Young Living & “Intent” to sell drugs

Young Living has been trying to reign in their zillions of consultants ever since the Petition to Protect the Future of Aromatherapy and the resulting FTC and FDA complaints by Aromatherapy United, resulted in Warning Letters to the company.

petition-closed

 

Some things they have done in the best interest of their finances, like label certain essential oils as “dietary supplements” in order to legally make structure and function claims. That serves no one but themselves, and eventually the FDA will catch up to the fact that most of the structure and function claims they make are unsubstantiated and that there is no reason to ingest essential oils on a daily or even regular basis. It may take a few more deaths, but I believe it will happen.

But other things are done well, and while also with the ultimate goal of protecting the company, has the positive side benefit of protecting consumers from misleading SNAKE OIL sales pitches and dangerous advice, which have led to so many adverse reactions over the past years. [example see the Injury Databases at Aromatherapy United].

Here are a couple examples from a publicly available Young Living presentation from last year.

YLftc

Funny, some people just don’t get the message. So I took a couple screen shots off Facebook yesterday and I’ll be adding to the ongoing File of complaints with both the FTC and the FDA!

This particular consultant is making “pain relief” testimonial claims for topically applied YL essential oils, in spite of the fact that pain relief products are a category of over-the-counter drugs.

  • It does not matter if the essential oil is labeled and sold for topical use – making it a cosmetic;
  • it does not matter if the essential oils is labeled and sold as a “dietary supplement”:
  • pain relief is a DRUG CLAIM.

So unless that bottle is labeled according to FDA regulations for OTC Drugs – it is illegal to imply it will work to relieve pain.

It is dangerous enough that this company casually sells Wintergreen Essential Oil with no hazard warnings, but when their consultants continue to promote it as a drug – well – the company still has a long way to go before consumers are safe from their “consultants”!

So the next time a Young Living consultant tells you it is healthy to ingest essential oils – whether the bottle they are trying to sell you is labeled according to the FDA regulations for cosmetics, or labeled according to the FDA regulations for “dietary supplements”… you can tell them Young Living themselves says

“There are no health claims approved for essential oils”!

ylEO

Wintergreen EO – Buyer Beware

WINTERGREEN

Wintergreen (Gaultheria procumbens) essential oil

CAS numbers
USA: 68917-75-9;
EINECS: 90045-28-6

EPA Reason for Regulation: Chemical in Commerce

Synonym: Wintergreen oil

List Name: Inert Ingredients in Pesticide Products

CHIP detailsXn; R22, 36; 0%; S26 (A26) – “Ingestion can cause severe poisoning and death, Lethal doses with children  at 10 ml, adults at 30 ml.” — Guenther, volume II, page 640

Wintergreen Essential Oil contains 85-99% of methyl salicylate, the same component of aspirin.

Thirty ml (about an ounce) of wintergreen oil is equivalent to about 171 adult aspirin tablets or about 60 grams of aspirin.

Members of the International Federation of Aromatherapists take a “vow” not to use Wintergreen essential oil. 

“How does it work?

Wintergreen leaf contains an aspirin-like chemical that might reduce pain, swelling, and fever.

WINTERGREEN Side Effects & Safety 

Wintergreen is safe in the amounts found in foods, and seems safe for most adults when used as a medicine.

The oil is UNSAFE to take by mouth. Taking wintergreen oil or large amounts of wintergreen leaf can cause ringing in the ears, nausea, vomiting, diarrhea, headache, stomach pain, and confusion.

When applied directly to the skin, wintergreen oil can cause skin irritation.

Special Precautions & Warnings:Children: Wintergreen leaf and oil can be poisonous for children. Taking 4-10 mL of wintergreen oil by mouth can be deadly. Don’t even use wintergreen oil on the skin of children less than 2 years old.

Pregnancy and breast-feeding: Wintergreen is safe in amounts found in food, but there’s not enough information to know if it’s safe in the larger amounts that are used as medicine. Don’t take it by mouth or put it on your skin, if you are pregnant.

If you are breast-feeding, don’t take wintergreen by mouth or put it on your skin. Wintergreen products might be toxic to nursing infants.

Stomach and intestinal inflammation: Taking wintergreen by mouth might make these conditions worse.

Salicylate or aspirinallergy, asthma, or nasal polyps: Wintergreen might cause an allergic reaction in people who are allergic to aspirin or other salicylate compounds, or have asthma or nasal polyps. Use wintergreen with caution if you have one of these conditions.”

http://www.webmd.com/vitamins-supplements/ingredientmono-783-WINTERGREEN.aspx?activeIngredientId=783&activeIngredientName=WINTERGREEN

INTERACTIONS http://www.webmd.com/vitamins-supplements/ingredientmono-783-WINTERGREEN.aspx?activeIngredientId=783&activeIngredientName=WINTERGREEN

“Methyl salicylate must be absolutely avoided by anyone taking blood-thinning drugs, as it increases the action of the drug, and this causes blood to leak into tissues and  internal bruising occurs. Knowing a lethal dose tells you very little about what (a) a therapeutic dose would be or (b) a safe dose would be, but it does tell you what dose not to use!”http://roberttisserand.com/2012/03/wintergreen-oil-safety/

TITLE 21–FOOD AND DRUGSCHAPTER I–FOOD AND DRUG ADMINISTRATIONDEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER C–DRUGS: GENERAL   PART 201 LABELING Subpart G–Specific Labeling Requirements for Specific Drug Products

Sec. 201.303 Labeling of drug preparations containing significant proportions of wintergreen oil.  

