FDA faced hard decisions, criticism in crafting regulations

deeming regulations news package - in context 900x540Striving for science-based policy-making in the deeming regulations, the FDA faced a tough task in attempting to corral the rapidly-developing and often contradictory data on e-cigarettes at the same time as it was dealing with pleas and criticisms from the industry and pressure groups.

While a few vaping advocates argued that the agency should not regulate e-cigarettes at all, or at least treat them far more gently than tobacco – perhaps like an innocuous food – the biggest focus of concern from the vapour industry was the “grandfathering date” of 15th February 2007.

All products put on the market after that date, which means effectively all e-cigarettes, will have to go through the FDA’s arduous authorisation process, although they will be allowed to stay on sale while it is conducted.

Critics said this was unfair because the whole category would have to undergo approval, something which did not happen with combustibles when the FDA started to regulate them in the mid-2000s.

However, the agency has argued that it does not have the right to change the February 2007 date – itself originally set for combustible tobacco products – without new law being created in Congress.

Attempts continue in Congress to change the date, but in the final version of the deeming regulations it remains.

Other criticism has come from Congress itself as well as from health organisations. Particular concerns from those corners have been the slow process of passing the deeming regulations into force, and the perceived lack of adequate measures for child protection. There have also been repeated suggestions that the agency regulate flavours.

 

Sticking to its guns

 

Despite all this, however, the final version of the deeming regulations remains remarkably close to the original one published in April 2014, although there are plans for follow-up guidance and rules which will expand on some missing areas.

The FDA said it “noted that there are distinctions in the health risks presented by various nicotine-delivering products” and “requested comment as to how e-cigarettes should be regulated based on this continuum of risk”.

It was concerned about youth vaping, but nevertheless “recognizes that completely switching from combusted cigarettes to ENDS [electronic nicotine delivery systems] may reduce the risk of tobacco-related disease for individuals currently using combusted tobacco products, given the products’ comparative placements on the continuum of nicotine-delivering products”.

And indeed the possibility of users moving from combustible cigarettes to e-cigarettes was one reason that the agency decided not to restrict flavours. “Some adults may potentially use flavored ENDS to transition from combusted tobacco use,” it acknowledged.

But the FDA stresses that the deeming rule as it stands is merely “a foundational rule” which, along with providing public health benefits, will enable it to gather “critical information about the health risks of ENDS and other newly deemed products”.

It fully expects to follow up with other rules or guidelines on issues including:

  • Liquid nicotine safety. The agency plans “draft guidance, which when final will describe FDA’s current thinking regarding some appropriate means of addressing the premarket authorization requirements for newly deemed ENDS products, including recommendations for exposure warnings and child-resistant packaging that would help support a showing that the marketing of a product is appropriate for the protection of the public health”.
  • Fire risks and batteries.
  • Ingredients testing: the FDA first plans to issue guidance on testing for harmful and potentially harmful constituents (HPHCs), and later a regulation on testing and reporting.

 

The FDA noted that it would have the authority to issue rules on manufacturing, too.

 

What This Means: Commentary in the document the FDA published today shows the contradictory nature of much of the evidence received by the agency. It is perhaps no surprise that as a result it has taken a cautious position on most issues, and decided to be led by precaution where there is doubt. However, it does not appear to have caved in to pressure even on politically sensitive areas like flavours.

– ECigIntelligence staff

Graphic: Carl Gamble

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