Could the FDA Benefit Assessment Calculation Save the eCigarette Industry?
Mark Benson
While many in the electronic cigarette industry are still reeling from the recent FDA (Food and Drug Administration) regulations which on the surface appeared light touch, but on further investigation seem to be very restrictive in the longer term, there seems to be hope for the future. Alongside the proposed regulations for the electronic cigarette industry another FDA document was quietly released into the public domain. This highlights the so-called “benefit assessment calculation” which could be something of a lifesaver for the industry in the longer term.
So what exactly is the “benefit assessment calculation“, what does it mean and how might it impact the electronic cigarette industry going forward?
Benefits and cost of regulation
To many people regulators around the world seem determined to introduce restrictive measures against the electronic cigarette industry – no matter what the cost. So far we have seen the introduction of an array of new guidelines and regulations for the future, currently out to consultation, which seem to increase the cost of operating in the industry and potentially leave it wide-open for the larger players. However, the benefits and cost of regulation may yet play a major role in the future of the vaping industry!
When creating regulations the FDA has to take into account a number of factors one of which is the projected benefits to the wider public. However, the FDA is also legally obliged to take into account what is known as “customer deprivation” which is effectively an adjustment factor on the benefits of regulating. This factor for the electronic cigarette industry has been calculated at 70% which means that the value placed upon longer and improved life for the wider public should be reduced by 70% to take into account “customer deprivation”. How might this work in reality?
Calculating the overall benefit
In simple terms, if the FDA was to place a $100,000 value on a longer and improved life for the wider public, due to its electronic cigarette regulations, this would need to be reduced by 70% to just $30,000. These are guideline figures as we wait the final outcome but the adjusted figure needs to be closely examined in relation to the cost of regulation, something which was introduced by President Bill Clinton back in 1993.
President Clinton attempted to focus the minds of regulators by taking into account the costs and the benefits of future changes to individual industries. For example, if the FDA, or indeed any other regulator in the US, introduced new regulations which would cost $1 billion to abide by, but only save a potential $100 million, then it would be unlikely that these changes would ever see the light of day. There are some who will argue that you cannot put a price on the health of an individual while others would have you believe that certain regulations already in play are attempting to crack a nut with a sledgehammer.
This is obviously a very controversial figure and a controversial way of assessing the viability of future regulations but it could potentially offer a means of avoiding restrictive regulations planned for the electronic cigarette industry?
Conclusion
Whether or not you agree with the “benefit assessment calculation” it is something which has been set in stone since 1993. So far there has been little recognition of the impact this may or may not have on the electronic cigarette industry although it is something which vaping supporters will be studying more closely in the weeks and months ahead. There are some concerns that tobacco cigarette companies could use this to reduce tobacco cigarette regulations and this could potentially open up a whole new can of worms.
At worst it looks as if there are many legal challenges awaiting the FDA which will probably delay the introduction of any future vaping industry regulations. Is common sense actually starting to prevail?
Mark Benson
Mark Benson is a contributing author for Spinfuel eMagazine. His continuing columns will bring a levelheaded approach to the dynamics involved in realizing a positive future for the e-cigarette industry. For more information on OK Eliquids and other products available please visit the OKCigs website.
