Tag: Blu

FDA Denies Blu Marketing of 5 Flavored Products
Credit: Fontem US
The U.S. Food and Drug Administration continued its de-facto flavor ban and issued marketing denial orders (MDOs) to Fontem US LLC for four Blu disposables and one Myblu brand e-cigarette product.
The currently marketed products that received an MDO are:

Blu Disposable Menthol 2.4%
Blu Disposable Vanilla 2.4%
Blu Disposable Polar Mint 2.4%
Blu Disposable Cherry 2.4%
Myblu Menthol 1.2%
After reviewing the company’s premarket tobacco product applications (PMTAs), the regulatory agency determined that the applications lacked sufficient evidence to demonstrate that permitting marketing of the products would be appropriate for the protection of the public health, which is the standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act, according to a press note.
“The application lacked sufficient evidence regarding harmful and potentially harmful ingredients in the aerosol for one product and battery safety for several products,” the release states. “Additionally, the applicant did not present sufficient data demonstrating that the new products have a potential to benefit adult smokers, in terms of complete switching or significant cigarette use reduction, that would outweigh the risk to youth.”
While the FDA has approved 23 vaping products, none have been a flavored product. Last month, the agency also issued Fontem US, LLC MDOs for its Blu PLUS+ brand e-cigarette products. Fontem is expected to appeal the FDA decision.
February 5, 2024
FDA Denies Marketing of Suorin, Blu Plus+ Products
The U.S. Food and Drug Administration has issued marketing denial orders (MDOs) to Shenzhen Youme Information Technology Co. Ltd. for two Suorin brand e-cigarette products. It also issued Fontem US, LLC MDOs for its Blu PLUS+ brand e-cigarette products.
“Thorough scientific review of tobacco products applications is a key pillar of FDA’s comprehensive regulatory approach,” said Brian King, director of FDA’s Center for Tobacco Products (CTP). “It is the applicant’s responsibility to ensure that sufficient scientific evidence is included in an application to meet the necessary public health standard required by law. In these cases, such evidence was lacking.”
The companies must not market or distribute these products in the United States or they risk FDA enforcement action. The companies may submit new applications for the products that are subject to these MDOs, according to an agency press release.
The FDA denied Suorin Air refillable vaporizers in various colors and an empty refillable cartridge. The FDA stated that Suorin Air’s empty cartridges would allow consumers to fill the cartridge with an e-liquid purchased separately.
“The applications submitted by Shenzhen Youme Information Technology Co. Ltd. lacked sufficient evidence regarding abuse liability, which is the ability of a tobacco product to promote continued use and the development of addiction and dependence,” the release states.
SMOK recently had 22 products denied, including devices, pods, atomizers, and cartridges. It was the first time the agency has denied strictly hardware products from one company en mass. The products were denied because they were submitted without a specific e-liquid to be used with the devices, according to the FDA.
The denied Blu PLUS+ products include a battery and several prefilled e-liquid pods:

