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

FDA Issues Two Warning Letters to E-cigarette Businesses for Unauthorized Sales
In this file photo, E-cigarettes appear on display at Vape store in Chicago. (Nam Y. Huh/AP Photo)
Marina Zhang

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.

Nicotine Takedown

The news comes weeks after the FDA took action against another major e-cigarette company, Juul Labs. The popular e-cigarette brand was swiftly banned by the FDA on June 23, with all of its products found to be unauthorized for sale due to lacking “sufficient evidence” on the products’ toxicology.
The ban has since been temporarily paused after Juul appealed the FDA decision to the U.S. Court of Appeals, which granted the company “sufficient opportunity” to hear further arguments on the matter.
Juul was banned two days after the Biden administration announced a plan to set a lower benchmark for the amount of nicotine allowed in tobacco.

The Department of Health and Human Services (HHS) published a brief on June 21, outlining plans to set a lower ceiling for nicotine levels in cigarettes and other similar products.

Trials for drugs to treat tobacco and nicotine addictions were announced by Achieve Life Sciences, a late-stage clinical pharmaceutical company based in Seattle and Vancouver. The company announced phase two trials on June 29 to test the safety and dosage of their drug cytisinicline in the cessation of smoking and nicotine addictions.
Marina Zhang is a health writer for The Epoch Times, based in New York. She mainly covers stories on COVID-19 and the healthcare system and has a bachelors in biomedicine from The University of Melbourne. Contact her at [email protected].