the aromaconnection blog

Advice for Aromatherapists and Natural Perfumers re: H.R. 5786 Safe Cosmetics Act 2010

You may think if you are a natural perfumer,  aromatherapist, massage therapist, or other alternative practitioner using essential oils or other raw botanical extracts or materials in your practice, craft or art,  that this bill will not directly affect you. At least you don’t think so.  However, you could be dead wrong.  If you are not a licensed doctor (M.D. or D.O. have the broadest authority) who can legally write a prescription, then you may be at risk under H.R. 5786 if you make essential oil blends or synergies for your clients or natural perfumes sold to clients (the general public). Thus far, essential oils have not been legally designated as either prescription or over-the-counter drugs.  The definition most used is, “A volatile oil, usually having the characteristic odor or flavor of the plant from which it is obtained, used to make perfumes and flavorings.”  In other words, they are manufacturing ingredients.

In H.R. 5786 (subchapter B), the definition of ‘ingredient’ reads:

“The term ‘ingredient’ means a chemical in a cosmetic, including - -
(A)  chemicals that provide a technical or functional effect;
(B)  chemicals that have no technical or functional effect in the cosmetic but are present by reason of having been added to a cosmetic during the processing of such cosmetic;
(C)  processing aids that are present by reason of having been added to a cosmetic during the processing of such cosmetics;
(D)  substances that are present by reason of having been added to a cosmetic during processing for their technical or functional effect;
(E)  contaminants present at levels above technically feasible detection limits;
(F)  contaminants that may leach from container materials or form via reactions over the shelf life of a cosmetic and that may be present at levels above technically feasible detection limits;
(G)  the components of a fragrance, flavor, or preservative declared individually by their appropriate label names; and
(H)  any individual components of a botanical, petroleum-derived, animal-derived, or other ingredient that the Secretary determines to be considered an ingredient. 

It is probably worth your while to ponder these definitions and take in their full impact.

Here in Washington state, the definition of ‘manufacturing’ in the state revenue code (RCW) reads:

"Manufacturer" means every person who, either directly or by contracting with others for the necessary labor or mechanical services, manufactures for sale or for commercial or industrial use from his or her own materials or ingredients any articles, substances or commodities.” (RCW 82.04.110)

"To manufacture" embraces all activities of a commercial or industrial nature where labor or skill is applied, by hand or machinery, to materials so that as a result thereof a new, different or useful substance or article of tangible personal property is produced for sale or commercial or industrial use . . . “

As you can see, this definition applies to the individual ‘person’, whether they are registered or incorporated as a business or not.  We can find similar manufacturing legislation in every state of the Union.  There is no exemption for individual practitioners, as many would define themselves.

I urge all, whether large corporations, small businesses or individuals to become more aware of the growing legislative efforts across the world that may affect the use of essential oils.  Please join the other 3,593 (and growing) signers in the advocacy efforts to oppose H.R. 5786 and make a point to stay abreast of similar legislative issues.  

Does Jojoba Oil Contain Myristic Acid?

Jojoba Oil or Wax from Simmondsia chinensis is claimed on several thousand web sites to contain Myristic Acid, but I have found no evidence that it is present in more than a trace amount. I began looking into this while researching Jojoba oil for Samara Botane’s new website (still a work in progress). When I started looking into it (via Wikipedia—not necessarily a good source) and a variety of other sources, I found that things are somewhat confusing. This article reveals the sordid truth.

Note for the chemistry impaired: The naming conventions for fatty acids are somewhat confusing, with many different names often used for the same acid. To reduce the confusion factor, it has become a convention to refer to a fatty acid by a C followed by a two part number with a colon in between denoting the number of carbon atoms and the number of double or triple bonds, e.g. C14:0 is myristic acid which has 14 carbon atoms and no double or triple bonds. Monounsaturated acids have one double bond e.g. C18:1 oleic acid, and polyunsaturated acids have multiple double bonds e.g. C18:2 is linoleic acid and C18:3 is linolenic acid.
An Ester consists of an acid and an alcohol connected into a single compound, but apparently when identified by MSGC, the two components show up as separate peaks.

