A federal court on June 11 enjoined a Colorado company and its owner from manufacturing, distributing, or selling unauthorized vaping products.
In a complaint filed on June 6 in the U.S. District Court for the District of Colorado, the government alleged that Boosted LLC, also known as Boosted E-Juice, and its owner, Cory Vigil, violated the Federal Food, Drug and Cosmetic Act by introducing or delivering for introduction into interstate commerce adulterated and misbranded tobacco products. According to the complaint, the defendants manufactured and sold electronic finished nicotine delivery systems (ENDS) products, including finished e-liquids.
The complaint alleged that the Food and Drug Administration (FDA) warned the defendants that their products, including flavored e-liquids sold as “Dragon Fruit Coconut Milkshake,” “Horchata Milkshake” and “Raspberry Milkshake,” were adulterated and misbranded because they lacked the required marketing authorization order from FDA. The government also alleged that despite repeated FDA written warnings, the defendants continued to illegally sell their flavored e-liquid products online.
The defendants agreed to settle the lawsuit and be bound by a consent decree of permanent injunction. The order entered by the court permanently enjoins the defendants from directly or indirectly manufacturing, distributing, selling, and/or offering for sale any new tobacco product that has not received marketing authorization from FDA. The court also ordered the defendants to destroy ENDS products in their custody, control, or possession.
The injunction against Boosted is the first enforcement action finalized since the Justice Department and FDA announced the creation of a federal multi-agency task force to combat illegal distribution and sale of e-cigarettes. To date, the FDA has authorized the sale of 23 specific tobacco-flavored e-cigarette products and devices. These are currently the only e-cigarette products that may be lawfully marketed and sold in the United States.
“The illegal distribution of unauthorized vaping products poses a serious public health threat, particularly to youth,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The Justice Department will use all available criminal and civil authorities to bring new enforcement actions in coordination with our task force partners.”
“Those who disregard law are responsible for consequences," said Director Brian King of FDA’s Center for Tobacco Products (CTP). "This latest action brought by FDA and DOJ shows how we’re taking an ‘all government’ approach toward addressing illegal e-cigarettes in this country.”
Trial Attorney Michael J. Murali of Civil Division’s Consumer Protection Branch handled case with assistance from Assistant Chief Counsel Sarah Rosenberg of FDA’s Office of Chief Counsel.
Additional information about Consumer Protection Branch can be found at www.justice.gov/civil/consumer-protection-branch.
Claims made in a complaint are allegations that if case were to proceed to trial government would be required to prove by preponderance of evidence.