FDA Says Juul Violated Regulations, Sold Vaping As Safer Than Smoking

FDA Says Juul Violated Regulations, Sold Vaping As Safer Than Smoking”

Last week, Rep. Raja Krishnamoorthi, chairman of the House Oversight Subcommittee on Economic and Consumer Policy, asked the FDA in a letter to take "appropriate enforcement action" against Juul. "JUUL has ignored the law, and very concerningly, has made some of these statements in school to our nation's youth", said Acting FDA Commissioner Dr. Ned Sharpless, in a statement. "Have a reduced level of or exposure to a substance, and/or that JUUL products present a lower risk of tobacco-related disease or are less harmful than one or more other commercially marketed tobacco products".

The letter was sent two days after the FDA reviewed testimony from a congressional hearing on Juul, which took place in July.

JUUL "was much safer than cigarettes" and that "FDA would approve it any day".

Currently, there are no authorized e-cigarette products on the market. And he said that that would happen very soon and that it was in FDA approval while the talk was going on.

The company, which has 15 days to submit plans to correct any violations or face fines or seizure of product among possible penalties, has said it is reviewing the letter as well as an additional letter it received from the FDA over continuing concerns around marketing to youth despite steps Juul has taken in this area.

The agency also pointed out troubling aspects of testimony about a "Switching Program" presentation to the Cheyenne River Sioux Tribe Health Committee, in which Juul representatives made similarly unsubstantiated claims.

"'[JUUL is] a smart, really well thought-out alternative to smoking.' Make the switch". I don't know how we lived without that.

"Juul has maintained that its products are meant to convert adult smokers to what it described in the past as a less-harmful alternative". The letter goes on to explain that if a company wants to claim that vaping is a safer alternative to cigarettes, it needs to get the product approved under a specific section of the law. The FDA said it found that Juul illegally sold or distributed its products as "modified risk tobacco products without an FDA order in effect that permits such sale or distribution".

The company uses a nicotine concentration of 5% in its products, which could potentially increase their addictiveness, and nicotine salts that are used to mask the harshness of nicotine, the agency said questioning their usage.

The other was sent to JUUL CEO Kevin Burns "to request documents and information. regarding JUUL's marketing, advertising, promotional, and education campaigns, as well as certain product development activity". Additionally, the agency has conducted inspections of several of JUUL's contract manufacturing facilities to determine compliance with all applicable FDA laws and regulatory requirements. Sweet-flavored electronic cigarettes promote youth vaping.

The FDA has been under fire recently by parents and health NGOs over its negligence to investigate the recent respiratory illnesses and deaths associated with vaping especially among the youth.

On Tuesday, Kansas health officials confirmed that state's first death tied to a vaping-related lung illness, following similar deaths in Minnesota, Indiana, Oregon, Illinois and Los Angeles.

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