FDA警告信 (全文中英文對照)
Department of Health and Human Services | Public Health Service |
September 22, 2014
WARNING LETTER
警告信
VIA OVERNIGHT DELIVERY
RETURN RECEIPT REQUESTED
Young Living
Attn: Mr. Gary Young, CEO
3125 Executive Parkway
Lehi, UT 84043
Dear Mr. Young:
致Mr. Young：
This is to advise you that in August 2014 the U.S. Food and Drug Administration (FDA) reviewed websites and social media accounts (e.g., Facebook, Twitter, and Pinterest) for several Young Living essential oil consultants that your firm refers to as “Young Living distributors.” FDA also reviewed a 2012-2013 product guide found on your website http://www.youngliving.com. Based on our review, FDA has determined that many of your Young Living Essential Oil products, such as, but not limited to, “Thieves,” “Cinnamon Bark,” “Oregano,” “ImmuPower,” “Rosemary,” “Myrtle,” “Sandalwood,” “Eucalyptus Blue,” “Peppermint,” “Ylang Ylang,” “Frankincense,” and “Orange,” are promoted for conditions that cause them to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)], because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. 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. § 201.128. As described below, the marketing and distribution of your Young Living Essential Oil products without FDA-approved applications is in violation of the Act.
這信件是要通知你，在2014年8月，美國食物及藥物管理局（FDA）檢查過數名Young Living精油顧問的網站和社交媒體帳號（例如Facebook、Twitter和Pinterest），他們是你公司所聲稱的「Young Living分銷商」。FDA亦檢查過在你網站（http://www.youngliving.com）找到的2012至2013年産品介紹。根據我們的檢查，FDA認為很多Young Living精油産品的推廣用途都使它們被視為藥物，這些産品包括（但不限於）：「盜賊精油」、「肉桂樹皮」、「牛至花」、「免疫力精油」、「迷迭香」、「桃金娘」、「檀香木」、「桉藍」、「薄荷」、「依蘭」、「乳香」、「橙」。因為根據聯邦食品、藥品和化妝品法（Federal Food, Drug, and Cosmetic Act）（FD&C法）第201(g)(1)(B)段[21 U.S.C. § 321(g)(1)(B)]的規定，它們的意圖用途是診斷、治療、舒緩、處理，或預防疾病。一個産品的意圖用途可以由其他東西來決定：它的標籤、廣告、它的銷售環境（21 C.F.R. § 201.128）。如以下所述，未經FDA批准，你們Young Living精油産品的推廣和銷售，是違反FD&C法的。
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. 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. 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 (i.e., consultants).[1]
你們透過受雇顧問去推廣你們Young Living精油的産品；你們網站（www.youngliving.com/en_US/opportunity/compensation-plan）已解釋了你們給予你們顧問的報酬計劃。你們的顧問，推廣很多你們Young Living精油産品去用於以下情況，例如（但不限於）：病毒感染（包括伊波拉病毒）、柏金遜病、自閉症、糖尿病、高血壓、癌症、失眠、心臟病、創傷後心理壓力緊張症候群（PTSD）、失智症和多發性硬化症，它們都是不能由非醫生作出自行診斷和處理的。對你們Young Living精油産品感興趣的顧客，會被你們的顧問引導向你們的網站（http://www.youngliving.com），去構買你們的産品，以及/或註冊為會員（即是顧問）。[1]
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:
以下是由你們顧問的網站，找到對你們Young Living精油産品聲稱的意圖用途，包括（但可能不限於）以下例子：
On the website, www.theoildropper.com, under the heading, “Young Living Versus Ebola Virus”:
在網站www.theoildropper.com，在標題《Young Living對抗伊波拉病毒》之下：
Under the subheading, “Be Prepared”:
o “Since I have become an avid Young Living essential oil user I have learned all about the anti-microbial properties of so many oils, including ANTI-VIRAL constituents in many of our essential oils.”
o “Viruses (including Ebola) are no match for Young Living Essential Oils”
- 在副標題「作好準備」之下：
- 「自從我成為了一名Young Living精油的熱心用家後，我就學習到所有這些精油的抗微生物性質，包括我們很多精油中的抗病毒成份。」
- 「病毒（包括伊波拉病毒）都不能與Young Living精油匹敵」
Under the subheading, “Top Oil Choices for Viruses”:
o “Top on my list is Thieves. Thieves is highly anti-microbial . . . it could help against Ebola.”
o “Ebola Virus can not live in the presence of cinnamon bark (this is in Thieves) nor Oregano.” [sic]
o “ImmuPower by Young Living would be a top choice as well. ImmuPower is a blended oil containing (oregano, clove, frankincense, ravintsara, cistus, mountain savory and hyssop). Every single one of these individual oils has anti-viral properties.”
