Legal Issues

ARC announces “Raindrop” Policy

The Aromatherapy Registration Council hereby formally clarifies its prohibition on the use or the teaching of “Raindrop Therapy”.

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Read the complete official Statement of Policy http://aromatherapycouncil.org/wp-content/uploads/2010/12/ARC-LH-RDT-Policy-Statement-Final-.pdf

To read the complete White Paper on Raindrop Therapy go to

Thank you to AEOTA Member, Kristin Barber, co-author of the White Paper, for her valuable contribution to our knowledge about the safe use of essential oils and practices.

About Dietary Supplements

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.

Dietary supplements are neither evaluated nor regulated for efficacy or safety under the Dietary Supplement Health and Education Act (DSHEA) of 1994. In addition, FDA approval is not required for dietary supplements to be marketed.

Topical products and other products that are not intended for ingestion are not dietary supplements.

Whether or not they are intended for ingestion, medical claims make a product a drug under section 201(g)(1)(B) of the Act; meaning a dietary supplement with medical claims, is no longer a dietary supplements under section 201(ff) of the Act. Both Young Living and doTerra were warned by the FDA for selling essential Oil products which they marketed as dietary supplements, but which are offered for topical use and/or intended for inhalation.

A *true* dietary supplement will be formulated to provide nutritional benefits missing from the diet – that is why they are called dietary supplements – they supplement the diet. The FDA regulation DSHEA also allows products to be formulated for and marketed with claims that they will impact the structure or function of the body. What is a structure/function claim? This page answers that question: 

One thing I have read more than a few times, which is false, is that the FDA Mandatory Disclaimer mean the FDA has approved the product. It ACTUALLY means the opposite!

” If a dietary supplement label includes such a claim, it must state in a “disclaimer” that FDA has not evaluated the claim. The disclaimer must also state that the dietary supplement product is not intended to “diagnose, treat, cure or prevent any disease,” because only a drug can legally make such a claim. “

This is basically a consumer WARNING not a FDA endorsement!

Essential oils sold as “dietary supplements” are doing so in order to take advantage of two *loopholes*: many essential oils are Generally Recognized as Safe as food flavorings, and the laws regulating dietary supplements [DSHEA] allows them to be marketed with the structure or function claims which are not allowed for essential oils sold for topical or inhalation use. They are NOT selling them as “dietary supplements” because they actually supplement the diet in any way. No ones diet is missing essential oils. They do not contain vitamins.

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Essential oils are occasionally ingested for medicinal/therapeutic purposes. Oral dosing has risks which often outweigh any potential benefits.

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FAQ – Product Labeling

Q. What can I put on my essential oil and/or aromatherapy product label?

A. Legally these products are cosmetics, so they need to be labeled according to FDA regulations for cosmetics.

 

Now the Essential Oil industry does encourage certain information for essential oil labels, but none of this is legally required. One resource is the American Herbal Products Association whose standards offer the following guidance “Trade Requirement & Guidance Policy for Labeling of Undiluted Essential Oils Used Topically and Offered for Retail Sale

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Marketing Terms – Guest Post, Martin Watt

In the middle 1990’s, the new trade organisations in the UK, the EOTA and Aromatherapy Trade Council (ATC), organised two meetings with an adviser to the Medicines Control Agency. The MCA had started to flex their muscles over medicinal claims which were banned way back in 1969, but which many aromatherapy outlets were ignoring. At this meeting, participants were given a list of terms that it was agreed we could use in trade literature relating to essential oils. It was made clear at that meeting that no words could be used which related to the physical medicinal uses of essential oils, unless the condition referred to was classified as a ‘normal life event’ such as morning sickness, birth, menstruation, menopause, etc. Many members of the Aromatherapy organisations attended that meeting. Most of them have more or less complied with these guidelines.

Permitted words:

  • BALANCING
  • CHEERING
  • COMFORTING
  • LIFTS
  • NORMALIZING
  • RELAXING
  • REFRESHING
  • RESTORATIVE
  • REVIVING
  • SOOTHING
  • STIMULATING
  • STRENGTHENING
  • TONIC
  • TONING
  • UPLIFTING
  • WARMING

Additional terms:

Relating to sleep: ENJOY AS YOU DRIFT OFF TO SLEEP

Relating to colds and catarrh: IDEAL DURING COLDS SEASON

This was a list of some of the permitted terms allowed in the UK in the past, but may not be the same in the USA.

Martin Watt

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FOOTNOTE: One of the benefits of Membership in the AEOTA, will be guidance documents, verified by the FDA, regarding acceptable cosmetic marketing terms for essential oils. You have questions, we will have answers…

How Can a Candle be a Drug?

Q. What if an essential oil is just *sold* for diffusing, like scenting a room, and not for topical use or for internal use. Do the rules for making medical claims still apply? What if that essential oil is used to scent a candle, can therapeutic claims really make a candle a drug?

A. Yes. The reason is, the aroma-chemicals which enter the air, are being introduced into the body by the process of inhaling. So even a candle can be a drug if a medical claim is made about it. Perfumes with medical claims would be a drug, too. And of course, a room fragrance with therapeutic claims would be considered a drug as well.

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If no medical claims are made, then the intended use determines what governmental agency regulates the product; so the perfume would be a cosmetic, and the candle or the *room fragrance* essential oil would be a household product, regulated by the Consumer Product Safety Commission.

Essential Oil Use in Professional Settings

Does the practice of using essential oils medically violate FDA regulations?

No. This was confirmed to me today with the following email reply:

States regulate how essential oils and aromatherapy products are used in professional settings - not the FDA.

So an AEOTA Member who accepts the Ethics Statement and agrees to follow FDA regulations, would not be in violation of FDA regulations (or the AEOTA Ethics Statement) if they used essential oils “off label” for medicinal purposes as part of their profession. The FDA regulations concern manufacturing, packaging, labeling and storage. Members do however, have to follow State Laws which regulate any licensing or CAM practices. Learn more about Aromatherapy and the Law.

Aromatherapy and the Law

Questions about who can practice aromatherapy and what the laws probably the most frequently asked question.

“In many states, a practitioner can be criminally charged with practicing medicine without a license for offering alternative therapies such as herbal medicine, homeopathy, and aromatherapy. This is also the root issue that spawned the “Health Freedom” movement, which supports patients’ rights to access alternative treatments and health practitioners of their choosing.” — Dorene Petersen

Read the complete article – LINKED WITH PERMISSION from
Dorene Petersen, President
American College of Healthcare Sciences

http://info.achs.edu/blog/the-aroma-of-choice-health-freedom-and-aromatherapy