- Promote Safety in Essential Oil and Aromatherapy Product Sales
- Educate about Dangerous and Illegal Medical Claims
- To work to positively influence the regulatory environment affecting the essential oil and aromatherapy product industry by demonstrating pro-active and effective self-regulation standards; focusing on ethics, safety, and integrity
- Advance the Efforts to Educate both Consumers and those Selling Essential Oils and Aromatherapy Products
- Officially structure the Trade Association as a not-for-profit
CURRENT STATE OF AFFAIRS
The public is at risk from the sale of essential oils with dangerous and illegal medical claims, by salespeople who promote their use both without the proper safety advice as well by promoting them for treating, curing or preventing illnesses which are not only unsubstantiated, but which can result in neurological damage, liver and/or kidney failure, even death.
The FDA recently sent WARNING LETTERs to two such companies. The reaction from the independent contractors selling these and other brands has been to “shoot the messenger”. They scheme to find loopholes such as using different sales and marketing language, completely missing the point – in many cases the claims they are making are false and dangerous claims, not just illegal.
The laws regulating the labeling and marketing of essential oils are nothing new, but the only enforcement by the FDA has been to confiscate the essential oils of one company, based upon the illegal medical claims made by another! So far, at least. Which is why now is the time to actively self-regulate our essential oil and aromatherapy products industry.
We believe the companies and the people who are selling essential oils safely, within the law, and for the proper purpose, should not be held accountable for those who are breaking laws and placing the public in danger. So our primary goal is promoting the safe sales of essential oils and aromatherapy products.
But we also feel that there are essential oils which have stood the test of time, and which salespeople should be able to sell with certain over-the-counter medical claims. There are essential oils which can be used just as safely and effectively as existing OTC drugs.
Example, in Canada, a company legally sells a blend of essential oils as a Sleep Aid. But, in the United States, any product marketed as a Sleep Aid is regulated as an over-the-counter (OTC) drug; the product has to contain FDA approved ‘active ingredients’ and be sold according to the proper monograph. [Such as 338.10(a)] Is Lavender essential oil, sold with proper safety advice, really a greater risk than the products examined in this FDA Consumer Health Information flyer? We think not.
One of our goals is to effectively decriminalize the sale of the following essential oils*, when sold for basic first aid and health care; the same conditions many existing over-the-counter medications are legally sold to treat, cure or prevent.
It is our plan, to submit either a Citizen Petition or a Time and Extent Application (TEA) to request to Amend the OTC drug monograph (rules) for this and a number of other conditions. UPDATE: we are also entertaining another approach, drafting a bill to change the regulations which pertain to essential oils when marketed for over-the-counter purposes.
Initially, we will focus on a short list of essential oils, which we can document are safe and appropriate for use without the supervision of a health care professional such as a physician. As part of our efforts, once approved, we will create an Open Source document which will reflect proper safety information including the appropriate dose and instructions for use. This way, suppliers and individuals who sell essential oils and whose products meet a monograph’s requirements, may market them legally without FDA review.
Our focus will be OTC conditions which fit under an existing monograph, rather than seeking approval through the “New Drug” application process.
Examples include: acne; sleep aid; cough/cold (expectorant); external analgesic (insect bite/sting); and skin protectant…all conditions which we feel essential oils can be used to treat safely and appropriately if consumers are protected with the proper safety information.
Consumers are already self-medicating with essential oils; sometimes under the guidance of a Qualified Aromatherapist. But too often, based on advice from a salesperson who may or may not have any actual training or education in the safe or appropriate use of essential oils for medicinal use. Our goal is to keep the practice of Aromatherapy self-regulated, as well as keep the tools of the Trade, essential oils, available to any consumer who wishes to purchase them…but with better and more accurate information about how they may be used both safely and appropriately.
*The first essential oils we select to submit will be selected from the following list:
Clary Sage (Salvia sclarea)
Eucalyptus (Eucalyptus globulus)
Frankincense (Boswellia carteri)
Geranium (Pelargonium graveolens)
Lavender (Lavandula angustifolia)
Lemon (Citrus limon)
Mandarin (Citrus nobilis)
Peppermint (Mentha x piperita)
Roman Chamomile (Anthemis nobilis)
Rose (Rosa damascena)
Rosemary (Rosmarinus officinalis)
Sweet Orange (Citrus sinensis)
Tea Tree (Melaleuca alternifolia
Ylang Ylang (Cananga odorata)