents, teachers, law enforcement or other adults,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “Even in the midst of the COVID-19 pandemic, we have not lost our focus on protecting youth against the dangers of e-cigarettes and will do everything we can to take action. These warning letters should send a clear message to all tobacco product manufacturers and retailers that the FDA is keeping a close watch on the marketplace. If you’re marketing or selling these products to youth, the FDA will not tolerate it.”
The following retailers and/or manufacturers or importers received a warning letter:
Shenzhen Uwell Technology Co., Ltd. d/b/a DTD Distribution Inc. (importer, retailer)
The FDA has also issued warning letters to 73 brick-and-mortar retailers for selling unauthorized flavored, cartridge-based ENDS products. This follows 22 warning letters that FDA issued last month for similar violations to online and brick-and-mortar retailers and manufacturers across the country. These warning letters are part of a series of ongoing actions consistent with the FDA’s recently issued policy of enforcement priorities for e-cigarettes and other deemed products on the market.
The U.S. Food and Drug Administration (FDA) has suspended domestic compliance checks and vape shop inspections amid the spread of coronavirus.
The FDA has temporarily deferred all domestic routine surveillance facility inspections and postponed most foreign inspections through April. Administrative work can continue for two weeks, though, according to the Center for Tobacco Products.
The US Food and Drug Administration’s Center for Tobacco Products is due to explain the processes it uses in the review of tobacco product applications.
In a press note, the FDA said it planned to hold a meeting of the Tobacco Products Scientific Advisory Committee (TPSAC) on April 6.
‘During this meeting, representatives from the FDA’s Center for Tobacco Products will present information to the Committee, which includes several new members, on the processes CTP uses in the review of tobacco product applications, including substantial equivalence (SE), modified risk tobacco product (MRTP) and premarket tobacco applications (PMTA),’ the note said.
‘Topics will include the statutory standards applicable to the different types of applications; the scientific basis for review decisions, with a focus on PMTA and MRTPA; and the role of the committee in the review process.
‘People interested in presenting data, information, or views, either in person or in writing, must send in their submissions by March 15 or March 23, respectively.’
The US Food and Drug Administration has sought to clarify what in its view tobacco products and products derived from tobacco are, and which part of the agency deals with those products.
The clarification comes in the form of a recently issued final rule entitled: Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ‘Intended Uses’.
‘This rule describes circumstances in which a product made or derived from tobacco is subject to regulation by the FDA’s Center for Drug Evaluation and Research, Center for Devices and Radiological Health, or Center for Tobacco Products,’ the FDA said in a recent posting.
‘This rule is intended to help manufacturers and researchers better understand which regulatory standards apply to their products or studies, respectively.
‘The agency also anticipates that the rule will help consumers clearly distinguish products made or derived from tobacco that are intended for tobacco cessation from those intended for other uses.’
The US Food and Drug Administration has issued a final rule regarding the refuse-to-accept procedures for premarket tobacco submissions.
Under this rule, the agency says, it will refuse to accept tobacco product submissions or applications that are not in English, do not pertain to a tobacco product, do not include contact information, or do not meet other requirements as listed in the rule.
At the same time, the FDA has issued its Submission of Warning Plans for Cigars, a guide to assist industry players that are required to submit warning plans related to statements on cigar packaging and advertising.
Those concerned are required to submit a proposed warning plan to the FDA no later than May 10, 2017, or 12 months prior to advertising or commercially marketing the cigar, whichever is later.
Meanwhile, the FDA has published its final guidance entitled Listing of Ingredients in Tobacco Products.
‘This guidance is intended to assist manufacturers and importers making tobacco product ingredient submissions to the FDA, as required by the Tobacco Control Act,’ said the FDA. ‘Revisions to this guidance include minor clarifying and editorial changes to promote consistency throughout the FDA’s guidances and updated submission compliance dates.
‘The guidance also explains the statutory requirement to submit a list of all ingredients in tobacco products, who submits ingredient information, what information is included in the submissions, how and when to submit the information, the FDA’s compliance policies, and definitions.
‘Under the policies outlined in the guidance, the FDA does not intend to enforce the submission requirement for newly deemed tobacco products that were on the market as of August 8, 2016, until August 8, 2017, or February 8, 2018 for small-scale manufacturers. Tobacco products entering the market after August 8, 2016, must submit the ingredient information at least 90 days before the product is introduced into interstate commerce.
‘FDA is currently accepting ingredient listings for tobacco products and encourages manufacturers to start the processes as early as possible.’
Jason Rock is the chief technology officer and co-founder of GlobalSubmit.
Rock has been integral in the FDA’s efforts to harmonize regulatory submission standards for the tobacco industry, as he was when the FDA first implemented similar standards for life sciences.
He served as the project lead for the first-ever MRTP application accepted for review by the CTP and the first-ever approved PMTA.
During the April 9–10, 2015, Tobacco Products Scientific Advisory Committee (TPSAC) meeting to discuss MRTP applications submitted by Swedish Match, Rock was the only non-FDA, non-tobacco industry participant to address the audience.
