Tomorrow, the FDA ends its comments period in the potential federal flavored e-juice bans for vapes. Originally intending to have ended the comments period last month, the FDA reconsidered and kept the option open for an extra 30 days after the passing of Proposition E in San Francisco in June.
“Tobacco Product Standard for Nicotine Level of Combusted Cigarettes
Docket No: FDA-2017-N-6189
Date: Comment period extended through July 16, 2018
Summary: The Food and Drug Administration (FDA) is issuing this advance notice of proposed rulemaking (ANPRM) to obtain information for consideration in developing a tobacco product standard to set the maximum nicotine level for cigarettes. Because tobacco-related harms ultimately result from addiction to the nicotine in such products, causing repeated use and exposure to toxicants, FDA is considering taking this action to reduce the level of nicotine in these products so they are minimally addictive or nonaddictive, using the best available science to determine a level that is appropriate for the protection of the public health.”
Proposition E – among many other legislative changes in the city of San Francisco – banned the sale of flavored e-liquids in the city. Other major metropolitan hubs, like New York and Chicago, are alleged to follow suit soon. The controversy over flavored vape juices arose from concern that some products were marketed specifically to younger demographics, such as teens. Since the rise of simple, compact, and easy to use e-cig devices like the Juul over the last 2-3 years, the industry has come into public media spotlights and under scrutiny more than once for device mishandling, labeling, sales, and lack of scientific study.
The US Food and Drug Administration (FDA) Commissioner, Scott Gottlieb, recently addressed the American Society of Clinical Oncology (ASCO) and expressed pointedly: “They (The American vaping industry) better step up and step up soon – to address these trends along with us. So far, I must say, I’ve mostly been disappointed by the tepid response from companies that know that a meaningful portion of their sales are being derived from kids.” Many vape manufacturers have been largely silent on the issue, with no press statements or public pushes to change perception.
With the comments period coming to a close, however, one group apparently attempted to make a grand gesture. The FBI is investigating a report of some 250,000+ comments hitting the site around the 4th of July. A video from RegulatorWatch notes that the majority of the comments were anti-vaping and seemingly come from only 4 different IP addresses. Current authorities on the phenomenon classify the comments as spam, and much of the language used in the comments leads authorities to believe the group Campaign for Tobacco-Free Kids may be behind the comment spam submissions. No word has been given on whether the FDA will accept or reject the submissions as legitimate.
