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

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.

Haypp Voluntarily Sets a 20 mg Nicotine-Strength Cap for Nicotine Pouches and Urges the UK to Establish a Regulatory Limit
Haypp Voluntarily Sets a 20 mg Nicotine-Strength Cap for Nicotine Pouches and Urges the UK to Establish a Regulatory Limit
Online nicotine pouch retailer Haypp said it has voluntarily adopted a 20 mg per pouch nicotine-strength cap across its e-commerce platforms and is urging the UK government to formalize that cap as the limit as it develops a regulatory framework. Haypp said proportionate limits would protect consumers while preserving nicotine pouches as a viable reduced-risk alternative to cigarettes.
Feb.26 by 2FIRSTS.ai
Costa Rica’s Constitutional Court Rejects Challenge, New Vape Rules to Take Effect on August 6
Costa Rica’s Constitutional Court Rejects Challenge, New Vape Rules to Take Effect on August 6
Costa Rica’s Constitutional Court has rejected an injunction seeking to stop a new vape regulation from taking effect, ruling that there was no specific harm to constitutional rights. As a result, Technical Regulation RTCR 519-2025, promoted by the Health Ministry, will enter into force on August 6 as originally planned.
Mar.20 by 2FIRSTS.ai
Smoore, Distributors Move to Toss Cannabis Vape Price-Fixing Suit
Smoore, Distributors Move to Toss Cannabis Vape Price-Fixing Suit
Several vape manufacturers and distributors, including Shenzhen Smoore Technology Co. Ltd., Smoore International Holdings, 3Win Corp., Jupiter Research LLC, Canna Brand Solutions, and Greenlane Holdings Inc., have filed motions seeking dismissal of consumer claims in consolidated antitrust litigation in the U.S. District Court for the Northern District of California.
Events
Feb.24
PMI Sells Stake in Swedish Match Brazil Business, Including Fiat Lux Brand
PMI Sells Stake in Swedish Match Brazil Business, Including Fiat Lux Brand
Philip Morris International said it is selling its stake in Swedish Match do Brasil, which controls the Brazilian household goods brand Fiat Lux. The buyer is Ignis FIP, a Brazilian private investment vehicle backed by businessman Marcos Fernando Garms. The transaction also includes Swedish Match da Amazônia, but the value of the deal was not disclosed. PMI said the sale is aligned with its vision of a smoke-free future.
Mar.20 by 2FIRSTS.ai
Can hookah go institutional? A hookah company seeking to go public makes its case with capital, technology and regulation
Can hookah go institutional? A hookah company seeking to go public makes its case with capital, technology and regulation
2Firsts explored whether hookah can evolve into a more mature and governable category by interviewing Dubai-based hookah company AIR. AIR argues that strong margins, OOKA’s closed-system model and the prospect of differentiated regulation could support that shift. The larger question is whether this is simply AIR’s capital-markets narrative, or an early sign that competition, regulation and category boundaries in hookah are beginning to change.
Apr.02
U.S. Adult Smoking Rate Falls to Historic Single-Digit Low of 9.9%, Study Shows Shift in Nicotine Use Patterns
U.S. Adult Smoking Rate Falls to Historic Single-Digit Low of 9.9%, Study Shows Shift in Nicotine Use Patterns
A new study analyzing National Health Interview Survey data found that adult cigarette smoking in the United States declined to 9.9% in 2024, down from 10.8% in 2023. The findings, published in NEJM Evidence, represent a historic milestone in U.S. tobacco control efforts. Researchers noted that while cigarette smoking is decreasing, the prevalence of e-cigarette and cigar use remained largely unchanged, suggesting a shift in nicotine consumption rather than the elimination of tobacco use.
Market
Mar.20