FDA Sends JUUL Labs, Inc. Warning Letter Regarding Its Marketing Of Electronic Cigarettes

Juul Labs, Inc. (“JUUL”) is an electronic cigarette company that makes the Juul e-cigarette that packages nicotine salts from leaf tobacco into one-time use cartridges. JUULpods contain cigarette-like strength nicotine levels via proprietary nicotine salts formula. Smart temperature-regulation technology is used to heat the material to an optimal level of vaporization. Source

On September 9, 2019, the FDA sent a warning letter to JUUL, stating, in part: “Certain tobacco products, including ENDS products (e.g., e-cigarettes and e-liquids), are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b))… FDA has determined that JUUL adulterated its products under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)) by selling or distributing them as modified risk tobacco products without an FDA order in effect that permits such sale or distribution … Referring to your ENDS [electronic nicotine delivery system] products as “99% safer” than cigarettes, “much safer” than cigarettes, “totally safe,” and “a safer alternative than smoking cigarettes” is particularly concerning because these statements were made directly to children in school. Our concern is amplified by the epidemic rate of increase in youth use of ENDS products, including JUUL’s products, and evidence that ENDS products contribute to youth use of, and addiction to, nicotine, to which youth are especially vulnerable.”

“JUUL has marketed its ENDS products as modified risk tobacco products because JUUL’s labeling, advertising, and/or other actions directed to consumers (examples of which are referenced above), represent, or would be reasonably expected to result in consumers believing, that the products present a lower risk of tobacco-related disease or are less harmful than one or more other commercially marketed tobacco products; contain a reduced level of a substance or present a reduced exposure to a substance; and/or do not contain or are free of a substance or substances. JUUL adulterated its products under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)) by selling or distributing them as modified risk tobacco products without an appropriate FDA order in effect under section 911(g) of the FD&C Act (21 U.S.C. § 387k(g)) that permits such sale or distribution.”

“It is your responsibility to ensure that your tobacco products, all related labeling and advertising, and all other activities by JUUL directed to consumers, such as in any media in which you advertise and any retail establishments, comply with each applicable provision of the FD&C Act and FDA’s implementing regulations. Failure to ensure compliance with the FD&C Act may result in FDA initiating further action, including, but not limited to, civil money penalties, seizure, and/or injunction. Please note that any adulterated and misbranded tobacco products offered for import into the United States are subject to detention and refusal of admission.”

Source

If you or a loved one may have been injured by a JUUL product, you may be entitled to compensation for your injuries. MedicalMalpracticeLawyers.com is investigating possible claims against JUUL for injuries sustained as a result of use of its products. Please click on the “CONTACT US NOW” tab to the right, or telephone us toll free in the United States at 800-295-3959, to discuss your possible claim against JUUL.

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This entry was posted on Monday, September 9th, 2019 at 2:40 pm. Both comments and pings are currently closed.

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