Session 4: Global implications of product standards

Everyone can agree the tobacco industry needs standards. Not everyone agrees the industry needs regulation. Moderated by Rolf Lutz, director of product policy for Philip Morris International, Session 4: “Global implications of product standards,” attempted to educate attendees on the differences between regulations and standards. A regulation is a document providing binding legislative rules that is adopted by an authority. Regulations set mandatory requirements and related conformity assessments deemed necessary by legislators for protecting citizens, the environment, infrastructure and property (intellectual and physical).

A standard is a document, established by consensus and approved by a recognized body, which provides for common and repeated use, rules, guidelines or characteristics for activities or their results. Standards are aimed at the achievement of the optimum degree of order in a given context. There are also two separate types of standards, mandatory and voluntary. A mandatory standard means that if a product is not compliant with the requirements of a technical regulation, the product is not allowed to be put on the market. In a voluntary standard situation, a noncompliant product will still be allowed on the market, but the market share may be affected if consumers prefer products that meet local quality standards, according to a panelist.

The U.S. Food and Drug Administration (FDA) may establish a tobacco product standard if it finds it is appropriate for the protection of public health. The FDA is required to assess the risks and benefits to the population as a whole, including users and nonusers of tobacco products, and the increased or decreased likelihood that existing users will stop or that nonusers will start using tobacco products, according to a speaker. The FDA also considers the technical achievability of compliance, countervailing effects on the health of adolescent and adult tobacco users and nonusers, and the potential for the creation of significant demand for contraband products.

New tobacco product categories have brought about various challenges for the development of testing standards and test equipment manufacturers, according to a panelist. The rapid evolution of electronic nicotine-delivery systems (ENDS) and heat-not-burn products and a need by device manufacturers to test devices for aerosol yield, quality, etc., has outpaced the development of testing standards. This, in turn, has led to the accelerated development of analytical testing devices such as smoking/vaping machines often based on the thought “what we can do today that might help us” rather than “what do we need to know?” according to a speaker.

Current standards for ENDS products are based on machines designed for combustible products. With combustible products, testing standards have around for decades. The first U.S. federal standards for cigarettes were developed in 1966. These methods have been refined over more than half a century. However, with ENDS products, things like puff frequency and duration are different than with combustibles. The size of the puff taken in is also different. One speaker said that organizations such as Coresta now recognize additional parameters are needed to deal with different product types. Even machines recently developed for cigalike products may not be the appropriate testing application for more sophisticated vaporizers.

Another flaw in the standards development system is that organizations such as the World Health Organization don’t accept any recommendations from tobacco industry companies, according to a panelist. There are some standards or guidelines for testing of e-liquids such as the BSI PAS 54115:2015 and Russian Federation GOST R 57458–2017. Scientific organizations such as Coresta and ISO are also both working on the development of methods for aerosol generation by vaping machines that are expected to be published later this year, according to a panelist. Unfortunately, many published standards do not enjoy widespread adoption, often partially due to lack of supporting tools and information infrastructure.

Globalization and increased use of contract manufacturing amplifies the need for manufacturers, suppliers and service providers to have open, globally acceptable technical standards and the required conformance tests to ensure compatibility with the intended end use. Panelists agreed that it will take time for robust and reliable testing standards to be developed, particularly for machine aerosol generation and collection from the different types of products.

The development of these standards must be a collaborative effort between device manufacturers, testing machine manufacturers and regulators. There needs to be consensus-based standards that address technicalities and good practices for implementation, which are developed by a transparent process involving all the interested stakeholders.

These groups should also recognize that there is a measurement of uncertainty with any testing method, and understanding the implications is important. If you under-specify, the results are meaningless. If you over-specify the uncertainty, then you pay the price in time and money in developing the equipment. Standards should set an appropriate bar; however, regulators should let the scientists and engineers devise the means to get there.