Jojoba Oil

Jojoba Oil is a liquid wax produced from the seed of Simmondsia chinensis, a shrub native to the Southwestern US and Northern Mexico. According to Wikipedia, it is a mixture of long chain wax esters, 36 to 46 carbon atoms. It is liquid at room temperature, which is why it is called a liquid wax, or an oil—even though it is not an oil. The long chain esters consist of a fatty acid that is attached to an alcohol by an ester bond. What this means, apparently, is that jojoba oil can appear to be constituted of fatty acids and fatty acids as well as the fatty ester that it is actually made up of. Note that this particular chemical makeup appears to be unique to jojoba, although it has some characteristics similar to human sebum and whale oil, which is one of the reasons that it is valued in the cosmetics industry.

Although as we shall see, the claims vary, the principle fatty acids in Jojoba wax according to Wikipedia are Eicosenoic C20:0 (66-71%), Docosanoic C22:0(14-20%) and Oleic C18:1 (10-13%). Price (1999) counts it up differently, with Saturated fatty acids palmitic C16:0 (11%), stearic C18:0 (71%), arachidic C20:0 (14%); monounsaturates oleic C18:1 (6.7%) and curiously not mentioning myristic acid at all in his Principal Constituents table on p. 85.

Myristic Acid

Myristic Acid is also called tetradecanoic acid or C14:0. It is classified as a medium chain fatty acid because it has 14 carbon atoms and it is a Saturated fatty acid because it has no double or triple bonds. It is named after the nutmeg (Myristica fragrans) where it was originally isolated,  It is also found in palm oil, coconut oil, butter fat, and spermacetin, the crystallized fraction of oil from the sperm whale. Note that Wikipedia, the source for the above information, doesn’t mention jojoba.

The Claims

Since Price didn’t mention myristic acid in his table of Principal Constituents, I was curious as to why he stated on p. 86 that jojoba “contains myristic acid which is an antiinflammatory (sic) agent . . .”. To find out I did a Google search on “Jojoba”, “Myristic Acid” and to my amazement got 57,100 hits. Admittedly, just because these two terms occur in the same webpage doesn’t mean they are actually connected, but browsing through the first 20-40 hits revealed they they all were connected, with statements like “It contains myristic acid which also has an anti-inflammatory action”, “Jojoba also contains myristic acid, which has anti-inflammatory properties”, “Organic jojoba contains a natural anti-inflammatory called myristic acid”, all of which were clearly referring to jojoba. I added the term “anti-inflammatory” to my search and now got 2,190 hits.

Of course most of the top level hits were from commercial sites trying to sell jojoba oil and apparently not going beyond reading p. 86 in Price. About 50 hits down, I started getting into some books that I thought might reveal the truth. I’m not going to provide a complete list here, but suffice it to say that several supposedly authoritative books are getting crossed off my list of sources. I eventually jumped ahead to 300 or more, and here I started getting a higher number of hits that listed ingredients or had several oils on one page and were not claiming myristic acid in jojoba—but there were still a number of the same old claims. Finally, after 626 hits, Google stopped delivering new stuff, so I gave up on that search phrase, and started to try to find something more authoritative. I added “MSGC”  or “Composition” to my search.

The Facts

The first thing I found a table that showed the constituents of jojoba by chain length, starting with C16 and going up to C24 (Kleiman 1990).  No C14 here.

Next, I found the original study from 1975 (National Academy of Sciences, 1975). Table 2 shows the Alcohol/Acid Structures of Jojoba Oil Determined by Gas Chromatography, Mass Spectrometry, and Ozonolysis. This should be an authorative source! And it mentions C14:0 as well as C12:0 and C16:0. All three were found in “trace” amounts. Effectively, no C14:0 here.

OK, what about Wisniak’s book about Jojoba? Table 1-26 is the same table as the 1975 NAS study and Spencer et al, but “trace” is defined as 0.01-0.05%. Not much C14:0 here either. Table 1-27 looks at the Jojoba Oil Wax Ester Composition and breaks down the long chain esters by their Alcohol/acid combination. No C14 in the table, as would be expected. Table 1-28 looks at the Composition of Fatty Acid Methyl Esters and Fatty Alcohol Acetates Derived from Jojoba Wax. Again C12, C14, and C15 acids are only in trace quantities.

