FDA Issues Two Warning Letters to E-cigarette Businesses for Unauthorized Sales

2Firsts Events
Jun.30.2022

The Food and Drug Administration (FDA) posted warning letters on June 28 to two e-cigarette businesses, VAPORIZIT LLC and Elk River Vapor Shop, for selling e-cigarette products not previously on the market.

 

According to the Federal Food, Drug, and Cosmetic Act, new tobacco products, including vapes, need a pre-market authorization order to be sold in the United States.

 

However, the FDA found Elk River’s Crack the Whip 6mg 60 ml and Peach Wht. Grape 3mg 60ml were new products not previously commercially marketed in the United States. Therefore, the products need FDA marketing authorization orders to allow the stores to sell them legally.

 

The company has over 1,100 products listed with FDA and has opened four stores across Alabama and Tennessee.

 

VAPORIZIT, with over 12,800 of its products listed with the FDA, was warned for selling Vaporizit Cosmic Cow e-liquid products without FDA approval, as the vape has not been marketed commercially before.

 

However, Victory Liquid, a business founded before VAPORIZIT in 2013, sells the same product on its website, though it is not known which company sold it first.

 

VAPORIZIT and Elk River Vapor Shop have 15 working days from June 28 to “address any violations” and bring their “products into compliance,” announce the date they will discontinue sales, or provide reasoning if they believe their sales were not a violation of the food and drug policies.

PMI Global R&D Chief Meets Chinese Tobacco Regulator as China Advances Heated Cigarette Standards
PMI Global R&D Chief Meets Chinese Tobacco Regulator as China Advances Heated Cigarette Standards
Philip Morris International’s global R&D chief Michele Cattoni met Liu Sanjiang, deputy director of China’s State Tobacco Monopoly Administration, in Beijing on Aug. 27. The meeting comes as China advances mandatory standards for heated cigarettes and nicotine pouches, laying groundwork for their domestic introduction. Cattoni has held senior roles in PMI’s heated tobacco development, while China’s draft standard covers multiple heating architectures, including systems similar in principle to PMI’s IQOS ILUMA technology.
Aug.27
Malaysia Withdraws Appeal Against Liquid Nicotine Ruling as Vape Regulation Framework Enters New Phase
Malaysia Withdraws Appeal Against Liquid Nicotine Ruling as Vape Regulation Framework Enters New Phase
Malaysia’s government has withdrawn its appeal against a High Court ruling concerning the regulatory status of liquid nicotine used in vape and e-cigarette products, according to reports by New Straits Times, Free Malaysia Today and CodeBlue on August 18, 2026. The Kuala Lumpur High Court ruled on May 15 that the government’s decision to remove liquid nicotine from the scheduled poisons list under the Poisons Act 1952 was irrational and made without proper consultation with the Poisons Board. The withdrawal ends the government’s appeal process, while the future regulatory framework for nicotine vape products remains under discussion.
Aug.21
FDA Grants PMTA Authorization to 11 ZYN ULTRA Nicotine Pouches, Bringing Total Authorized Pouches to 43
FDA Grants PMTA Authorization to 11 ZYN ULTRA Nicotine Pouches, Bringing Total Authorized Pouches to 43
The U.S. Food and Drug Administration authorized 11 ZYN ULTRA nicotine pouch products made by Swedish Match USA through the premarket tobacco product application pathway on August 21, 2026. Ten of the authorized products have a labeled nicotine content of 9 mg, while ZYN ULTRA Smooth was authorized at 11 mg. The reviews were conducted through FDA’s nicotine pouch PMTA pilot program. FDA has now authorized 43 nicotine pouch products, including 23 through the pilot.
Aug.24
Former Roche Neuroscience and Rare Diseases Communications Director Ria Kioupritzi Joins PMI as Scientific Affairs Director
Former Roche Neuroscience and Rare Diseases Communications Director Ria Kioupritzi Joins PMI as Scientific Affairs Director
Eleftheria (Ria) Kioupritzi, a biopharmaceutical professional with more than 15 years of experience, has joined Philip Morris International as Director Scientific Affairs within Corporate Affairs. She previously served at Roche as Senior Scientific Communications Director for Neuroscience and Rare Diseases and worked extensively in spinal muscular atrophy. Her earlier career also covered competitive intelligence, clinical and regulatory monitoring, pipeline development and launch preparation. During her time working in Roche's SMA field, Evrysdi passed through several U.S. FDA milestones, including its initial approval, an expanded indication for younger infants and approval of a tablet formulation. Public records do not show that Kioupritzi herself led the FDA submissions.
Sep.22
Exclusive Analysis | Smoore H1 Revenue Rises 19.9% Amid Growth Concentration, Profit Pressure and Slowing Momentum
Exclusive Analysis | Smoore H1 Revenue Rises 19.9% Amid Growth Concentration, Profit Pressure and Slowing Momentum
Smoore’s first-half 2026 revenue rose 19.9%, but the results revealed growing structural risks beneath the headline growth. Heat-not-burn contributed about 61% of incremental revenue and remains driven largely by one core customer, while traditional vaping markets diverged, own-brand growth slowed and China enterprise revenue declined further. Gross profit and adjusted profit lagged revenue growth, while second-quarter revenue growth slowed to about 1.9%, putting greater focus on the quality, concentration and sustainability of Smoore’s expansion.
Capital Markets
Aug.20
California Lawmakers Pass Disposable Nicotine Vape Ban, With Sales Prohibition Set for 2028
California Lawmakers Pass Disposable Nicotine Vape Ban, With Sales Prohibition Set for 2028
According to CBS Los Angeles on August 27, 2026, California lawmakers have passed Assembly Bill 762, which would phase out disposable, battery-embedded nicotine vapes in the state. If signed by Governor Gavin Newsom, manufacturing and importation of the covered products would be prohibited beginning January 1, 2027, followed by a sales ban on January 1, 2028. Driven primarily by concerns over electronic waste, lithium-battery fires and environmental pollution, the legislation would further shift California’s legal vape market toward rechargeable, refillable or replaceable-pod devices.
Aug.28