E-cigarettes are a complex type of product to market and sell. Due to the relative newness of these items, the legal picture around them is clarifying itself incrementally, with regulations about how e-cigarettes and related items can be sold still in flux. The U.S. Food and Drug Administration's labeling rules have changed once again. Frequent discussion of the health benefits of e-cigarettes as a smoking alternative has left makers and sellers of these alternative tobacco products carefully watching each development.
An Unexpected Ruling
As a demonstration of how volatile and unpredictable the e-cigarette labeling market can be, industry members need look no further than the FDA's refusal to grant labeling approval to Philip Morris International for its iQOS items. Convenience Store Decisions reported that the manufacturer was hoping to have iQOS approved as a reduced-risk tobacco product, and that such a vote of confidence was expected, but the FDA turned down three of the four issues brought before it by Philip Morris.
Analysts believe approval could still be forthcoming following more research. Convenience Store Decisions added that despite the disconnect between manufacturers and the FDA, there is still public interest in and approval of e-cigarettes. The rechargeable category, in particular, made large gains throughout 2017, with refills cutting into disposable e-cigarettes' market share significantly.
Possible Effects of FDA Control
The Penn Program on Regulation's publication, The Regulatory Review, recently highlighted a scholarly critique of the FDA's efforts to get involved in labeling and regulating e-cigarettes. Case Western Reserve University School of Law professor Jonathan Adler opined that by insisting on many warning labels on e-cigarettes and related items, the government may be inadvertently scaring people away from a product category that could stop them from smoking. This is highly relevant today, as more than half of U.S. smokers want to stop, per survey results.
The fact that the next round of FDA moves is meant to carefully monitor health claims made on e-cigarette labels raised a red flag for Adler, according to The Regulatory Review. He pointed out that there may be an especially strong disconnect between the FDA and companies that are trying to sell e-cigarettes primarily for recreational purposes rather than as a smoking cessation aid. Such companies would have to get FDA medical device approval before they can make relative risk claims.
Dealing with an ever-chaning regulatory picture means companies that manufacture e-cigarettes may have to change their packaging styles often compared to peers in other sectors. To learn more about printing high-quality product labels in-house, reach out to Argon Technology in the U.S. or in Canada.