Everything Lavender

We headed to Mesa Arizona last month for the United States Lavender Conference (USLC) in Mesa AZ with my husband. This was the 3^rd conference put on by the newly founded United States Lavender Growers Association (of which I am a founding member by the way). We had three tracks of speakers; for beginning growers, experienced growers and for people who may or may not grow, but do use lavender. Lavender is used extensively in aromatherapy, cooking and in skin care products as well as for crafts and availability of US grown lavender is growing.

Lavender can help with stress, anxiety and promoting sleep.  These are important applications because trouble in any one of these areas can lead to a host of other health problems.  Our keynote speaker, Nancy Baggett just released her cookbook, “Cooking with Lavender” which you can actually purchase in our store in Longmont now.

During the conference there was much focus on a common pathogen that is affecting lavender in our country now, Phytophthora. The goal is to stop the spread by controlling it at the source; small plants that are purchased for field planting. We learned about making products with lavender, cooking with lavender and more.  We learned about marketing our products from one of my mentors, Indie Business Network owner, Donna Marie Johnson. 

I gave a talk on cosmetic regulations for people who are making skin care products with lavender; “Your Product Smells Great, but is it Compliant?”  Maybe not the most stimulating topic there is, but one that indeed makers need to know about. Here is a brief overview:

 

Even though we know lavender is wonderful and a valuable contribution to skin care, the FDA requires that we make no claims, either for aromatherapy benefits or skin care benefits.  Doing so categorizes lavender as a drug and that is not approved by the FDA.

A cosmetic label has several requirements;

it must contain the name and use of the product

it must contain the weight of the product

it must contain the company name and contact information

it must contain the ingredients of the product.

I also addressed how to make a safe cosmetic, the use of preservatives and antioxidants (they are not the same thing) and good manufacturing practices.

Some of the best moments of the conference were the unscheduled moments when we learn from each other, by talking and networking.  There was a pre-conference farm tour as well as a farm dinner that we did not make. It would have been interesting to see farms in such a different climate than ours.

And then of course there was hiking in the Superstition Mountains. You can read about that on our other blog here.

What is Fractionated Coconut Oil?

Fractionated coconut oil (FCO) is often used in aromatherapy and cosmetics because it is a very light, odorless oil. Massage therapists like FCO because it leaves less of a stain on clothing and sheets than other oils. It is also used in cosmetics because it gives a lighter feel to a product as well as a glide. FCO is a very stable oil in that it will not go rancid quickly giving it a longer shelf life than other oils. FCO is also used in cooking and is said to not contribute to a rise in cholesterol. 

Photo credit: Peter Davis/AusAID, CC BY 2.0, https://commons.wikimedia.org/w/index.php?curid=32167591

But how does it compare to other Coconut oils? Besides FCO you can readily find coconut oils referred to as 72 degree and 92 degree.

Coconut oil 72 degrees means that it is oil pressed from the copra (meat) of the coconut and melts between 72-78 degrees Fahrenheit. Most of this is then refined and deodorized and labeled RBD, but unrefined coconut oil is also available. Virgin coconut oil is typically made from the milk rather than the copra.

Coconut oil 92 degrees melts at about 92 degrees Fahrenheit. It is similar to the 72 degree coconut oil but has been hydrogenated (hydrogen added across a double bond) so the melting point increases. It is possible to get coconut oil of higher melting point but these are less commercially available.

Fractionated coconut oil refers to only the medium chain fatty acids of coconut oil. Fatty acids which make up triglycerides, come in different lengths most fall between 4 carbons to 28 carbons. Short chain fatty acids are defined as less than 6 carbons, medium chain fatty acids defined as 6-12 carbons, long chain as 13-21 carbons and greater than 21 carbons are very long chain fatty acids.

