Date: August 16, 2018
Source: Vapor Voice Magazine
It’s getting worse. The vapor industry’s flavor fight has evolved into becoming the centerpiece in its battle for overall survival. From flavor’s role in youth access to how flavors keep smokers from going back to combustible cigarettes to when products entered the market, it seems every aspect of the vapor industry is under fire. Unfortunately, misinformation is becoming the weapon of choice for many anti-vapor advocates.
Sometimes, it’s a small mistake. For example, Education Week, a U.S.-based non-profit publication focused on precollegiate education, in July published an article suggesting that Juul flavor cartridges come in kid-friendly varieties such as mango, crème brulee and gummi bear. Juul does not and has never marketed a gummi bear flavor, according to Juul Labs spokesperson Victoria Davis.
Other times, it’s much larger. In April, the Campaign for Tobacco Free Kids (CTFK) stated that six leading public health and medical organizations sent a letter urging the U.S. Food and Drug Administration (FDA) “to take action to address Juul’s popularity among youth, including removing from the market Juul flavors such as mango and cool cucumber that appear to have been introduced after Aug. 8, 2016, the FDA’s deeming deadline, without FDA review.”
However, in an email to Vapor Voice, Davis wrote that “those flavors were commercially marketed consistent with FDA regulations.”
Then, again, in early August, the same six organizations sent another letter urging the FDA “to stop the sale of new electronic cigarette products that have been illegally introduced in recent months without the agency’s prior review and authorization,” according to a statement posted on the CTFK’s, one of the signatories, website. News of the letter was picked up by several major media organizations, including the Associated Press, USA Today and Good Morning America. The problem, however, is that at least some of the products mentioned in the letter were already on the market when the regulatory agency’s deeming deadline passed.
For example, Altria’s MarkTen Elite, R.J. Reynolds’ Vuse Alto and ITG Brands, Imperial Tobacco’s U.S. arm, Myblu devices were all on the market prior to Aug. 8, 2016, according to several sources who asked not to be named since they didn’t have permission to discuss the products because manufacturing and marketing data is confidential.
The public health groups did correctly interpret the law in that it prohibits any product changes, however slight, to any SKU that was on the market as of Aug. 8, 2016. However, there are some other rules that apply. Firstly, a product could have been on the market with the same, or with another name, as of the deeming deadline even in a very small quantity. While the Tobacco Control Act (TCA) suggests that selling a product in a “test market” may not be the same as placing a product into interstate commerce, the FDA has taken the position that all product sales, including online sales, qualify as interstate commerce and there is no minimum requirement for market size or quantities sold.
To meet the deadline, the manufacturer could have either rebranded or renamed that same exact product or began marketing the product more visibly so as to appear to consumers that it is a “new” product, when in fact the product could have existed on the market prior to the deadline. Altria’s MarkTen Elite, for example, was on the market prior to the deeming deadline under a different brand, according to industry sources.
Regulation is complicated and vapor industry rules are no different. The reason why vapor products (which the FDA has deemed tobacco products) may be renamed or rebranded without a premarket tobacco authorization (PMTA), is due to a 2016 court decision, Philip Morris USA v. FDA (U.S. District Court for the District of Columbia, No. 15-1590).
In that case, Judge Amit Mehta vacated an FDA draft guidance, which stated that a label change made a tobacco product a “new product” and thus subject to premarket review. In other words, all products subject to the TCA may change their labels (which may include a name change, as well as a color and branding change) without any premarket review requirement by the FDA.
Therefore, a vapor product marketed under a specific name and packaging color on Aug. 8, 2016, may be rebranded at any time without any need to obtain an FDA premarket authorization (new products must be reviewed and approved by the FDA before they can be legally marketed) under either of the two premarket review pathways provided. The FDA also has a substantial equivalence (SE) pathway, which allows products similar to an approved product to have an easier path to market than the PMTA process.