Here’s another without C14:

Triglyceride compounds isolated from jojoba seed oil by column chromatography were composed predominantly of C_18′ C_20′ C_22′ and C₂₄ n−9 fatty acids with minor amounts of saturated C₁₆. (van Boven et al Abstract)

And another:

The results wax indicated that the main constituents in jojoba wax were various kinds of wax esters, namely eicosenyl octadecenoate (C20:1-C18:1)(1), eicosenyl directly, eicosenoate (C20:1-C20:1)(II), docosenyl eicosenoate (C22:1-C20:1)(III), eicosenyl docosenoate (C20:1-C22:1)(IV) and tetracosenyl eiosenoate (C24:1-C20:1)(V). . . . The concentrations of the wax esters I, II and III, in jojoba wax were 5.5, 21.4 and 37.8%, respectively. (Tada et al)

Finally, I did find one curious document on the Internet (Simon, 2006)that possibly needs to be given some credence and which includes myristic acid among the constituents of Jojoba Oil. It has no documented sources so it’s not clear where the information came from. It is a “Technical Memorandum” written for the Michigan Department of Environmental Quality (MDEQ) listing secondary Constituents of Interest (COI) for substances used or produced at the Dow Chemical Plant in Midland, Michigan. This list was to be used to identify pollutants in the nearby rivers that might have originated in the plant. The purpose of this document was to resolve discrepancies in their data base, and one of the entries is (in a table entitled CASE NARRATIVE – Multi-Compound Listings):

456

Jojoba Ester – High Internal Phase (Myristic Acid, Palmetic (sic) Acid, Oleic Acid, Eicosenic Acid, Erucic Acid, Nervonic Acid, Eiconsenol, Docosenol, Tetracosenol)

DOW RESOLVED. Multi-compound listing individual components are [544-63-8] myristic acid, (remainder of items omitted here – rs)

The number in [] brackets is the CAS number of myristic acid.

Conclusion

Based on the studies referenced above, there are no appreciable amounts of myristic acid in jojoba oil. This doesn’t necessarily mean that there isn’t genetic or geographic variation (Busson-Breysse et al), but I haven’t found any evidence that that has occurred. If anyone is to make a valid claim that there is C14:0 in jojoba, they need to present their proof. In the meantime, Internet vendors should stop making claims that Jojoba Oil contains Myristic Acid.

References:

http://en.wikipedia.org/wiki/Jojoba_oil Accessed 9/19/2009

http://en.wikipedia.org/wiki/Myristic_acid Accessed 9/19/2009

Busson-Breysse J., M.Farines, J.Soulier, “Jojoba wax: Its esters and some of its minor components” in Journal of the American Oil Chemists’ Society, 71 (1994) Abstract accessed 9/20/2009.

Clark, Sue Essential chemistry for safe aromatherapy, Elsevier, 2002 Accessed in Google Books 9/19/2009

Kleiman, R “Chemistry of New industrial Oilseed Crops”  http://www.hort.purdue.edu/newcrop/proceedings1990/v1-196.html#Table%205 accessed 9/19/2009

National Academy of Sciences, 1975. Jojoba: Feasibility for Cultivation on Indian Reservations in the Sonoran Desert Region. Accessed on Google Books.

Price, Len, Carrier Oils for Aromatherapy & Massage, Third Edition. Stratford-upon-Avon: Riverhead Press, 1999.

Simon, PB and Simon, PM “Technical Memorandum to Mr. Allan Taylor, MDEQ Waste and Hazardous Materials Division” , Dec 1, 2006. PDF Accessed 9/20/2009.

Spencer, G.F, RD Plattner and T. Miwa, “Jojoba Oil Analysis by High Pressure Liquid Chromatography and Gas Chromatography/Mass Spectrometry” Journal of the American Oil Chemists Society, 1977 Accessed 9/20/2009.

Tada, Atsuko, Zhe-Long Jin, Naoki Sugimoto, Kyoko Sato, Takeshi Yamazaki, Kenichi Tanamoto “Analysis of the constituents in jojoba wax used as a food additive by LC/MS/MS,” Shokuhin Eiseigaku Zasshi. 2005 Oct ;46 (5):198-204 16305174 (P,S,G,E,B) Abstract accessed 9/20/2009

Van Boven M., RA Holser, M , Cokelaere, E. Decuypere, C Goveaerts and J. Lemy, “Characterization of triglycerides isolated from jojoba oil,” Journal of the American Oil Chemists’ Society, 77 (2000) Abstract accessed 9/20/2009.