This is how the fatty acid profile of regular coconut oil breaks down:

Long chain, saturated fatty acids:

Myristic acid (C14) 19%, palmitic acid (C16) 8%, stearic acid (C18) 3%

Long chain unsaturated fatty acids:

Oleic acid (C18:1) 5%, linoleic acid (C18:2) 2%

Medium chain saturated fatty acids:

Caprylic (C8) 8%, Capric (C10) 7%, lauric acid (C12) 48%

Fractionated coconut oil refers to just two of the medium chain fatty acids; caprylic and capric fatty acid. The INCI (International Nomenclature for Cosmetic Ingredients) for FCO is Caprylic/Capric Triglyceride. The lauric acid with 12 carbons is borderline long chain and not extracted into the FCO or also called MCT for Medium Chain Triglycerides. 

So how are they separated? The ‘fractionating’ is done first by hydrolyzing the triglyceride to separate it into glycerol and fatty acids. This is the same reaction a soapmaker uses to make soap. The fatty acids are then gradually heated so that the lower carbon chains melt first and the various fatty acids are ‘fractionated’ or separated.  This actual separation is done through distillation. Once this is finished the result is MCFA for medium chain fatty acids, rather than a triglyceride. The triglyceride is then reformed by esterification with glycerin/glycerol to reform the triglyceride or MCT for medium chain triglycerides, also the fractionated coconut oil. Fractionated coconut oil is commonly referred to as Mixed Chain Triglycerides (MCT). It's INCI name is

Caprylic/Capric Triglyceride which refers to the carbon chain length of the fatty acids.

These reactions that occur (hydrolysis, distillation, esterification) are generally found to be acceptable in natural products and green chemistry products. The resulting product is a triglyceride that is formed from the medium chain fatty acids; caprylic and capric acid. This FCO is lightweight and absorbs well into the skin, is odorless and has a long shelf life. It is used as a carrier oil for herbalists and aromatherapists, as a dietary supplement and as a cosmetic ingredient.

The Importance of Farms

Farms are important for many reasons including preserving open space around a city, providing wildlife habitats, as well as the crops they produce. Most people are well aware that their food comes from a farm in the form of vegetables and meat. But are you aware of the other, non-food crops that come from a farm? Throughout time people have always had a rich relationship with plants and plants that were particularly useful then became cultivated. The study of this relationship is often called Economic Botany. 

Plants produce fiber, medicines (both traditional and modern), spices, herbs, perfumes, vegetable oils, waxes, latex, resins, poisons, psychoactive drugs, and alcoholic beverages.

Smaller farms might be especially important because they are more likely to have biodiversity on the farm than large corporate farms that are interested in a single crop.

Lets look for instance at some of the uses of plants that are grown on a farm.

Arts and crafts. Many plants can be used for arts and crafts. Various types of grasses have been used for making baskets, mats, and hats. People are even using pine needles and lavender stems to make baskets. One of my favorite crafts is the lavender wand.

Medicine. Herbs are important medicines used throughout the world. Some of the top medicinal herbs that can be grown in Colorado are Echinacea, Mint and Chamomile. 

Modern medicine has obtained many of their drugs from plants too. Some of these pharmaceutical crops include Yew grown for Paclitaxel, Camptotheca grown for camptothecin, and Galanthus woronowii grown for Galantamine (an Alzheimers drug). The active ingredients from these plants are extracted after harvest for preparation of the therapeutic substances . GlaxoSmithKline makes digoxin from foxglove that is grown in the Netherlands. http://pubs.acs.org/cen/coverstory/83/8325/8325digoxin.html

Perfume. Scent is one of the most delightful things about herbs and this property also makes them important in sensory gardens. The most common way of obtaining scent or perfume from plants is by distillation to produce an essential oil. However, there are other ways that scent is extracted as well. Common plants used for perfume are lavender and rose. On our farm we distill aromatic herbs to obtain the aromatic water. We routinely distill lavender, rose, tulsi, cucumber, lemon balm, clary sage and mint.

Fiber. Fiber crops can be used for clothing, basketry or building materials. Common crops used for clothing are hemp, agave, cotton, and linen. Animal hairs are also common fibers used such as wool from sheep and mohair from angora goats.

Flavor. Culinary herbs provide the bulk of plants grown for flavor. Some of my favorites are Basil used in pesto, garlic used in a variety of dishes and sage.

