Vicks VapoRub a topical ointment made of ingredients including camphor, eucalyptus oil and menthol that you rub on your throat and chest doesn't relieve nasal congestion. He asked them, next time you feel an attack coming on, try one quick inhalation of our Patent Pending Breathe Formula. Vicks Sinex Soother, contains oxymetazoline, relief of nasal congestion. It started when she developed pregnancy rhinitis and needed to relieve the severe nasal congestion. ask a doctor. . 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. This similarity sparked concerns among regulatory bodies, leading them to investigate the potential risks of Vicks Inhalers active ingredient. Used as a nervous system tonic, it decreases jitteriness, and panic attacks., o Works amazing for seasonal allergies, chest and sinus tightness, and asthma. The message states that Vicks Vaporub is banned in America as it is toxic and leads to deadly diseases like Asthma and TB. The nicotine oral inhaler is a small plastic tube shaped like a fat cigarette. While you might think a blocked nose is bad, carrying one of these in Japan could land you in prison - yikes. 321(p). All Products. Levmetamfetamine, also known as L-methamphetamine, is a stereoisomer of methamphetamine, which is commonly used in the production of illicit drugs. . All rights reserved. . You should take prompt action to address the violations cited in this letter. In 2011, Japan banned the importation and sale of Vicks Inhaler due to concerns surrounding its active ingredient, levmetamfetamine. - Quora. I often feel tired, but am restless and can't achieve sleep. We also share information about your use of our site with our social media, advertising and analytics partners. . Director Vicks VapoInhaler is a convenient non-medicated nasal inhaler formulated with a proprietary blend of ingredients including menthol & camphor so you can experience non-medicated soothing vapors. We use cookies to personalise content and ads, to provide social media features and to analyse our traffic. Its important to consult with a healthcare professional before using oral decongestants, especially if you have a history of heart problems or high blood pressure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. and our Is it alright? When ingested, L-methamphetamine can be metabolized into compounds that are indistinguishable from those produced by the consumption of D-methamphetamine. Awesome!, o Ginkgo Biloba (Salisburia adiantifolia) . Vicks VapoRub is a mentholated ointment made by U.S. household and personal care manufacturer Procter & Gamble. The site is secure. 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., o [T]he Breathe Formula in particular was created by the founder of VitaStik. However, like Vicks Inhaler, these products should not be used for more than a few days at a time to avoid rebound congestion. 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. Do not use Vicks VapoInhaler if you are allergic to any of its . Is buttercups and berry bellini discontinued? 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. This is not a complete list of side effects and others may occur. The excessive use of inhalers may cause rhinitis medicamentosa, where the mucosa lining of the nose is damaged. Prolonged use of Vicks Inhaler was associated with rebound congestion, a condition where the nasal passages become more congested after the effects of the decongestant wear off. Chest Congestion. 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. You can find the FD&C Act and FDA regulations through links on FDAs home page at www.fda.gov. Required fields are marked *. It actually works - better than pharmaceuticals . We have also reviewed your social media websites at www.facebook.com/vitastik, www.instagram.com/vitastik, and www.youtube.com. For example, the product packaging for your VitaStik Sleepy Time Diffuser contains a Supplement Facts panel. . Some countries, such as Japan, outright banned the product, while others imposed strict regulations on its sale and distribution. Great for asthma, anxiety, relaxation, nasal congestion, and help quitting smoking., 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. Cold & Flu. . Before sharing sensitive information, make sure you're on a federal government site. Always read the label. . 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. By rejecting non-essential cookies, Reddit may still use certain cookies to ensure the proper functionality of our platform. steady your mind, so that Dreams may follow. . 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. For over two years he mixed various organics searching for a way to find breathing relief, without the addicting chemicals used in inhalers. This, in turn, could result in chronic congestion and damage to the nasal passages. Sincerely, Vicks manufactures NyQuil and its sister medication, DayQuil as well as other medications in the "Quil" line. Beverly Hills, CA 90210-4416 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, its been used as a [sic] organic asthma remedy, ADHD remedy, and dementia treatment. Cough. . If pregnant or breast-feeding, ask a health professional before use. As a result, individuals using Vicks Inhaler could inadvertently test positive for illicit drug use, leading to negative consequences such as job loss or legal troubles. 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. FIND YOUR VICKS. New comments cannot be posted and votes cannot be cast. Like millions of other people, our founder suffered from acute Asthma. These medications are available over-the-counter but may have side effects, such as increased heart rate or blood pressure. In some cases, the product was reformulated to replace levmetamfetamine with other, less controversial decongestants. Another issue with levmetamfetamine is its ability to cause false positives in drug tests. These social media websites direct consumers to your website www.vitastik.com to purchase your products. o I really like it, just wish it worked for my asthma a little quicker!, o This is the best, fresh and minty! . Although L-methamphetamine does not produce the same euphoric effects as its counterpart, D-methamphetamine, it shares a similar chemical structure. Cookie Notice 6 yiffing_for_jesus 2 yr. ago Sort By. The concerns over its active ingredient, levmetamfetamine, and the potential risks associated with its use led to increased scrutiny and eventual removal from the market. Give it 30 seconds he said, and if you don't feel an instant relief, then resume to your standard drug relief treatment . 