The “deeming rule” was finalized in May 2016 and put into effect in August 2016 which would require e-cigarette makers to go through a “lengthy and expensive” application process for products that were not being distributed on the market before February 15, 2007.
Large tech groups like TechFreedom and High Tech Forum as well as 11 other organizations reached out to Congress to pass legislation which would loosen regulations on electronic cigarette manufacturers which took effect in August of 2016.
The organizations wrote a letter to Congress addressed to Senate Majority Leader Mitch McConnell (R.-Ky.) and House Speaker Paul Ryan (R.-Wi.) that included statements like “The FDA has reflexively applied the precautionary principle, giving more weight to theoretical concerns about problems that might arise rather than any concrete evidence of harm,” and “In doing so, the agency is depriving smokers of a demonstrably safer alternative out of pure speculation.” This is an attempt at swaying the opinions of Congress by calling attention to the fact that they are “depriving American smokers of safer alternatives” for tobacco consumption.
Not only do these regulations interfere with the development and advancement of new technology in the smoking cessation and vaping industry, they also hinder small businesses from making a profit and running a legitimate business. This is a problem considering that small businesses make up much of the vaping industry and they have indeed been dealt the most difficult hand.
Groups such as Americans for Tax Reform and R. Street Institute have also joined the coalition by signing the letter to Congress and voicing their concerns.
The letter sent to Congress by the coalition suggests that lawmakers should pass legislation that would require companies with products not on the market before August 16th of 2016 to submit applications for approval instead of the original date of February 15, 2007. Passing such legislation would in no way effect the FDA’s goal to continue to protect consumers and regulate e-cigarettes, but would still allow manufacturers and vape shops to manufacture and sell e-cigarette products without going through a lengthy application process, or being forced out of business due to capital restrictions.
During the 114th Congress, an amendment offered by representatives Tom Cole (R.-Ok.) and Sanford Bishop (D.-Ga.) which would have nullified the February 15, 2007 predicate did peak interest and was adopted 31-19 by the House Appropriations Committee in April, but unfortunately, the overall effort did not extend further.
Because this “rule” from the FDA threatens “to crush the e-cigarette industry and potentially hurt the public’s health by making it harder for consumers to access products that serve as an alternative to smoking, Senator(s) Ron Johnson (R.-Wi) and Duncan Hunter (R.-Ca.) wrote to Vice Vice President Pence requesting that the FDA’s e-cigarette rules be repealed or suspended by the administration.