Product Standards at the Highest Level

Product Standards at the Highest Level

We are committed to developing and promoting higher product standards.

What are Product Standards?

Generally speaking, product standards refers to certain criteria that must be met in the design and manufacture of consumer products to ensure a desired outcome — usually a safe or quality product. These should be differentiated from standard test methods. You may be familiar with ISO (International Organization for Standardization), or CEN (European Committee for Standardization). For electronic cigarettes, e-liquids and other vaping products, the definition of product standards is very specific and differs depending on the country or jurisdiction in which one operates.

U.S. Tobacco Product Standards

In the United States, vaping products, including electronic cigarettes, e-liquids, and devices, will be regulated as tobacco products by the Food and Drug Administration (FDA) under the 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). Section 907 of the Tobacco Control Act gives the FDA authority to issue product standards through rulemaking.

Mitch Zeller, Director of the Center for Tobacco Products, Food and Drug Administration

(November 6, 2013 interview with New Public Health):

“There are some very powerful tools that Congress has given FDA to use wisely and supported by evidence … The first is something called product standards, which is basically the power to ban, restrict or limit the allowable level of ingredients in tobacco or tobacco smoke. We are exploring potential product standards in three areas: toxicity, addiction and appeal.”

Thus, the FDA may adopt tobacco product standards if it finds that it is appropriate for the protection of the public health. In determining this, the FDA shall consider scientific evidence concerning the following:

  1. The risks and benefits to the population as a whole, including users and nonusers of tobacco products, of the proposed standard.
  2. The increased or decreased likelihood that existing users of tobacco products will stop using such products.
  3. The increased or decreased likelihood that those who do not use tobacco products will start using such products.

In the event that the FDA determines that an additive, constituent, or other component of a tobacco product is or may be harmful, it will set forth a tobacco product standard through a proposed rule that requires the reduction or elimination of the additive, constituent (including a smoke constituent) or component. The FDA will do so on the basis that is appropriate for the protection of public health. Any party objecting on the grounds that the proposed standard will not reduce or eliminate the risk of illness or injury may provide scientific evidence for the FDA’s consideration that demonstrates such.

In the United States, tobacco product standards may be adopted only through notice-and-comment rule making, according to the statute, the FDA must also consider information submitted in connection with a proposed standard.

This includes the technical achievability of compliance with the proposed standard, information concerning the countervailing effects of the tobacco product standard on the health of adolescent tobacco users, adult tobacco users or non-tobacco users and information on the creation of significant demand, and the significance of such demand, for contraband or other tobacco products that do not meet the respective standards.

We will continue to engage with rule makers to ensure the most progressive, technically achievable standards are submitted for consideration by regulators. Additionally, we are constantly engaging with various industry working groups to accelerate development of voluntary industry standards that will fill any regulatory gaps.

International Vaping Product Standards

Elsewhere in the world, most notably in the European Union, product standards are being developed through various national and international standardization bodies.

Thus, AFNOR (The French Standardization Organization) published the first voluntary product standards on electronic cigarettes and e-liquids.

ISO has established a new technical committee on vapor products, ISO/TC 126, which is currently working on developing testing methodologies for nicotine content and other substances in e-liquids and definitions and standard conditions for routine analytical e-cigarette vaping machines. ISO’s current work is geared more toward testing methodology than product standards.

Furthermore, the European Commission will issue a Commission Implementing Decision under the Tobacco Products Directive, regarding technical standards for the refill mechanism of electronic cigarettes, encompassing all vaping products. We have engaged with the European Commission via a comment opportunity offered by the government of the United Kingdom and our comments can be accessed here: Nicopure Labs LLC Comments Draft Commission Implementing Decision on Technical Standards for the Refill Mechanism of Electronic Cigarettes.

In the near future, our company will issue its own voluntary product standards and will encourage industry colleagues to follow suit.