- 在副標題「應付病毒的最佳精油選擇」之下：
- 「我名單上的最佳選擇是盜賊精油。盜賊精油是高度抗微生物的……它有助對抗伊波拉。」
- 「伊波拉病毒不能在肉桂樹皮（這存在於盜賊精油中）或牛至花面前生存。」[sic]
- 「Young Living的免疫力精油亦是最佳選擇。免疫力精油是一種混合精油，含有牛至花、丁香、乳香、羅文莎葉、巖薔薇、山香薄荷和海索草。每一個這些獨立精油都有抗病毒特性。」
On the website, www.theoildropper.com, under the heading, “Rosemary Essential Oil by Young Living”:
“[R]egular use of rosemary essential oil may . . . 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 . . . has antimicrobial and antiseptic qualities than [sic] may help eliminate . . . eczema and dermatitis.”
在網站www.theoildropper.com，在標題《Young Living迷迭香精油》之下：
- 「定期使用迷迭香精油可以……有助預防關自由基有關的疾病，包括癌症和心臟病。」
- 「迷迭香與阿茲海默症的研究指出，芳香療法是一個有潛力的療法，去處理失智症造成的認知（例如記憶力）損害。」
- 「迷迭香……有抗微生物和抗菌特性，所以可幫助消除……濕疹和皮膚炎。」
On the website, www.theoildropper.com, under the heading, “Myrtle Essential Oil Uses & Benefits”:
“Myrtle is a wonderful antiseptic . . . It has been known to protect against tetanus . . ..”
“Myrtle . . . is also beneficial for other conditions that affect the nerves such as Parkinson’s, Alzheimer’s . . ..”
“[M]yrtle . . . can help with sexual dysfunction issues such as impotency . . . and ED.”
“Cancer protection…According to a study . . . Myrtle inhibited prostate and breast cancer cells along with Sandalwood at very low concentrations. Sandalwood essential oil ranked number one for inhibiting growth of breast cancer at 98.1% and Myrtle was at 95.2%.”
在網站www.theoildropper.com，在標題《金桃娘精油的使用和益處》之下：
- 「金桃娘是一種卓越的抗菌劑……它是著名於預防破傷風的……」
- 「金桃娘……亦有助於其他影響神經的情況，例如柏金遜病、阿茲海默症……」
- 「金桃娘……能幫助處理性機能障礙，例如陽萎……和ED。」
- 「預防癌症……根據研究……與低濃度的檀香木一起時，金桃娘會抑制前列腺癌和乳癌細胞。檀香木精油對於抑制乳癌，是排名第一的（98.1%），而金桃娘是95.2%。」
On the website, www.theoilessentials.com, under the heading, “Are you panicked about the Ebola Virus after watching the news this week?”:
“[T]he Ebola virus cannot survive in the presence of a therapeutic grade Cinnamon Bark and Oregano essential oil.”
在網站www.theoilessentials.com，在標題《在看過本星期的新聞後，你對伊波拉病毒感到恐慌嗎？》之下：
- 「伊波拉病毒不能在治療級別的肉桂樹皮和牛至花精油面前生存。」
On the website, www.theoilessentials.com, under the heading, “Young Living August 2014 Monthly Promotion”:
Under the subheading, “Young Living Eucalyptus Blue essential oil”:
o “Eucalyptus Blue essential oil has antiviral and anti-inflammatory properties.”
Under the subheading, “Young Living Peppermint Essential Oil”:
o “Peppermint oil has so many more uses . . . asthma, autism, brain injury . . . Crohn’s disease . . . multiple sclerosis, paralysis . . ..”
