WARNING LETTER
VitaStik, Inc.
MARCS-CMS 617713 —
December 01, 2021
Delivery Method:
Via Email
Product:
Drugs
Recipient:
Recipient Name
Alfred Santos
VitaStik, Inc.
433 N. Camden Dr. #600
Beverly Hills
,
CA
90210-4416
United States
Info@VitaStik.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
WARNING LETTER
December 1, 2021
RE: 617713
Dear Mr. Santos:
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.vitastik.com in September 2021 and has determined that you take orders there for a variety of oral inhalation products under the “VitaStik” product line including, but not limited to: “VitaStik Breathe Essential Oil Stick - Spearmint Menthol Aromatherapy,” “VitaStik Nootropic Inhaler – Focus Vitamin Essential Oil Inhaler,” “VitaStik Calm - Vanilla Green Tea with Valerian Aromatherapy for Anxiety,” “VitaStik Sleepy Time Sweet Honey Lavender Melatonin Diffuser,” and “VitaStik Silver Bullet Menthol Arctic Blast - Asthma, Nasal, Allergy Relief” (hereinafter “VitaStik products”). We have also reviewed your social media websites at www.facebook.com/vitastik, www.instagram.com/vitastik, and www.youtube.com. These social media websites direct consumers to your website www.vitastik.com to purchase your products. The claims on your website and social media websites 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). As explained further below, introducing or delivering these products for introduction into interstate commerce violates the FD&C Act. You can find the FD&C Act and FDA regulations through links on FDA’s home page at
www.fda.gov.
Furthermore, the use of VitaStik 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.
You appear to be marketing your products as supplements. For example, the product packaging for your “VitaStik Sleepy Time Diffuser” contains a Supplement Facts panel. Although you market your products as “edible formulas,” your products’ labeling states that they are intended for inhalation. For example, your product labeling instructs on the “INHALE METHOD: Short, Shallow Breath from White Air Hole Side. Hold, then Exhale via the nose for Maximum Aromatherapy Effect. Best to pause at least 1 minute between uses.” The FD&C Act defines the term “dietary supplement” in section 201(ff)(2)(A)(i), 21 U.S.C. 321(ff)(2)(A)(i), as a product that is “intended for ingestion.” Your VitaStik products are not intended for ingestion. Therefore, your VitaStik products do not meet the definition of a dietary supplement under the FD&C Act.
Based on our review of your website, your VitaStik 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.
Examples of some of the claims observed on your website www.vitastik.com and your social media websites at www.facebook.com/vitastik, www.instagram.com/vitastik, and www.youtube.com, that provide evidence that your products are intended for use as drugs include, but may not be limited to, the following:
On the website www.vitastik.com:
Under the heading, “Why is VitaStik the Most Trusted Name in the Business?”:
o “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.”
From your “VitaStik Breathe Essential Oil Stick - Spearmint Menthol Aromatherapy” product webpage:
o “[T]he Breathe Formula in particular was created by the founder of VitaStik. Like millions of other people, our founder suffered from acute Asthma. . . For over two years he mixed various organics searching for a way to find breathing relief, without the addicting chemicals used in inhalers. After many, many, many failures, the Final Breathe Formula was born. . . so he gave the Breathe Formula to some friends who suffered from Asthma and Bronchitis. He asked them, next time you feel an attack coming on, try one quick inhalation of our Patent Pending Breathe Formula. Give it 30 seconds he said, and if you don't feel an instant relief, then resume to your standard drug relief treatment . . . 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.”
o “I really like it, just wish it worked for my asthma a little quicker!”
o “This is the best, fresh and minty! Helped with my allergies, sinus headache, and allergic asthma. Awesome!”
From your “VitaStik Nootropic Inhaler – Focus Vitamin Essential Oil Inhaler” product webpage, under the heading, “Formula Details”:
o “Ginkgo Biloba (
Salisburia adiantifolia
) . . . Widely studied for its effective anti-inflammatory, antioxidant, platelet-forming and circulation-boosting effects. Current research show ginkgo benefits include improved cognitive function, positive mood, increased energy, improved memory and reduced symptoms related to multiple chronic diseases — for instance, it’s been used as a [sic] organic asthma remedy, ADHD remedy, and dementia treatment.”
o “Vetiver (
Vetiveria zizanioides
) . . . Great for boosting energy levels during exhaustion. Used as a nervous system tonic, it decreases jitteriness, and panic attacks.”
From your “VitaStik Silver Bullet Menthol Arctic Blast - Asthma, Nasal, Allergy Relief” product webpage:
o “Works amazing for seasonal allergies, chest and sinus tightness, and asthma.”
o “If you have a loved one that you want to quit smoking, try giving them this.”
o “Asthma, Nasal, Allergy Relief”
From your “VitaStik Calm - Vanilla Green Tea with Valerian Aromatherapy for Anxiety” product webpage:
o “Everyday we get feedback about this Formula helping people Calm, deal with Anxiety Attacks, Stress, PTSD . . . and other related symptoms.”
From your “VitaStik Sleepy Time Sweet Honey Lavender Melatonin Diffuser” product webpage:
o “We have combined some . . . herbs, and essential oils, and vitamins, that will . . . steady your mind, so that Dreams may follow. Enhanced with 5mg of Melatonin, B12 and Vitamin-C for the perfect nights [sic] sleep.”
o “I have major insomnia, this helped calm me down. With just a few uses i [sic] could feel myself getting better sleep.”
o “I have epilepsy and terrible insomnia and have tried a ton of herbal remedies in the past that did nothing. I was expecting this to be another bunk product, but gave it a go. 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.”
Your website www.vitastik.com also includes various “Category” tags such as “Asthma / Nasal Decongestant,” “Mental Clarity / Focus,” “Relaxation / Anxiety / Stress / PTSD,” “Quit Smoking,” and “Weight Loss” that link to different VitaStik products and provide evidence of your products’ intended uses.
On your Instagram social media website at www.instagram.com/vitastik:
On your June 18, 2018 post for the product “VitaStik Calm - Vanilla Green Tea with Valerian Aromatherapy for Anxiety”: “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.”
On your June 28, 2018 post for the product “VitaStik Breathe Essential Oil Stick - Spearmint Menthol Aromatherapy”: “The Worlds’ [sic] only BREATHE Essential Oil Diffuser Aromatherapy Stick . . . Great for asthma, anxiety, relaxation, nasal congestion, and help quitting smoking.”
On your YouTube channel at https://www.youtube.com/watch?v=6dS0hrncVBM:
On your August 14, 2018 post for the product “VitaStik Breathe Essential Oil Stick - Spearmint Menthol Aromatherapy”: “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.”
Your VitaStik 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). With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. No approved applications are in effect for your products.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your marketed products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. 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.
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. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete addressing these violations within fifteen working days, state the reason for the delay and the time within which you will do so.
Your written reply should be directed to the U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAADVISORY@fda.hhs.gov.
Sincerely,
/S/
Carolyn E. Becker
Director
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
Content current as of:
12/07/2021
Regulated Product(s)
Drugs