JUUL products banned by FDA

Today, the U.S. Food and Drug Administration issued an order to JUUL Labs Inc. for all of their products currently marketed in the United States. As a result, the company must stop selling and distributing these products. In addition, those currently on the U.S. market must be removed, or risk enforcement action.  The products include the JUUL device and four types of JUULpods: Virginia tobacco flavored pods at nicotine concentrations of 5.0% and 3.0% and menthol flavored pods at nicotine concentrations of 5.0% and 3.0%. Retailers should contact JUUL with any questions about products in their inventory.

The ban only pertains to the commercial distribution, importation and retail sales of these products, and do not restrict individual consumer possession or use – the FDA cannot and will not enforce against individual consumer possession or use of JUUL products or any other tobacco products.

After reviewing the company’s premarket tobacco product applications (PMTAs), the FDA determined that the applications lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health. In particular, some of the company’s study findings raised concerns due to insufficient and conflicting data – including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods – that have not been adequately addressed and precluded the FDA from completing a full toxicological risk assessment of the products named in the company’s applications. 

In addition to ensuring that JUUL complies with this order, as with unauthorized products generally, the FDA intends to ensure compliance by distributors and retailers. Specifically, the FDA notes that all new tobacco products on the market without the statutorily required premarket authorization are marketed unlawfully and are subject to enforcement action.  

As the FDA has stated in the past, unauthorized electronic nicotine delivery system (ENDS) products for which no application is pending, including for example, those with an MDO, are among our highest enforcement priorities. Therefore, the FDA encourages retailers to discuss products in their inventory with their suppliers including the current status of any particular tobacco product’s marketing application or marketing authorization. Manufacturers will be the best source of that information and retailers should rely on manufacturers directly to inform decisions about which products to continue selling.

There are many resources to help smokers who want to quit. Quitting all tobacco products is the best possible path to good health. Some current JUUL users who will not have access to JUUL products following this action or current smokers who want to transition away from cigarettes and cigars may decide to switch to other ENDS products that have been reviewed and authorized by the FDA based on their potential to benefit adult smokers. If you would like to talk to someone who can help you quit, call 800-QUIT-NOW.

To date, the FDA has authorized 23 ENDS products. Under the PMTA pathway, applicants must demonstrate to the agency, among other things, that permitting the marketing of the new tobacco product would be appropriate for the protection of the public health. 

The FDA continues to work to complete its review of the remaining pending applications for deemed products submitted by the Sept. 9, 2020, deadline.

Answering questions about vaccinating your children

As early as next week, parents and caregivers may be able to get their youngest children vaccinated against COVID-19. The U.S. Food and Drug Administration’s advisory committee met today, June 15, and recommended approval of emergency use for Moderna and Pfizer’s pediatric COVID-19 vaccines. Moderna’s application is for vaccinating kids ages 6 months through 5 years, and Pfizer’s is for kids ages 6 months through 4 years.

“The vaccine is an important tool to protect them from the virus. It prevents kids from getting very sick and from spreading it others, both at home, in school and at day care,” said Dr. Kim Bonner, epidemic intelligence service officer for acute and communicable disease prevention with the Centers for Disease Control and Prevention. Read on for answers to common questions about vaccinating this age group.

Oregon Health Authority, Oregon Department of Education release ‘Fentanyl & Opioid Response Toolkit’ for schools

Oregon Health Authority and the Oregon Department of Education are releasing a Fentanyl & Opioid Response Toolkit for Schools to support educators, administrators, school nurses, students and families. The toolkit is in response to a public health crisis related to rising youth and adult opioid overdoses and deaths in Oregon. 

This toolkit provides information about how schools can create an emergency protocol to administer naloxone, also known as Narcan. The toolkit includes information on how to access, administer and store this life-saving opioid overdose prevention medication. In addition, the toolkit has resources to support staff training, prevention education and other resources essential to developing and implementing school emergency response procedures.

“The resources in this toolkit can save lives,” said Colt Gill, Director of the Oregon Department of Education. “We strongly encourage schools to adopt policies and practices for safe and effective management and prevention of opioid-related overdoses in schools. When drug-related emergencies occur in or around schools, proper response is critical to save lives.”

According to the Centers for Disease Control and Prevention (CDC), from May 2020 to April 2021, deaths due to accidental overdose surpassed 100,000 for the first time on record. Sixty-four percent of those deaths were attributed to illicitly manufactured fentanyl, which often comes in the form of pills that closely resemble prescription oxycodone or benzodiazepines such as Xanax.

In Oregon, fentanyl-related overdose deaths increased by 74% from 2019 to 2020, for a total of 298 fentanyl-related deaths in 2020.

“Rising opioid overdose deaths are a public health crisis, and schools are the heart of Oregon communities. Unfortunately, this trend is expected to continue, as Oregon has continued to see an increase in accidental overdose deaths due to fentanyl,” said OHA Director Patrick Allen.

Some additional facts about fentanyl can be found on the Fentanyl Awareness Day website, here. Among the facts given on that site, “according to the CDC, fentanyl is involved in more deaths of Americans under 50 than any other cause of death, including heart disease, cancer, and all other accidents. Among teenagers, overdose deaths linked to synthetic opioids like fentanyl tripled in the past two years, yet 73% have never heard of fake prescription pills being made with fentanyl.”

Image courtesy DEA.gov

Second COVID-19 boosters now available

Second COVID-19 boosters are now available for people over 50 and certain immunocompromised individuals after federal authorization this week.

According to newly-adopted protocols, individuals who meet the criteria and received an initial booster dose at least four months ago can now get a second booster dose of either of the mRNA vaccines – made by Pfizer-BioNTech and Moderna – to increase their protection against severe disease from COVID-19. Adults who received a primary vaccine and booster dose of Johnson and Johnson’s vaccine at least four months ago can now receive a second booster dose using an mRNA COVID-19 vaccine.

Centers for Disease Control and Food and Drug Administration experts say booster doses of the mRNA vaccines have been shown to increase immune response among individuals who completed primary doses of the shots as well as prevent severe disease among those infected with the virus. They also found no safety concerns linked with the second boosters.

Oregon Health Authority officials say there’s more than enough vaccine supply in Oregon to accommodate the groups eligible for second boosters, and new demand should help providers use up some of their excess vaccine stocks.

In Malheur County, 4,824 people, or 44.1% of those eligible, received their first booster dose, according to OHA data. Of those, 59.8%, or 3,523 are over 50, and eligible for their second booster four months after their first.

OHA strongly encourages everyone eligible in Oregon to get their primary doses of the COVID-19 vaccines followed by a booster shot. Those most at risk for the virus are people who have not yet received a primary series of the vaccines.

Vaccines are offered every Wednesday at the Malheur County Health Department, 1108 SW 4th St., in Ontario, Oregon, from 9 a.m. to 4:30 p.m. on a walk-in basis. Call 541-889-7279 for more information.