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The deeming regulations and the TPD: restrictive in different ways

Written by || 6th May 2016 || Regulatory news analysis |

deeming regulations news package - how they compare 900x540While the U.S. deeming regulations and the EU’s TPD will come into effect almost simultaneously this summer, bringing some regulatory consistency and clarity to the world’s largest e-cigarette markets, their approaches could hardly be more different.

Both regulate e-cigarettes as consumer tobacco products rather than as pharmaceuticals, and both allow local governments – states in the case of the FDA, EU member nations in the case of the TPD – much leeway in regulating further as long as they do not clash with the over-arching rules.

But in the detail there are more differences than resemblances.

Where the actual products are concerned, the philosophy of the EU’s TPD (Tobacco Products Directive) is to set some limits – most notably on nicotine concentration and container size, though also mentioning ingredients – and then allow any product compliant with those, and notified to the authorities, to be sold six months after notification. The assumption is that compliant products are acceptable unless a particular problem arises.

By contrast, the deeming regulations from the U.S. Food and Drug Administration (FDA) require every product to be submitted for approval before it can be placed on the market.

 

Open questions

 

One of the biggest questions facing the U.S. industry is the extent to which those approvals, known as PMTAs (premarket tobacco applications), really will be individually judged for each product or whether the FDA will in practice adopt a policy of waving through whole classes that meet certain criteria – which would in effect mean a more EU-like model.

One interpretation is that the FDA will require clinical trials to be carried out on each individual product that requires a PMTA, in which case the worst fears of the industry may be realised, with regulatory approval costing many hundreds of thousands of dollars per product.

On the other hand, as discussed in the FDA’s deeming regulations document published this week, the agency may be satisfied without the need for any clinical trials, and merely require generic data on the health impacts of the products in general.

The problem is that the new regulatory regime will leave huge discretion to the FDA in either case, and in the early days it may not be clear what will and will not satisfy the regulators  – though there are some indications that where smaller firms in particular are concerned, the FDA will be prepared to give informal advice.

Also affecting this key question is the issue of how far the FDA will accept substantial equivalence (SE) arguments, under which a product can merit approval if it can be shown that it is very similar to an already-existing one. Again, this could lead to de facto standard criteria for acceptable products if it is widely applied.

The FDA goes so far as to say that it has identified an ENDS (e-cigarette) product which “may” have been on the market on 15th February 2007, the cut-off date after which all e-cigs require approval, giving the industry some hope that there are predicate products with which to compare those currently on the market.

However, elsewhere the FDA indicates that this predicate product is an e-cigar, leaving manufacturers only to guess whether it could really be considered substantially equivalent to current sophisticated, refillable tank devices.

In both the EU and the U.S. there are transition provisions which give existing products a period of time to continue to be sold once the new regulations come into effect – 20th May in the case of the TPD, early August in the case of the deeming rule.

 

Minors and media

 

Other major differences relate to under-age sales and advertising.

The FDA rules forbid the sale of e-cigarettes to under-18s, but the EU’s TPD makes no such prohibition. However, the differences in this respect may be more academic than practical: sales to minors were already banned in the majority of U.S. states and EU states anyway.

A more significant disparity lies in the treatment of advertising. The TPD effectively outlaws online, TV, radio and print advertising, which could significantly reduce the industry’s ability to attract new customers to the category. The FDA does not regulate any of those media.

However, it does prohibit free sampling – something which the TPD does not proscribe, although many individual EU member states have done so.

 

What This Means: Broadly, the deeming regulations could be said to impose fewer outright limitations but more arduous procedural requirements on the e-cigarette industry; with the TPD, the compliance burden may well be smaller yet the constraints on product capabilities will be firmer.

But it is too early to say which regime will turn out to be, in the long term, kinder from the industry’s point of view. So much depends on the way that the FDA approvals process, the single most important aspect of the deeming rule, is handled in practice.

– Barnaby Page ECigIntelligence staff

Graphic: Carl Gamble