FDA Issues Warning Letters to Four ‘Wellness’ Vape Firms

The U.S. Food and Drug Administration has issued warning letters to four companies marketing “wellness” vaping products. The FDA says the vaping devices contain vitamins and/or essential oils and the companies are making unproven health claims about them. Currently, no vaping products are approved by the FDA to prevent or treat any health conditions or diseases. The devices in question do not contain nicotine. The FDA calls the products “unapproved new drugs” sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act. 

“The FDA issued warning letters to companies for illegally selling these vaping products with unproven health claims. The letters provide the companies notice and request that they take prompt action to address any violations of the law,” according to an FDA press release. “If companies refuse to comply, the FDA may take enforcement actions to prevent the products from reaching consumers.”

The FDA stated that it had received complaints concerning several “wellness” products being advertised and sold to minors. “Online advertising, especially social media posts, often make false claims and cite the latest ‘scientific study,’ or do not include important details that may apply to you or allow you to make an informed decision,” the release states. “Other red flags include claims like “miracle cure” or “guaranteed results.” Remember, if a company really made a breakthrough, revolutionary health-related discovery, the news, researchers, and the government would discuss it in depth.” The letters were issued through the FDA’s Center for Drug Evaluation and Research (CDER).

The letters to Vitastick, Vitacig, NV Nutrition (NVN) and Vitamin Vape were issued on Dec. 1. Some of the unproven health or wellness claims include improving mental clarity or treating tumors or asthma. Some examples of the fraudulent product claims are:

• “Fight off tumors and alleviate symptoms of chemotherapy!”
• “It’s been used as a [sic] organic asthma remedy, ADHD remedy, and dementia treatment.”
• “Helps prevent a type of anemia called megaloblastic anemia that makes people tired and weak.”
• “Neroli oil… has long been used as a treatment against anxiety and depression, to calm the mind and soothe away tension.”

The FDA, Centers for Disease Control and Prevention, state and local health departments, and other clinical and public health partners are continuing to monitor and research vaping-associated lung injury. The FDA warns consumers to not be misled by vaping products claiming to contain “vitamins” and other “natural” ingredients or being advertised for “wellness” purposes.