Wisniak, J., The Chemistry and technology of jojoba oil. American Oil Chemists Society, Accessed on Google Books

Technorati Tags: Jojoba Oil,jojoba wax,myristic acid,jojoba oil composition

Website wins Health Care Standard of Excellence Award from Web Marketing Association

The Taking Charge of your Health Website at the University of Minnesota has won an "Health Care Standard of Excellence" award from the Web Marketing Association, according to a U of M press release. The website promotes complementary and alternative medical approaches integrated with conventional medicine, including Aromatherapy and Massage Therapy. The site is conservative and based on sound established references.

Aromatherapy Massages With Music Dramatically Reduced Stress Levels In Nurses

ScienceDaily reports on research done in Australia and published in the Journal of Clinical Nursing that found that nurses working in an emergency room reported that their anxiety levels fell "dramatically" when they were given aromatherapy massages while listening to music.

Researchers found that 60 per cent of the staff - 54 per cent in summer and 65 per cent in winter - suffered from moderate to extreme anxiety.

But this fell to just eight per cent, regardless of the season, once staff had received 15-minute aromatherapy massages while listening to relaxing new-age music.

Reference: "The effect of aromatherapy massage with music on the stress and anxiety levels of emergency nurses: comparison between summer and winter." Cooke et al. Journal of Clinical Nursing. 16, pages 1695-1703 (September 2007).

Essential Oils Reduce Dysmenorrhea

A Research Review in Herbalgram No. 74 [not on line yet] discusses a Korean research study "Effect of aromatherapy on symptoms of dysmenorrhea in college students: a randomized placebo-controlled trial" that was published in the Journal of Alternative Complementary Medicine in 2006. The study involved 67 women who were (in the experimental group) received aromatherapy through abdominal massage using lavender, clary sage, and rose oils mixed with almond carrier oil. The placebo group received only almond oil massage, while the control group received no treatment.

The authors concluded that aromatherapy with this formula was effective in reducing the severity of menstrual cramps., and suggested that further research is warranted.

The Herbalgram peer review team pointed out the limitations of the study because the placebo, lacking odor, was not a true placebo. They also had a problem with the method used for blinding.

The full review should be on-line in a few days and will be linked here. As usual, obtaining the full original study online costs money.

Let CAM Continue to Develop Freely

This is the legal brief from the Natural Solutions Foundation mentioned in the previous post.

 

04/06/07

Let CAM Continue to Develop Freely

To: Food and Drug Administration

From: Natural Solutions Foundation

Re: FDA Docket No. 2006D-0480

These comments are submitted by Major General Albert N. Stubblebine, Rima Laibow, MD and Ralph Fucetola, JD on behalf of Natural Solutions Foundation with regard to the Food and Drug Administration’s draft “Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration.” They are submitted with reference to the request of FDA for comments on the proposed Guidance stated at: http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-3259.htm.

The Natural Solutions Foundation is a tax exempt, recognized nongovernmental organization active in the United States and internationally, communicating Natural Solutions to the many health problems caused by government intervention, with emphasis on FDA and Codex Alimentarius over-regulation of natural foods and supplements.

Complementary and Alternative Modalities (CAM), including traditional remedies and nutrition to achieve and maintain a healthy status, are preferred by many Americans to so-called “standard” allopathic medical treatment, primarily due to the well-documented iatrogenic death and disabilities, the dangerous side effects and persistent failures of the so-called “standard” model. The Dietary Supplement and Natural Remedies market has grown to over $28 billion dollars annually as Americans consistently vote with their dollars choosing CAM products out of un-reimbursed funds.

The Foundation urges the FDA to take into account an important legal distinction that FDA appears to ignore totally in the draft Guidance. That distinction is between “treatment of disease” and “therapies that may benefit.” In keeping with that distinction, explained below, it is suggested that the Guidance be titled, “Guidance for Industry on Complementary and Alternative Modality Products and Their Regulation by the Food and Drug Administration.” CAM is not “medicine”, does not rest in medical models and allopathic methods and does not seek to be considered “medicine.” In fact, CAM seeks to shed the appearance of “medicine” which is not in keeping with CAM traditions and activities.

