Five E-cigarette Regulatory Myths

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During informal conversations with e-liquid and device manufacturers at the various conventions and expos this year, many have expressed their opinions and interpretations of the TPD.

These exchanges have, in my view, exposed a number of misunderstandings, falsehoods, and inaccuracies. In order to provide some clarity, I have addressed some of the most common ones below:

 

Myth 1)

 

“The TPD is a mess – it’s not fit for purpose / poorly thought out”

 

Not true. But I can understand why some individuals think it is.

 

A chasm exists between the broad requirements of the TPD and the e-cigarette industry with its huge diversity of products.   But the TPD uses ‘broad-stroke’, top-level requirements precisely because there is so much diversity. It would not be effective or efficient to attempt to capture the specifics of every design, composition or configuration.

 

But that’s not all.

 

An important element of working with the TPD is interpretation – the TPD requires a degree of interpretation and reading between the lines. The role of a regulatory consultant is, in part, to do the interpreting on behalf of their clients.

 

Myth 2)

 

“Nothing is ‘set’ / There is still much to work out”

 

Not completely true.

 

This view is widely held. Of course, this is an industry with a regulatory framework still in development: official standards are absent and guidelines are limited. But there is less to work out than most people realise.

 

Testing e-liquids and devices is a good example. Behind the scenes progress has been made in the development of guidelines for testing and based on currently available information one can make informed decisions about e-liquid and device testing. This can enable manufacturers to, at the very least, move in the right direction.

 

Myth 3)

 

“It’s better to wait for clear guidance and instructions before acting”

 

Waiting for clear instructions and guidance before acting is often sensible and wise and most companies are likely to adopt this approach. However, specialist regulatory advice can help a company make informed business decisions now rather than waiting for the guidance/instructions, which may not be available for several months.

 

Notably, an investment in working towards compliance in the absence of official guidelines is not wasted. Any effort enables a manufacturer to comply with the standards more quickly when they do become available.

 

It is also worth noting that even though some guidelines are published not all questions for all business situations and products are answered.

 

A similar situation exists in the pharma industry where guidelines are available but they do not answer every question. It is normally the role of the regulatory consultant to fill in the gaps.

 

The lesson here is: those acting now will be best placed when the standards and guidelines become available.

 

Myth 4)

 

“The 6 month pre-market notification period will stifle innovation”

 

Currently, it seems like a new product line is launched every month. Under the new rules, a pre-market notification of 6 months before marketing is required. Many believe this will impede innovation.   I disagree.

 

Slowing down the rapid turnover of product lines with ever advancing technology does not necessarily stifle innovation. Rather, it puts greater pressure on manufacturers to focus on more sophisticated products in the first instance.

 

For example, some small pharmaceutical companies only have one product design in their portfolio with everything hanging on the success of that single product. This situation certainly focuses the mind on innovation. And some small companies enjoy great success with this business model.

 

Myth 5)

 

“Products not described in the TPD such as heat-not-burn products are not in scope of the TPD and so exempt from the requirements”

 

Not completely true.

Of course, if there is no provision for a particular product in the TPD then it is indeed out of scope.

However, it should be noted that the Commission is aware of these ‘outliers’ which include heat-not-burn type products, also known as herbal vapourisers, and nicotine-containing film for oral use (e.g. Nicoccino).

Both these products, given their intended use, are highly likely to be included in the next update to the TPD.

In the meantime, manufacturers of these types of product are advised to use the TPD requirements as a model, especially when it comes to product testing. After all, the correct interpretation of the requirements of the General Products Safety Directive should result in a similar course of action.

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