VitaStik, Inc.
FDA issued a warning letter to VitaStik, Inc. (Beverly Hills, CA) in December 2021 after reviewing the company's website and social media, finding that its line of oral inhalation/aromatherapy sticks made disease-treatment claims for conditions including asthma, COPD, anxiety, PTSD, epilepsy, insomnia, and nasal congestion. These claims caused the products to be classified as unapproved new drugs under sections 505(a) and 301(d) of the FD&C Act, and FDA also noted the products do not qualify as dietary supplements because they are intended for inhalation, not ingestion. FDA warned that failure to promptly correct violations could result in seizure and/or injunction, and required a written response within fifteen working days.
Flagged claims (11)
Our customers range from . . . people dealing with Asthma, Terminal Cancer Patients (including Lung), sufferers of COPD, Anxiety, PTSD, Epilepsy, Sleep Insomnia, Nasal Congestion, all the way to people looking for a healthier way to Quit Smoking, or Quick [sic] Vaping.
The Worlds' [sic] only BREATHE Essential Oil Diffuser Aromatherapy Stick . . . Great for asthma, anxiety, relaxation, nasal congestion, and help quitting smoking.
It actually works - better than pharmaceuticals . . . I often feel tired, but am restless and can't achieve sleep. This put me to sleep for the night, and I woke up feeling refreshed for the first time in months. I highly recommend this to anyone suffering from sleep issues, whatever they may be.
Keep CALM . . . with crushed organic Green-Tea, Vanilla, and Valerian Root. . . Valerian Root has been used for centuries to ease insomnia, anxiety and nervous restlessness. . . . Customers claim it helps them relax, and manage Anxiety Attacks, Stress, PTSD, and other related symptoms.
Vetiver (Vetiveria zizanioides) . . . Great for boosting energy levels during exhaustion. Used as a nervous system tonic, it decreases jitteriness, and panic attacks.
Asthma, Nasal, Allergy Relief
Ginkgo Biloba (Salisburia adiantifolia) . . . it's been used as a [sic] organic asthma remedy, ADHD remedy, and dementia treatment.
Organic Breathe Aid, Asthma and Chest Tightness Relief, using Essential Oils, Holistic Wellness Herbs, and Vitamins. Works to instantly open your breathing pathways. . . The Breathe Stick and Silver Bullet also work as a Nasal Decongestant.
All agreed . . .and we repeat the word 'all' agreed, that there was an instant bronchial relief provided after just 1 deep inhalation from the Breathe Stick.
Works amazing for seasonal allergies, chest and sinus tightness, and asthma.
Everyday we get feedback about this Formula helping people Calm, deal with Anxiety Attacks, Stress, PTSD . . . and other related symptoms.
Required actions (3)
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps that you have taken to address these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
You should take prompt action to address the violations cited in this letter. Failure to promptly address these violations may result in enforcement action without further notice, including, without limitation, seizure and/or injunction.
Failure to promptly address these violations may result in enforcement action without further notice, including, without limitation, seizure and/or injunction.
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