White Cloud’s submission to the FDA: Comments on Modified Risk Tobacco Product Applications
“Whilst I represent the views of White Cloud Electronic Cigarettes and it’s belief that electronic cigarettes have the opportunity to provide smokers with the first true alternative to combustible cigarettes (whilst maintaining their desire for nicotine), it is impossible to ignore the fact that, for tobacco users, Swedish style Snus has a clear role to play in Tobacco Harm Reduction as part of, what has become commonly referred to as, the Continuum of Risk.”
Read the full Submission to the FDA by Robert Burton Here.
White Cloud Responds to FDA Regarding Proposed Rule
August 7th 2014 – Comment Submitted in Response to FDA Regarding Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products.
Written Statement, presented by: Robert Burton, Director, Corporate & Regulatory Affairs, White Cloud Electronic Cigarettes.
Thank you for allowing us the opportunity to submit comments to the aforementioned Deeming Regulations, on behalf of Lead By Sales LLC (dba White Cloud Electronic Cigarettes) and the range of products currently marketed by our company under the White Cloud brand. I would like to utilize this written submission as an attempt to address some of the questions raised by the FDA. Read the full response.
Our Position on the FDA’s Deeming Regulation:
On the 25th of April 2014, the FDA issued its long-awaited proposal for “Deeming Regulations” for electronic cigarettes. The proposed regulations are still not final and the FDA has been holding a series of public workshops on the draft regulations (the last of which is in June 2015), as well as previously opening up the draft regulations to public comment for 75 days from the original publishing date. In response to this, they received over 100,000 comments; all of which have to be reviewed. We are anticipating further details on what the final regulations could look like later this year; potentially, as early as the end of June. The FDA – Current form of the draft regulations can be found (in full) via the FDA’s Tobacco Products website. http://www.fda.gov/TobaccoProducts
At White Cloud, we agree with many professionals and experts in the area of public health who see the potential for electronic cigarettes to significantly reduce the harm and risk associated with existing combustible tobacco use. The FDA has also hinted at a “Continuum of Risk” in relation to Tobacco Harm Reduction (THR) in which electronic cigarettes could play a pivotal role. The recently proposed Deeming Regulation issued by the FDA has a number of key elements, such as underage restrictions, no ban on internet sales or flavors and the requirement to submit ingredients and new products for review, which we fully support.
As the industry currently stands, there is wide variation in electronic cigarettes, their quality and individual company approaches to marketing to consumers. As such, we at White Cloud support the intent behind the FDA Deeming Regulations that propose the submission of ingredients and the review of any product entering the market.
We believe that future regulation of electronic cigarettes should be science and evidence-based with appropriate product and manufacturing standards, thus ensuring the maximum quality of product whilst providing current tobacco consumers with a significantly lower risk alternative to existing combustible tobacco products.
Our own research, with independently selected focus groups, has highlighted the demand for both smokers and vapors to have more information about what is included in e-liquids.
The specific regulatory areas to be addressed with respect to electronic cigarettes should not restrict the opportunity for consumers to make an educated decision relating to their future health risks, but should give Public Health and Regulators alike confidence that the products meet acceptable quality, safety and efficacy standards. We believe that the ingredient submission and new product review process detailed in the FDA’s Deeming Regulations are a positive step in the direction of safety, quality and consistency, but the process of compliance should not be unduly prohibitive or costly.
We also support the FDA in their aim to restrict access of electronic cigarettes to those over the age of 18. In fact, at White Cloud, we have had such restrictions in place since we started business back in 2008 and have developed (and implemented) bespoke and sophisticated software in order to make sure that only adult consumers are able to purchase electronic cigarettes via our online order system.
We believe that any regulation of electronic cigarettes should be based upon peer reviewed and published scientific evidence and be developed in consultation with both electronic cigarette manufacturers and other relevant stakeholders, such as public health experts. We were encouraged to hear that the FDA will base their decisions on the implementation of this Deeming Regulation, and future regulatory developments, on scientific evidence and not restrict specific elements, such as flavors, without supportive data.
Whilst we are the first to admit that more research is needed, electronic cigarettes, as a category, are generally accepted as being significantly less harmful than conventional cigarettes, their potential to reduce the harm associated with tobacco use should be recognized and not unduly restricted.
The US Family Smoking Prevention and Tobacco Control Act 22 June 2009 and the Food and Drug Administration
The Family Smoking Prevention and Tobacco Control Act (the Act) placed tobacco products under the regulatory authority of the US Food and Drug Administration (FDA) and has substantially changed the way that all tobacco products are marketed and sold in the US, including those made outside the country.
Impact: With the introduction of the Act the regulatory environment in the US has moved from one with minimal regulation to one with the broadest scope and detail of any jurisdiction. However, the consultative nature of the FDA and the requirement to involve all stakeholders, together with its historic emphasis on evidence and scientific-based regulation, gives the opportunity to engage.
Scope: The Act applies to all cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and to any other tobacco products that the FDA may by regulation deem subject to the Act. (e.g. electronic cigarettes) The Act applies to tobacco products imported into, marketed and sold in the US. The Act prohibits the FDA from banning “all cigarettes, all smokeless tobacco products, all little cigars, all cigars other than little cigars, all pipe tobacco, or all roll-your-own tobacco products”, or from requiring “the reduction of nicotine yields of a tobacco product to zero”.