What should be noticed by vapor industry representatives, however, is that in the same ruling, Mehta found that changing the quantity of the product in the packaging does make the respective product a new product, and thus subject to premarket review by the FDA before such changes can be made. So, if a pod size in a closed system were to be increased or if the tank size or battery capacity increased after the deeming deadline, according to the ruling, this would create a new product and would require a PMTA before being sold.
Complicating matters, the FDA has not reviewed and does not have under review any vaping product PMTA as of the writing of this article. There are also no suitable predicate products available (the deadline for grandfathered products under the TCA was Feb. 15, 2007) for vaping products to pursue the less onerous SE premarket authorization pathway. This has been a point of contention for many in the vapor industry who say a new date should be realized by the FDA, possibly the date the deeming rule was made public. The FDA contends that only the U.S. Congress can change the grandfather date.
Another problem plaguing the industry is that even if a product is sold under the exact same name and packaging, manufacturing records can only be accessed by the FDA during an authorized inspection. Only the FDA can require that a company demonstrate that a product is completely unchanged since the deadline. Meaning that a product’s recipe, ingredients, parts and materials used in the manufacturing of the product (whether a liquid, device or combination of the two) remain the same.
“Because of the proprietary nature of the ingredient and technology information, there is no way for any of us to know if a certain product being sold today has the exact same formulation or technology as on August 8, 2016 (which is legally required, or else the product is termed ‘adulterated and misbranded’ under the TCA),” said Patricia Kovacevic, an experienced tobacco attorney who has been working in the vapor industry for nearly a decade. “However, the Tobacco Control Act is not self-executing—meaning it takes an enforcement act by the FDA to remove a product found to be violative from the market.”
To date, the FDA has not acted to take any vapor product off the market for changes made after Aug. 8, 2016. Many vape shops also mix and create new liquids every day. The deeming rule clearly states that vape shops creating their own in-house e-liquids are considered manufacturers and must file a PMTA for every “new” bottle produced.
Numerous vapor companies have expressed concern to the FDA stating that the lack of any enforcement creates extremely unfair competition issues for manufacturers who try to remain compliant. “There is no exception for ‘test markets’ or ‘small batch’ sales, as it is sometimes implied,” says Kovacevic. “In fact, there is no exception explicitly sanctioned by the FDA, period.”
One of the tools the FDA does have at its disposal is to encourage innovation in spite of the prohibition against product changes. The FDA could issue a guidance describing an enforcement discretion policy regarding a defined set of product changes, according to Kovacevic.
“[The] FDA has the ability, if there is political will, to allow innovation in the vaping space by announcing a policy of enforcement discretion with respect to vaping product changes made after August 8, 2016,” she told Vapor Voice. “This was required in various comments to the proposed deeming rule docket when introduced in 2014. The agency has, in the past, exercised enforcement discretion on numerous occasions.”
This means that the FDA could state in a supplemental draft guidance that any changes to a vaporizer’s battery, coils, or other parts of the device with similar (but not identical) parts that are functionally interchangeable, would not trigger a premarket review requirement. “It is unlikely—though highly desirable – that the FDA will do so in the near future. With over 1.5 million individual SKUs registered with the FDA (some say over 2.5 million), there is a clear impossibility to enforce against product changes anyway,” says Kovacevic. Some believe that the FDA will simply remove vaping products from the market only after Aug. 8, 2022 (the FDA’s due date for applications to market deemed non-combustible products, such as vapor products) and only those products that either fail to file a PMTA by the deadline or file an insufficient/not compelling PMTA.
In the meantime, industry and public health advocates alike will continue to be confused and frustrated by the myriad of products being trumpeted as “new” to the consumer, without any real possibility to verify if a product adheres to the FDA’s deeming rule (absent FDA intervention). Kovacevic adds another twist: “Of course, consumer-driven litigation for deceptive practices could change all that, but it would take time for the litigation to percolate through the court system.”
For now, confusion will remain commonplace.
Source: Vapor Voice Magazine