433 N. Camden Dr. #600 . . . Therefore, your VitaStik products do not meet the definition of a dietary supplement under the FD&C Act. The use of levmetamfetamine, a nasal decongestant, raised concerns over its potential misuse and side effects. Due to its chemical structure, levmetamfetamine can be converted into methamphetamine through a series of chemical reactions. On your Instagram social media website at www.instagram.com/vitastik: On your YouTube channel at https://www.youtube.com/watch?v=6dS0hrncVBM: 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. Go to r/benzedrex for more info on PPX. Less serious side effects may be more likely, and you may have none at all. 321(ff)(2)(A)(i), as a product that is intended for ingestion. Your VitaStik products are not intended for ingestion. . Reddit and its partners use cookies and similar technologies to provide you with a better experience. adults and children 12 years and over. Overuse of the product could lead to a cycle of dependence, with users requiring more frequent applications to achieve the same level of relief. /S/ 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 . . For many years, people relied on this small, portable device to provide quick relief from stuffy noses caused by colds, allergies, or sinus infections. Vicks non-medicated nasal inhaler provides you with refreshing Vicks Vapors for on-the-go use. 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. The Japanese government classified the compound as a stimulant drug, making it illegal to possess or sell within the country. . 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. Vicks Inhaler contains a substance known as pseudoephedrine, which is exclusively used in nasal spray and decongestants. For instance, the compound could increase the risk of serotonin syndrome when used in combination with certain antidepressants. and other related symptoms., o We have combined some . United States. This raised concerns about the potential misuse of Vicks Inhaler as a precursor for the production of illegal drugs. Valerian Root has been used for centuries to ease insomnia, anxiety and nervous restlessness. Works to instantly open your breathing pathways. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. 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: o Our customers range from . . children 2 to under 6 years. . o Vetiver (Vetiveria zizanioides) . Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Vicks Vaporub is a common over the counter topical cream used to get relief from symptoms of common cold, cough and congestion. The average inhaler price combines prices for 16 leading inhaler products. Something went wrong. The ready availability and low cost of the Vick's Inhaler, and the ingenuity of the drug abuser in extracting drugs from inhalers [l], strongly suggest that the product may have high abuse potential. But the strong menthol odor of VapoRub may trick your brain, so you feel like you're breathing through an unclogged nose. 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. These sprays can be used as often as needed without the risk of side effects or rebound congestion. This move marked the beginning of a shift in attitudes towards the popular nasal decongestant. Food and Drug Administration, An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, Inspections, Compliance, Enforcement, and Criminal Investigations. Failure to promptly address these violations may result in enforcement action without further notice, including, without limitation, seizure and/or injunction. .and we repeat the word all agreed, that there was an instant bronchial relief provided after just 1 deep inhalation from the Breathe Stick. Its popularity stemmed from its convenience and effectiveness. 355(a) and 331(d). do not use more often than every 2 hours. Originally formulated by . Is dial power berries bar soap discontinued? o Asthma, Nasal, Allergy Relief, o Everyday we get feedback about this Formula helping people Calm, deal with Anxiety Attacks, Stress, PTSD . Keep out of reach of children. I highly recommend this to anyone suffering from sleep issues, whatever they may be.. . However, the issues surrounding its key ingredient eventually led to its removal from the market. so he gave the Breathe Formula to some friends who suffered from Asthma and Bronchitis. You appear to be marketing your products as supplements. herbs, and essential oils, and vitamins, that will . For example, your product labeling instructs on the INHALE METHOD: Short, Shallow Breath from White Air Hole Side. Use of this inhaler by more than one person may spread infection. Reviews of the Vicks Portable Steam Inhaler and the Vicks Personal Sinus Steam Inhaler on Amazon give the products average ratings of 3.6 and 4.3 out of five stars, respectively. All agreed . Nicotine Oral Inhaler. . Love propylhexedrine, never bother to try the other shit. The Breathe Stick and Silver Bullet also work as a Nasal Decongestant.. Using Vicks VapoRub may help relieve cough and congestion. For more information, please see our 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). (February 2017) Vicks is an American brand of over-the-counter medications owned by the American companies Procter & Gamble and Helen of Troy Limited. The primary reason Vicks Inhaler was discontinued lies in its ingredients. Sinus & Nasal Congestion. Archived post. The use of levmetamfetamine, a nasal decongestant, raised concerns over its potential misuse and side effects. . . . While Vicks Inhalers convenience and effectiveness are missed by many, the safety of consumers remains the top priority for regulatory bodies and healthcare professionals alike. Drug Free. Widely studied for its effective anti-inflammatory, antioxidant, platelet-forming and circulation-boosting effects. High Blood Pressure. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. Oral decongestants, such as pseudoephedrine and phenylephrine, can also help relieve nasal congestion. Some nations implemented stricter regulations on its sale, such as requiring a prescription or limiting the number of inhalers that could be purchased at one time. Is Sanders hot fudge discontinued - Where To Buy it? Decongestant nasal sprays containing ingredients like oxymetazoline or phenylephrine are available over-the-counter and can provide quick relief from nasal congestion. I was expecting this to be another bunk product, but gave it a go. Following Japans ban, other countries began to scrutinize Vicks Inhaler more closely. Due to Japan's extremely strict anti-stimulant drug laws, any drugs containing pseudoephedrine such as Vicks inhalers are banned from the country. Helped with my allergies, sinus headache, and allergic asthma. . The average cash price for one inhaler of Advair, a leading medication for asthma, increased from $316 in 2013 to $496 in 2018 a 56% increase. Sore Throat. . 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. Although such conversions are not straightforward and require a certain level of expertise, the risk of misuse was enough to warrant further scrutiny. Serotonin syndrome is a life-threatening condition characterized by a dangerous increase in serotonin levels, causing symptoms such as rapid heartbeat, muscle rigidity, and confusion. children 6 to under 12 years (with adult supervision) 1 inhalation in each nostril. 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.