精油傳銷公司的真實故事
內容全部由外國醫生及精油專家的公開文章翻譯,
亦提出了全部連結
總括來說,Gary Young是一名沒受過教育,並曾重覆偽造和誇大他證書的人。他曾最少兩次,因為健康詐騙相關的指控,而被逮捕。
他沒能認清他缺乏訓練和技術有限,造成了他自己嬰兒的死亡。他聲稱是一名虔誠和懼怕神的人,但他襲擊了他的家人。
他的著作,揭示了他對基本科學完全缺乏知識,更何況是精油般的深奧學科。
他診所的醫生曾經承認犯了殺人罪,造成一名朋友的死亡,並偽造她的死亡證明去嘗試掩飾罪行,而這醫生帶領著Gary Young的診所。
http://portexaminer.com/trade-data/kunshan-toxen-imp-exp-co-ltd-young-living-essential-oils/banqsha5454262/
從公開的入口資料可見,單單於2015年4月6日,Young Living 就從中國入口了2750公斤精油,當中申報時更列明包括冬青精油 (Wintergreen Essential)。直接由Young living郵寄至中立實驗室的檢測證實:
Young living 精油摻雜了人工肉桂醛、苯基戊二醛(同分異構物)、人工芳樟醇。
This sample has been adulterated with synthetic cinnamaldehyde, indicated by the presence of phenylpentadienal isomers. Synthetic linalool may also have been added.
檢測報告: http://holisticessentials.ca/download/test_reports/youngliving/Cinnamon-Bark-Lot-16121203.pdf
http://holisticessentials.ca/download/test_reports/youngliving/Cinnamon-Bark-Lot-14120235.pdf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。
使用精油導致受傷總結報告
http://aromatherapyunited.org/oct2015/
摘要聲明:
Dr Pappa 說他第一次聽到YOUNG LIVING是在Purdue University主講授課的時候。在他的講課完結之後,有YOUNG LIVING 的人想他去檢測他們售賣的茉莉精油(jasmine oil)。之後,Dr. Pappas發現被當作「純」茉莉精油當中,竟含有大量二丙二醇醚 DPG (dipropylene glycol)。
但YOUNG LIVING的代表竟要求他刪除其記錄!當然他並沒有,因為這些結果都是準確的。
諷刺的,幾年後,YOUNG LIVING請了Dr Pappa當他們的顧問,說是想改善其精油的品質。Dr Pappa以為他們是真的有心要改善,就接受了聘請。
不過,他入了YOUNG LIVING的廠時,就發現那所謂的樺木油Birch oil 並不是真的,事實上是水楊酸甲酯 (即冬青油!) 。 YOUNG LIVING 又叫他刪除其結果,甚至叫他道歉。Dr Pappa拿著報告,跟GARY YOUNG說,你聘請我是一場鬧劇,你只是想利用我的名聲來推銷你的精油!之後,他就離開YOUNG LIVING了。
Young的著作顯示他毫無科學/醫學常識,令Dr. Eva Briggs相信,這男人與他聲稱的精油權威沒有任何關係,然後Dr. Eva決定去調查他的背景。他聲稱,在他受到頭部創傷造成據說的「永久癱瘓」後,他發現了精油的治療力量。他聲稱發現了一種精油,根治了這假設的癱瘓,但他從沒有提供任何證明,不論是創傷,或他的奇跡根治。
在1980年代早期,Young搬遷到華盛頓的斯波坎(Spokane)。雖然他缺乏任何醫學、産科,或助産學的訓練,但他堅持讓他首位妻子在浴缸水中分娩。
他將那健康的嬰兒留在水底一小時。那本來健康正常的嬰兒淹死了。
https://adulteratedoils.wordpress.com/did-gary-young-murder-his-baby/Young聲稱,他後來在墨西哥經營了一間診所,使用扁桃苷(laetrile)去處理癌症病人。扁桃苷是一種無用和危險的藥物,能損害或殺害人體,因為它在身體中形成氰化物。這是違法的,而且這應是Young感到慚愧,而非自豪的事。
