..”, “[M]yrtle . Both were watered down or ‘pre-diluted’ on oils that needed no dilution. What the "Organic" Label Means According to the USDA Blog : "Produce can be called organic if it’s certified to have grown on soil that had no prohibited substances applied for three years prior to harvest. . Your products, “Thieves,” “Cinnamon Bark,” “Oregano,” “ImmuPower,” “Rosemary,” “Myrtle,” “Sandalwood,” “Eucalyptus Blue,” “Peppermint,” “Ylang Ylang,” “Frankincense,” and “Orange,” are prescription drugs as defined in section 503(b)(1)(A) of the Act [21 U.S.C. . When a company abides by the regulations set by the FDA, they are being FDA compliant. Failure to implement lasting corrective action on violations may result in regulatory action being initiated by FDA without further notice. It is a trademark of sorts, CTPG. can help with sexual dysfunction issues such as impotency . Therefore, it is impossible to write “adequate directions for use” for a prescription drug to be used by a layperson. . To download this presentation and to learn more about approved … The range offers superior quality FDA approved dietary supplement essential oils which are same like normal essential oils but are formulated in a way that they are safe for intake. FDA-approved prescription drugs which bear their FDA-approved labeling are exempt from the requirement that they bear adequate directions for use by a layperson (21 C.F.R. §§ 331(d) and 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for the drug. The .gov means it’s official.Federal government websites often end in .gov or .mil. The FDA does not approve Young Living products as a whole, but rather each ingredient used in their products. For essential oils, this means approximate doses in the range of 1 to 3 drops, 1 to 3 times per day. jkaneko@youngliving.com These changes where made to align our labels with FDA regulations that state a product cannot be labeled for use as a dietary supplement AND for topical … O: 801.221.7128. As such, the cited violations in this letter should not be viewed to apply solely to the specific products mentioned in this letter. § 352(f)(1)], in that the labeling for these products fail to bear adequate directions for use for all of their claims. Young Living essential oils are not FDA approved and are not scientifically proven to cure diseases. Essential Oils by Roxy Bentsen Faulkner February 17, 2017. In light of the comment wars that went on in my blog post Warning dōTERRA and Young Living Won’t Tell You it is clear that many misunderstand the law as […] The oils speak for themselves. Young Living oils are changing my life emotionally and physically. The only company I know of that has FDA approved essential oils for ingestion is Young Living. They are the only oils I would ever choose to take internally because the are guaranteed from the seed that is planted to the ground it is planted in, to the distillation process, to the bottle. The FDA’s documents note only that the items on the list are safe in commonly used amounts, or amounts sufficient to achieve the necessary effect as a food additive. . Go ahead and contact the legal department of that company, they will tell you the same thing. Before sharing sensitive information, make sure you're on a federal government site. Try me for . BUY ESSENTIAL OILS. As described below, the marketing and distribution of your Young Living Essential Oil products without FDA-approved applications is in violation of the Act. . When you become a distributor for Young Living, you will need to sell products and recruit lots of people if … Help 4 Vets that suffer PTSD”, www.pinterest.com/naturesezremedy/young-living-testimonials/ – “Young Living Works! The company promotes only FDA-compliant marketing material and all members are instructed to only use materials approved by Young Living. View list of essential oils certified as GRAS (Generally Recognized As Safe) by the FDA for internal consumption Revised as of April 1, 2019. . Just because the companies or oils do not have FDA approval as a ‘drug’ DOES NOT MEAN they have not been subjected to rigourous testing. It is said that the Ebola virus can’t live in the presence of Cinnamon Oil and Oregano Oil.”, www.facebook.com/getwellwithoils (August 9, 2014 posting) – “Oils for the Autism Spectrum! Kis is a lesser-known name and is a smaller company, but it offers a decent selection of single and blended oils. . Young Living Essential Oils, LC, is the world leader in essential oils with a strict Seed to Seal® process to produce pure essential oil products for every individual, family, and lifestyle. This process ensures that all products are genuine, free of synthetic chemicals, and pure. § 201.5). §§ 201.100(c)(2) and 201.115). It is there Vitality line. . No one has FDA approved oils because the FDA doesn't do that. Essential Oil Suggestions for Use with Colon Hydrotherapy and/or Colon Implants. There are not yet any vaccines or drugs approved by the FDA to treat or prevent COVID-19. In addition to the OTC products, Young Living unveiled 15 additional new or rebranded products. Perfect for adding flavor to your favorite foods or using as dietary supplements, the Vitality line of dietary essential oils gives you the freedom to share and explore some of our best-loved essential oils in a variety of nutritious and delicious ways. All ingredients in Young Living’s food or dietary supplements are evaluated by the FDA and approved for human consumption. § 201.128. With a focus on living a lifestyle of