Source: https://www.fda.gov/ICECI/EnforcementActions/Warningletters/ucm415809.htm
Timestamp: 2019-04-22 00:40:12+00:00

Document:
Your products are marketed through the website http://www.anytimeessentials.com/ and through paid "consultants," http://www.anytimeessentials.com/work-home/, otherwise referred to as "wellness advocates," http://www.mydoterra.com/. Your consultants promote your above mentioned dōTERRA Essential Oil products for conditions including, but not limited to, viral infections (including ebola), bacterial infections, cancer, brain injury, autism, endometriosis, Grave’s Disease, Alzheimer’s Disease, tumor reduction, ADD/ADHD, and other conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Moreover, your consultants redirect consumers to your website, www.doterra.com, to register as a customer or member (i.e., consultant), and to purchase your dōTERRA Essential Oil products.
o Both posts include a link to the website, www.anytimeessentials.com where disease claims can be found and where consumers can purchase products from your webpage, www.mydoterra.com/anytimeessentials.
It is clear from the above claims that your “Melaleuca,” “Oregano,” “On Guard,” “Clove,” “Eucalyptus,” “Frankincense,” “Geranium,” “Lavender,” “Lemongrass,” “Myrrh,” “Peppermint,” “Rosemary,” “Wintergreen,” “Cassia,” “Clary Sage,” and “Vetiver” are promoted for conditions that cause them to be 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, your products are “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 their 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 it. Your sale of these products without approved applications violates these provisions of the Act. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
Your products 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 them.
Your dōTERRA Essential Oil products, “Melaleuca,” “Oregano,” “On Guard,” “Clove,” “Eucalyptus,” “Frankincense,” “Geranium,” “Lavender,” “Lemongrass,” “Myrrh,” “Peppermint,” “Rosemary,” “Wintergreen,” “Cassia,” “Clary Sage,” and “Vetiver” 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. As previously mentioned, these dōTERRA Essential Oil products are offered for conditions, such as ebola virus infection, that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Therefore, adequate directions cannot be written so that a layman can use these drugs safely for those intended uses. 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). 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. Accordingly, the introduction or delivery for introduction into interstate commerce of your misbranded dōTERRA Essential Oil products 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 dōTERRA Essential Oil products in this letter, there are drug claims being made by your consultants for a wide range of your dōTERRA 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 products are marketed as dietary supplements, but are marketed for topical use. 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 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 dōTERRA Essential Oil products are drugs under section 201(g)(1)(B) of the Act and not dietary supplements under section 201(ff) of the Act.
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.

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