Young由墨西哥搬遷到加洲,並開設了一間診所,對癌症和其他疾病提供了所謂的療程。他不實地聲稱當時是一名醫生(M.D.)。在1988年加州,他由於出售無效和無價值醫學療程的多種指控,而被逮捕。
Young然後回到斯波坎地區。他由於使用斧頭襲擊多名家庭成員,在1994年1月10日被逮捕。這行為竟然是來自一名聲稱虔誠和靈性的人。
另外,Young聲稱的N.D.,或自然療法的醫生,又怎麼樣呢?它們都是虛假的。他的「學位」是一張無價值的紙,是由一間惡名昭彰的畢業證書製造廠Bernadean University中,購買所得的。帶著這張無價值的證書,Young從沒有在猶他州或其他地方,得到認可,去施行自然療法。
雖然Young缺乏教育,並有犯罪背景,YLEO的分銷商卻持續地支持他,有著迷信般的熱情。Young自己本身,似乎想宣傳他自己的「治療」想法。最終,在2000年10月,他在猶他州的史普林維爾,開辦了那自命不凡的天然藥物學院Young Life研究診所。
由於Young沒有牌照,他不能合法地檢查、診斷,或治療病人。他聘請了執業醫生去經營診所。醫學主管是兒科醫生Sherman Johnson, M.D.。
什麼類型的醫生,會願意為一名沒有牌照、沒受過教育、有犯罪記錄,並出版完全缺乏智力的書籍的人工作呢?我探索過Dr. Johnson的背景。
簡而言之,Johnson曾承認犯過殺人罪,那是由於他為他的病人(一名長久的女朋友)注射了過量致命的麻醉藥。他偽造了她的死亡證明去掩藏他的罪行。他的罪行被揭發,是由於一名護士懷疑,並要求調查,然後屍體就被掘出來。整個故事真是非常奇異,我建議讀者在我的Quackwatch文章(http://www.quackwatch.org/11Ind/young.html)中,閱讀更詳細敘述。
這診所的營運只接受現金。這讓他們避免健康保險公司和醫療照護和醫療救助服務中心(CMS)的規管性檢查。例如他們能明目張膽地進行實驗室試驗,而無需適當證書,因為他們不受CMS的處罰影響。FBI(美國聯邦調查局)本來是應該去執行這法律的,但它們忙碌於更重要的問題。
預期的病人必需支付$349的診所註冊費,然後會被建議接受一星期的療程,費用$2000至$3000美金。病人亦必需簽署一張表格,指出他或她不是報刊或任何規管代理機構的成員。另外,病人要支付食物、交通和住宿的費用。
Young Life研究診所的療程包括大份量只由YLEO出售的精油和營養補充品。根據一個在2002年Young Living大會上展示的個案,一名當時接受處理乳癌的女士,得到了一份「病人補充品建議方案」,她被建議服用14種不同補充品,每天總共超過65劑Young Living産品。
媽媽每日將一滴複方香薰精油塗於小朋友腳底,以防感冒,IFPA註冊香薰治療師兼導師林家儀(Kylie) 都有聽聞,「近年,這風氣在網上媽媽群組流傳得好快,好似覺得『精油搽腳底』之後,小朋友就會有一層防護膜保護!這問題在香薰治療師界議論紛紛,擔心家長誤用精油會影響小朋友健康。」
在精油的使用上,家長有不少謬誤,Kylie逐一拆解﹕
謬誤1﹕
精油提煉自天然植物,對人體沒有害處,嬰兒都可以放心使用!
不是。Kylie說,以現時市面上非常流行的一種複方精油(一般是混合三至四種精油的治療性精油)為例,內含肉桂皮、丁香、迷迭香、檸檬、尤加利等精油成分,並不適合小朋友使用。
「丁香、肉桂皮精油含有高的酚類(Phenol),藥性強,具抗病毒、殺菌、止痛作用;但危險度高,直接使用除了易刺激皮膚,亦可能影響肝臟功能。小朋友因未發育完成,情况更令人關注,恐加重肝臟負擔,故不適合使用;而成人亦要肝臟沒問題、非長期病患者的健康人士才適宜使用。」
酚類或損肝 樟腦誘發蠶豆症
「另外,這複方精油含迷迭香(Rosemary),亦要小心,部分人士使用後可出現強烈反應。因含樟腦成分,若蠶豆症(葡萄糖六磷酸脫氫酵素缺乏症,簡稱G6PD缺乏症)患者使用,嚴重可出現溶血現象,令血液缺氧,非常危險。最怕小朋友有隱性蠶豆症,用後出事,故不宜用於嬰兒或年幼的小朋友身上。即使大人用Rosemary都有禁忌,高血壓患者易血壓急升,頭暈、想嘔;心臟病患者易突然心跳加速;癲癇症患者則會誘發癲癇,故須避免使用。」
Kylie叮囑,家長不宜亂用坊間的複方精油,「不少精油都有使用禁忌,故很難有一種複方適合所有人使用。正統的香薰治療,是由香薰治療師,根據各種精油的特性、不同人的需要、身體狀况,調配出複方。因此事前諮詢、溝通、敏感測試都很重要」。
謬誤2﹕
香薰精油有治療功效,傷風感冒時,毋須食藥!
