FDA News

FDA seizes Juul-related documents

The FDA took control of more than 1,000 pages of documents in a surprise inspection of e-cigarette maker Juul Labs last week, an FDA spokesperson told Healio Family Medicine, who also said the paperwork was connected to Juul’s marketing and sales practices.

The FDA’s seizing of the documents is the second step the FDA has taken to curb use of the pod electronic cigarette devices that resemble USB flash drives in less than a month.

On Sept. 12, it announced it conducted a “nationwide, undercover blitz of brick-and-mortar and online stores” — the largest coordinated enforcement effort in its history — that led to the FDA issuing more than 1,300 warning letters and fines to retailers who illegally sold Juul and other e-cigarette products to minors. Both events fall under the Youth Tobacco Prevention Plan that Commissioner Scott Gottlieb, MD, first announced this past spring.

News of the raid came on the same day as data published in JAMA indicated Juul Laboratories sales increased 641% from $2.2 million in 2016 to $16.2 million in 2017. At the same time, Juul Laboratories’ average annual market share of total e-cigarette sales increased 515%, from 2% to 13%, and by Dec. 2017, Juul Laboratories’ sales made up 29% of total e-cigarette sales, which gave it the greatest market share. The age of the buyers could not be determined, and not all retailers were included in the JAMA report, researchers wrote.

Prior to the data in JAMA, clinicians and researchers have expressed concern regarding the health of those who use Juul, with one team of researchers concluding those aged 12 to 21 years who used it and other recently developed pod devices had levels of nicotine in their urine that were higher than those who used combustible, traditional cigarettes. – by Janel Miller

Reference: King BA, et al. JAMA. 2018; Vol. 320, No. 13, Pages 1379-1380.

Disclosure: Healio Family Medicine was unable to determine relevant disclosures prior to publication.

 

The FDA took control of more than 1,000 pages of documents in a surprise inspection of e-cigarette maker Juul Labs last week, an FDA spokesperson told Healio Family Medicine, who also said the paperwork was connected to Juul’s marketing and sales practices.

The FDA’s seizing of the documents is the second step the FDA has taken to curb use of the pod electronic cigarette devices that resemble USB flash drives in less than a month.

On Sept. 12, it announced it conducted a “nationwide, undercover blitz of brick-and-mortar and online stores” — the largest coordinated enforcement effort in its history — that led to the FDA issuing more than 1,300 warning letters and fines to retailers who illegally sold Juul and other e-cigarette products to minors. Both events fall under the Youth Tobacco Prevention Plan that Commissioner Scott Gottlieb, MD, first announced this past spring.

News of the raid came on the same day as data published in JAMA indicated Juul Laboratories sales increased 641% from $2.2 million in 2016 to $16.2 million in 2017. At the same time, Juul Laboratories’ average annual market share of total e-cigarette sales increased 515%, from 2% to 13%, and by Dec. 2017, Juul Laboratories’ sales made up 29% of total e-cigarette sales, which gave it the greatest market share. The age of the buyers could not be determined, and not all retailers were included in the JAMA report, researchers wrote.

Prior to the data in JAMA, clinicians and researchers have expressed concern regarding the health of those who use Juul, with one team of researchers concluding those aged 12 to 21 years who used it and other recently developed pod devices had levels of nicotine in their urine that were higher than those who used combustible, traditional cigarettes. – by Janel Miller

Reference: King BA, et al. JAMA. 2018; Vol. 320, No. 13, Pages 1379-1380.

Disclosure: Healio Family Medicine was unable to determine relevant disclosures prior to publication.