Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm416023.htm
Timestamp: 2019-04-19 12:23:32+00:00

Document:
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).
www.pinterest.com/caricaraway/the-oil-dropper-young-living-essential-oils/ – “Young Living’s Orange. Try me for . . . Arteriosclerosis . . . Hypertension . . . Cancer . . . Insomnia . .
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.
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.
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.
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)].
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.
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.
 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.

References: § 321
 § 353
 § 352
 § 201
 § 331
 § 321