「首先,精油只有輔助作用,不能取代藥物及正規治療。一年前,FDA(美國食品及藥物管理局)規定銷售精油的公司,不能聲稱其產品具治療功效。」Kylie說。
輔助紓緩不適 不能代替退燒藥
「網上見過一宗個案,小朋友發高燒四十幾度,媽媽將薄荷精油當作退燒藥,每小時塗抹在小朋友腳底,小朋友不斷嗌『好辣』。其實精油不能亂用,薄荷精油劑量過多,可引致中毒,導致神經系統麻痺、停止呼吸,嚴重甚至猝死。小朋友發燒,家長與其不斷塗精油,為什麼不用暖水抹身,或餵食退燒藥呢?」Kylie指,應先經醫生斷症、處方藥物,有需要時才借助精油輔助,以紓緩不適徵狀,例如鼻塞時,可將尤加利、羅文沙葉精油滴於熱水中吸聞,以蒸氣薰鼻,紓緩鼻塞。
謬誤3﹕
一滴精油,劑量很少,不會引起大問題。
Kylie﹕「一滴精油,劑量絕不少!這一滴是由成千上萬的植物蒸餾而成,非常濃縮,通常三歲以下小朋友,必須將精油稀釋千分之一,即一滴精油須以50ml植物油作『底油』稀釋才使用,以免刺激及灼傷皮膚。直接將未經稀釋的精油塗抹在腳底,分量大大超出安全劑量。外國曾有嬰兒在塗抹性質溫和的薰衣草精油後,腳底皮膚被灼傷。」
3歲以下 每滴須用50ml底油稀釋
「除了皮膚損傷,精油亦會經皮膚走入血液,再經血液循環運行全身,每日一滴,可在體內累積,累積到某個階段後,有機會影響小朋友的免疫系統。」她提醒,不論男女老幼,外塗精油都必須經稀釋。
謬誤4﹕
將精油塗抹於腳底,最有效滲進體內,發揮功效!
正統的香薰治療,的確有外塗的用法,但並非塗抹於腳底。「若針對腳底對應身體不同部位的『反射區』塗抹精油,則有根據,但塗抹於整個腳底,則令人不解。因腳底的皮膚較厚,若想令精油滲進入皮膚吸收,為什麼不塗抹於其他部位?正確用法是先以植物油將精油稀釋,並塗抹於不適的位置,例如喉嚨不適,則塗抹於喉嚨位置。」Kylie說。
謬誤5﹕
內服精油,療效更強!
Kylie表示,內服精油的問題很值得關注。「最近在facebook見到一個恐怖的個案,一個男人傷風感冒,太太將精油滴入膠囊內,讓他吞服。從前香薰治療確實有此用法,但後來不少人因誤服不當分量而中毒。於是,幾個國際認可的大型香薰治療師協會,包括英國IFPA、IFA、美國NAHA,均在十多年前禁止內服精油,認為有風險。外國亦曾有內服精油後,消化道遭灼傷的案例。」
內服有灼傷中毒風險
她補充,精油濃度很高,甚至是帶酸性、腐蝕性的物質,因此才需要用玻璃瓶存放。「過往曾有香薰治療師做過測試,將精油滴在發泡膠杯上,發現發泡膠有溶解迹象。所以,怎麼會有人膽敢內服精油?」
■用得安全
宜選溫和種類 擴香器散發香氣
Kylie說,藉精油對抗流感,這觀念並非錯誤,但必須認清使用方法及精油性質,以確保安全,可嘗試以下方式﹕
將精油以擴香器擴香,散發到空氣中,為該空間內的空氣殺菌、抗病毒。「檸檬、薑、羅文沙葉、薰衣草、松樹等精油,性質較溫和,小朋友亦適宜使用。精油通常不會單一使用,因此可將這類精油,每次抽三至四種混合使用,透過協同效應,令功效和氣味達至和諧。使用時,每種各用兩滴,一共六至八滴精油滴在擴香器中,日間用兩至三小時已足夠。」
混合精油使用 須不時轉款
精油經擴香才使用,可減低劑量,令它不會於身體累積,造成負擔。而精油亦毋須每日使用,且精油配方應不時轉換,否則會在身體適應後,影響效用。
文:吳穎湘
圖:吳穎湘、資料圖片
編輯:屈曉彤
近期多個社交網站的熱門煮食專頁,興起提倡精油煮食,引發不少爭議,有支持者稱燒烤、飲果汁也落一、兩滴,甚至上載圖片與網民分享,反對者則擔心食用精油不當,隨時損害健康。
IFPA註冊香薰治療師及香薰治療師林家儀表示,極為關注提倡精油煮食的情況,她提醒市民誤用精油有一定危險性,更點出4種或被用作煮食的危險精油,警告可能導致傷害肝臟惡果。
林家儀表示,煮食以新鮮食材最好,以精油煮食即內服精油,具有危險性,因不同精油化學成分不一樣,或會影響身體。
她舉例說,被指可煮食的羅勒精油,當中含有草蒿腦(Estragole),而草蒿腦已被證實有致癌的風險,早年香港曾流行食用的明列子,即羅勒種子,食物安全中心亦曾發指引說明過量服用的風險,而羅勒精油中草蒿腦的含量,更是遠超食物中的含量,長期食用致癌風險亦會隨之增加。
另一或被用來煮食的丁香精油,林家儀亦指內服有危險,因丁香精油含90%丁香酚,而丁香酚已證實對黏膜組織有刺激性,若沒經稀釋的丁香精油刺激到黏膜會令服用者有痲痺的現象,「由口腔開始到胃部就全都是黏膜組織,可想而知刺激性會有多大」。
她又指丁香精油中的丁香酚,會抑制肝臟中其中酵素榖胱甘肽的形成,她解釋這是一種可以分解毒素的酵素,如肝臟中這種酵素用盡,又未能及時產生,當人體吃了含毒性的食物,就沒辦法即時分解,會提高中毒既風險。
林家儀另指,檸檬草精油含有75%檸檬醛,有研究報告指出在猴子測試中發現,日服極低劑量也會使猴子眼壓增加,擔心檸檬醛或令服用者眼球受壓,對青光眼患者尤其危險,而對眼球未發育完成的小孩,亦同樣存有風險。
至於薄荷油中含有薄荷酮,林家儀指如內服薄荷酮會分解代謝為薄荷呋喃,或會破壞重要的肝細胞色素P450,此酵素在肝臟中肩負起分解藥物或致癌物的重任,若此酵素被破壞會造成嚴重的肝損害。
林家儀重申一般外用再加上稀釋精油,沒有相關風險,但精油煮食後內服,當有關的致癌物進入身體後,肝臟便難以代謝,致癌風險亦相對提高很多,「不要以為每天一、兩滴不會出事,這一、兩滴精油未必是即時排出體外,當有一天損肝到無法負荷時,身體問題亦隨之而生」。
她特別提醒,內服精油對懷孕婦女、小童、癌症患者及長期病患者影響較大,食用過多或致中毒風險,「媽媽煮小童就會食,如果由細食到大,隨時係食致癌物質到大」,希望家長們注意。
2015年10月
本報告的目的:
本報告的目的是要透過案例通報告知公眾有關使用精油後的不良效果,以致能夠更深入了解不安全使用後的影響。
本報告是:
本報告是由直接受到精油影響人士的經驗,又或直接觀察使用單方∕複方精油後不適人士的總結。並由以上人士完成報告。總結報告(以下)旨在向讀者提供通報個案的綜合觀。查看此表格後,請單擊鏈結以轉到提供額外資料的原始數據收集報告,如使用數量和額外獨立證供。
研究方法:
「純粹的現象學研究以尋找本質上的描述而不是作出解釋,由一個任意假設或沒有偏見的觀點開始(胡塞爾 1970)。」這個過程沒有前設或偏見,隨著數據的增長,模式就會出現。第一個報告有34份。這份報告包含剛才提及的34份已接近50份多。
資料的收集方法:
資料由經歷該事件的人,或直接觀察使用單方∕複方精油的人以匿名報告格式輸入。所有人均以電郵、全名∕首字母確定為認可人士。所有資料都直接由報告中剪下和貼上到原始數據報告中,當中沒有經過任何修改,這是一份總結。
未包括的報告:
有6份沒有包括在本報告內:3份使用了精油,但沒有不良影響;1份使用了好幾種產品當中包含特殊的精油,2份是道聽途說並沒有目擊事件經過。
摘要聲明:
Number of Reports 報告數目 |
133 |
Sex of Injured Individuals 受傷人士性別 |
121 Females 15 Males 121 女 15 男 |
Age Category 年齡組別 | Number of individuals 人數
|
Infants/Toddlers (ages 0-2 years) 嬰兒∕幼童(0-2歲) | 6 |
Children (ages 3-12) 兒童(3-12歲) | 10 |
Adolescents (ages 12-18) 青少年(12-18歲) | 1 |
Adults (ages 18-59) 成年人(18-59歲) | 107 |
Elderly (60+) 長者(60+) | 11 |
Essential Oil Blends Used 使用的複方精油 | |||
Blend Name 複方精油名稱 | Number of individuals that reported usage 使用複方精油後通報人數 | ID Numbers 識別號碼 | |
Anti-Anxiety (Plant Therapy, the name of this blend has been changed to Stress Free Synergy) 抗焦慮(植物療法,這種混合物的名稱已改變成無壓力複方) | 1 reported usage 1份使用報告 | 84 | |
Aromatouch Technique (dōTERRA) | 1 reported usage 1份使用報告 | 115 | |
Balance (dōTERRA) | 1 reported usage 1份使用報告 | 8 | |
Breathe (dōTERRA) | 4 reported usages 4份使用報告 | 17, 68, 90, 95 | |
Chill Pill (Aura Cacia) | 1 reported usage 1份使用報告 | 28 | |
Christmas Spirit (Young Living) | 1 reported usage 1份使用報告 | 69 | |
Citrus Bliss (dōTERRA) | 2 reported usages 2份使用報告 | 18, 107 | |
ClaryCalm | 1 reported usage 1份使用報告 | 85 | |
Deodorant (home crafted) | 1 reported usage 1份使用報告 | 37 | |
DigestZen (dōTERRA) | 5 reported usage 5份使用報告 | 6, 57, 91, 106, 116 | |
Deep Blue (dōTERRA) | 2 reported usages 2份使用報告 | 93, 109 | |
Deep Blue Rub (dōTERRA) | 1 reported usage 1份使用報告 | 124 | |
Germ Fighter (Plant Therapy) 1 | 1 reported usage 1份使用報告 | 21 | |
InTune (dōTERRA) | 1 reported usage 1份使用報告 | 133 |
Joy (Young Living) | 3 reported usage 3份使用報告 | 30, 42, 98 |
LavaDerm (Young Living) | 1 reported usage 1份使用報告 | 102 |
Omega Complex (dōTERRA) | 1 reported usage 1份使用報告 | 27 |
On Guard (dōTERRA) | 11 reported usage 11份使用報告 | 12, 39, 40, 65, 74, 76, 80, 86, 90, 91, 110 |
PanAway (Young Living) | 1 reported usage 1份使用報告 | 78 |
Past Tense (dōTERRA) | 3 reported usage 3份使用報告 | 13, 91, 132 |
Peace and Calming (Young Living) | 2 reported usages 2份使用報告 | 63, 131 |
Purification (Young Living) | 5 reported usage 5份使用報告 | 10, 35, 53, 54, 75 |
R.C. (Young Living) | 1 reported usage 1份使用報告 | 87 |
Serenity (dōTERRA) | 3 reported usages 3份使用報告 | 84, 107, 129 |
Slim and Sassy (dōTERRA) | 6 reported usages 6份使用報告 | 4, 5 , 8, 25, 48, 110 |
Slim & Sassy gelcaps (dōTERRA) | 1 reported usage 1份使用報告 | 116 |
Slique (Young Living) | 1 reported usage 1份使用報告 | 83 |
Stress Away (Young Living)
| 1 reported usage 1份使用報告 | 75 |
Thieves (Young Living) | 7 reported usages 7份使用報告 | 76, 45, 53, 69, 21, 96, 98 |
Unidentified 未能識別 | 1 reported usage 1份使用報告
| 12 |
Unknown 未知 | 1 reported usage 1份使用報告 | 47 |
Various 多種 | 1 reported usage 1份使用報告 | 41 |
