Aromatherapy Basics

General Aromatherapy Information
Aromatherapy is a derivative of herbal medicine, which is itself a subset of the biological or nature-based complementary and alternative medicine (CAM) therapies. Aromatherapy has been defined as the therapeutic use of essential oils from plants for the improvement of physical, emotional, and spiritual well-being. The proponents of aromatherapy claim it is an all-natural, nontoxic adjunct to conventional medicines.

Essential oils are volatile liquid substances extracted from aromatic plant material by steam distillation or mechanical expression. Oils produced with the aid of chemical solvents are not considered true essential oils, as the solvent residues can alter the purity of the oils themselves and lead to adulteration of the fragrance or to skin irritation.

Essential oils are made up of a large array of chemical components that consist of the secondary metabolites found in various plant materials. The major chemical components of essential oils include terpenes, esters, aldehydes, ketones, alcohols, phenols, and oxides, which are volatile and may produce characteristic odors. Different types of oils contain varying amounts of each of these compounds, which are said to give each oil its particular fragrance and therapeutic characteristics. Different varieties of the same species may have different chemotypes (different chemical composition of the same plant species as a result of different harvesting methods or locations) and thus different types of effects. [1]

Synthetic odors are often made up of many of the same compounds, which are synthesized and combined with other novel odor-producing chemicals. Most aromatherapists believe that synthetic fragrances are inferior to essential oils because they lack natural or vital energy; however, this has been contested by odor psychologists and biochemists [2] who probably work for the perfume industry and concoct synthetic fragrances to be sold as pure and 100% natural.

Aromatherapy is used or claimed to be useful for a vast array of symptoms and conditions. A book on aromatherapy for children suggests aromatherapy remedies for everything from acne to whooping cough. [3] Published studies regarding the uses of aromatherapy have generally focused on its psychological effects (used as a stress reliever or anxiolytic agent) or its use as a topical treatment for skin-related conditions.

A large body of literature has been published on the effects of odors on the human brain and emotions. Some studies have tested the effects of essential oils on mood, alertness, and mental stress in healthy subjects. Other studies investigated the effects of various (usually synthetic) odors on task performance, reaction time, and autonomic parameters or evaluated the direct effects of odors on the brain via electroencephalogram patterns and functional imaging studies. [4]

Such studies have consistently shown that odors can produce specific effects on human neuropsychological and autonomic function and that odors can influence mood, perceived health, and arousal. These studies suggest that odors may have therapeutic applications in the context of stressful and adverse psychological conditions.

Practitioners of aromatherapy apply essential oils using several different methods, including direct inhalation via diffuser or drops of oil placed near the patient (e.g., on a pillow); aromatherapy massage, which is the application to the body of essential oils diluted in a carrier oil; and other direct and indirect applications such as placing drops of oil in bathwater, lotions, or dressings.

Different aromatherapy practitioners may have different recipes for treating specific illnesses, involving various combinations of oils and methods of application. Differences seem to be practitioner-dependent, with some common uses more accepted throughout the aromatherapy community.

Training in aromatherapy is available at several schools throughout the United States and United Kingdom; but there is no professional standardization, and no license is required to practice in either country. Thus, there is not a great deal of consistency in the specific treatments for specific illnesses among practitioners.

This lack of standardization has led to poor consistency in research on the effects of aromatherapy: because anecdotal evidence alone or previous experience drives the choice of oils, different researchers often choose different oils when studying the same applications.

Although essential oils are given internally by aromatherapists in France and Germany, their use is generally limited to inhalation or topical application in the United Kingdom and United States.

Non medical use of essential oils is common in the flavoring and fragrance industries, however, and most essential oils have been classified as GRAS (generally recognized as safe), at specified concentration limits, by the U.S. Food and Drug Administration (FDA).

Aromatherapy products do not need approval by the FDA.

References
1. Wildwood C: The Encyclopedia of Aromatherapy. Rochester, Vt: Healing Arts Press, 1996. 2. Dodd GH: The molecular dimension in perfumery. In: Van Toller S, Dodd GH, eds.: Perfumery: The Psychology and Biology of Fragrance. New York, NY: Chapman and Hall, 1988, pp 19-46.
3. Worwood VA: Aromatherapy for the Healthy Child: More Than 300 Natural, Non-Toxic, and Fragrant Essential Oil Blends. Novato, Calif: New World Library, 2000.
4. Buchbauer G, Jirovetz L, Jäger W, et al.: Fragrance compounds and essential oils with sedative effects upon inhalation. J Pharm Sci 82 (6): 660-4, 1993. [PUBMED Abstract]


Maria Schasteen is the owner of Aroma-essence.com and publisher of the Aromatherapy Tip of the Week.

Improve The Quality Of Life Of Cancer Patients

This complementary and alternative medicine (CAM)

information summary provided by the National Cancer Institute (www.cancer.gov) gives an overview of the use of aromatherapy and essential oils primarily to improve the quality of life of cancer patients.

This summary includes a brief history of aromatherapy, a review of laboratory studies and clinical trials, and possible adverse effects associated with aromatherapy use.

This summary contains the following key information:

• Aromatherapy is the therapeutic use of essential oils (also known as volatile oils) from plants (flowers, herbs, or trees) for the improvement of physical, emotional, and spiritual well-being.



• Aromatherapy is used by patients with cancer primarily as a supportive care agent for general well-being.



• Aromatherapy is used with other complementary treatments (e.g., massage and acupuncture) as well as standard treatment.



• Essential oils are volatile liquid substances extracted from aromatic plant material by steam distillation or mechanical expression; oils produced with the aid of chemical solvents are not considered true essential oils.



• Essential oils are available in the United States for inhalation and topical treatment. Topical treatments are generally used in diluted forms.



• Aromatherapy is not widely administered via ingestion.



• The effects of aromatherapy are theorized to result from the effect of odorant molecules from essential oils on the brain’s emotional center, the limbic system. Topical application of aromatic oils may exert antibacterial, anti-inflammatory, and analgesic effects.



• Studies in animals show sedative and stimulant effects of specific essential oils as well as positive effects on behavior and the immune system. Functional imaging studies in humans support the influence of odors on the limbic system and its emotional pathways.



• Human clinical trials have investigated aromatherapy primarily in the treatment of stress and anxiety in patients with critical illnesses or in other hospitalized subjects. Several clinical trials involving patients with cancer have been published.



• Aromatherapy has a relatively low toxicity profile when administered by inhalation or diluted topical application.



• Aromatherapy products do not need approval by the U.S. Food and Drug Administration because there is no claim for treatment of specific diseases.
  Many of the medical and scientific terms used in the summary are hypertext linked (at first use in each section) to the NCI Dictionary, which is oriented toward nonexperts. When a linked term is clicked, a definition will appear in a separate window.

Maria Schasteen is the owner of Aroma-essence.com and publisher of the Aromatherapy Tip of the Week.

How The FDA Defines Soap

Not every product marketed as soap meets FDA's definition of the term. FDA interprets the term "soap" to apply only when:

• The bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the product's detergent properties are due to the alkali-fatty acid compounds, and
  
• The product is labeled, sold, and represented solely as soap [21 CFR 701.20].

If a cleanser does not meet all of these criteria ...
If a product intended to cleanse the human body does not meet all the criteria for soap, as listed above, it is either a cosmetic or a drug. For example:

If a product:

• consists of detergents or
• primarily of alkali salts of fatty acids and
• is intended not only for cleansing but also for other cosmetic uses, such as beautifying or moisturizing,
  it is regulated as a cosmetic.

If a product:

• consists of detergents or
• primarily of alkali salts of fatty acids and
• is intended not only for cleansing but also to cure, treat, or prevent disease or to affect the structure or any function of the human body,
  it is regulated as a drug.

If a product:

• is intended solely for cleansing the human body and
• has the characteristics consumers generally associate with soap,
• does not consist primarily of alkali salts of fatty acids,
  it may be identified in labeling as soap, but it is regulated as a cosmetic.

Maria Schasteen is the owner of Aroma-essence.com and publisher of the Aromatherapy Tip of the Week.

Aromatherapy: Good Manufacturing Practices

How good manufacturing practice requirements are different

Good manufacturing practice (GMP) is an important factor in assuring that your aromatherapy and cosmetic products are neither adulterated nor misbranded.

However, no regulations set forth specific Good Manufacturing Practice requirements for cosmetics. Do you know what this means?

It simply means, everything in the cosmetic aromatherapy manufacturing is allowed. No wonder that you find about five carcinogens alone in lipsticks! Let alone the known carcinogens propylene glycol and sodium lauryl sulfate in your bubble bath and shampoo. Did you read the labels lately? Your toothpaste has a Warning Label: "Contact the Poison Control Center immediately!"

Propylene glycol is a substance that is smooth like velvet (commonly used as garage floor cleaner and engine degreaser). It is often mixed with essential oils to give the oil a luxurious texture.

In addition, there are companies out there that have made it their mission to manufacture a synthetic oil for every pure essential oil distilled. You may well guess that synthetic oils are considerable cheaper. Aromatherapy companies that solely operate for their profits with no consideration of people's wellbeing use of course synthetic oils.

In contrast to cosmetic and aromatherapy product regulations, the law requires strict adherence to GMP requirements for drugs, and there are regulations specifying minimum current GMP requirements for drugs [Title 21 of the Code of Federal Regulations (CFR), parts 210 and 211]. Failure to follow GMP requirements causes a drug to be adulterated [FD&C Act, sec. 501(a)(2)(B)].

How registration requirements are different
FDA maintains the Voluntary Cosmetic Registration Program, or VCRP, for cosmetic establishments and formulations [21 CFR 710 and 720]. As its name indicates, this program is voluntary. That's right - voluntary. In contrast, it is mandatory for drug firms to register their establishments and list their drug products with FDA [FD&C Act, sec. 510; 21 CFR 207].

How labeling requirements are different
A cosmetic product must be labeled according to cosmetic labeling regulations. See the Cosmetic Labeling Manual for guidance on cosmetic labeling. OTC drugs must be labeled according to OTC drug regulations, including the "Drug Facts" labeling, as described in 21 CFR 201.63. Combination OTC drug/cosmetic products must have combination OTC drug/cosmetic labeling. For example, the drug ingredients must be listed alphabetically as "Active Ingredients," followed by cosmetic ingredients, listed in order of predominance as "Inactive Ingredients."


Maria Schasteen is the owner of Aroma-essence.com and publisher of the Aromatherapy Tip of the Week.

Aromatherapy: Is It a Cosmetic, a Drug, or Both? Or Is It Soap?

The legal difference between a cosmetic and a drug is determined by a product's intended use. Different laws and regulations apply to each type of product. Firms sometimes violate the law by marketing a cosmetic with a drug claim, or by marketing a drug as if it were a cosmetic, without adhering to requirements for drugs.

How does the law define a cosmetic?
The Food, Drug and Cosmetic Act (FD&C Act) defines cosmetics by their intended use, as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body ... for cleansing, beautifying, promoting attractiveness, or altering the appearance" [FD&C Act, sec. 201(i)].

Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, shampoos, permanent waves, hair colors, toothpastes, and deodorants, as well as any material intended for use as a component of a cosmetic product.

How does the law define a drug?
The FD&C Act defines drugs by their intended use, as "(A) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease ... and (B) articles (other than food) intended to affect the structure or any function of the body of man or other animals" [FD&C Act, sec. 201(g)(1)].

How can a product be both a cosmetic and a drug?
Some products meet the definitions of both cosmetics and drugs. This may happen when a product has two intended uses. For example, a shampoo is a cosmetic because its intended use is to cleanse the hair. An antidandruff treatment is a drug because its intended use is to treat dandruff. Consequently, an antidandruff shampoo is both a cosmetic and a drug.

Among other cosmetic/drug combinations are toothpastes that contain fluoride, deodorants that are also antiperspirants, and moisturizers and makeup marketed with sun-protection claims. Such products must comply with the requirements for both cosmetics and drugs.

What about "cosmeceuticals"?
The FD&C Act does not recognize any such category as "cosmeceuticals." A product can be a drug, a cosmetic, or a combination of both, but the term "cosmeceutical" has no meaning under the law.

How is a product's intended use established?
Intended use may be established in a number of ways. Among them are:

• Claims stated on the product labeling, in advertising, on the Internet, or in other promotional materials. Certain claims may cause a product to be considered a drug, even if the product is marketed as if it were a cosmetic. Such claims establish the product as a drug because the intended use is to treat or prevent disease or otherwise affect the structure or functions of the human body. Some examples are claims that products will restore hair growth, reduce cellulite, treat varicose veins, or revitalize cells.

• Consumer perception, which may be established through the product's reputation. This means asking why the consumer is buying it and what the consumer expects it to do.

• Ingredients that may cause a product to be considered a drug because they have a well known (to the public and industry) therapeutic use. An example is fluoride in toothpaste.

• This principle also holds true for essential oils in fragrance products. A fragrance marketed for promoting attractiveness is a cosmetic. But a fragrance marketed with certain "aromatherapy" claims, such as assertions that the scent will help the consumer sleep or quit smoking, meets the definition of a drug because of its intended use.
  

And what if it's "soap"?
Soap is a category that needs special explanation. That's because the regulatory definition of "soap" is different from the way in which people commonly use the word. Products that meet the definition of "soap" are exempt from the provisions of the FD&C Act because -- even though Section 201(i)(1) of the act includes "articles ... for cleansing" in the definition of a cosmetic -- Section 201(i)(2) excludes soap from the definition of a cosmetic.

Maria Schasteen is the owner of Aroma-essence.com and publisher of the Aromatherapy Tip of the Week.

Aromatherapy Regulations

Aromatherapy (fagrance) products are sometimes marketed with claims or implications that their use will improve personal wellbeing in a variety of ways, such as "strengthening the body's self-defense mechanisms." These are also known as "behavioral fragrance" or "aromatherapy" products.

Traditionally, perfumes have been considered cosmetics by FDA. The Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics in part as articles intended to be applied to or introduced into the human body "for cleansing, beautifying, promoting attractiveness, or altering the appearance" (FD&C Act, Section 201).

On the other hand, articles intended for use in the diagnosis, mitigation, treatment, or prevention of disease, and intended to affect the structure or any function of the body, are considered to be drugs -- with all "new drugs" requiring FDA's premarket approval.

While cosmetics and drugs both are under FDA's jurisdiction, the legal requirements applying to them differ. A claim that a perfume's aroma makes a person feel more attractive, in general, is a cosmetic claim not requiring FDA approval before a product is sold.

But if someone tries to market a scent suggesting effectiveness as an aid in quitting smoking, as a sleeping aid, or to treat or prevent any other condition or disease, or otherwise affect the body's structure or function, such a claim may cause the product to be regulated as a drug, requiring premarket approval. The agency will make judgments on a case-by-case basis.

Claims made in advertising but not on product labeling are regulated by the Federal Trade Commission, although advertising claims can be used to establish a product's intended use. Room fragrance systems (deodorizers, odor control) are theConsumer Product Safety Commission's responsibility.

Aroma-essence.com offers therapeutic-grade essential oils and aromatherapy products. Not all oils are created equal. There is a difference between fragrance oils (often synthetic or adulterated oils) and pure therapeutic A-Grade essential oils.