FDA, WHO petitioners advised to focus on public health

Written by || 2 July, 2014 || Regulatory news analysis |

letter writing 300x180Comments to the U.S. Food and Drug Administration (FDA) on its proposed e-cigarette regulations should emphasise public health and skip business issues, an industry organisation has advised.

Cynthia Cabrera, executive director of the Smoke-Free Alternatives Trade Association (SFATA) in the U.S., told delegates at the Global Forum on Nicotine in Warsaw last week that business-related arguments are wasted on the FDA and are the concern, instead, of the Office of Management and Budget (OMB) in the White House.

The OMB may review the regulations later, but it is the FDA that is running the recently-extended process inviting comments on a wide range of topics.

Stakeholders seeking a light touch on e-cig regulation should address the category’s potential contribution to public health and the need for continuous innovation to support that, Cabrera said.

They could also add that the 2007 cut-off date for the FDA’s “substantial equivalence” test  – which allows products on sale before then to be fast-tracked to market  – is unrealistic and inapplicable to e-cigs, according to Cabrera, having originally been set for combustible tobacco products.

While characterising the FDA’s request for comments as a positive sign showing that it was open to outside input, Cabrera also cautioned that the proposed “deeming regulations” as they stand would be complex and expensive to comply with. She had heard three separate definitions for SE in three different meetings, she pointed out, and observed that “none of the companies that I know can afford [Premarket Tobacco Applications or PMTAs, the heart of the FDA’s planned approval process for e-cigs] because of the number of SKUs that they have”.

“Sometimes regulation gets ahead of itself,” said Cabrera. “First we have to decide what the goal is, then we regulate. The opposite happened here.”

WHO’s in charge around here?

At the same conference, speakers also mulled ways to influence the decision of the World Health Organisation (WHO) at the October meeting in Moscow of its Framework Convention on Tobacco Control (FCTC), which is likely to bring e-cigarettes into the international treaty’s remit. It would strongly influence domestic regulation in most major nations with the exception of the U.S., which is not a party to the convention.

There have been indications that the WHO is considering stringent tobacco-style rules for e-cigs, and dozens of scientists have weighed in with arguments both for and against heavy regulation.

Deborah Arnott, chief executive of UK anti-smoking group Action on Smoking and Health (ASH), urged those with an interest to engage their national health ministers, but to be moderate. “Accusing people of having wrong motives is not helpful if you want to change their position,” she said.

Clive Bates, the prominent e-cigarette blogger and a predecessor of Arnott at ASH, echoed the recommendation to petition national governments rather than the WHO bureaucracy itself. It is the signatory countries that will make the final decision on the global body’s policy.

“All the parties to the convention need to hear [that tobacco regulation is inappropriate for e-cigarettes] so when they go to Moscow there is a big question mark,” he said.

What This Means: It is certainly easy to assume that the regulations created by powerful bodies such as the FDA and WHO are “things that happen to us” rather than “things we can influence”. Cabrera, Arnott and Bates all remind us, though, that stakeholders (whatever their position) can influence these organisations’ thinking – and that in both cases, the time to do it is now.

– Barnaby Page ECigIntelligence staff

Photo: William Arthur Fine Stationery