Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1The claims on your website establish that your products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d).
Passage 2Based on our review of your website, your VitaCig products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body.
Passage 3On the website https://www.vitaciggroup.com/: - "VitaCig® is a unique NICOTINE & TOBACCO FREE personal aromatherapy device, pre-filled with vitamin-enhanced liquids and diluted natural essential oils. Its formulation is based on the knowledge and centuries-old experience of using herbs and natural extracts to assist our wellbeing, to balance our mental, emotional and physical levels of energy. Each VitaCig® is bursting with flavors and mood enhancing effects. Let yourself feel your emotions with every VitaCig® blend."
Passage 4From your "VitaCig® Cool Citrus" product webpage: "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."
Passage 5From your "VitaCig® Watermelon Wave" product webpage: o "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." o "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."
Passage 6From your "VitaCig® Vintage Vanilla" product webpage: "The Valerian Oil can lessen anxiety as well as improve both the quality and duration of sleep"
Passage 7From your "VitaCig® Focus" product webpage: o "Asian ginseng is prescribed for those with low energy, tendency to feel cold, and a lack of sex drive. Studies have shown ginseng improves erectile dysfunction in men"***1*** o "VitaCig® FOCUS . . . is an inhalable natural cognitive booster. . . . It has a stimulation effect, improves your concentration, helps support optimal cognition and acute focus, bringing clarity of mind."
Passage 8From your "VitaCig® Rejuvenate" product webpage: "Both calming and uplifting, geranium makes a natural antidepressant and helps to relieve anxiety."
Passage 9From your "VitaCig® Sleep" product webpage: o "Lack of sleep weakens the immune system, slows reaction times and makes you more prone to depression, anxiety and a low mood." o "Neroli Oil …has long been used as a treatment against anxiety and depression, to calm the mind and soothe away tension."
Passage 10From your "VitaCig® Slim" product webpage: "Hoodia is used as a weight loss aid."
Passage 11Your VitaCig products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are "new drugs" under section 201(p) of the FD&C Act, 21 U.S.C. 321(p).