Best practices for filing FDA tobacco product applications
By Jason Rock
The final deeming regulation extending the U.S. Food and Drug Administration’s (FDA) authority to additional products has, to put it mildly, captured the attention of the entire tobacco industry. A predicate—or “grandfather”—date of Feb. 15, 2007, will force the majority, if not all, of e-cigarette or electronic nicotine-delivery system manufacturers into the premarket tobacco product application (PMTA) pathway—the costliest and most complex avenue from a regulatory standpoint.
In this article, I’ll give you an idea of what to expect when filing a large application to the FDA and provide general guidelines for formulating a successful approach.
Similarities between pharma and tobacco
A few years ago, I read an account from a major tobacco company executive predicting that tobacco companies would one day be regarded in the same vein as pharmaceuticals. The comparison is especially apt when considering the size and content of applications. Typically, a large New Drug Application (NDA) submitted to the FDA contains 20–25 studies and ranges anywhere from 100,000–300,000 pages. There are always exceptions, and I’ve seen applications with as few as five studies while others have broken the 100-study barrier.
In all likelihood, PMTAs are comparable in scope, if not equivalent, to these large marketing applications. Modified-risk tobacco products (MRTPs) are much larger, as they require the submission of case report forms. Swedish Match, the first company to receive marketing authorization from the FDA under the PMTA pathway, submitted a 130,000-page MRTP application for eight products.
Timing and project management
If you’re committed to the PMTA pathway, the date marked on your calendar is Aug. 8, 2018. A missed filing deadline could trigger FDA enforcement action for your products currently on the market. Work on large pharmaceutical applications typically precedes the filing date by at least 12 months. It’s not unusual for applicants to begin work 18–24 months prior to the filing deadline set for an NDA.
A winning timing strategy for PMTAs is to start early and set an internal submission target for six months prior to the statutory deadline (Feb. 8, 2018). The natural instinct is to start the submission process once your summary documents are in progress. Don’t wait! Start early to lower your risk. Any studies already completed should be published as soon as possible, whereas other parts of the application can be completed on a rolling basis. Plan for late document delivery and work ahead. We believe it’s better to have 20 percent of the documents 100 percent complete versus 100 percent of the documents 20 percent complete.
In terms of project management, you’ll want to appoint an internal resource to manage the document production process or find an expert with experience. A custom tracking tool is the most plausible solution for tracking the delivery date and submission readiness for each document.
You’ll want to schedule a pre-submission meeting with the FDA to review your strategy. The probability of project success goes up if you can achieve agency buy-in up front.
Submission publishing standards
In preparing electronic applications for drug products, pharmaceutical companies have to adhere to internationally harmonized standards for documents and folder structures or face technical rejection. These standards have been in place for over a decade. And while regulatory requirements around PDF versions, bookmarks and hyperlinks, fonts, and headings and hierarchy might sound unduly burdensome, the formatting standards are integral to streamlined document review and timely approval.
Without the luxury of documented standards as are in place for pharmaceutical companies, tobacco applicants should strive to meet as many existing standards as possible. The men and women who will ultimately review your tobacco applications are descendants of the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research. The reviewers are familiar with pharmaceutical standards and prefer tobacco submissions to resemble what they are used to receiving.
Your strategy should center on setting up a pre-submission meeting with the FDA Center for Tobacco Products and proposing use of existing standards such as CDISC (Clinical Data Interchange Standards Consortium ) or CDISC-like datasets for clinical and nonclinical study data, International Conference on Harmonization E3 guidelines for clinical study reports, pre-eCTD PDF publishing specifications, and best practices for laboratory testing and manufacturing.
Cost
How much does it cost to prepare a PMTA?
The answer depends on who you ask. In the final deeming regulation, the FDA estimated an effort of more than 1,700 hours to prepare a PMTA, which adds up to roughly $1 million per product. Independent tobacco industry figures project a high-end cost of up to $10 million per PMTA, if not higher.
Submission publishing, project management and quality review of documents fit into the administrative portion of the estimate. As is true in the pharmaceutical industry, these activities are the least expensive part of a very expensive process. Standard rates for submission publishing and related activities are set per page. For a quick ballpark estimation, you can use a $5 per page rate inclusive of publishing, management and other tasks.
Learn from experience
Prior to the successful MRTP and PMTA submission filed by Swedish Match, a number of applicants were rejected by the FDA for failure to adhere to the aforementioned standards and failure to adequately articulate a submission strategy.
In the early preparatory stages of its filing, Swedish Match was challenged about the mechanics of filing an MRTP application. In the end, three key discoveries emerged: (1) the true scope of the project, (2) the FDA’s expectations for document formatting and (3) the role of correspondence with the FDA CTP during the project.
Successfully filing a PMTA requires drawing on the considerable experience of the pharmaceutical industry, starting the process early and securing the proper expert resources, adhering to existing and agreed upon standards, and following the lead of others who have achieved the desired outcomes.
VapeMentors, the only educational resource exclusively devoted to the vape space, will host a free webinar on Nov. 18 at 5 p.m. PST/8 p.m. EST to help vape space businesses prepare for upcoming U.S. Food and Drug Administration (FDA) regulations.