Cosmetics and Beauty. This is the area that I am most familiar with since I grow herbs to use in Colorado Aromatics Skin Care. Herbs provide an abundant amount of antioxidants and anti-inflammatory agents; far more than what you could add to a product from other sources. Perhaps one of the most important herbs used in skin care is calendula, but the number is limitless due to the variety of benefits they provide. Growing these herbs allows us to produce a unique, highly functional, farm to skin brand and to be members of our local farmers market.

Fatty Oils that can be used for cooking and more including cosmetics. In Colorado sunflowers are grown for this purpose although most are used for the production of energy.

Alcohol. The most obvious plants grown for alcohol would be grapes for wine, barley for beer and other grains for distilled spirits. But many other herbs are grown for flavoring alcoholic beverages too. For instance, juniper for flavoring gin. Other herbs used in alcohol are coriander, anise, cardamom and licorice. At Colorado Aromatics, we grow lemon balm for flavoring Trinity Absinthe. 

The Society for Economic Botany is a professional society who's members study the relationship between plants and people. You can find them here.

http://www.econbot.org/

We are Certified!

I'm happy to announce that our farm has just become Certified Naturally Grown (CNG). I am excited about this program and you can read more about here http://www.naturallygrown.org/.  Its standards are similar to the USDA's Certified Organic program in that it does not allow synthetic fertilizers, pesticides, herbicides, fungicides or GMO seeds. It differs in that it is a small, private and grass roots organization not associated with the government and encourages collaboration, transparency and community involvement.

I've never been quite comfortable with the Certified Organic Program; its a government sponsored program that seems more tailored towards the larger sometimes corporate farms involved in monocropping. Not to mention their ownership of the word 'organic'. USDA COP farm inspectors are forbidden to make suggestions or help the farmers in any way while CNP farm inspectors are peers and volunteers that are encouraged to share information.  I look forward to my first farm inspection this spring by one of my peers who has volunteered to do so and I expect it to be a learning process. I've asked Darrell Cook of Ginger Cat Farm to do my inspection. CNP relies on volunteers like this which encourages community involvement and collaborations.

At Colorado Aromatics Herb Farm I grow things the way my Mother taught me and she learned from her Mother, the traditional way, long before there even were synthetic fertilizers, herbicides and pesticides. I do have the benefit of having herbs and lavender as my main crop which are probably easier to grow than vegetable crops. But we fertilize our fields in the winter using manure produced by our horses, goats and chickens. Although we are still learning how to best control weeks; we pick by hand until our backs ache, we use weed cloth and we hoe (we also accept volunteers). We try to reduce the amount of gasoline we use on the farm too by doing most of the work by hand rather than by tractor (we don't own a tractor). Because of the way we farm, beneficial insects such as bees, ladybugs and praying mantis abound. When we do get damaging insects such as aphids our first choice is to take care of them with the garden hose.

I think growing my herbs with the Certified Naturally Grown seal partners well with the extracts I make from them for natural cosmetics. I'll soon be adding pictures and information to our profile at CNG http://www.naturallygrown.org/farms/3421.

Registration Requirements of the Safe Cosmetics Act

Registration Requirements of the Safe cosmetics Act
Section 612

Registration of cosmetics manufacturers seems reasonable, and I think that anyone who makes cosmetics should be registered with the FDA. By doing so it allows open communication between FDA and cosmetics manufacturers so that information about ingredient toxicity can be openly shared. Its interesting though that this bill exempts small businesses, those that sell less than $2M annually, from registering with the FDA. I am confused about the reason for this. Without registering there is no open communication and no means for small businesses to get up to date information from the FDA. It also brings up the suspicion by consumers and other regulatory organizations that small businesses do not necessarily make safe cosmetics since they are not in contact with FDA. This is anything but leveling the playing field. As a small (micro) business I do not want to feel second rate and am proud to be voluntarily registered with the FDA already.