wellness, purpose, and abundance, these new products are a welcome addition to our product family and are available for purchase at YoungLiving.com. According to Business Insider, from 2013 to 2014, at least 11 reports of “Young Living customers claiming serious adverse event reactions to the products” were received by the FDA. The designation of a substance as "GRAS", or "Generally Recognized as Safe" means it is not subject to FDA approval for its use as a food additive. Cancer . Along with its expansive collection of single and blended essential oils, Young Living also added oil-infused products. www.pinterest.com/caricaraway/the-oil-dropper-young-living-essential-oils/ – “Young Living’s Orange. Young Living is often a well-recognized name in the industry with a large offering of oil and oil-based products. This is to advise you that in August 2014 the U.S. Food and Drug Administration (FDA) reviewed websites and social media accounts (, You market your Young Living Essential Oil products through paid consultants; your compensation plan for your consultants is explained on your website www.youngliving.com/en_US/opportunity/compensation-plan. Take charge of your own health and rely on your own judgment and research instead of relying solely on the research from those people making the money! The top brands are dōTERRA and Young Living. What The White House Doesn’t Know About Marijuana Policy, Ingredients you’ll never find in YL products, The ultimate guide to CBD products (plus why you need each one in your squad), Essential Oils Might Be the New Antibiotics, 10 Tricks To Make A Box Cake Mix Taste Homemade, 25 Aesthetic Words Every Book Lover Will Appreciate, Life-Saving Trick to Save Yourself If You Are Choking With No One Around to Help. They are therapeutic (medicinal) grade PURE essential oils … Box 25087, 6, Julie Behling-Hovdal (Consultant #853324), An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, Inspections, Compliance, Enforcement, and Criminal Investigations. For more information, visit YoungLiving.com. Your Young Living Essential Oil products, “Thieves,” “Cinnamon Bark,” “Oregano,” “ImmuPower,” “Rosemary,” “Myrtle,” “Sandalwood,” “Eucalyptus Blue,” “Peppermint,” “Ylang Ylang,” “Frankincense,” and “Orange,” are also misbranded under section 502(f)(1) of the Act [21 U.S.C. The introduction or delivery for introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. . About the Author: Mi Essential Oils Apart from the usual essential oils and blends, the brand Young Living has its own line of FDA approved dietary essential oils called Vitality™. Vitality is labeled for internal usage and the regular oils … LEHI, Utah, June 28, 2016 /PRNewswire/ — Young Living Essential Oils, LC, the world leader in essential oils, introduced its first Over-the-Counter (OTC) products, and unveiled 15 new or rebranded products at the Young Living International Grand Convention in Salt Lake City, Utah. Essential Oils FDA-Approved for Internal Consumption. On the site, you will see the following statement for these and other products: “These statements have not been evaluated by the Food and Drug Administration. So while it is a big accomplishment that Young Living created its first OTC products, neither is technically FDA approved, as stated on the Young Living Website. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and please include a timetable for the implementation of any remaining corrections. Doing a search on essential oils, or essential oil components, on PubMed.com reveals over 16000 search returns. is also beneficial for other conditions that affect the nerves such as Parkinson’s, Alzheimer’s . Glad to hear it, this is good news for you and your company! . . Sorry, your blog cannot share posts by email. Discover Vitality—for food, for family, for life! Great stuff! To doTerra’s credit, company administrators created new guidelines for their advocates and their websites. This commitment stems from the company’s 20 years of stewardship toward the earth and its people. Many have found a protocol of essential oils and supplements have helped ease the symptoms of autism-related issues . . . Just one of the many examples pointed out is below: On the website, www.theoilessentials.com, under the heading, “Young Living July 2014 Monthly Promotion” Sr. PR Manager . Glad that there are more natural products being approved by the FDA! Young Living Essential Oils are not labeled organic, but our standards actually far outweigh what that label means. It is clear from the claims above that your Young Living Essential Oil products, “Thieves,” “Cinnamon Bark,” “Oregano,” “ImmuPower,” “Rosemary,” “Myrtle,” “Sandalwood,” “Eucalyptus Blue,” “Peppermint,” “Ylang Ylang,” “Frankincense,” and “Orange,” are drugs under section 201(g)(1)(B) of the Act because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. . Is Cannabis Chocolate the Ultimate Edible? Prescription drugs can only be used safely at the direction, and under the supervision, of a licensed practitioner. Young Living products are not intended to diagnose, treat, cure, or prevent any … I’ve been using essential oils for around 10 years. Like any other product, essential oils can cause rashes if … “These additions enable us to enter into the marketplace in a way we never have before, and we are excited to offer products that provide natural relief to common ailments.”, “Developing OTC products for our members is a milestone for Young Living,” said Dr.  