The use of fragrances and essences from plants to affect or alter a person's mood or behavior and to facilitate physical, mental, and emotional well-being. The chemicals comprising essential oils in plants has a host of therapeutic properties and has been used historically in Africa, Asia, and India. Its greatest application is in the field of alternative medicine. (From Random House Unabridged Dictionary, 2d ed; from Dr. Atiba Vheir, Dove Center, Washington, D.C.)

Essential oils, which are obtained through mechanical pressing or distillation, are concentrated plant extracts that retain the natural smell and flavor of their source. Each essential oil has a unique composition of chemicals, and this variation affects the smell, absorption, and effects on the body. The chemical composition of an essential oil may vary within the same plant species, or from plant to plant. As an example of how concentrated essential oils are, 220 pounds of lavender flowers are required to produce approximately one pound of lavender oil. Synthetic oils are not considered true essential oils.

You may see fragrance products, such as “essential oils,” marketed with “aromatherapy” claims that they will treat health problems or improve well-being. Who regulates these products, and how? Find answers here.

What's the "intended use"?

Under the law, how “aromatherapy” products are regulated depends mainly on how they are intended to be used.

FDA determines a product’s intended use based on factors such as claims made in the labeling, on websites, and in advertising, as well as what consumers expect it to do. We also look at how a product is marketed, not just a word or phrase taken out of context. Finally, we make decisions on a case-by-case basis.

Is it a cosmetic?

If a product is intended only to cleanse the body or to make a person more attractive, it’s a cosmetic. So, if a product such as a shower gel is intended only to cleanse the body, or a perfume or cologne is intended only to make a person smell good, it’s a cosmetic.

The law doesn’t require cosmetics to have FDA approval before they go on the market. But FDA can take action against a cosmetic on the market if we have reliable information showing that it is unsafe when consumers use it according to directions on the label, or in the customary or expected way, or if it is not labeled properly.

Is it a drug?

If a product is intended for a therapeutic use, such as treating or preventing disease, or to affect the structure or function of the body, it’s a drug. For example, claims that a product will relieve colic, ease pain, relax muscles, treat depression or anxiety, or help you sleep are drug claims.

Such claims are sometimes made for products such as soaps, lotions, and massage oils containing “essential oils” and marketed as “aromatherapy.” The fact that a fragrance material or other ingredient comes from a plant doesn’t keep it from being regulated as a drug.

Under the law, drugs must meet requirements such as FDA approval for safety and effectiveness before they go on the market. To find out if a product marketed with drug claims is FDA-approved, contact FDA’s Center for Drug Evaluation and Research (CDER), at druginfo@fda.hhs.gov.

Is it both a cosmetic and a drug?

Some products are both cosmetics and drugs. For example, a baby lotion marketed with claims that it both moisturizes the baby’s skin and relieves colic would be both a cosmetic and a drug. Such products must meet the requirements for both cosmetics and drugs.

Is it something else?

Some fragrance products are regulated by the Consumer Product Safety Commission (CPSC). These include products such as air fresheners, scented candles, laundry detergents, and household cleansers.

If an “essential oil” or other fragrance is “natural” or “organic,” doesn’t that mean it’s safe?

Sometimes people think that if an “essential oil” or other ingredient comes from a plant, it must be safe. But many plants contain materials that are toxic, irritating, or likely to cause allergic reactions when applied to the skin.

For example, cumin oil is safe in food, but can cause the skin to blister. Certain citrus oils used safely in food can also be harmful in cosmetics, particularly when applied to skin exposed to the sun.

FDA doesn’t have regulations defining “natural” or “organic” for cosmetics. All cosmetic products and ingredients must meet the same safety requirement, regardless of their source.

Who regulates advertising claims?

While FDA regulates labeling for cosmetics and drugs, advertising claims are regulated by the Federal Trade Commission.

An investigation on how aromatherapy affects health failed to show any improvement in immune status, wound healing, or pain control among people exposed to two scents. But results of the randomized controlled trial, published in the journal Psychoneuroendocrinology, did show that lemon (considered to be a stimulant) appeared to enhance mood, while lavender (thought to be a relaxant) had no effect on mood.

