While an FDA media briefing managed to shed some additional light on the agency’s September 15 decision to order R.J. Reynolds Tobacco Company to stop the sale and distribution of four provisionally marketed cigarettes, the FDA was unable to respond to a question regarding when the tobacco industry can expect to see the final tobacco deeming regulations.
Overview
According to Mitch Zeller, the Director of the FDA Center for Tobacco Products, the September 15 stop order came after the FDA conducted a rigorous scientific review of R.J. Reynolds’ applications for Camel Crush Bold, Vantage Tech 13, Pall Mall Deep Set Recessed Filter Menthol, and Pall Mall Deep Set Recessed Filter cigarettes. The four cigarettes were allowed provisional marketing during the agency’s scientific review. According to Zeller, they were “considered provisional because they entered the market during a grace period established by the Family Smoking Prevention and Tobacco Control Act of 2009 [Tobacco Control Act].” The grace period covers products that entered the market between February 15, 2007, and March 22, 2011.
Historically, tobacco companies could market new tobacco products without FDA review, but since enactment of the Tobacco Control Act, the FDA now requires that companies show that a provisional product is substantially equivalent (SE) to a predicate product (i.e., a product that was already commercially marketed as of February 15, 2007). Zeller explained in the briefing that SE can be achieved by showing that the provisional product has the same characteristics as the predicate product, or if different, that the characteristics do not raise different questions of public health. According to Zeller, “the FDA’s review found just that — these four products have different characteristics than their predicates and the company did not adequately show that those differences do not cause the new products to raise different questions of public health.”
On September 8, 2015, the FDA issued a frequently asked questions guidance on how to demonstrate the SE of a new tobacco product.
Scientific Rationale
David Ashley, Director of the Office of Science at the FDA Center for Tobacco Products, elaborated on the scientific rationale for the agency’s not substantially equivalent (NSE) decision on the four applications. Ashley stated that “the reviews of these applications looked at the characteristics of the products…including…design, ingredients, materials, and composition, and how — if there are differences — it may cause the new product to raise different questions of public health such as toxicity, addictiveness, and appeal.” This was accomplished, according to Ashley, “by evaluating the product’s engineering, chemistry, microbiology, toxicology, user behavior, addictiveness, clinical effects, and/or user and non-user perception.” Ashley concluded, that “some of the differences between the products and their predicates included findings of increased yields of harmful or potentially harmful constituents — such as toluene, formaldehyde and 1,3-butadiene — high levels of menthol, and the addition of new ingredients that could impact toxicity or appeal.”
The full decision summaries for the products are available on the FDA’s tobacco product marketing orders webpage.
Enforcement Policy
Ann Simoneau, Director of Office of Compliance and Enforcement at the FDA Center for Tobacco Products, provided information on how the tobacco industry can comply with these stop orders and how the FDA intends to enforce them. Simoneau made it clear that because R.J. Reynolds did not comply with FDA marketing requirements, the four products are now considered misbranded and adulterated. This means that it is illegal to sell or distribute them in interstate commerce, and doing so could result in FDA enforcement action, including seizure without notice. Simoneau recognized, however, that “some retailers may have current inventories of these products with limited ways of disposing them. As such, “for 30 days the FDA does not intend to take enforcement action on previously purchased products that the retailer has in inventory.” This policy is outlined in a guidance, entitled “Enforcement Policy for Certain (Provisional) Tobacco Products that FDA Finds Not Substantially Equivalent.”
Media Q&A
During the question and answer session, Matt Perrone of Associated Press asked why there was a media briefing called for this action and whether R.J. Reynolds had some sort of a preliminary warning of the action. Zeller responded that the media briefing was called because “we thought that there would be more public interest in these actions because some of these are brand name products.” Zeller added that there had been a significant amount of back-and-forth between the Center for Tobacco Products and R.J. Reynolds on the products and when the FDA concluded the products’ characteristics were different from their predicates, the burden shifted to R.J. Reynolds to demonstrate that those differences did not raise different questions of public health. “Ultimately the evidence that was submitted…was inadequate to overcome the conclusion that we reached,” said Zeller. Ashley added that “we send out a notification letter to the companies 45 days before we begin our review. So if they decide that the application they had in-house is not appropriate they can make changes during those 45 days.” In addition, Ashley noted that “companies that get an NSE decision are allowed to come back in with a new application, but that does not relieve them of the responsibility to remove the products from the market during the period before the [new] application is reviewed.”
Mike Esterl of the Wall Street Journal asked how may applications the FDA has received for SE review, how many authorizations have been given, and how many rejections have been issued. In his response, Zeller broke the SE applications into 2 buckets: (1) regular applications for new products not currently marketed, and (2) applications for the so-called provisional products. According to Zeller, the first bucket is the smaller of the two buckets and involves roughly 1,100 products. To date, Zeller reported that 65 percent of the 1,100 regular SE applications have been resolved either by saying they are SE, not SE, or because the company withdrew the application. The second bucket is much larger and involves the provisional products, such as the ones at issue. Zeller indicated that there are approximately 3,600 provisional SE applications, of which around 12 percent have been resolved by saying they are SE, not SE, or through withdrawals, and another 700 or so currently under scientific review. When pressed for more definitive numbers, Zeller said that the FDA has issued 257 SE orders, and 113 NSE orders, and about another thousand applications have been withdrawn.
Deeming Rule Query Snuffed Out
An unrelated but very important matter was raised by Lydia Wheeler of The Hill. She asked when the FDA was going to issue its final tobacco deeming regulations. Wheeler indicated that it seems “to be taking a long time to come out and a lot of groups were hoping that they would be out by the summer and now we’re more into the fall. So, can you give us an idea when we could expect to see those?”
The deeming regulations, proposed on April 25, 2014 (80 FR 23142), would extend the FDA’s authority to cover additional products that meet the definition of a tobacco product. Currently, the FDA regulates cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco. The proposed newly “deemed” products would include electronic cigarettes, cigars, pipe tobacco, certain dissolvables that are not “smokeless tobacco,” gels, and waterpipe tobacco. Once the proposed rule is final, the FDA will be able to use regulatory tools, such as age restrictions and rigorous scientific review of newly deemed tobacco products and their claims.
The proposed rule requested comments on the FDA’s proposed options for regulation of cigars, electronic cigarettes and other non-combustible tobacco products, pathways to market for proposed deemed tobacco products, and compliance dates for certain provisions. Comments on the proposed rule, originally due by July 9, 2014, were extended to August 8, 2014 (80 FR 35711).
In response to Wheeler’s question, Zeller said “while we are not surprised that there is a question being asked about deeming, we can’t answer that question. Thank you.” The moderator quickly adding “Next question, please.”