Verage Face Product (dōTERRA) Verage面部產品(多特瑞) | 1 reported usage 1份使用報告 | 72 |
Zendocrine capsules (dōTERRA) 元氣複方膠囊(多特瑞) | 1 reported usage 1份使用報告 | 116 |
Single Essential Oils Used 單方精油的使用 | ||
50 report usage 50份使用報告 | ID# 1, 3, 11, 13, 14, 15, 20, 22, 23, 24, 26, 31, 32, 33, 34, 35, 36, 38, 46, 50, 51, 52, 53, 55, 56, 60, 61, 66, 67, 79, 80, 82, 86, 87, 92, 94, 97, 103, 105, 108, 111, 113, 114, 117, 119, 121, 122, 123, 128, 129 | |
Combination of More Than One Oil Used 使用多於一種精油的組合 | ||
31 report usage 31份使用報告 | ID# 2, 9, 13, 16, 19, 29, 44, 49, 59, 62, 64, 70, 71, 72, 73, 77, 81, 90, 93, 99, 100, 101, 106, 110, 112, 118, 120, 125, 127, 129, 132 | |
Brand Names reported 品牌名稱報告 | |||||
Name of the Company 公司名稱 | Total Reported 報告總數 | Pre-formulated Blends 預先調製複方精油 | Single Essential Oils 單方精油 | Combination Oils 混合精油 | |
Aura Cacia | 2 report 2份報告 | 1 reported (ID# 28) 1項通報 |
| 1 reported (ID# 100) 1項通報 | |
dōTERRA 多特瑞 | 69 reports 69份報告 | 34 reported (ID# 4, 5, 6, 7, 8, 12, 13, 17, 25, 27, 37, 39, 40, 48, 57, 65, 68, 72, 74, 76, 80, 84, 85, 86, 90, 95, 106, 107, 109, 110, 116, 123, 132, 133) 34項通報 | 20 reported (ID# 3, 11, 13, 14, 15, 20, 23, 24, 50, 51, 55, 60, 61, 66, 80, 95, 116, 119, 122, 130) 20項通報 | 21 reported (ID# 9, 13, 19, 29, 64, 62, 71, 72, 77, 90, 93, 99, 101, 106, 112, 115, 116, 120, 125, 129, 132) 21項通報 | |
Joy of the Mountains | 1 report 1份報告 |
| 1 reported (ID# 1) 1項通報 |
| |
Mountain Rose Herbs | 2 report 2份報告 |
| 2 reported (ID# 24, 52) 2項通報 |
| |
Native American Nutritionals | 1 report 1份報告 | 1 reported (ID# 43) 1項通報 |
|
| |
NOW | 4 reports 4份報告 |
| 3 reported (ID# 31, 103, 111) 3項通報 | 1 reported (ID# 101) 1項通報 | |
NYR Organics | 1 report 1份報告 |
| 1 reported (ID# 22) 1項通報 |
| |
The perfumery | 1 report 1份報告 |
|
| 1 reported (ID# 62) 1項通報 | |
Plant Therapy 1 | 1 report 1份報告 | 1 reported (ID# 84) 1項通報 |
|
| |
Rite Aid | 1 report 1份報告 |
| 1 reported (ID# 89) 1項通報 |
| |
Simplers Botanicals | 1 report 1份報告 |
| 1 reported (ID# 87) 1項通報 |
| |
Spark Naturals | 1 report 1份報告 | 1 reported (ID# 105) 1項通報 |
|
| |
Won with Nature | 1 report 1份報告 |
| 1 reported (ID# 26) 1項通報 |
| |
Young Living | 44 reports 44份報告 | 21 reported (ID# 27, 37, 39, 40, 48, 57, 65, 68, 69, 72, 74, 75, 76, 78, 80, 83, 88, 96, 98, 102, 131) 21項通報 | 16 reported (ID# 3, 20, 35, 46, 53, 79, 82, 94, 108, 110, 113, 114, 117, 125, 126, 128) 16項通報 | 6 reported (ID# 71, 72, 77, 70, 73, 118) 6項通報 | |
Diluted or Undiluted 稀釋或未經稀釋 | ||
Undiluted/Neat 未經稀釋∕純正 | 77 reported usages 77份使用報告 | |
Diluted in Water 用水稀釋 | 26 reported usages 26份使用報告 | |
Diluted 稀釋 | 18 reported usages 18份使用報告 | |
Diluted after application 塗抹後稀釋 | 6 reported usages 6份使用報告 | |
Route of Administration 使用方法 | ||
Oral Ingestion 口服 | 30 reported usages 30份使用報告