在網站www.theoilessentials.com，在標題《2014年8月，Young Living每月推廣》之下
- 在副標題「Young Living桉藍精油」之下：
- 「桉藍精油有抗病毒和抗發炎特性。」
- 在副標題「Young Living薄荷精油」之下：
- 「薄荷精油還有很多用途……哮喘、自閉症、腦部創傷……克隆氏症……多發性硬化症、癱瘓……」
On the website, www.theoilessentials.com, under the heading, “Young Living July 2014 Monthly Promotion”:
Under the subheading, “Ylang Ylang Essential Oil”:
o “Ylang Ylang is used medicinally . . . for the treatment of . . . arterial hypertension . . . diabetes . . . insomnia, heart palpitations, and tachycardia.”
在網站www.theoilessentials.com，在標題《2014年7月，Young Living每月推廣》之下
- 在副標題「Young Living依蘭精油」之下：
- 「依蘭被用於醫學上……去處理……動脈高血壓……糖尿病……失眠、心悸，以及心動過速。」
On the website, http://essentialsurvival.org, under the heading, “Essential Oils & More to Combat Ebola Virus”:
Under the subheading, “My Essential Oil Picks for Ebola”:
o “The most potent anti-viral essential oils that I have in my arsenal are Thieves, ImmuPower . . ..”
o “Thieves oil is a blend of cinnamon, rosemary, clove, eucalyptus, and lemon oils that has been shown in university studies to obliterate bacteria and viruses, as well as mold . . ..”
o “Thieves oil can be . . . applied topically on the skin to help the body fight off infection . . . If Ebola was going around in my area . . . I would apply it to my feet and armpits 2x/day or more and take it in capsules at least 2x/day for preventive purposes.”
o “If I were exposed to Ebola or had reason to believe I could be sick with it, I would use some of these oils every 10 minutes for a few hours, then cut back to every hour for the rest of the first day. Then I would use them every 2 waking hours of the day for at least a week, or longer if it was known I was sick.”
在網站http://essentialsurvival.org，在標題《精油與進一步對抗伊波拉病毒》之下
- 在副標題「我的精油選擇 – 對抗伊波拉」之下：
- 「在我的庫存中，最有力的抗病毒精油是盜賊精油、免疫力精油……」
- 「盜賊精油是混合了肉桂、迷迭香、丁香、桉樹和檸檬精油，大學研究已指出它們能消滅細菌和病毒，以及黴菌……」
- 「盜賊精油能……局部地敷於皮膚上，有助身體對抗感染……如果伊波拉病毒來到我的地區……我會將它敷於我的足部和腋窩，每天2次或更多，以及每天最少服用2次它的膠囊，作預防用途。」
- 「如果我接觸過伊波拉病毒，或有理由相信我將會患上這病，我將會使用這些精油，每10分鐘使用一次，持續數小時，然後在第一天的餘下時間每小時使用一次。然後我會在醒來時，每2小時使用一次，持續最少一星期，或者，如果我認為我仍有不適，就持續更長時間。」
On the website, http://essentialsurvival.org, under the heading, “Frankincense – Medicine for Wise Men & Women”:
Under the subheading, “Frankincense Cancer Research”:
o “Research shows that components of frankincense oil called boswellic acids have an anti-tumor effect on the following types of cancer cells, causing them to implode . . . Prostate cancer cells . . . Colon cancer cells . . . Cervical cancer cells . . . Bladder cancer cells . . . Leukemia cells . . . Melanoma and fibrosarcoma cells . . . Brain tumor cells.”
o “Boswellic acids also appear promising to help with multiple myeloma, and have general anti-cancer properties.”
Under the subheading, “In summary, frankincense oil”:
o “Is toxic only to cancer cells (unlike chemotherapy that kills healthy cells too) . . . Causes cancer cells to implode through ‘apoptosis’, the best way for cancer cells to go . . . Shrinks tumors in preliminary research with animals . . . Helps the body heal from all types of cancer in clinical data . . . Helps to prevent cancer – using it appears to lower risk of cancer . . ..”