blu PLUS+ Battery
blu PLUS+ Carolina Bold 2.0%
blu PLUS+ Classic Tobacco 1.2%
blu PLUS+ Classic Tobacco 2.4%
blu PLUS+ Gold Leaf 1.2%
blu PLUS+ Gold Leaf 2.4%
blu PLUS+ Menthol 1.2%
blu PLUS+ Menthol 2.4%
“Among other deficiencies in their applications, Fontem US, LLC failed to include sufficient ingredient information, harmful and potentially harmful constituent (HPHC) yield quantities, and abuse liability information.,” the FDA stated. “In addition, the applicant did not provide sufficient evidence demonstrating that the flavored new products have a potential to benefit adult smokers, in terms of complete switching or significant cigarette use reduction, that would outweigh the risk to youth.
The FDA also issued MDOs for additional blu PLUS+ products not listed above. The regulatory only publicly names products that the FDA or the manufacturer has confirmed to be currently marketed to avoid the release of confidential commercial information.
January 19, 2024
U.S. Vapor Sales Still Slow After Enhanced Regulation
Thee market-share gap between the top-selling U.S. electronic cigarettes remained unchanged with both having a slight decline in the latest Nielsen analysis of convenience store data. The report covers the four-week period ending Dec. 18, according to the Winston-Salem Journal.
Nielsen determined No. 1 Juul was at 37.6 percent, down from 38.2 percent in the previous report.
Meanwhile, the Vuse brand of R.J. Reynolds Vapor Co. had a 33.5 percent market share, down from 34 percent in the previous report. NJoy was at 3 percent, unchanged from the previous report, while Fontem Ventures’ blu eCigs was at 2.3 percent, down from 2.4 percent.
Overall, sales of electronic cigarettes were up 4.8 percent year over year for the latest four-week period, boosted by recent price hikes. Still, e-cigarette sales overall have slumped since February 2020, when the Food and Drug Administration implemented its latest round of heightened regulations on the products.
Those restrictions foremost required manufacturers of cartridge-based e-cigarettes, such as Juul Labs Inc., Reynolds Vapor, NJoy and Fontem, to stop making, distributing and selling “unauthorized flavorings” in February 2021, or risk enforcement actions.
Goldman Sachs analyst Bonnie Herzog said another factor in the slump is “the impact of e-cigarette market denial orders by the FDA as it continues to work through premarket tobacco applications.”
December 30, 2021
Vuse Quickly Narrowing Market Share Gap With Juul
Vuse is now only 4.2 percent of the market behind Juul. According to a Nielsen analysis of convenience store data, covering the four-week period ending Dec. 4, Juul was at 38.2 percent, down from 38.8 percent in the previous report. Vuse, however, held steady with 34 percent of the market.
Credit: Overland Park Vape Shop
NJoy was at 3 percent, unchanged from the previous report, while Fontem Ventures’ blu eCigs was at 2.4 percent, also unchanged, according to a Winston-Salem Journal report. Overall, sales of electronic cigarettes were up 6.7 percent year over year for the latest four-week period, boosted by recent price hikes.
Juul’s four-week dollar sales have dropped from a 50.2 percent increase in the Aug. 10, 2019, report to a 9.7 percent decline in the latest report. By comparison, Reynolds’ Vuse was up 50.1 percent in the latest report, while No. 3 NJoy was down 23.2 percent and No. 4 blu eCigs down 13.8 percent.
Goldman Sachs analyst Bonnie Herzog has said that NJoy “refutes Nielsen’s data and methodology.”
On Oct. 12, the FDA issued a landmark ruling in approving a Vuse Solo product as appropriate to market to smokers from a public-health standpoint. The FDA’s order covers the tobacco flavor of the Vuse Solo closed electronic nicotine delivery system, its power unit and two replacement cartridges.
However, the FDA rejected submissions for 10 flavored Vuse Solo products. It said it “is still evaluating” the company’s application for menthol-flavored products for Vuse Solo.
Reynolds has said the FDA’s orders “confirm that Vuse Solo products are appropriate for the protection of the public health, underscoring years of scientific study and research dedicated to ensuring that adult nicotine consumers age 21+ have access to innovative and potentially less harmful alternatives to traditional tobacco products.”
December 16, 2021
Blu Plus+ debuts in Las Vegas
Blu Ecigs’ is officially launching its new Blu Plus+ rechargeable kit during the NACS Trade Show, Oct. 7-10, 2014, at the Las Vegas Convention Center in Las Vegas, Nevada, USA.
The Blu line is equipped with a new, pre-filled tank system and a larger battery, which last twice as long as before. There are no buttons to push, dials to twist, or any other complicated procedures to get the tank ready.
“Here at Blu, we are constantly chasing the cigarette experience and satisfaction adult smokers want from an e-cigarette, and the Plus+ is certainly a step in the right direction,” says Jason Healy, president of Blu Ecigs.
“The benefits that we have just unleashed speak to what adult smokers have been searching for in both cigalikes and vapor-tank mods, combining technology with the simple enjoyment that Blu Ecigs electronic cigarettes have been known for.”
The new Blu Plus+ will be available in retail stores across the U.S. by mid-November.
October 7, 2014