| |
Oral in capsule 吞服膠囊 | 13 reported usages 13份使用報告 | |
Topical 局部 | 79 reported usages 79份使用報告 | |
Inhaled 吸入 | 19 reported usages 19份使用報告 | |
Where Oil Was Applied 精油使用部位 | ||
Abdomen 腹部 | 1 reported usage 1份使用報告 | |
Armpits 腋下 | 2 reported usages 2份使用報告 | |
Back 背部 | 6 reported usages 6份使用報告 | |
Breast 乳房 | 1 reported usage 1份使用報告 | |
Chest 胸部 | 8 reported usages 8份使用報告 | |
Face 面部 | 6 reported usages 6份使用報告 | |
Feet 腳部 | 14 reported usages 14份使用報告 | |
Finger 手指 | 3 reported usages 3份使用報告 | |
Hands 手部 | 5 reported usages 5份使用報告 | |
In mouth 口腔 | 2 reported usages 2份使用報告 | |
Inhaled through nose and mouth 透過鼻和口吸入 | 18 reported usages 18份使用報告 | |
Inside Ears 耳內 | 1 reported usage 1份使用報告 | |
Knees 膝蓋 | 1 reported usage 1份使用報告 | |
Leg 腿部 | 1 reported usage 1份使用報告 | |
Lip 嘴唇 | 2 reported usage 2份使用報告 | |
Neck 頸部 | 13 reported usages 13份使用報告 | |
Nose 鼻 | 2 reported usage 2份使用報告 | |
Orally 口服 | 43 reported usages 43份使用報告 | |
Shoulder 肩膀 | 2 reported usages 2份使用報告 | |
Skin 皮膚 | 3 reported usages 3份使用報告 |
Spine 脊柱 | 1 reported usage 1份使用報告 |
Temples 太陽穴 | 1 reported usage 1份使用報告 |
Throat 喉部 | 3 reported usage 3 份使用報告 |
Vagina 陰道 | 1 reported usage 1份使用報告 |
Whole body/foot bath 全身∕足浴 | 4 reported usages 4份使用報告 |
Wrist 手腕 | 1 reported usage 1份使用報告 |
Non Specific 沒有指明 | 10 reported usages 10份使用報告 |
Oil over 6 months oil 使用出產6個月以上的精油 | ||
This question was answered but it would be difficult to know unless there was a distillation date on the product. People answered based on how long they had the essential oil/blend in their possession. 這條問題雖然得到回覆,除非在產品上印有蒸餾日期,否則使用者很難知道。使用者根據他們擁有單方∕複方精油的時間長短而回答。 | ||
No否 | 91 | |
Yes是 | 8 | |
Unknown不知道 | 29 | |
No comment 無可奉告 | 2 | |
Description of Adverse Effect/Injury 不良影響∕受傷的描述 | ||
These were the combined descriptions of effects “During and Immediately Afterwards” 這是對不良影響的綜合描述 「在使用期間和之後」 | ||
Description 描述 | Total Number of Reports 報告總數 | ID Numbers 識別號碼 |
Application site was irritated/ inflamed 使用部位感刺激∕發炎 | 11 | 18, 75, 57, 4, 5, 22, 27, 40, 85, 114, 130 |
Boils/Blisters/ welts/sores 腫脹∕水泡∕傷痕∕潰瘍 | 7 | 57, 30, 31, 60, 87, 109, 114 |
Burning sensation 灼燒感覺 | 26 | 6, 39, 8, 15, 21, 32, 43, 44, 46, 52, 56, 62, 78, 79, 87, 90, 92, 93, 97, 102, 103, 114, 119, 120, 122, 131 |
Cold sweats/chills 冷汗∕發抖 | 1 | 80 |
Coughing/gagging 咳嗽∕作嘔 | 4 | 52, 34, 17, 69 |
Cyst 囊腫 | 1 | 101 |
Delusions/Cognitive dysfunction/ anxiety/irritability 妄想∕認知功能障礙∕焦慮∕煩躁 | 4 | 13, 58, 54, 74 |
Diarrhea 腹瀉 | 3 | 48, 6, 61 |
Difficulty breathing/shortness of breath 呼吸困難∕呼吸急促 | 6 | 76, 34, 63, 82, 68, 127 |
Disoriented 迷失方向 | 2 | 3, 58 |
Dizzy/lightheaded 眩暈∕頭暈 | 5 | 74, 53, 49, 3, 86 |
Face flushed/puffy 面部潮紅∕浮腫 | 2 | 67, 72 |
Fever 發燒 | 1 | 68 |
