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Colorado e-cigarette company settles with FDA, DOJ on unapproved products

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Joe Mueller

(The Center Square) – A federal court ordered a Colorado company to stop manufacturing, distributing or selling unauthorized vaping products.

Earlier this month, a complaint against Boosted LLC, which markets itself as Boosted E-Juice, and its owner, Cory Vigil, was filed in the U.S. District Court for the District of Colorado. The complaint stated the company violated the Federal Food, Drug and Cosmetic Act by introducing or delivering for interstate commerce adulterated products and others misbranded as tobacco, according to the U.S. Department of Justice.

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The complaint alleges the defendants manufactured and sold electronic finished nicotine delivery systems products and e-liquids. The Food and Drug Administration warned the company its products, including flavored e-liquids were adulterated and misbranded because they didn’t have the required marketing authorization from the FDA, according to the complaint. The e-liquids were called “Dragon Fruit Coconut Milkshake,” “Horchata Milkshake” and “Raspberry Milkshake.”

Despite repeated written warnings by the FDA, the complaint states the defendants continued to illegally sell their flavored e-liquids online.

The company and its owner agreed to settle the lawsuit by a consent decree of permanent injunction. The order stops all direct or indirect manufacturing, distributing, selling and/or offering for sale any new tobacco product that hasn’t received marketing approval from the FDA. The company also was ordered to destroy the products in their custody, control or possession.

“The illegal distribution of unauthorized vaping products poses a serious public health threat, particularly to youth,” Brian Boynton, an assistant Attorney General and head of the Justice Department’s Civil Division, said in a statement. “The Justice Department will use all available criminal and civil authorities to bring new enforcement actions in coordination with our task force partners.”

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Phil Weiser

Earlier this month, Colorado Democrat Attorney General Phil Weiser announced the state would spend up to $20 million from its $31.7 million settlement with JUUL Lab, Inc., a national e-cigarette company, to promote youth mental health services. The funds are part of a $462 million multistate settlement with JUUL.

The action against Boosted is the first enforcement action finalized since the FDA and the Justice Department crated a federal multi-agency task force to investigate and prosecute the illegal distribution and sale of e-cigarettes. There are only 23 specific tobacco-flavored e-cigarette products and devices currently authorized by the FDA for sale.

“Those who disregard the law are responsible for the consequences, and today’s action is further demonstration of FDA working with our federal partners to hold those who break the law accountable,” Brian King, director of the FDA’s Center for Tobacco Products, said in a statement. “This latest action brought by the FDA and DOJ shows how we’re taking an ‘all government’ approach toward addressing illegal e-cigarettes in this country.”