在網站http://essentialsurvival.org，在標題《乳香——明志男女的藥物》之下
- 在副標題「乳香的癌症研究」之下：
- 「研究指出，乳香精油的成份乳香酸，有一種抗腫瘤效果，對以下類型癌細胞有作用，令它們內爆……前列腺癌細胞……結腸癌細胞……子宮頸癌細胞……膀胱癌細胞…………白血病細胞……黑色素瘤和纖維肉瘤細胞……腦腫瘤細胞。」
- 「乳香酸亦顯然有助於多骨髓瘤，而以有普遍的抗癌特性。」
- 在副標題「總結，乳香精油」之下：
- 「只對癌細胞有毒性（與化療不同，化療亦會殺死健康細胞）……透過『脫噬作用』，令癌細胞內爆，是最佳消滅癌細胞的方法……在初步動物研究中令腫瘤萎縮……臨床數據指出，有助於身體由所有種類的癌症中複原……有助預防癌症——使用它似乎降低患癌率……」
In addition, examples of claims that establish the intended use of your Young Living Essential Oil products found on the social media accounts (e.g., Facebook, Twitter, and Pinterest) of your consultants include, but may not be limited to, the following:
還有，以下是由你們顧問的社交媒體帳號（例如Facebook、Twitter，以及Pinterest）中，找到對你們Young Living精油産品聲稱的意圖用途，包括（但可能不限於）以下例子：
On Facebook.com:
www.facebook.com/theoildropper (August 11, 2014 posting) – “Be prepared for any virus that may attack! 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! . . . Many have found a protocol of essential oils and supplements have helped ease the symptoms of autism-related issues . . .”
在Facebook.com：
www.facebook.com/theoildropper（張貼於2014年8月11日）——「對所有可能攻擊你的病毒作用準備！伊波拉病毒不能在肉桂精油和牛至花精油面前生存。」
www.facebook.com/getwellwithoils（張貼於2014年8月9日）——「處理泛自閉症障礙的精油！……很多人都發現，使用精油和補充品，可有助減輕自閉症相關問題的症狀……」
On Twitter.com:
www.twitter.com/YLWaterloo (August 21, 2014 posting) – “Victory over arthritis! 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. Help 4 Vets that suffer PTSD”
在Twitter.com：
www.twitter.com/YLWaterloo（張貼於2014年8月21日）——「戰勝關節炎！使用 #YL薄荷精油 #YLPanaway精油 和 #YL乳香精油」
www.twitter.com/Oil_Distributor（張貼於2014年8月23日）——「#YoungLiving 其中一種新産品Freedom Sleep & Freedom Release kits。幫助了4位於有創傷後心理壓力緊張症候群（PTSD）的獸醫」
On Pinterest.com:
www.pinterest.com/naturesezremedy/young-living-testimonials/ – “Young Living Works! Lupus Gone”
www.pinterest.com/caricaraway/the-oil-dropper-young-living-essential-oils/ – “Young Living’s Orange. Try me for . . . Arteriosclerosis . . . Hypertension . . . Cancer . . . Insomnia . .
www.pinterest.com/yloilslady/heart-disease-treat-heart-disease-naturally-get-a-/
o “Heart Disease – Treat heart disease naturally. Get a Healthy Heart with Young Living Essential oils”
o “Heart disease can be prevented. Learn more – www.ylscents.com/ ... #heartdisease #essentialoil”
www.pinterest.com/pin/184225440979760087/ – “Essential Survival Daily Essential Oil Tip . . . Frankincense . . . For Alzheimer’s Disease . . ..”
在Pinterest.com：
www.pinterest.com/naturesezremedy/young-living-testimonials/ – 「Young Living真的有效！狼瘡消失了！」
www.pinterest.com/caricaraway/the-oil-dropper-young-living-essential-oils/ – 「Young Living的橙精油。可用來處理……動脈硬化……高血壓……癌症……失眠」
www.pinterest.com/yloilslady/heart-disease-treat-heart-disease-naturally-get-a-/
o 「心臟病——天然處理心臟病。使用Young Living精油，獲得健康心臟」
o 「可以預防心臟病。了解更多：www.ylscents.com/ ... #心臟病 #精油」
www.pinterest.com/pin/184225440979760087/ – 「每天生存必要的精油小提示……乳香……可處理阿茲海默症……」
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.
