The FDA recently released the much-anticipated additional regulations for tobacco and nicotine products. An earlier phase of the regulation changes was released in April 2014. This second phase is slated to go into effect in August 2016.
The updated regulations will affect products introduced on the market since February 2007, which includes the entire e-cig industry. The new products, according to the FDA, are to be substantially equivalent to products already on the market as of February 2007.
Substantially different is defined as “being the same in terms of ingredients, design, composition, heating source and other characteristics to an existing, single predicate product or have different characteristics, but not raise different questions of public health.”
The demand for compliance is expected to trigger lawsuits from product manufacturers and vape shops needing to retroactively follow stricter regulatory requirements in order to prove their products don’t cause public harm. Proof would have to come in the form of more detailed information on liquid nicotine ingredients and manufacturing processes
The cost of complying to the new regulations could be in the millions of dollars and litigation could easily extend the uncertainty about health risks that plagues the industry. It could also hamper product innovations by companies with budgets that can’t compare with those of the big tobacco companies’ research and development departments.
There are several recent studies that show e-cigs and vaporizers may be less harmful than traditional cigarettes by as much as 95 percent, though the FDA has not evaluated any research or products to validate those statistics.
In the interim, manufacturers who submit new tobacco product applications to the FDA will be permitted to sell products affected by the regulations for up to two years and receive one more year while their application is reviewed. Marketing of e-cigs and vaporizers can continue, though no claims regarding public health can be made without approval by the FDA.
The first phase regulation changes included, among other things, a ban on the sale of e-cigs and vaporizers to minors, requiring proof of age to buy the products, a ban on distribution of free samples and no vending machine sales except in adult-only settings. In addition to e-cigs and vaporizers, other tobacco-related products affected by the new regulations are pipe/water-pipe/hookah tobaccos, cigars, dissolvable tobacco products and nicotine gels.
Source: Richard Craver. “FDA decision likely to spur lawsuits from e-cig manufacturers, vape shops and others.” www.journalnow.com. May 5, 2016Posted By: Paul L. Owens
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