FDA WARNING_LETTER - Vitamin Vape, Inc. - December 07, 2021

The FDA issued a Warning Letter to Vitamin Vape, LLC and Vitamin Vape, Inc. on December 1, 2021, following a September 2021 review of their websites (https://www.vitaminvape.co, https://www.vitaminvape.com) and social media (https://www.facebook.com/VitaminVape). The FDA determined that the "B12 VITAMINVAPE" product is an unapproved new drug, sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The product is deemed a drug under section 201(g)(1) of the FD&C Act due to claims on their websites indicating intent for use in the cure, mitigation, treatment, or prevention of disease, and/or to affect the body's structure or function. Examples of such claims include "Nerve Function B12 plays a key role in healthy nerve function," "Cell Health B12 plays a key role in cell health and DNA creation," and statements about B12 inhalation being "100s of times more effectively absorbed than pills" and "safe and very effective."

The FDA also noted safety concerns regarding oral inhalation products, citing potential for laryngospasm, bronchospasm, toxicity to airways, or undesirable systemic effects. The product's marketing with a