Is the FDA’s job to stifle product development or protect the general public?

The FDA (Food and Drug Administration) is in a very difficult position with regards to the electronic cigarette industry which continues to gain in popularity. This is a sector which until the turn of the century was seen as something of a niche player and to all intents and purposes an irrelevance. However, those involved within the industry very quickly gained a reputation for ground breaking product development which caught the eye of the regulators and indeed politicians across the USA. This prompts the question, is the FDA’s role to stifle development of new products or protect the general public?

Before we look at the various aspects of the FDA’s role it is worth considering that this very powerful administration attempted to ban electronic cigarettes outright just a few years ago. It was forced into a humiliating U-turn when a court ruling confirmed that the ban was illegal and unenforceable.

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Uncertainty costing the industry

While the FDA is currently in year three (or year four depending on your view) of a two-year review into the vaping industry, we do not appear to be anywhere near the introduction of new regulations. The consultation period has been extended, there is extensive lobbying behind-the-scenes and no certainty that the regulations will be confirmed and placed on the statute books in the short term. If the FDA was looking to inject uncertainty into the vaping industry then it has most certainly been successful!

Those in the investment arena will be well aware that any uncertainty is reflected in the potential risk/reward ratio of an investment. If you are looking to significantly ramp up your vaping product development but you are unsure of the regulatory environment in the short, medium and longer term, would you plough ahead regardless? The simple answer is no – the more uncertainty the more funding is withdrawn in the short to medium term which leads to a significant slowdown in product development and indeed expansion of the industry.

What is the role of the FDA?

In simple terms the role of the FDA is to not only protect the public but to also ensure that services and products are delivered within a comforting regulatory framework. Some may well translate this as stifling entrepreneurship and product development while others may see this as a form of “putting on the brakes” to allow regulators to catch up with fast-moving industries. On the surface this seems a very balanced argument but what if we delve a little deeper?

Only those with a serious interest in the vaping industry and the ongoing regulatory struggles will be aware that all ingredients connected with vaping devices are already in the human food chain. Indeed many of the ingredients which are being reviewed by the FDA occur naturally in even stronger forms. Whether or not the FDA finally does put in place strict and potentially stifling regulations remains to be seen but even if it was to take a backward step and take a more relaxed approach, is the damage already done?

Conclusion

In many ways it does depend upon which side of the fence you sit as to whether the FDA is a brake on innovative product development or simply a means of protecting the wider public. The administration has not covered itself in glory in relation to electronic cigarettes and an attempted ban some years ago begs the question whether it is totally unbiased?

The ongoing regulatory review by the FDA has most certainly created something of an information and product development vacuum which does really play into the hands of the tobacco industry. On one hand there are rumours that big tobacco is lobbying against electronic cigarettes while on the other they are openly looking to invest and increase their influence. Unfortunately there does not appear to be any short-term endgame in sight with regards to the regulatory issue and this concern is not helping innovation and product development.

Mark Benson

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For further information about electronic cigarettes please visit the OKCigs.co.uk website

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