The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has proposed that it regulates the manufacture, import and sale of e-cigarettes in Britain – effectively branding e-cigs as a type of “medicine”. Is this a draconian step too far, a sensible precaution to control an entirely new form of product, or an invitation for big business enterprises to muscle into the market and prevent smaller suppliers from competing?
A tobacco story re-told?
The manufacture of such a new and potentially marketable (that is to say, lucrative) product as the e-cigarette attracts both large, rich and powerful companies as well as a whole host of many smaller competitors. As a result there are currently more than 1,000 different e-cigs on the market.
Paradoxically, it is almost a re-play of the state of affairs that existed between the much longer established tobacco companies that existed up until very recent times. The Philip Morris empire, for example, was such a powerful, economic giant that it could apply its considerable financial muscle to stay at least one step ahead of its competition. Even if that advantage meant complying with increasing government controls on the use of tobacco in cigarettes, Philip Morris could afford to comply (and lobby for compliance) in order to force smaller, weaker competitors out of the market place.
What this meant in practice was that a tobacco empire like Philip Morris could in fact lend its support for the US Food and Drug Agency (FDA) control of tobacco products, actively negotiate the so-called Family Smoking Prevention and Tobacco Control Act (FSPTCA) in the United States by working with its Campaign for Tobacco-Free Kids (CTFK), and lobby Congress for passing the Act.
With all the financial clout on its side, in other words, Philip Morris could pose as one of the “good guys” in order to comply with whatever controls on tobacco might be introduced whilst watching its economically weaker competitors in the tobacco industry go to the wall.
Today’s e-cig version of the same story?
The similarity of the battle being fought by some of the major producers of e-cigarettes, their competitors and increasing government control has certainly been taken up in the United States.
The Executive Director of a lobby group called Smokefree Pennsylvania, Bill Godshall, for example, has written* a scathing protest to the President and Chief Executive Officer of the e-cig giant NJOY complaining about the latter’s apparent endorsement of moves by the UK’s MHRA to treat electronic cigarettes as a kind of medicine.
Godshall in fact worked alongside the UK’s well-known lobbyists Action on Smoking and Health (ASH) in the 1990s. Today he is accusing e-cig manufacturer NJOY of using its considerable economic muscle to fund compliance with whatever government regulation is proposed for the industry (such as that by the MHRA) in a bid to keep out the thousands of other potential competitors.
The result, says Godshall, is that draconian measures such as those proposed by the MHRA, and supported by NJOY, will have the effect of stimulating a black market in completely unregulated e-cig products – with all the risks and potential damage to the health of consumers that some unscrupulous suppliers may pose. The combined might of government regulation and big business lobbying, in other words, could have the simple effect of just flooding the market with potentially unsafe black market substitutes.
In support of his argument, Godshall cites the 500% growth in the use of black market electronic cigarettes when the FDA attempted to impose a complete ban on the import of e-cigs into the United States between 2009 and 2011. The result was a mushrooming in the use of completely unregulated black market products and a significantly increased risk, therefore, to the health of consumers.
Quite unsurprisingly, of course, the President and CEO of NJOY, Craig Weiss, has defended the company’s position in attempting to rebut Godshall’s criticisms.
What the defence seems to boil down to is the former’s assertion that “the FDA circa 2009 is not the MHRA circa 2013”. What he seems to be saying in this bald statement is that unlike the US FDA in 2009 the MHRA in the UK actually sees the point in electronic cigarettes, recognises that they may be a safer alternative to tobacco products and simply want to ensure that all e-cigs manufactured in or imported into the UK are fit for consumption. Subject to those essentially sensible precautions, therefore, NJOY reckons that the MHRA wants to see electronic cigarettes on the market.
Referring to the difference in approach from the FDA in 2009 and the MHRA in 2013, Weiss says that whereas the FDA proposals involved manufacturers engaging in very stringent clinical trials, MHRA regulation would not pose such an obstacle. Whilst clinical trials could cost manufacturers many years and millions of dollars, regulation by the MHRA involves a much lighter touch, representing “an achievable hurdle that any responsible company should be able to clear”.
In that reference to achievable hurdles, of course, Weiss is claiming that NJOY is sponsoring a sensible approach to the regulation of electronic cigarettes and is in no way trying to use its financial strength to gain ground in the commercial market place.
NJOY helped to create the legal framework that today regulates the industry in the United States, says Weiss. He argues that his company did this for the benefit of everyone and without outside funding from anyone else. He does not go on to say, of course, that by maintaining an inside edge and moulding the regulatory framework to suit its own interests, NJOY was also seeking to stay at least one step ahead of the competition. But that does not mean unfair competition, he argues.
In conclusion, the head of NJOY argues that his company, together with the MHRA and ASH in the UK, are all simply striving to be sensible and responsible actors, in defence of consumers’ interests.
He ends his reply by insisting that his company lies completely outside the realms of what he calls “Big Tobacco” and therefore resents any comparison with the past activities of the Philip Morris group. This rather misses the point, however, that Godshall’s reference to the tobacco giant’s past activities was more a comparison of the way in which big business tends to behave, rather than any direct connection with the products they may be attempting to promote or defend.