根據FD&C法的第201(g)(1)(B)段的規定，以上的聲稱，明顯地指出你們Young Living精油産品、「盜賊精油」、「肉桂樹皮」、「牛至花」、「免疫力精油」、「迷迭香」、「姚金娘」、「檀香木」、「桉藍」、「薄荷」、「依蘭」、「乳香」和「橙」都是藥物，因為它們是意圖用於診斷、治療、舒緩、處理，或預防疾病的物品。
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. § 321(p)], because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. Under sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 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. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
另外，根據FD&C法[21 U.S.C. § 321(p)]，「盜賊精油」、「肉桂樹皮」、「牛至花」、「免疫力精油」、「迷迭香」、「姚金娘」、「檀香木」、「桉藍」、「薄荷」、「依蘭」、「乳香」和「橙」亦是「新式藥品」，因為對於處方處理的情況、建議處理的情況，或標籤提出的情況，它們都並非普遍認為安全和有效的。根據FD&C法第301(d)和 505(a)段[21 U.S.C. §§ 331(d) and 355(a)]，一種新式藥品不可被引入進，或運送去引入進州際商業活動，除非FDA對該藥品的許可申請已生效。FDA會根據該藥品的安全性和有效性的科學數據和資料，去批准一種新式藥品。
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. § 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.
根據FD&C法第503(b)(1)(A)段[21 U.S.C. § 353(b)(1)(A)]的定義，你們的産品、「盜賊精油」、「肉桂樹皮」、「牛至花」、「免疫力精油」、「迷迭香」、「姚金娘」、「檀香木」、「桉藍」、「薄荷」、「依蘭」、「乳香」和「橙」，都是處方藥品，因為依據它們的毒性，或其他潛在的有害效果、它們的使用方法，或使用它們時附隨的必要措施，使用它們都並不安全，除非在法律許可的醫生監督下處方它。
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. § 352(f)(1)], in that the labeling for these products fail to bear adequate directions for use for all of their claims. “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. § 201.5). Prescription drugs can only be used safely at the direction, and under the supervision, of a licensed practitioner. Therefore, it is impossible to write “adequate directions for use” for a prescription drug to be used by a layperson. 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. §§ 201.100(c)(2) and 201.115). 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. 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. § 331(a)].
根據FD&C法第502(f)(1)段[21 U.S.C. § 352(f)(1)]，你們Young Living精油産品、「盜賊精油」、「肉桂樹皮」、「牛至花」、「免疫力精油」、「迷迭香」、「姚金娘」、「檀香木」、「桉藍」、「薄荷」、「依蘭」、「乳香」和「橙」亦是錯誤標籤的，在這些産品的標籤中，缺乏足夠使用指示，去指示它們聲稱的用途。「足夠使用指示」的意思是，能讓非專業人士安全地使用該藥品於其意圖用途的指示（21 C.F.R. § 201.5）。處方藥品只能在執業醫生的指示和監督下，才能安全地使用。所以，給非專業人士在處方藥品上寫下「足夠使用指示」，是不可能的。那些受FDA許可，並有著FDA許可標籤的處方藥物，是豁免於「給非專業人士足夠使用指示」這條件的（21 C.F.R. §§ 201.100(c)(2) and 201.115）。因此，由於這些産品沒有FDA許可的申請，而這些産品的標籤亦沒有對它們的意圖用途有足夠指示，所以，根據FD&C法第502(f)(1)段，這些産品是錯誤標籤的。引入一種錯誤標籤藥品，或運送去引入它至州際商業活動，是違反FD&C法第301(a)段[21 U.S.C. § 331(a)]的。
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist in connection with your products. 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. As such, the cited violations in this letter should not be viewed to apply solely to the specific products mentioned in this letter. It is your responsibility to ensure that all of your products are in compliance with all requirements of the Act and federal regulations. You should take prompt action to correct the violations cited in this letter. Failure to implement lasting corrective action on violations may result in regulatory action being initiated by FDA without further notice.
