The U.S. Food and Drug Administration issued warning letters to several companies selling vaping products containing vitamins or essential oils, telling them to stop making unproven health and wellness claims.  In announcing the action, the FDA said that, "no vaping products are approved by the FDA to prevent or treat any health conditions or diseases." 

The FDA sent warning letters to Eagle Energy USA, NV Nutrition, VitaCig, Vitamin Vape, and VitaStik.  In the letters, the FDA asserts that the companies are selling new drugs that have not been approved by the FDA.  In addition, the FDA said that the use of the companies' products "raises safety concerns for the agency because the ingredients and/or impurities in oral inhalation products may trigger laryngospasm or bronchospasm, may be toxic to the tissues in the upper or lower airways, or may be absorbed and exert undesirable systemic effects or organ toxicity."  The FDA told they companies that they have fifteen business days to notify the FDA in writing of the specific steps the companies have taken to address the violations.  

For example, in its warning letter to VitaCig, the FDA said that the company was unlawfully promoting its products as drugs by making claims such as: 

  • "The Lemon Essential Oil has a clarifying quality, good for mental fatigue and emotional confusion, stimulates the mind and increase the ability to [sic] memorise";
  • "Watermelons are loaded with antioxidants and have been associated with a wide range of health benefits - such as better heart health, enhanced immunity and increased weight loss";
  • "Lychee is a wonderful fruit with plenty of health benefits, including its ability to aid in weight loss, protect the skin, boost the immune system prevent cancer, improve digestion, build strong bones, lower blood pressure, defend the body against viruses, improve circulation, and optimize metabolic activities"; and
  • "The Valerian Oil can lessen anxiety as well as improve both the quality and duration of sleep."

In a consumer alert issued in connection with the warning letters, the FDA warned that the types of health claims that these companies are making are "unproven, and the products may be ineffective, a waste of money, unsafe, and may prevent or delay you from seeking an appropriate diagnosis and treatment from a health care professional." 

www.fkks.com

This alert provides general coverage of its subject area. We provide it with the understanding that Frankfurt Kurnit Klein & Selz is not engaged herein in rendering legal advice, and shall not be liable for any damages resulting from any error, inaccuracy, or omission. Our attorneys practice law only in jurisdictions in which they are properly authorized to do so. We do not seek to represent clients in other jurisdictions.