Cosmetic companies would be required to file a report of all cosmetics they produce and the functions of such cosmetics. The FDA already defines cosmetics 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" so its unclear if they are wanting more information on the function of the cosmetic or not. Reporting gross sales from cosmetics is required; forcing small privately owned businesses to reveal personal financial information. Yes, I do feel like this violates my rights. Sole proprietorship's and LLCs should not be required to make public their personal finances. I’m curious how FDA will even be able to keep track of this, especially when small businesses are not even required to register. I fear a lot of companies will be trying to ‘fly under the wire’ or go ‘underground’ so to speak, not have the knowledge they need and make unsafe cosmetics because of that.

The part I mainly object to is that companies must supply the name and address of any company that supplies ingredients. This is especially difficult for a small company as suppliers can change frequently. This prevents any last minute changes in formulas. If I happen to run out of olive oil from my supplier I have listed, I cannot go to the grocery store to buy emergency olive oil as I have been known to do. Any errors or inaccuracies in information submitted can lead to cancellation of registration or even

What's an alternative? I think cosmetics companies should all register with the FDA. This allows a path of communication between the FDA and manufacturers that is important. Not only to receive up to date information from the FDA but also for the FDA to receive information from manufacturers and consumers on adverse reactions. Fees can and should be waived for small companies. Suppliers should not have to be reported to the FDA. If olive oil is safe why does the FDA care who I buy it from? As long as safe ingredients are used it doesn't seem like a good use of FDA time to have to keep track of where I buy them from.

But what's worse is that now legislation is being introduced in a number of states to regulate cosmetics at that level as well. This means there is a good chance that you will have to deal with this type of registration in each and every state as well as at the national level.

If you are a small business how do you feel about this part of the bill?

Safe Cosmetics Act of 2011

After spending a good several hours reading the new Safe Cosmetics Act of 2011 I see that the changes in this bill compared to 2010 are minimal. Here is my initial take on the bill which may or may not change depending on if some points get clarified or others appear as I reread it.

Again this bill includes in the definition of an ingredient any contaminants that are present at levels above technically feasible detection limits. As we all know, detection limits now are quite minute so any type of contaminant would be included here. This includes contaminants from the container as well. But what contaminants are they referring to here and why don’t they specify?

Ingredient safety can fall under just two categories: ‘Safe Without Limits’ and ‘Prohibited and Restricted’ This is misleading to both the consumer and the manufacturer since there is no such thing as a substance that is safe without limits. Even water can be lethal under certain conditions. It mentions ‘considerations’ in determining toxicity such as “is found to be present in the body through biomonitoring”. Does this mean that something is toxic if found in the body? I’m not sure I understand this. Many things are found in the body through biomonitoring including water. A second consideration is an ingredient that is suspected immunological toxicant. Is this another way of saying “allergen”? If so, does this mean that a substance that causes allergies will be prohibited? Anything can be an allergen and some common allergens are shea butter, almond butter, soy oil, milk, etc. Many herbs are also allergens. All in all, the bill has very poor definitions of toxicity and leaves most of it up to the FDA to determine in one year’s time! Wow, where is the FDA going to find those resources?

Labels must list ingredients in decreasing order of concentration. This is already required by the FDA so is redundant here. Contaminants however must also be listed. Knowing that water alone can contain any number of contaminants this immediately causes problems. Is testing of all our ingredients for contamination required?? Besides water, vegetable oils will contain contaminants, herbs grown in the backyard could contain contaminants. However, it does allow the FDA to determine such possible contaminants within one year’s time as well as determine requirements for testing and detection limits. If it is determined that cosmetic manufacturers are required to test for various contaminants this would add considerably to the cost of cosmetics. I am glad to see that ingredient lists are required on websites that sell cosmetics.

Some of the most dangerous contaminants of cosmetics are fungus and bacteria that can grow on nutrients in the product. Unfortunately, no specific mention of this is made. This is one area where consumers have suffered because of improperly made and improperly preserved products – in fact, this is the only area of documented harm to consumers from cosmetics.

Again, toxic is defined as a 1 in a million risk for adverse health effects. Toxic effects include allergic reactions and I challenge anyone to find any ingredient natural or synthetic that does not cause an allergic reaction in one in a million people.

