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

The FDA issued a Warning Letter to VitaStik on December 1, 2021, following a September 2021 review of their website (www.vitastik.com) and social media (Facebook, Instagram, YouTube). The FDA determined that VitaStik's oral inhalation products, including "VitaStik Breathe Essential Oil Stick" and "VitaStik Sleepy Time Sweet Honey Lavender Melatonin Diffuser," are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the FD&C Act.

The products are marketed for inhalation, not ingestion, thus not meeting the definition of a dietary supplement despite some packaging including a "Supplement Facts" panel. The FDA classifies them as drugs under section 201(g)(1) due to claims indicating intended use for disease diagnosis, cure, mitigation, treatment, or prevention, and/or to affect body structure/function. Examples of drug claims include treating asthma, COPD, anxiety, PTSD, epilepsy, insomnia, allergies, and aiding in quitting smoking.

The FDA also raised safety concerns regarding potential laryngospasm, bronchospasm, tissue toxicity, or systemic effects from inhaled ingredients. Since the products are not generally recognized as safe and effective for their claimed uses, they are considered "new drugs" requiring prior FDA approval, which they lack. VitaStik must respond within fifteen working days with corrective actions and a plan