FDA Commissioner Says E-Cigarette Ban Policy Expected Within Weeks

On September 26, news from CNN reported that due to concerns about the risks of e-cigarettes, the federal government may soon crack down on e-cigarettes. Acting FDA Commissioner Dr. Ned Sharpless stated on Wednesday that the FDA is expected to finalize policies regarding flavored e-cigarettes and electronic vaping products within the next few weeks.
 
Sharpless stated in prepared testimony for a House subcommittee: "This policy will prioritize the FDA's premarket authorization requirements for non-tobacco flavors."

He said that the FDA intends to enforce existing laws that restrict the sale of such products. This policy does not mean that flavored e-cigarettes will never be sold. If companies can demonstrate through applications submitted to the FDA that specific products meet the standards set by Congress, the FDA will authorize the sale of ENDS products.

E-cigarettes, sometimes referred to as ENDS, are short for electronic nicotine delivery systems. Using them is often referred to as vaping, and flavored varieties are considered the most appealing to young people.

Earlier this month, President Donald Trump announced that the FDA would propose some very strong recommendations regarding the use of flavored e-cigarettes. In the same announcement, U.S. Secretary of Health and Human Services Alex Azar stated that enforcement policies would require flavored e-cigarette companies to remove their products from the market.

Azar said: "We will take a few weeks to publish final guidance, announcing all parameters regarding enforcement policies, and then as is customary, there may be a 30-day delay before the effective date. However, by that time, all flavored e-cigarettes except for tobacco flavor must be removed from the market.

He stated that by May 20, 2020, e-cigarette companies producing tobacco-flavored products will have the opportunity to apply for FDA approval. At that time, flavored product manufacturers will also have the opportunity to apply, but their products will be removed from the market until approved.

The U.S. is currently facing an outbreak of lung diseases related to vaping, which the CDC and FDA are investigating.

Dr. Anne Schuchat, Deputy Director of the CDC, stated at a hearing on Wednesday that new cases are being diagnosed daily, and the agency expects the number of vaping-related illnesses reported this week to be hundreds of times higher than last week.

The CDC is expected to update the disease count on Thursday. As of September 17, there have been 530 confirmed and possible cases of lung injuries associated with e-cigarettes.

There are also 9 known deaths related to vaping, with 2 in California, 2 in Kansas, and 1 each in Illinois, Indiana, Minnesota, Missouri, and Oregon.

Dr. Lee Norman, Secretary of the Kansas Department of Health and Environment, testified at the hearing that these casualties are just the tip of the iceberg.

After the hearing, he told CNN in a phone interview that what we are seeing is actually an epidemic. We support the Trump administration's plan to crack down on counterfeit e-cigarette solutions, and we believe this is a good start.

On Wednesday, Rhode Island Governor Gina Raimondo signed an executive order directing the state's health department to develop emergency regulations to ban the sale of flavored e-cigarette products.

On Tuesday, Massachusetts Governor Charlie Baker called for a temporary four-month ban to prohibit all e-cigarettes and vaping products in the state. On the same day, the Los Angeles County Board of Supervisors unanimously voted to ban flavored e-cigarettes.

Earlier this month, Michigan banned the sale of flavored e-cigarettes, while New York State banned most flavored e-cigarettes. In June, San Francisco became the first city in the U.S. to effectively ban all e-cigarette sales.

Dr. Peter Shields, a thoracic oncologist at the Ohio State University Comprehensive Cancer Center, stated that opinions on whether flavored e-cigarette products should be removed from the market seem to have shifted among medical professionals working directly with smokers or former smokers.

Finding Balance

The CDC states that smoking is the leading cause of preventable disease, disability, and death in the U.S. Nearly 40 million adults still smoke in the U.S., and even if e-cigarettes are not approved by the FDA as a smoking cessation tool, some may still wish to use e-cigarette products as a way to quit smoking.

At the same time, the number of young people using e-cigarettes has increased.

"The question is: How do you calculate the balance between how many kids might become addicted to nicotine versus smokers who want to quit?" Shields said, adding that research on whether e-cigarettes effectively help smokers quit is still unclear. #p#分页标题#e#

He said: "With what is happening to kids, and holding onto this notion, we must protect smokers at all costs, and that includes not banning flavors. At least in my view, this has shifted."
Shields believes that "banning these flavors may be a prudent approach," he said. "This may make it more difficult to increase the number of people quitting smoking, but as long as we are still selling tobacco flavors or menthol tobacco, at least this will mimic their behavior, so we will at least attract smokers to try another option that they are accustomed to. This is my personal view."