Many things are not clear for instance “the safety standard results in exposure to the amount or concentration of an ingredient or cosmetic that is shown to produce no adverse health effects, incorporating a margin of safety of at least 1,000 and considering the impact of cumulative exposure from all sources (including environmental sources).” Does anyone know what this means and if so can you tell me? Does it mean 1000^th of the determined toxic dose? If so, who determines this dose?

The bill goes on to require that the FDA issue guidance prescribing Good Manufacturing Practices. This is something that again, the FDA already has issued and so is redundant.

The bill requires manufacturers of cosmetics and ingredients to submit information including toxicological properties of each such ingredient or cosmetic. I’m not sure if this means the manufacturer who is buying ingredients is required to submit data to the FDA on those ingredients or not. Since the source of this data would probably be from the ingredient manufacturer this seems redundant. When this ingredient is purchased at the grocery store such as some small manufacturers do with vegetable oils, where is the toxicological data and contaminant data and how is this reported as an ingredient source? When the ingredient is an herb from the small manufacturer’s back yard where will this toxicological information come from or will this no longer be possible? I am still very concerned about the future of using natural ingredients in cosmetics with this bill. There are many herbs, oils, and natural extracts that have quite a data gap in toxicological studies.

I find it interesting that the ‘authoritative source’ of toxicology information includes the (A) Environmental Protection Agency,

(B) the International Agency for Research on Cancer,

(C) the National Toxicology Program,

(D) the California Environmental Protection Agency and

(E) any other authoritative international, Federal, and State Entity, as determined by the Secretary.

I’m not sure what E means but I know there are pseudo science activists groups who may pose as an authority so that they can determine law. I would rather be sure toxicity was determined by peer reviewed scientific literature.

Some of the considerations in the bill for toxicity are also quite vague, for instance; if it is found in the body through biomonitoring. Does this imply that if something is found in the body it is toxic? I use water in my cosmetic formulas and I know it is found in the body. Another consideration is known or suspected immunological toxicant. Is an immunological toxicant the same thing as an allergen? Anyone can be allergic to anything but some of the more common allergens are shea butter, almond oil, soy oil, wheat and herbs. Will these ingredients be prohibited?

There is no definition of an ingredient manufacture. Many small companies use ingredients from their backyard; herbs and other botanicals. Are these companies required to have these ingredients tested to find what contaminants might be present and in what levels?

The thing that concerns me the most here though is that microbusinesses (those with sales less than $2 million) are not required to register with the FDA. Although I am glad to see that the bill waives a costly registration fee for these small companies (of which I am one) I don’t understand the lack of even registering with the FDA. Registration allows a link with the FDA so that companies can get timely information regarding ingredients and toxicity but just as important is that it allows consumers a way to report adverse effects that may occur due to cosmetic usage. By not registering, these microbusinesses are out of the communications link with the FDA. FDA will have no knowledge of the microbusiness’s existence, their activities, the products they manufacture or the functions and toxicities of those cosmetics. In the initial bill of 2010 small businesses rallied hard to be exempt from paying high registration and testing fees. However, we did not rally against registration.

If small companies are exempt from registering and having communication with the FDA are they exempt from submitting information on toxicological properties of ingredients and cosmetic product; exempt from “cease distribution” orders due to misbranding; exempt from use that causes serious adverse health effects; exempt from using contaminants and testing for these contaminants, exempt from good manufacturing practices issued by the FDA, etc? Having that link to the FDA could be valuable for a small business to learn the laws and requirements necessary especially when it comes to testing. This concerns me because many small cosmetics business owners just starting out do not have the knowledge base to draw from to know how to make safe cosmetics and have the potential to put something out there that is less than safe. And consumers should have a way to report possible adverse effects. It was the costs involved in the first version of this bill that had small business owners concerned, not having to register and be held accountable for their actions.

Should small businesses be just as responsible for their actions? Registration is important to keep open communication with the FDA.

Overall it is still a case of an activist group who knows nothing about the cosmetics business trying to make laws about things they do not understand. The bottom line still is that this bill will not make cosmetics safer.