Michael Buch, Young Living Vice President of Research & Development and Product Management. According to the UOSHD, "the entire operation had been designed by Young Living founder Donald Gary Young and built onsite". . The site is secure. . Under the subheading, “Young Living Eucalyptus Blue essential oil”: Under the subheading, “Young Living Peppermint Essential Oil”: Under the subheading, “Ylang Ylang Essential Oil”: Under the subheading, “My Essential Oil Picks for Ebola”: Under the subheading, “Frankincense Cancer Research”: www.facebook.com/theoildropper (August 11, 2014 posting) – “Be prepared for any virus that may attack! has antimicrobial and antiseptic qualities than [, “Myrtle . Essential Oils will not make their way through the FDA approval process because there just isn’t enough money in it. YOUNG LIVING ESSENTIAL OILS SHARING YOUNG LIVING THE RIGHT WAY . .”, www.twitter.com/YLWaterloo (August 21, 2014 posting) – “Victory over arthritis! Under the subheading, “Top Oil Choices for Viruses”: “[R]egular use of rosemary essential oil may . “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 C.F.R. all Young Living members remain compliant with federal regulatory authorities, we compiled a list of hot words to avoid when promoting and selling Young Living products. Both companies offer essential oils to help manage a variety of symptoms ranging … This article briefly compares Kis Oils vs Young Living to provide you an informed overview of what each company provides. This is huge news. The Vitality Oils allow Young Living to stay within the compliant FDA guidelines since the FDA does not allow more than one use per “sku” number. About Young Living Essential Oils Compliance is important because it helps ensure public safety and because the FDA has the power to shut down non-compliant facilities. As such, whether or not they are intended for ingestion, the above-mentioned products are drugs under section 201(g)(1)(B) of the Act and not dietary supplements under section 201(ff) of the Act. § 331(a)]. Consumers interested in your Young Living Essential Oil products are then redirected by your consultants to your website, http://www.youngliving.com, to purchase your products and/or register as members (. LEHI, Utah, June 28, 2016 /PRNewswire/ — Young Living Essential Oils, LC, the world leader in essential oils, introduced its first Over-the-Counter (OTC) products, and unveiled 15 new or rebranded products at the Young Living International Grand Convention in Salt Lake City, Utah. We request that you notify this office in writing within 15 working days from your receipt of this letter of the current status of your corrective actions and the specific steps you have taken to correct the noted violations. . For Alzheimer’s Disease . Your consultants promote many of your Young Living Essential Oil Products for conditions such as, but not limited to, viral infections (including ebola), Parkinson’s disease, autism, diabetes, hypertension, cancer, insomnia, heart disease, post-traumatic stress disorder (PTSD), dementia, and multiple sclerosis, that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Similarly, their cosmetics are approved by the FDA for cosmetic use. ..”. . Use #YLPeppermint #YLPanaway and #YLFrankensence”, www.twitter.com/Oil_Distributor (August 23, 2014 posting) – “One of the many #YoungLiving New Products the Freedom Sleep & Freedom Release kits. . It is your responsibility to ensure that all of your products are in compliance with all requirements of the Act and federal regulations. www.pinterest.com/yloilslady/heart-disease-treat-heart-disease-naturally-get-a-/, www.pinterest.com/pin/184225440979760087/ – “Essential Survival Daily Essential Oil Tip . Beach Bum, Blogger, Cook, Baker,Bottle Washer, Fisherwoman, Crafter, Photographer, Domestic Goddess, Wife and Mother! You may respond in writing to LaTonya M. Mitchell, District Director, Denver District Office, Building 20 – Denver Federal Center, P.O. More than 20,000 Young Living members from all over the world gathered to experience workshops, networking, and social activities focused on business building and integrating essential oils into a healthy lifestyle. The FDA does not approve anything related to essential oils. Essential Oils Have Potential Side Effects. The intended use of a product may be determined by, among other things, its labeling, advertising, and the circumstances surrounding its distribution, 21 C.F.R. The company’s latest claim, that its oils can kill the Ebola virus, has had distributor websites shut down by the FDA. Accordingly, because there are no FDA-approved applications for these products, the labeling of these products fails to bear adequate directions for their intended use and, therefore the products are misbranded under section 502(f)(1) of the Act. Hypertension . FDA Aims to Censor Essential Oils In September of 2014, the FDA began a coordinated attack on companies that market essential oils. . The change in how the oils can be labeled as either safe for ingestion OR topical (Not both) took place about 3 years ago (as of 2019). The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. and ED.”, “[T]he Ebola virus cannot survive in the presence of a therapeutic grade Cinnamon Bark and Oregano essential oil.”