FDA May Introduce New Vaping Policy in the Coming Weeks

According to the Qiaobao USA website, acting Food and Drug Administration (FDA) Commissioner Sharpless said on the 25th that the agency expects to finalize its policy on flavored e-cigarettes and vaping devices within the next few weeks.

Under the FDA's policy, all flavored e-cigarette products currently on the market—except original tobacco flavor—would need to be removed from shelves. Any delisted products would have to obtain “premarket authorization” before they could return to the market.
 
In remarks before a House legislative committee, Sharpless said: “The FDA intends to enforce existing laws restricting the sale of these products. This policy does not mean flavored e-cigarettes can never be marketed again. If a company can submit an application to the FDA demonstrating that a specific product meets the standards established by Congress, then the FDA will approve that product for eventual sale.”

Earlier in September, U.S. President Trump announced that the FDA would put forward “some very strong recommendations” regarding flavored e-cigarette use. In the same statement, Health and Human Services Secretary Azar said the new policy would require flavored e-cigarette companies to pull their products from the market.

At the time, Azar said: “We will need a few weeks to issue final guidance and announce all the details regarding policy enforcement. After that, as is customary, implementation will be delayed by around 30 days. At that point, all e-cigarettes except original flavor will leave the market.”

He also said that by May 20, 2020, e-cigarette companies producing tobacco-flavored products would have the opportunity to obtain FDA approval. By then, manufacturers of flavored e-cigarette products would also have a chance to file applications, but their products could not be marketed until approval is granted.

At a September 25 hearing, CDC Principal Deputy Director Schuchat said new vaping-related cases are being diagnosed every day, and the agency expected the number of vaping-related illnesses identified that week to “increase by several hundred cases” compared with the previous week. As of September 17, there had been 530 confirmed and probable cases of vaping-related lung injury.

In addition, there were 9 known deaths linked to e-cigarette use, including 2 in California, 2 in Kansas, and 1 each in Illinois, Indiana, Minnesota, Missouri, and Oregon.

On the 25th, Rhode Island Governor Gina Raimondo signed an executive order directing the state's health department to develop “emergency regulations” banning the sale of flavored e-cigarette products. On the 24th, Massachusetts Governor Charlie Baker called for a temporary 4-month ban on the sale of all e-cigarette products in the state. On the same day, the Los Angeles County Board of Supervisors voted unanimously to ban the sale of flavored e-cigarettes.

In addition, earlier in September, Michigan banned the sale of flavored e-cigarettes, and New York banned the sale of most flavored e-cigarettes. In June, San Francisco became the first U.S. city to ban the sale of all e-cigarettes.

However, thoracic oncology specialist Peter Shields said there has now been a shift away from the idea of removing e-cigarettes from the market entirely, moving instead from prohibition toward some form of regulatory policy.

He said: “Banning flavored e-cigarettes is a sensible move, but it also makes quitting smoking more difficult. So the market still needs original-flavor or menthol tobacco e-cigarettes to provide smokers trying to quit with some alternatives.”