For US consumers, where they live is increasingly determining which e-cigarettes and other smoke-free nicotine products are available to buy. The FDA has relaxed parts of its regulations, whilst the states are introducing their own rules, bans and product requirements. The result is an increasingly fragmented nicotine market – where the same product can be treated very differently depending on where in the US it is sold.
When Vejpkollen wrote about developments in the US in March this year, it became clear that federal regulation no longer governed the market on its own. Flavour bans, sales regulations and product requirements already varied considerably from one state to another.
Since then, that picture has become even clearer.
In early May, the US Food and Drug Administration (FDA) granted marketing authorisation for the first fruit-flavoured e-cigarettes – mango and blueberry – outside the traditional tobacco and menthol flavours. A few days later, the agency also announced that, in certain cases, it would refrain from taking action against products whose applications were already at an advanced stage in their review process, known as the PMTA. This means that all new nicotine products must undergo extensive testing, during which manufacturers must demonstrate that the product is suitable for sale from a public health perspective. According to the FDA, the aim of the new policy is to focus resources on the extensive illegal market.
For both manufacturers and retailers, this announcement means that more products can remain on the market whilst the FDA continues its scientific assessment.
Critics warn of a loss of confidence
At the same time, the change has been met with criticism from several former senior FDA officials.
– This raises the question of whether the agency’s own experts actually opposed this policy but were ordered to implement it anyway. And ultimately, it’s about the public’s ability to have confidence in institutions such as the FDA,” Mitch Zeller, former director of the FDA’s Centre for Tobacco Products, told the AP news agency.
Brian King, who until recently headed the same department, also believes that the agency has changed course.
“What we’re seeing is that the authority has become considerably more open to flavoured products, both through a greater willingness to approve them and a reduced inclination to take action against such products,” he told the AP.
The federal states continue to go their own way
At the same time, the federal states continue to make their own decisions.
Some ban flavoured products altogether. Others introduce specific product registers or restrict which products may be sold. A few, however, opt for a more lenient approach.
As a result, the regulations governing the same product can vary considerably between different parts of the US.
According to Reuters, current and former FDA officials estimate that between 100 and 200 products may be directly affected by the new regulation. At the same time, around 1,000 applications are already well into the agency’s review process, which means that significantly more products could be affected in the long term.
This does not mean that the products are automatically approved. They must still undergo the FDA’s review process before they can be granted permanent marketing authorisation. The difference is that, in certain cases, the authority chooses not to intervene whilst the review is ongoing.
An increasingly weak federal system of governance
The federal authority is still attempting to maintain a national regulatory framework, whilst the states are introducing their own laws and the FDA is changing the way the regulations are applied. For both consumers and businesses, the result is becoming increasingly difficult to navigate.
