Two cheers only

Despite the approval of IQOS, the FDA’s premarket application process is still flawed.

By Michael McGrady

At the end of April, the U.S. Food and Drug Administration (FDA) approved Philip Morris Products’ premarket tobacco product application (PMTA)  for the company’s heat-not-burn device known as the I Quit Original Smoking system, or IQOS. An FDA press release states that the agency recognizes the potential improvement for population-level public health by authorizing such a product due to how heat-not-burn (HnB) systems work.

HnB systems, as we know, heat the tobacco instead of burning it, providing a cleaner nicotine-delivery system. “The agency determined that authorizing these products for the U.S. market is appropriate for the protection of the public health because, among several key considerations, the products produce fewer or lower levels of some toxins than combustible cigarettes,” the FDA admitted.

This is an astounding and surprising move by the FDA. However, there is still the elephant in the room. While the IQOS approval is undoubtedly a step in the right direction for the post-Gottlieb regulatory environment, the premarket approval process is still dangerously flawed and inefficient.

When the Obama-era Tobacco Control Act of 2009 granted the FDA the power to regulate all nicotine-containing products under the deeming provisions, the law additionally encouraged the implementation of a regulatory framework that prohibits new and modified products without agency approval. Premarket approval regulations, as promulgated by FDA guidance, cover every aspect of a tobacco product or deemed product. From the risk the product poses to health to the design of the label, a PMTA covers virtually every aspect of a product’s configuration.

According to a recently published position paper titled, “The Public Health Rationale for Recommended Restrictions on New Tobacco Product Labeling, Advertising, Marketing and Promotion,” the FDA justifies a broad regulatory query as a process that is vital to protecting not only general public health but also the country’s youth.

“Given the level of evidence indicating the direct and powerful impact of tobacco marketing on youth

tobacco use, and FDA’s statutory mandate to protect young people from the dangers of tobacco use, it

is both reasonable and critical for firms to submit planned labeling, advertising, marketing, and

promotional materials and plans for new tobacco products that are seeking or have received premarket authorization, and for FDA to place restrictions on the marketing of such products,” the agency’s position paper concludes.

While this justification is admirable, and many in the industry are employing self-regulatory measures and industry standards for marketing, product labeling, transparency as the FDA wants, the structure of the PMTA law still provides a case for government-supported market inefficiency.

PMTAs are designed to require a standard of substantial evidence that a current or new product was designed with relative risk. By consequence, the PMTA applications process requirements kick in and send product manufacturers and marketers down an expensive process.

Agency estimates put the cost of each PMTA at $300,000 per product application. Other calculations put the cost estimates into the millions. Timeframes for application reviews also average from 500 hours to 1,700 hours. At a minimum, that is about 63 days of review per product application. Applications for products that claim to offer modified-risk scenarios during use have yet to be approved despite overwhelming evidence suggesting a reduced-risk case.

However, in my opinion, the key reason why the PMTA regulation is still so inefficient is how it interacts with safety development in vapor products. For starters, consider the controversy surrounding the FDA’s block of safer e-cigarette products.

In October 2018, Joyetech released its eGo AiO to Canadian markets. This device is one of the very first to receive a safety certification that complies with Underwriters Laboratories’ (UL) 8139 standards for the manufacturing of electronic nicotine-delivery systems. UL 8139 is also a manufacturing standard that was not borne from a government agency; rather, UL coordinated with members of the industry to create a safer device.

PMTA rules prevent Joyetech from selling that product due to the process for approval. In an interview with NBC News around the release of the eGo AiO, Joyetech’s chief regulatory and compliance officer, Joshua Church said, “We’ve been frozen out of the U.S. market by the FDA, whose last concern is product innovation. So, we’re sitting here stuck in the water.” Given this design, the regulation is structured to prevent further inefficiencies when receiving a compliant status for a product.

PMTA rules also present several scenarios for concern when they conflict with the statutory mandate of other federal regulators. The Child Nicotine Poison Prevention Act (CNPPA) is a little-known product safety law that requires child-resistant packaging on liquid nicotine containers. The CNPPA is enforced and interpreted by the federal Consumer Product Safety Commission (CPSC) following the regulatory framework outlined in the Poison Packaging Prevention Act (PPPA). Since the CNPPA has gone into effect and the commission has promulgated rules, the requirements for liquid nicotine packaging have grown more stringent.

In the latest round of enforcement, CPSC leadership has begun interpreting the CNPPA requirements for packaging to include flow restrictors and provided guidance that mandate that all e-cigarette packages feature these new safety implementations. According to an analysis written on this issue by regulatory attorneys at Keller and Heckman LLP, this interpretation of rules could dramatically impact firms that are not compliant. “Companies with products that do not have both child-resistant closures and flow restrictors may be required to cease sales and initiate product recalls until their packaging is brought into full compliance,” the Keller and Heckman analysis indicates, additionally noting that changes to packaging may trigger the FDA’s PMTA requirements.

While the analysis was optimistic that the PMTA requirements would be waived to ensure product compliance with other areas of federal law, the FDA does not have the greatest track record of cooperating with the industry or its fellow regulators. Per a memorandum of understanding, the FDA and CPSC have intentions to work together in overlapping regulatory efforts. This, however, does not mean that the FDA will not attempt to add more requirements related to packaging configurations to put product manufacturers at higher levels of scrutiny during the PMTA process.

A remedy for many of the disputes outlined in this piece would be for the FDA to reinterpret the Tobacco Control Act to permit greater flexibility for the industry to voluntarily reach higher levels of safety. Existing rules are likely to stay the same as a part of the continued crusade to fight to a so-called youth vaping epidemic. If this holds, the only remedy would be a legislative fix that could come at a slower rate than amended agency guidance. Regardless, the PMTA still serves as an example of inefficient regulatory power that places industrial input last.