Flatulence /gassy 腸胃脹氣∕放屁 | 2 | 48, 58 |
Foaming at mouth 口腔起水泡 | 1 | 68 |
General Malaise 身體不適 | 1 | 99 |
GI upset 腸胃不適 | 11 | 20, 58, 6, 23, 39, 47, 48, 57, 70, 71, 77 |
Itching 發癢 | 19 | 30, 23, 24, 28, 29, 34, 37, 64, 67, 72, 75, 81, 85, 88, 96, 99, 105, 111, 112 |
Migraine/Headache 偏頭痛∕頭痛 | 9 | 2, 7, 9, 13, 20, 33, 42, 54, 58 |
Muscles tight/spasm/ache/ nerve pain 肌肉緊張∕痙攣∕疼痛∕神經痛 | 1 | 58 |
Nausea 噁心 | 8 | 58, 74, 53, 23, 47, 70, 42, 33 |
Rapid Heartbeat/elevated bp/ palpitations 心跳快∕血壓升高∕心悸 | 6 | 13, 74, 25, 53, 95, 127 |
Rash-red bumps/hives 紅腫的皮疹∕蕁麻疹 | 25 | 37, 72, 81, 1, 12, 16, 18, 19, 63, 66, 82, 87, 88, 90, 91, 98, 109, 110, 111, 116, 118, 122, 125 |
Relaxation 肌肉鬆弛 | 1 | 84 |
Seizure 疾病的發作 | 2 | 68,100 |
Sneezing/sniffling/Runny Nose 打噴嚏∕抽鼻子∕流鼻水 | 2 | 13, 41 |
Swelling 腫脹 | 2 | 45, 102 |
Thirst 口渴 | 2 | 4, 5 |
Tightening/scratchy/sore throat 拉緊∕刮痕∕喉嚨痛 | 5 | 69, 77, 76, 80, 120 |
Tingling and Redness 刺痛和發紅 | 4 | 49, 63, 64, 50 |
Tired/Fatigue 疲倦∕勞累 | 4 | 20, 42, 58, 86 |
Vomiting 嘔吐 | 5 | 58, 53, 33, 73, 110 |
Watery/inflamed eyes 眼睛充滿淚液∕受感染 | 3 | 55, 69, 120 |
Effects Sometime Later 隨後的影響 | |||
Description 描述 | Total Number of Reports 報告總數 | ID Numbers 識別號碼 | |
Anaphylaxis 過敏反應 | 1 | 94 (The anaphylaxis was not from an acute exposure to an oil, but was thought to be from chronic excessive oral use of frankincense, sensitizing the system to other things) 94(過敏反應不是由於即時接觸到精油所致,而是長期過度口服乳香導致身體對其他物質敏感而造成) | |
Application site was irritated/ inflamed 使用部位感刺激∕發炎 | 4 | 11, 26, 35, 85 | |
Bladder leaking 膀胱漏尿 | 1 | 36 | |
Boils/Blisters/ welts/sores 腫脹∕水泡∕傷痕∕潰瘍 | 6 | 59, 65, 87, 106, 109, 133 | |
Burning 灼熱 | 8 | 45, 83, 57, 87, 97, 103, 129, 131 | |
Cold sweats/chills 冷汗∕發抖 | 1 | 59 | |
Cough 咳嗽 | 1 | 86 | |
Difficulty breathing/shortness of breath 呼吸困難∕呼吸急促 | 3 | 59, 82, 98 | |
Difficulty concentrating 難以集中 | 1 | 121 | |
Fever 發燒 | 2 | 62, 98 | |
Fatigue 疲勞 | 3 | 95, 115, 121 | |
Flatulence /gassy 腸胃脹氣∕放屁 | 1 | 19 | |
General malaise/flu-like symptoms 身體不適∕類似流感症狀 | 1 | 115 | |
GI Upset 腸胃不適 | 4 | 70, 77, 51, 93 | |
Heart Attack 心臟病發 | 1 | 59 | |
Headache 頭痛 | 1 | 106 | |
Itchy 發癢 | 17 | 57, 75, 10, 65, 14, 22, 60, 85, 99, 103, 105, 106, 107, 108, 126, 129, 132 | |
Insomnia 失眠 | 3 | 93, 95, 128 | |
Migraine/Headache 偏頭痛∕頭痛 | 3 | 8, 86, 115 | |
Muscles tight/spasm/ache/ nerve pain 肌肉緊張∕痙攣∕疼痛∕神經痛 | 3 | 62, 46, 113 | |
Nausea 噁心 | 5 | 62, 59, 53, 93, 98 | |
Pain in chest 胸口痛 | 2 | 83, 86 | |
Permanent scaring 永久的傷痕 | 4 | 29, 32, 79, 51 | |
Prescription Medication Stopped Working 處方藥物失效 | 1 | 84 |
Rapid Heartbeat/elevated bp 心跳快∕血壓升高 | 1 | 59 |
Rash-red bumps/hives 紅腫的皮疹∕蕁麻疹 | 14 | 82, 1, 42, 27, 10, 98, 106, 107, 109, 117, 122, 124, 125, 132 |
Red/dry 發紅∕乾燥 | 7 | 75, 64, 90, 96, 108 |