The FDA sent its final deeming regulations to the Office of Management and Budget last week—the final step in the agency’s process to regulate the marketing and manufacturing of vapor products. The FDA’s final regulations are expected by the end of this year or in early 2016.
The one-hour webinar, which is entitled “‘Knock, Knock. It’s the FDA Calling,” aims to help business owners “future-proof” their vape shop or e-liquid company and avoid getting shut down by the FDA.
The webinar will be run by Azim Chowdhury, an attorney with Washington, D.C.-based Keller and Heckman, LLP and head of the firm’s e-cigarette practice who has represented many e-cigarette and e-liquid manufacturers, suppliers and trade associations in matters of FDA regulatory and corporate compliance.
“We have a pretty good idea what will be in the FDA’s final [regulations] and how will it affect vape shops and e-liquid manufacturers,” said Chowdhury. “Basically, anyone who’s mixing e-liquids would be considered a manufacturer, and your e-liquids will be subject to FDA regulation and inspections. Unless the FDA makes major changes from their deeming [regulations], e-liquid companies must submit their entire list of ingredients and obtain pre-market approval from the FDA. If they don’t comply, the FDA could shut them down forever. And it could happen as early as next spring.”
To register for the FDA webinar, visit www.vapementors.com/FDAwebinar. The webinar is free and open to anyone working or interested in the vape industry. It will also be recorded and available for replay.
The webinar is sponsored by Molecule Labs, NicSelect, VaporSearchUSA, Calco Commercial Insurance and Parrot Vapors.
The U.S. Food and Drug Administration (FDA) has ordered tobacco giant R.J. Reynolds to pull their Camel Crush Bold cigarette brand off the market. The FDA acted under a key provision of the 2009 law that requires prior FDA review and authorization before tobacco companies are permitted to market new or changed products.
The decision, which was announced on Sept. 15, marks the first time the agency has ordered a tobacco company to remove a major cigarette brand from the market since it was granted regulatory authority over tobacco products by the 2009 law. This move sets an important precedent that could apply to other brands as the FDA works to prevent the introduction of tobacco products to the market that may be more appealing to youth, more addictive or more harmful.
The 2009 law prohibits the introduction of a new or changed tobacco product unless the manufacturer proves to the FDA that the product is either “appropriate for the protection of public health” or “substantially equivalent” to a product already on the market. Manufacturers must also prove that the product “does not pose different questions of public health.”
In addition to Camel Crush Bold, the FDA also issued orders that will stop the further sale and distribution of three other cigarette products currently marketed by R.J. Reynolds: Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13 cigarettes. The FDA determined that these products were not substantially equivalent to existing products.
The FDA found that R.J. Reynolds failed to demonstrate that these products do not “raise different questions of public health,” particularly because of the higher levels of menthol, the addition of sugars and other sweeteners, a new method of delivering menthol, and increased levels of harmful and potentially harmful constituents.
Camel is one of the three most popular cigarette brands among youth smokers, with 15.1 percent preferring Camel, according to the 2013 National Survey on Drug Use and Health. Camel Crush is an extension of the brand with a capsule in the filter that releases menthol when crushed.
22nd Century Group, a leader in tobacco harm reduction, has appointed Gregg M. Gellman as the company’s director of business development and regulatory affairs. Gellman, who was hired for his experience in achieving U.S. Food and Drug Administration compliance approval for various types of products, will be tasked with driving 22nd Century’s regulatory affairs strategies for the company’s two modified risk cigarettes in development: “Brand A,” the world’s lowest nicotine tobacco cigarette, and “Brand B,” the world’s lowest tar-to-nicotine ratio cigarette.
Robert Califf, a cardiologist and researcher at Duke University in Durham, North Carolina, USA, was appointed as the U.S. Food and Drug Administration’s (FDA) deputy commissioner for medical products and tobacco on March 2. Califf—who was previously overseeing the FDA’s drug, medical device and tobacco policy—is a recognized global leader in cardiology, clinical research and medical economics, according to the FDA. He was appointed by FDA Commissioner Margaret A. Hamburg, who will leave the organization at the end of March, leading to speculation that Califf may be nominated to lead the FDA following her departure.
In his new role as deputy commissioner, Califf will provide executive leadership to the Center for Drug Evaluation and Research, the Center for Tobacco Products, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health. His duties will include providing policy direction and advice on the FDA’s medical product and tobacco priorities, and he will manage clinical, scientific and regulatory initiatives in areas ranging from pediatric science and personalized medicine to orphan drugs and the advisory committee system.
Califf previously served as vice chancellor of clinical and transnational research at Duke University, professor of medicine at Duke University Medical Center’s Division of Cardiology, director of the Duke Transnational Medicine Institute and founding director of the Duke Clinical Research Institute, the world’s largest academic research organization. The Institute for Scientific Information has recognized Califf as one of the top 10 most-cited medical authors due to his more than 1,200 peer-reviewed publications.
The US Food and Drug Administration’s Center for Tobacco Products is due to explain the processes it uses in the review of tobacco product applications.