Researchers from Ohio State University assembled a group of 56 men and women aged 18 to 43. Participants were exposed to the scent of lavender, the scent of lemon, and no scent (placebo) before and after a stress event (applying tape to skin and removing it, and immersing feet in icy water) during three separate visits. Some of the participants were not given any information about the scents they would smell, while others where told what scents they would smell and what outcomes to expect. The researchers analyzed the participants’ blood samples for the presence of stress indicators (such as norepinephrine and cortisol) and biochemical markers that indicate immune system changes (such as interleukin-6 and interleukin-10). The researchers also assessed mood through various psychological tests.

Findings from the study showed that neither lavender nor lemon scents affected participants’ heart rate, blood pressure, wound healing, pain ratings, or levels of interleukin-6 or interleukin-10. However, with lemon, blood levels of norepinephrine remained elevated following immersion in ice water; levels of the stress hormone declined to pre-stressor levels in response to the smell of lavender or distilled water.

Self-reports and three other mood assessment tests showed that lemon scent had a positive effect on mood regardless of expectancies or previous use of aromatherapy. In contrast, these indicators showed that lavender’s effects on mood were no better than water on some tests. The researchers concluded that neither scent appeared to offer any other health-related benefit.

Overview

• Aromatherapy is the use of essential oils from plants (flowers, herbs, or trees) as therapy to improve physical, mental, and spiritual well-being.
• Aromatherapy may be used with other complementary treatments, such as massage or acupuncture, as well as with standard medical treatments to manage symptomscaused by cancer or cancer treatment.
• Essential oils are most often used by inhaling them or by applying a diluted form of them to the skin.
• Aromatherapy research with cancer patients has studied the effect of essential oils on anxiety, nausea, vomiting, and other health-related conditions.
• Safety testing on essential oils has found very few side effects. Lavender and tea treeessential oils have been found to have some hormone -like effects.
• Aromatherapy products do not need approval by the U.S. Food and Drug Administration (FDA).

Questions and Answers About Aromatherapy

What is aromatherapy?

Aromatherapy is the use of essential oils from plants to improve the mind, body, and spirit. It is used by patients with cancer to improve quality of life and reduce stress, anxiety, pain, nausea, and vomiting caused by cancer and its treatment. Aromatherapy may be used with other complementary treatments like massage therapy and acupuncture, as well as with standard medical treatments, for symptom management.

Essential oils are the fragrant (aromatic) part found in many plants, often under the surface of leaves, bark, or peel. The fragrance is released if the plant is crushed or a special steam process is used.

There are many essential oils used in aromatherapy, including those from Roman chamomile, geranium, lavender, tea tree, lemon, ginger, cedarwood, and bergamot. Each plant's essential oil has a different chemical make-up that affects how it smells, how it is absorbed, and how it affects the body.

Essential oils are very concentrated. For example, it takes about 220 pounds of lavender flowers to make about 1 pound of essential oil. The aroma of essential oils fades away quickly when left open to air.

How is aromatherapy given or taken?

Aromatherapy is used in several ways.

• Indirect inhalation: The patient breathes in an essential oil by using a room diffuser, which spreads the essential oil through the air, or by placing drops on a tissue or piece of cotton nearby.
• Direct inhalation: The patient breathes in an essential oil by using an individual inhaler made by floating essential oil drops on top of hot water.
• Massage: In aromatherapy massage, one or more essential oils is diluted into a carrier oil and massaged into the skin.

Essential oils may also be mixed with bath salts and lotions or applied to bandages.

There are some essential oils used to treat specific conditions. However, the types of essential oils used and the ways they are combined vary, depending on the experience and training of the aromatherapist.

Have any preclinical (laboratory or animal) studies been done using aromatherapy?

In laboratory studies, tumor cells are used to test a substance to find out if it is likely to have any anticancer effects. In animal studies, tests are done to see if a drug, procedure, or treatment is safe and effective in animals. Laboratory and animal studies are done before a substance is tested in people.

Laboratory and animal studies have tested the effects of essential oils.

Have any clinical trials (research studies with people) of aromatherapy been done?

Clinical trials of aromatherapy have studied its use in the treatment of anxiety, nausea, vomiting, and other health-related conditions in cancer patients. No studies of aromatherapy used to treat cancer have been published in a peer-reviewed scientific journal.

Studies of aromatherapy have shown mixed results. There have been some reports of improved mood, anxiety, sleep, nausea, and pain. Other studies reported that aromatherapy showed no change in symptoms.

Studies on anxiety and depression

• A trial of 103 cancer patients studied the effects of massage compared to massage with Roman chamomile essential oil. Two weeks later, a decrease in anxiety and improved symptoms were noted in the group that had massage with essential oil. The group that had massage only did not have the same benefit.
• Another study of 58 patients with various cancers who completed six aromatherapy sessions showed a decrease in anxiety and depressioncompared with before the sessions began.
• A randomized controlled trial studied the effects of inhalation aromatherapy on anxiety during radiation therapy. There were 313 patients randomly assigned to either lavender, bergamot, or cedarwood essential oils. There were no differences reported in depression or anxiety between the groups.

Study on sleep

• Newly diagnosed patients with acute myeloid leukemia who were hospitalized to receive intensive chemotherapy inhaled an essential oil through a diffuser overnight for 3 weeks. Patients were given the choice of lavender, peppermint, or chamomile. Improvement was reported in sleep, tiredness, drowsiness, lack of appetite, depression, anxiety, and well-being.

Study on dry mouth

• Radioactive iodine may cause damage to salivary glands. Increased saliva production during treatment may decrease damage to salivary glands. In a randomized controlled trial, patients who inhaled a mixture of lemon and ginger essential oils had increased saliva production compared with the placebo group.

Studies on nausea and vomiting

• A study of inhaled ginger essential oil in women receiving chemotherapy for breast cancer somewhat decreased acute nausea, but did not lessen vomiting or chronic nausea.
• A study of inhaled bergamot essential oil in children and adolescents at the time of stem cell infusion reported an increase in anxiety and nausea and no effect on pain. In a study of adult patients at the time of stem cell infusion, tasting or sniffing sliced oranges was more effective at reducing nausea, retching, and coughing than inhaling an orange essential oil.

Studies on procedure-related symptoms

• Women having breast biopsies were randomly assigned to receive lavender-sandalwood or orange-peppermint essential oil drops placed on a felt tab and attached to their hospital gown or to no scent on the felt tab. Women who received the lavender-sandalwood aromatherapy tab had less anxiety than women who received the orange-peppermint aromatherapy tab or no scent tab.
• In a study of inhaled lavender essential oil, eucalyptus essential oil, or no essential oil in cancer patients having needles inserted into a central venous port catheter, patients who inhaled lavender essential oil reported less pain.

Have any side effects or risks been reported from aromatherapy?

Safety testing on essential oils shows very few side effects or risks when they are used as directed. Most essential oils have been approved as ingredients in food and fragrances and are labeled as GRAS (generally recognized as safe) by the U.S. Food and Drug Administration (FDA). Swallowing large amounts of essential oils is not recommended.

Allergic reactions and skin irritation may occur when essential oils are in contact with the skin for long periods of time. Sun sensitivity may occur when citrus or other essential oils are applied to the skin before going out in the sun.

Lavender and tea tree essential oils have been found to have effects similar to estrogen (female sex hormone) and also block or decrease the effect of androgens(male sex hormones). Applying lavender and tea tree essential oils to the skin over a long period of time was linked in one study to breast growth in boys who had not yet reached puberty.

Is aromatherapy approved by the FDA for use as a cancer treatment in the United States?

Aromatherapy products do not need FDA approval.

Aromatherapy is not regulated by state law, and there is no licensing required to practice aromatherapy in the United States. Practitioners often combine aromatherapy training with another field in which they are licensed, for example, massage therapy, nursing, acupuncture, or naturopathy.

The National Association for Holistic Aromatherapy (www.naha.org) and the Alliance of International Aromatherapists (www.alliance-aromatherapists.org) are two organizations that have national educational standards for aromatherapists. A list of schools that offer certificate programs approved by NAHA can be found at http://www.naha.org/schools_level_one_two.htm.

The Canadian Federation of Aromatherapists (www.cfacanada.com) certifies aromatherapists in Canada. See the International Federation of Aromatherapists website (www.ifaroma.org) for a list of international aromatherapy programs.