US federal government now enforcing Age-Verification requirements for e-cigarettes
This month, the US Food and Drug Administration will begin to enforce a longstanding requirement for age verification for online sales of the subset of e-cigarettes most popular with children.
The move marks the end of a softly-softly approach to the Tobacco Control Act, signed into law by President Obama over a decade ago. It also follows headlines that President Trump intended to ban flavoured e-cigarettes altogether, and further headlines that he was persuaded to change his mind during a flight on Air Force One to a campaign event after warnings about the impact on jobs.
Meanwhile, the FDA itself had been conflicted between the benefits of traditional tobacco smokers switching to vaping, and research that showed the popularity of flavoured e-cigarettes amongst school children. The 2019 National Youth Tobacco Survey (NYTS) on e-cigarette use finally persuaded officials to act. It showed that more than 5 million U.S. middle and high school students were current e-cigarette users (having used them within the last 30 days) and 970,000 use them daily. This was a dramatic increase on the previous year, and a reversal of a fall in use by children reported in 2016.
So, rather than apply a general ban, the FDA is concentrating electronic nicotine delivery systems (ENDS), such as e-cigarettes and e-liquids, sold in cartridge form. This compromise means it will focus enforcement action on three priority areas:
- Any flavoured, cartridge-based ENDS product (other than a tobacco- or menthol-flavoured ENDS product);
- All other ENDS products for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors’ access; and
- Any ENDS product that is targeted to minors or likely to promote the use of ENDS by minors.
In 2018, the FDA issued letters to five ENDS product manufacturers, requesting each company to submit a plan describing how it would address minors’ access to and use of its products. In response, manufacturers described safeguards that they could implement to help to restrict minors’ access to ENDS products sold at brick and mortar retailers and online. Examples of potential safeguards included using age-verification technology to better restrict access to the manufacturer’s website, such as through independent, third-party age and identity verification services that compare customer information against third-party data sources.
The outcome of this protracted legislative process is that a critical consideration in the FDA’s authorisation of new tobacco products will be the risk of their use by children. Keen to still market popular, flavoured products, the obvious and straightforward solution available to manufacturers is the rigorous, independent, age verification offered by AgeChecked for US-based e-cigarette vendors. AgeChecked can provide age-assurance for online sales to the USA conducted to the level required by the leading BSI Standard, PAS 1296:2018. This is the only existing standard for age verification and is on the way to becoming an international standard. It is expected to be a persuasive component of any authorization application to the FDA. Applying age checks to all products, old and new, and not just those supplied as pods, will dramatically reduce the risk of enforcement action by the FDA which has made its focus on keeping vaping out of the hands of children crystal clear.
FDA Commissioner Stephen M. Hahn, M.D commented:
“As we work to combat the troubling epidemic of youth e-cigarette use, the enforcement policy we’re issuing today confirms our commitment to dramatically limit children’s access to certain flavoured e-cigarette products we know are so appealing to them – so-called cartridge-based products that are both easy to use and easily concealable. We will continue to use our full regulatory authority thoughtfully and thoroughly to tackle this alarming crisis that’s affecting children, families, schools and communities. Coupled with the recently signed legislation increasing the minimum age of sale of tobacco to 21, we believe this policy balances the urgency with which we must address the public health threat of youth use of e-cigarette products with the potential role that e-cigarettes may play in helping adult smokers transition completely away from combustible tobacco to a potentially less risky form of nicotine delivery.
While we expect that responsible members of the industry will comply with premarket requirements, we’re ready to take action against any unauthorized e-cigarette products as outlined in our priorities. We’ll also closely monitor the use rates of all e-cigarette products and take additional steps to address youth use as necessary.”