Sensitivity to Sun 對陽光敏感 | 1 | 132 |
Scarring 疤痕 | 1 | 103 |
Swelling 腫脹 | 3 | 45, 98, 107 |
Tenderness where oil was applied 塗抹精油的位置壓痛 | 1 | 101 |
Tightening/scratchy/sore throat 拉緊∕刮痕∕喉嚨痛 | 2 | 83, 17 |
Tight Skin 皮膚拉緊 | 1 | 108 |
Vomiting 嘔吐 | 1 | 19 |
Watery/inflamed eyes 眼睛充滿淚液∕受感染 | 1 | 27 |
Weakness 虛弱 | 1 | 121 |
Weight Loss 體重減輕 | 1 | 121 |
Sought Medical Attention 尋求治療 | |||
Listed are the types of medical intervention, or medication. It is worthy to note that one individual may have sought medical treatment/opinions from more than one provider. 以下列出的是醫療介入或藥物治療。值得注意的是使用者可能已經從多過一個供應者中尋求治療∕意見。 | |||
Health Care Intervention 醫療保健介入 | Total Number of Reports 報告總數 | ID Numbers 識別號碼 | |
Called Poison Control 致電毒物控制中心 | 1 | 126 | |
Chinese Doctor 中醫 | 1 | 10 | |
Dermatologist 皮膚科醫生 | 2 | 65, 75 | |
ENT 耳鼻喉科 | 1 | 45 | |
General Practitioner 家庭醫生 | 12 | 1, 10, 17, 26, 51, 58, 101, 106, 109, 119, 124, 133 | |
Japanese Fungus Expert 日本真菌專家 | 1 | 18 | |
Medical Center/Urgent Care Center/ ER 醫療中心∕緊急護理中心∕急症室 | 21 | 13, 26, 32, 41, 42, 45, 46, 53, 58, 59, 65, 68, 72, 77, 79, 82, 83, 94, 100, 107, 121 | |
Naturopath (N.D.) 自然療法醫生 | 4 | 4, 19, 36, 125 | |
Neurologist 神經病學家 | 1 | 58 | |
OB/GYN 婦產科 | 1 | 79 |
OTC Medication 非處方藥物 | 13 | 24, 34, 70, 81, 91, 98, 102, 107, 111, 114, 126, 129, 132 |
Pediatrician 兒科醫生 | 1 | 10 |
Prescription Medication 處方藥物 | 10 | 8, 9, 46, 82, 106, 107, 114, 119, 127, 133 |
Psychiatrist 精神科醫生 | 1 | 10 |
Upon Whose Advice/aka What Type of Essential Oil Session Did You Receive 使用者受誰人意見而選擇何種精油 | |||
Most reports did not identify an individual; however this is what could be identified from the information provided in the report. 大多報告都未有確認出是誰;但在這報告中提供的資料是可確定的。 | |||
Description of Session/ Person 情況或人士的描述 | Total Number of Reports 報告總數 | Reports ID Number 報告識別號碼 | |
Sales Representative 銷售員 | 38 | 3, 10, 12, 15, 30, 51, 55, 57, 65, 71, 78, 79, 53, 66, 73, 85, 86, 88, 91, 93, 95, 96, 101, 102, 105, 106, 109, 110, 112, 114, 116, 117, 118, 120, 128, 129, 130, 131 | |
Nurse 護士 | 3 | 8, 9, 32 | |
Aromatouch 芳香療法 | 3 | 7, 8, 9 | |
RDT 注冊戲劇治療師 | 1 | 49 | |
Body Worker/Massage Therapist 身體能量工作者∕按摩治療師 | 2 | 41, 50 | |
You Tube | 1 | 26 | |
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”
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.”
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:
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:
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:
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
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
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
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
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。