Registration: The Act requires annual registration by manufacturers (including overseas) with a “product list”, including all consumer information, labeling, a sampling of advertisements, and any information required by tobacco product standards.
Submission of “Health Information” to FDA/Testing: The Act requires reporting of all ingredients any relevant health-related information, toxicological, behavioral, or physiologic effects of current or future tobacco products, their constituents (including smoke constituents), ingredients, components and additives. The addition, elimination, increase or decrease of an additive also must be disclosed. In June 2012, the FDA issued regulations requiring testing and reporting to the FDA of tobacco product constituents, ingredients, and additives, including smoke constituents (by brand and subbrand).
Tobacco Products Scientific Advisory Committee: TPSAC has been formed to provide guidance to the FDA on scientific and other health issues as requested. It will also review applications for modified risk tobacco products. TPSAC has 3 non-voting industry representatives. TPSAC recommended a list of 105 harmful and potentially harmful tobacco and smoke constituents for potential testing/reporting/disclosure. In March 2011 TPSAC published a report and recommendations to the FDA on the regulation of menthol cigarettes. The headline recommendation was that “removal of mentholated cigarettes from the marketplace would benefit public health in the United States”. The FDA has not yet acted on this recommendation.
Premarket Review/Approval of Tobacco Products: The Act requires premarket review and approval of “new tobacco products”. When a full new product application is required, it must contain all information concerning studies on the health risks of the product and whether such tobacco product presents less risk than other tobacco products.
Modified Risk Tobacco Products (MRTPs): MRTPs are products sold with explicit or implicit risk reduction claims and require FDA approval. An MRTP application must demonstrate that the proposed MRTP will significantly reduce harm and the risk of tobacco-related disease to individual tobacco users, and will benefit the health of the population as a whole taking into account both users and current non-users of tobacco products. At the request of the FDA, the US Institute of Medicine has reviewed and reported (15/12/11) on the “Scientific Standards for Studies on Modified Risk Tobacco Products”.
Tobacco Product Standards: The Act prohibits any flavour (other than tobacco or menthol) that is a “characterizing flavor” of the tobacco product or tobacco smoke. Tobacco imported to the US may not use a pesticide that has not been approved for use in the US on domestic tobacco. The FDA also may issue product standards addressing nicotine yields, tobacco or smoke constituents and ingredients, but it may not ban tobacco products or nicotine.
Dissolvable Tobacco Products: Following FDA referral, the Committee is to report, within 2 years, on the public heath issues surrounding the use of dissolvable tobacco products (including such use among underage persons). This referral does not limit the FDA’s ability to issue regulations directed to dissolvable tobacco products before that report is formally issued.
Good Manufacturing Practices (GMP): The Act authorizes the FDA to prescribe regulations requiring that tobacco products conform to “good manufacturing practice” or “hazard analysis and critical control point methodology.”
Products to Treat “Tobacco Dependence”: The Act calls for FDA consideration of fast track designation of smoking cessation products, including nicotine replacement products, as well as consideration of extended use of nicotine replacement products for the treatment of tobacco dependence and consideration of the evidence for additional indications for NRT products. The Act further required the FDA to report to Congress by June 2012 (and after consultation with the Institute of Medicine) on ways to regulate, develop and encourage products that promote abstinence from tobacco use, reduction in consumption and reduction in the harm associated with continued tobacco use. The full report is still pending.
Tar, Nicotine and other Smoke Constituent Disclosures: The Act authorizes the FDA to determine whether to require disclosure of tar and nicotine yields on the package or advertisement of a tobacco product (or both). This was not previously required in the US. In addition, the FDA may, require disclosure of the level of any constituent, including any smoke constituent if the FDA determines that disclosure would be of benefit to the public health.
Pictorial Health Warnings: The Act prescribed new rotating warning labels for cigarette packages which must comprise the top 50 percent of the front and rear package panels and regulations requiring color graphics to accompany the warnings. The Act also prescribed four new rotating warning labels with colour graphics for smokeless tobacco packages which must comprise up to 50 percent of each of the two principal display panels on a smokeless tobacco package.
Marketing: The Act requires advertisements to contain warnings that comprise at least 20 percent of the advertisement and reinstates, with some modification, the 1996 FDA final rule which imposed regulations regarding tobacco products’ advertising, labelling, and accessibility to underage persons, including restrictions that confine certain point-of-sale and print cigarette and smokeless tobacco advertising to black text on a white background (with exceptions for advertising in publications with adult readership of 85 percent or more).
Studies of Progress and Effectiveness: By June 2012 the FDA had to report to the US Congress on its progress in implementing the Act and data on the number of new product and MRTP applications received and acted upon. The progress report was not well received.
Illicit Trade: The Act contains several provisions directed to illicit trade including origin labelling requirements and also requires the FDA to promulgate regulations concerning recordkeeping for product tracking and tracing.
User Fees: The Act imposes user fees on tobacco product manufacturers and importers to cover the costs of the FDA’s tobacco regulation activities.
Civil Monetary Penalties for Violations of Tobacco Product Requirements: The Act imposes monetary penalties on any person who violates a requirement of the Act ranging from $15,000 for one violation to $10,000,000 for multiple violations.