. Topical products and other products that are not intended for ingestion are not dietary supplements. Young Living is not a way to earn easy money, nor it is a Get-Rich-Quick program. Yet Young Living reps continue to claim that ingesting essential oils is safe. Lupus Gone”. Under sections 301(d) and 505(a) of the Act [21 U.S.C. The “proper” certification is done by doTerra themselves. . . We note that some of your Young Living Essential Oil products are marketed as dietary supplements, but are offered for topical use and/or intended for inhalation. help prevent diseases associated with free radicals, including cancer and heart disease.”, “Rosemary research in regards to Alzheimer’s disease showed aromatherapy as a potential treatment for the cognitive (eg, memory) impairments caused by dementia.”, “Rosemary . Young Living oils are so pure, they’ve even developed their own purity standard called the Young Living therapeutic-grade standard. While FDA has mentioned specific Young Living Essential Oil products in this letter, there are drug claims being made by your consultants for a wide range of your Young Living Essential Oil products. Frankincense . In any case, the claims referenced above in this letter are drug claims, which are not suitable claims for dietary supplements. You should take prompt action to correct the violations cited in this letter. Young Living Essential Oils, developed by D. Gary Young, are the focus of a multi-level marketing program that have brought essential oil products to the mainstream. § 321(ff)](2)(A)(i)], a dietary supplement is defined, among other things, as a product intended for ingestion. They’re marketed as the purest oils on the market, never synthetic or diluted, 100% “seed to seal.” § 321(p)], because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. “We are thrilled to add two plant-based OTC products to our current offering of nearly 500 Young Living essential oils and oil-infused products,” said Jared Turner, Young Living Chief Operating Officer. Jamie Kaneko § … Enter your email address to follow this blog and receive notifications of new posts by email. They only regulate what you can say and not say, claim and not claim, about them. Hi Janet, Young Living® had recently made some changes to the instruction panel on our essential oil labels. DoTerra and Now are almost impossible for me to tell apart using. Insomnia . Arteriosclerosis . The FDA hasn't approved any essential oil products as drugs because they haven't met the agency's standard for safety or effectiveness — so any time a seller makes a claim about their potential therapeutic use, they're required to include the following FDA disclosure: "These statements have not been evaluated by the Food and Drug Administration. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. Post was not sent - check your email addresses! Today the FDA (U.S. Food and Drug Administration) sent doTerra and Young Living Inspections, Compliance, Enforcement, and Criminal Investigations Warning Letters. On September 22, 2014 the U.S. Food and Drug Administration (FDA) issued a Warning Letter to Young Living for alleged violations of the Federal Food, Drug & Cosmetic Act (FDCA) in connection with the marketing of their aromatherapy essential oils. Gary’s True Grit™ Wolfberry Crisp Bar, Chocolate Coated. Moreover, “Thieves,” “Cinnamon Bark,” “Oregano,” “ImmuPower,” “Rosemary,” “Myrtle,” “Sandalwood,” “Eucalyptus Blue,” “Peppermint,” “Ylang Ylang,” “Frankincense,” and “Orange” are also “new drugs” under section 201(p) of the Act [21 U.S.C. FDA Approves Young Living. Examples of claims found on some of your consultants’ websites that establish the intended use of your Young Living Essential Oils products include, but may not be limited to, the following: In addition, examples of claims that establish the intended use of your Young Living Essential Oil products found on the social media accounts (. The violations cited in this letter are not intended to be an all-inclusive list of violations that exist in connection with your products. . Your friend is mistaken. In fact, the FDA sent warning letters to two major essential oil companies, Young Living and doTerra, citing that the companies were making illegal medical claims on their websites. . Young Living’s essential oils and Vitality oils are the exact same oil. In your response, include documentation of your corrective actions. If you need additional information or have questions concerning any products distributed through your website, please contact the FDA. Under section 201(ff)(2)(A)(i) of the Act [21 U.S.C. The FDA’s GRAS list does not include dosages that are considered safe. The FDA warned Young Living and doTERRA that the companies’ products are not FDA-approved drugs, yet both are utilizing marketing that makes claims only approved drugs can make. . Give Young Living Essential Oils a try! "Many Young Living oils are designated by the FDA as GRAS, generally recognized as safe for ingestion." The intended use of a product may be determined by, among other things, its labeling, advertising, and the circumstances surrounding its distribution, 21 C.F.R. Essential oils sellers are trying to use coronavirus to sell products on Facebook. “These products meet OTC standards, and like all our products, they adhere to Young Living’s strict Seed to Seal® commitment to quality and purity.”. . Young living oils are approved by the FDA. . § 353(b)(1)(A)] for some of the claims made for them because, in light of their toxicity or other potentiality for harmful effect, the method of their use, or the collateral measures necessary to their use, they are not safe for use except under the supervision of a practitioner licensed by law to administer it. . I’ve tried DoTERRA, the NOW brand, and Young Living. Media Contact: