Essential oils are volatile, fragrant substances, derived from roots, bark, stems, leaves, flowers, buds, seeds and other aerial plant parts. Food, according to Webster’s dictionary, is defined as “material consisting essentially of protein, carbohydrate, and fat used in the body of an organism to sustain growth, repair, and vital processes and to furnish energy.” A drug, according to Webster is, ” a substance used as a medication or in the preparation of medication.” The Food and Drug administration (FDA) goes by the definition of the Food, Drug, and Cosmetic Act, which is (1) : a substance recognized in an official pharmacopoeia or formulary (2) : a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease (3) : a substance other than food intended to affect the structure or function of the body (4) : a substance intended for use as a component of a medicine but not a device or a component, part, or accessory of a device. The FDA proclaims its responsibility is to protect the public health by regulating the safety of foods, drugs, cosmetics, biological products and medical devices. This is admirable, but a huge task. The lines get blurred because the FDA decides things are drugs not by whether they are drugs but how they are marketed and what the “intended use” is.
For example, the FDA says in regard to essential oils, which are generally considered as cosmetics, “This principle also holds true for “essential oils.” For example, a fragrance marketed for promoting attractiveness is a cosmetic. But a fragrance marketed with certain 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. Similarly, a massage oil that is simply intended to lubricate the skin and impart fragrance is a cosmetic, but if the product is intended to treat diseases or conditions, such as relieving arthritis pain, it’s considered a drug.”
The problem with all of this is that in order to protect the consumer , the FDA must make methodical, makes arbitrary decisions, the effect of which may also limit peoples’ ability to educate and inform themselves, and severely limit their access to natural health options in favor of promoting synthetic patented pharmaceuticals which are big business.
According to Jeffrey Dach, MD, there is plenty of scientific research supporting the health benefits of eating cherries, but the FDA considers cherries to be unapproved drugs, and accordingly sent threatening letters to a number of fruit companies warning them not to mention any health benefits of cherries or they would pursue legal action. In 2010, Diamond Foods received an FDA Warning letter concluding that walnuts are drugs because of links to scientific studies and proven research Diamond had listed on their web page about some of the benefits of walnuts. This letter states, “Based on claims made on your firm’s website, we have determined that your walnut products are promoted for conditions that cause them to be drugs because these products are intended for use in the prevention, mitigation, and treatment of disease.” At the same time the FDA advocates a Heart Healthy Diet and links to the American Heart Association’s recommendations for Healthy Diet Goals which includes four servings of nuts per week. There appears to be no documented evidence that a single person has ever died because they ate walnuts or cherries believing them to be good for their health. However, a study in The Journal of the American Medical Association (JAMA) Vol 284, No 4, July 26th 2000, authored by Dr Barbara Starfield, MD, MPH, of the Johns Hopkins School of Hygiene and Public Health reported 106,000 deaths per year. This was actually a reprint, as the study was first published in 1996. In case one thinks this is old information, the FDA’s own records of reported Adverse Drug Events (ADEs) admits to 98,518 deaths and 573,111 serious outcomes (Serious outcomes include death, hospitalization, life-threatening, disability, congenital anomaly and/or other serious outcome) for 2011.
According to Dr. Joseph Mercola, 25% of Americans are now taking Statin Drugs to lower their cholesterol despite over 900 studies proving the adverse effects of statin drugs. Many statins such as Zocor and Lipitor cannot be taken at all with grapefruit juice – not even three days later – because the reaction, which inhibits a substance in your small intestine that helps break down medications, could cause too much of the drug’s active ingredient to enter your bloodstream with potentially lethal effects. Yet even though the drugs may be labeled with some warnings, many are not aware of the seriousness or the reason for them. In fact, a study published in the Canadian Medical Association Journal mentions that grapefruit-drug interactions have been on the increase, as many as 6 new drugs per year and over 85 total drugs may cause interactions. A study on the popular drug Avandia, prescribed for Type II diabetes, showed a 30 to 40% increased risk of heart attack. Yet the FDA allows this and other drugs with similar well documented harmful effects to be continue to be marketed while instead endeavoring to suppress knowledge of potential health benefits of natural substances such as essential oils, or foods such as walnuts or cherries with claims they are drugs.
Many essential oils are on the FDA Generally Recognized as Safe (GRAS) list, or as FDA approved food additives and flavoring agents. According to the FDA, this means “a substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive.” The Code of Federal Regulations, 21 CFR 170.30 (b) also allows a substance used in food before 1958, through experience based on common use in food to be defined as GRAS.
As Aromatherapy products, essential oils are generally regulated by the FDA as cosmetics unless specific health claims are made which would cause the FDA to view a particular oil as a drug. The cosmetic title of the Food, Drug, and Cosmetics Act has not been significantly amended in more than 70 years, and consists of only one page as compared to 112 pages regulating foods and drugs. It is important to note that cosmetic products are not required to list all the ingredients, particularly those considered trade secrets and fragrance. “Fragrance” in the ingredients list on a label usually indicates some or all ingredients are synthetic.
An essential oil may be labeled as “pure”, “organic”, “wildcrafted, or “therapeutic”. These terms mean little unless you know the company, know the source, and have a clear understanding of what they mean by these descriptions. They do not tell you, for instance, whether expert botanists have been hired to correctly identify the correct species and seed selection. They say nothing of soil conditions, whether the seeds were planted at the optimal time, were free of disease, had the needed water and weather conditions during growth, and were harvested at the right time of day. There are many variables, and they are different for each oil. There is no standardization in the US for essential oils, and neither the FDA or any other official organization in the US which certifies whether an essential oil is pure or has therapeutic properties. Neither does AFNOR (Association Francaise de Normalization), a standardization system of the French government with a membership of some 3000 companies, or The ISO (International Organization for Standardization), a worldwide federation of standardization bodies from 130 countries of which AFNOR is one member, representing France. These misconceptions are easily perpetuated when information is copied on the internet from one site to another, even when the original company is not making such claims, or have defined the terms they are using, but copied information is taken out of context. Young Living, for example, the world’s leading and the world’s longest running producer of high quality therapeutic grade oils, was the originator of the term “therapeutic grade” in describing their own oils which were defined as “Young Living Therapeutic Grade” or “YLTG”. When they began producing essential oils for this purpose, there were very few essential oils available in America except fragrance grade, most of which were, and still are, extended or adulterated for lower cost production. Other companies, seeing a high demand for therapeutic grade essential oils have since sought to join the market.
Another myth that many of these companies are passing on to the customers is to create the impression that any average person can discern the purity of an oil by smelling it. There is absolutely no scientific evidence to support this theory. There are many tasteless and odorless chemicals that can be, and frequently are, used to extend and adulterate essential oils, and other artificial means of enhancing the fragrance which will not show up on any but the most sophisticated testing equipment. FDA labeling requirements again do not adequately represent this as the structure of an essential oil is such that even very tiny amounts of trace components, whether real or synthetic, will affect both the purity of an oil and any therapeutic action it may have.
For example, an oil could be labeled “100% pure Frankincense” and it may be all Frankincense but could be adulterated or extended with multiple species, or it could be improperly distilled.
If one is truly interested in therapeutic properties of essential oils, it is important to know the company, and find one which adheres to the highest standards and state of the art testing.
To learn more about different therapeutic grade essential oils and how they may support a healthy lifestyle, please visit The Oil Well
For more information on the leading essential oil companies, their history, testing, and quality standards, check out the 45 page Young Living/DoTerra report.
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