We request the FDA take the following steps: (1) hold public hearings on the proposed Guidance; (2) formally revise the Guidance title to replace the word “Medicine” with “Modality” and (3) use of the terms “therapy” and “therapeutic” with reference to Complementary and Alternative Modality health practices, instead of the words “treat” and “treatment of disease” which are used exclusively in the draft Guidance. The terms “treat” and “treatment of disease” are, in fact, antithetical to CAM therapies.

CAM health practices can be generally defined as traditional or other practices that are used by individuals, often for self-help, to achieve and maintain a healthy status, either on their own or complementary to standard medical care. These practices do not include the potentially dangerous use of invasive techniques and toxic drugs that are the sole province of licensed medicine. They do, however, include developing therapies and nonstandard approaches that are outside the scope of licensed medicine. Such approaches as Nutrition, Homeopathy, Hands-on-Healing, Magnetics, Sound Health, Energy Therapies, Biofeedback, Meditation, Breath Work, Reiki, Chi Gong, Tai Chi and Herbology are examples of complementary and alternative therapeutic practices. Traditional Chinese, Ayurvedic medicine or folk remedies and "Dr. Mom" home remedies are also examples of CAM practices. These practices aim, in the words of the late Philip J. Hodes, PhD., at "more efficient physiological integration and function of the human organism, leading to optimal wellness." This definition is the polar opposite of non CAM practices which seek to suppress or ameliorate symptoms without an approach to optimal wellness.

The terms “therapy” and “therapeutic” do not occur, for example, in the context of the Dietary Supplement Health and Education Act of 1994 (DSHEA). Rather, that statute, passed by unanimous Congressional Consent, tells us that Dietary Supplements may not “diagnose, treat, cure or prevent” any disease. It does not specifically forbid the use of the word “therapy” (or “therapeutic”). Under the Supreme Court’s rule in the Thompson v Western Medical case, we should expect that these words would not be forbidden by the Courts and should not therefore be overtaken by the regulators.

Further, the Code of Medical Ethics of the American Medical Association also acknowledges an independent use of the term “therapy.” The original Hippocratic Oath, with its injunction to "Do no harm." has been replaced by a complex Code detailing the relationship between physician and patient and alternative practitioner. Changes made during the early 1990's were inspired by anti-trust lawsuits brought (and won) during the 1980's by chiropractors and other non medical practitioners. These changes are just now becoming recognized by regulators and courts.

While "treatment which has no scientific basis" remains condemned (Opinion 3.01), under Opinion 3.04, physicians are free to "refer" a patient "for therapeutic or diagnostic services to another physician, limited practitioner or any other provider of health care services permitted by law to furnish such services, whenever he or she believes that this may benefit the patient." Thus, unscientific "treatment" is distinguished from "health care services permitted by law." "Treatment" -- which means the use of standard medicine and surgery to "cure" disease -- is distinguished from other health care services (therapies) which need only meet the lesser "may benefit" standard. While physicians "prescribe" treatments for disease, therapies that may benefit may be subject to "referral" thereby further indicating the distinction. Thus, for example, Dietary Supplements that support normal structure and function to support therapeutic outcomes can be seen to complement licensed medicine, but not to be held to its strictures, nor limited in its practice to licensed physicians. Since such therapies are not prescription services, members of the public may choose such services without the permission of their physician. Purveyors may restrict sale of therapeutic products to physicians, complementary practitioners, exercise and health care professionals, although they should not be required to do so.

We have analyzed the word “therapy” and the similar word “therapeutic” because these words are not forbidden by DSHEA and are referenced by the AMA Ethics Code. We recommend “Therapeutic Nutritionals” for alternative practices centered on Nutrition. We recommend the use of the qualifying word, “Nutritional” in this context to make it completely clear that the practitioner is not offering “treatment of disease.”

The claims made for Therapeutic Nutritionals must, of course, be allowed Structure and Function Claims. Thus, for example, under current law as interpreted by the FDA, one cannot claim that a nutrient lowers cholesterol levels – since there is now a “disease” of hypercholesterolemia – but can claim that a nutrient maintains normal cholesterol levels for persons with normal cholesterol. A purveyor may say that a certain combination of multivitamins was designed to maintain normal structure and function for a person with diabetes, but not that the combination “treats” diabetes or affects the blood sugar level. Similarly, any Health Claim made for any alternative practice must meet the FTC standard of "truthful and not misleading" and must be based on standard commercial substantiation criteria.

