FDA WARNING_LETTER - VitaCig, Inc. - December 07, 2021

The FDA issued a Warning Letter to VitaCig Group on December 1, 2021, following a September 2021 review of their website, vitaciggroup.com. The FDA determined that VitaCig's "VitaCig products," including "Classic edition" and "S-edition" inhalers, and "Excalibur" rechargeable inhaler capsules, are unapproved new drugs.

The products are deemed drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), due to claims on their website indicating intent for disease treatment/prevention or affecting body structure/function. Examples of such claims include benefits for heart health, immunity, weight loss, cancer prevention, improved digestion, erectile dysfunction, cognitive enhancement, and treatment for anxiety/depression.

These products are considered "new drugs" under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), as they are not generally recognized as safe and effective for their claimed uses. Introducing or delivering these unapproved new drugs into interstate commerce violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). The