這信件所引述的違規，並不預期是有關你們産品的所有完整違規清單。雖然FDA在這信件上明確指明某些Young Living精油産品，但你們的顧問，對你們Young Living精油的廣泛産品都有著藥品聲稱。如此這般，這信件所引述的違規，都不應被視為僅僅應用於這信件提及過的特定産品。你們的責任是去確保你們所有産品都遵從FD&C法和聯邦條例的所有需求。你們應採取迅速行動，去修正這信件所引述的違規。沒有對違規作出永久性修正措施，FDA可能會發起管制行動，而不另行通知。
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. Under section 201(ff)(2)(A)(i) of the Act [21 U.S.C. § 321(ff)](2)(A)(i)], a dietary supplement is defined, among other things, as a product intended for ingestion. Topical products and other products that are not intended for ingestion are not dietary supplements. In any case, the claims referenced above in this letter are drug claims, which are not suitable claims for dietary supplements. 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.
我們注意到，你們Young Living精油的某些産品，被推廣為飲食補充品，但亦提供為局部使用，以及/或意圖用作吸入劑。根據FD&C法第201(ff)(2)(A)(i)段[21 U.S.C. § 321(ff)](2)(A)(i)]，一種飲食補充品，除了其他事項以外，被定義為一種意圖經口攝食的産品。局部使用的産品和其他並非意圖經口攝食的産品，都不是飲食補充品。在任何情況下，以上在信件引用的聲稱，都是藥品聲稱，都並不是適用於飲食補充品的聲稱。如此這般，根據FD&C法第201(g)(1)(B)段，不論以上提及的産品，是否意圖經口攝食的産品，它們都是藥品；並而根據FD&C法第201(ff)段，它們都不是飲食補充品。
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. In your response, include documentation of your corrective actions. 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.
我們要求你們，在收到此信件的15個工作天內，通知本辦事處，書面回覆你們執行修正措施的現況，以及你們對提及過的違規作出了的明確修正步驟。在你們的回覆中，應包含你們修正措施的文件。如果你們不能在回覆之前完成所有修正，我們預期你們會解釋你們延遲的原因，並請提供任何餘下修正措施的執行時間表。
If you need additional information or have questions concerning any products distributed through your website, please contact the FDA. You may respond in writing to LaTonya M. Mitchell, District Director, Denver District Office, Building 20 – Denver Federal Center, P.O. Box 25087, 6th Avenue & Kipling Street, Denver, Colorado 80225. If you have any questions concerning this letter, please contact Thomas R. Berry, PharmD, Compliance Officer, at 303-236-3028.
如果你需要更多資料，或有問題關於任何由你們網站發佈的産品，請聯絡FDA。你可以書面回覆至以下地址：LaTonya M. Mitchell, District Director, Denver District Office, Building 20 – Denver Federal Center, P.O. Box 25087, 6th Avenue & Kipling Street, Denver, Colorado 80225。如果你有任何問題關於這信件，請致電303-236-3028，聯絡合規官Thomas R. Berry, PharmD。
Sincerely,
/S/
LaTonya M. Mitchell
Denver District Director
Cc:
Cari Caraway (Consultant #1492362)
(b)(6)
cari@theoildropper.com
purelivingoil@gmail.com
Sarah Biskobing (Consultant #1583415)
(b)(6)
sarahbiskobing@gmail.com
Julie Behling-Hovdal (Consultant #853324)
(b)(6)
essentialsurvivalkit@gmail.com
Leslie Bartlett (Consultant #1591282)
(b)(6)
getwellwithoils@yahoo.com
Tracy Tait (Consultant #1638433)
(b)(6)
tracyyloils@gmail.com
Wendy Jewell (Consultant #1565867)
wendyjewell@youngliving.org
Lisa Krznarich (Consultant #1171668)
(b)(6)
lisa@naturesEZremedies.com
Jill Young (Consultant #28812)
(b)(6)
jillyoung@oilslady.com
jill@oilslady.com
[1] On your firm’s registration webpage, the consultant’s identification number will either pre-populate onto the registration form or consumers are asked to provide the referring consultant’s identification number.
在你們公司的註冊網頁裡，顧問的識別號碼要不是預先填寫在註冊表格上，就是詢問顧客提供轉介的顧問之識別號碼。