CAM products are intended to benefit normal structure and function and are not prescribed as treatment for medical or psychological conditions, nor for diagnosis, care, treatment or rehabilitation of individuals, nor to apply medical, mental health or human development principles.”

As the High Court said in Thompson, "We have previously rejected the notion that the Government has an interest in preventing the dissemination of truthful commercial information in order to prevent members of the public from making bad decisions with the information. * * * Even if the Government did argue that it had an interest in preventing misleading advertisements, this interest could be satisfied by the far less restrictive alternative of requiring … a warning..."

What is the proper level of substantiation for CAM nutrient or health claims? It is not the "significant scientific agreement" required of drug claims, but rather, the general "competent scientific evidence" standard that applies to all commercial claims. That does not imply that purveyors need to have multiple double-blind experiments (as may be required for drug approval). Substantiation merely needs to be competent and scientific. We urge this to include research studies (which is when scientists review the work of others and apply it to specific questions) and clinical trials (which may be as formal as double-blind, placebo controlled investigations but need not be, since multiple variables, like those involved in CAM practices designed to promote optimal health, are not well studied by double-blind, placebo controlled investigations) as well as traditional knowledge, clinical case studies, observational reports and clinical experience. All of these sources of information and experience have a role to play, but ultimately, such substantiation must rest on the informed professional opinion of some credentialed or appropriately experienced person who can (in the case of Dietary Supplements, for example) sign onto the Structure and Function Claims Notice to the FDA, attesting that "the notifying firm has substantiation that the Statement to which this Notice applies is truthful and not misleading." (Regulations under 21 U.S.C. 403(r) (6)).

The Natural Solutions Foundation favors a market approach to these issues and urges the FDA to reduce regulation to those minimum levels that will encourage the continued rapid development of CAM approaches. Especially when dealing with Dietary Supplements and Traditional Remedies, we are dealing with foods which, as foods, are presumed to be safe. There is no need for the high level of regulation that is required for the dangerous and invasive drugs and techniques of so-called “standard” medicine. Even with this stringent level of oversight, drugs are a major cause of death in every developed country while CAM remedies are an insignificant-to-absent cause of death world-wide. Rather, this is a situation where the public is best served by a policy of Laissez-Faire: allow CAM to develop freely in the public interest.

Throughout the world today people are looking to traditional methodologies and leading-edge CAM techniques because they offer alternatives to toxic, expensive drugs with their dangerous side effects, un-manageable and unreasonable costs and other invasive technologies of modern medicine. This search for alternatives is protected by the fundamental right of individuals to communicate and learn; to heal and be healed. This has been settled law for over a hundred years.

"The state has not restricted the cure of the body to the practice of medicine and surgery -- allopathy, as it is termed, -- nor required that, before anyone can be treated for any bodily ill, the physician must have acquired a competent knowledge of allopathy and be licensed by those skilled therein. To do that would be to limit progress by establishing allopathy as the state system of healing, and forbidding all others. This would be as foreign to our system as a state church for the cure of souls. All the state has done has been to enact that, when one wished to practice medicine or surgery, he must, as a protection to the public [not to the doctor], be examined and licensed by those skilled in surgery and medicine. To restrict all healing to that one kind -- to allopathy, excluding homeopathy, osteopathy, and all other treatments -- might be a protection to doctors in surgery and medicine; but that is not the object of the act, and might make it unconstitutional, because creating a monopoly." North Carolina's Supreme Court in State v MacKinght, 42 S.E. 580, 1902 at p 582.

Costs, safety and, most of all, liberty, require that the distinction be made and maintained by the FDA between “treatment” and “therapy” if the US Constitution and public are to be served.

Dated: April 6, 2007

Respectfully submitted,

Maj. Gen. Albert N. Stubblebine III,

(US Army, Ret.)

Rima Laibow MD

Ralph Fucetola JD

For: Natural Solutions Foundation

www.HealthFreedomUSA.org

Ref: Federal Register: February 27, 2007 (Volume 72, Number 38

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