(a) Because methyl salicylate (wintergreen oil) manifests no toxicity in the minute amounts in which it is used as a flavoring, it is mistakenly regarded by the public as harmless even when taken in substantially larger amounts. Actually, it is quite toxic when taken in quantities of a teaspoonful or more. Wintergreen oil and preparations containing it have caused a number of deaths through accidental misuse by both adults and children. Children are particularly attracted by the odor and are likely to swallow these products when left within reach.

(b) To safeguard against fatalities from this cause, the Department of Health and Human Services will regard as misbranded under the provisions of the Federal Food, Drug, and Cosmetic Act any drug containing more than 5 percent methyl salicylate (wintergreen oil), the labeling of which fails to warn that use otherwise than as directed therein may be dangerous and that the article should be kept out of reach of children to prevent accidental poisoning.

(c) This statement of interpretation in no way exempts methyl salicylate (wintergreen oil) or its preparations from complying in all other respects with the requirements of the Federal Food, Drug, and Cosmetic Act.

and

(g)(1) The label of any drug containing more than 5 percent methyl salicylate (wintergreen oil) should bear a conspicuous warning such as: “Do not use otherwise than as directed.” These drug products must also include the “Keep out of reach of children” warning and the accidental ingestion warning as required in 330.1(g) of this chapter.

(2) If the preparation is a counterirritant or rubefacient, it should also bear a caution such as, “Caution: Discontinue use if excessive irritation of the skin develops. Avoid getting into the eyes or on mucous membranes.” (See also 201.303.)

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=201&showfr=1&subpartnode=21:4.0.1.1.2.7


Originally Published on: Oct 4, 2014 @ 06:03

UPDATED 8/21/2016

wintergreen

NOTE: when Wintergreen EO is sold with medical claims, such as referring to pain relief – the product is being sold as a misbranded drug.  Wintergreen products which contain more than 5% methyl salicylate (and 100% pure Wintergreen EO is 85-99% of methyl salicylate) – are required to have very specific WARNINGS. Does the brand you buy have these warnings?

poisonousplants

There is a reason to keep EOs out of the reach of children, and take their use seriously.  These are wonderful products when used properly and safely.  Potential poisons when not.  Wintergreen is one of the EOs which due to it’s chemical nature – is absorbed through the skin and may reach the bloodstream.  Many people have been hospitalized and there is at least one death, attributed to topical application of wintergreen oil or products which contain it as an ingredient.  That is why products with Wintergreen are supposed to be labeled as OTC or prescription drugs, and contain dosages, contraindications, “when to seek medical attention” and all the other labeling requirements of DRUGS.

Essential Oils as Food Flavors

If you eat prepared foods, or eat peppermint candy for example, you have ingested essential oils.

That’s not snarky, that’s a fact.

There is a HUGE difference between the internal therapeutic use (oral, vaginal or rectal) of essential oils and “ingestion” of essential oils as food flavorings.

The Alliance of International Aromatherapists does not recommend internal therapeutic use “unless recommended by a health care practitioner trained at an appropriate clinical level. An appropriate level of training must include chemistry, anatomy, diagnostics, physiology, formulation guidelines and safety issues regarding each specific internal route (oral, vaginal or rectal).

Herbal medicine
Herbal medicine

In the USA there a law called DSHEA which was introduced in order to allow certain ingredients or combinations of ingredients to be sold as “Dietary Supplements”. This is a great thing, it is why we can buy herbs, and vitamins without a prescription and without them being regulated as over-the-counter drugs. But it is also an unfortunate loophole for the suppliers who sell essential oils, and who do so with certain claims which are not allowed for essential oils sold for topical use.

An essential oil labeled according to the Trade Requirement & Guidance Policy of the American Herbal Products Association will have:

  • Common name;
  • Latin name;
  • Plant part;
  • The extraction process;
  • “Keep out of reach of children”
  • “External Use Only”or “Not for Internal Use” or “Not for Ingestion”

These product labels and their marketing, cannot make any medical claims, nor can they make any “structure or function” claims, because products sold for topical use with structure or function claims, are automatically considered drugs (OTC or prescription). [Example – FDA Warning Letter to Young Living]

So certain companies have decided to market and label their essential oils “as” dietary supplements for the sole purpose of being able to make structure function claims!

Nothing different about the ingredient itself is requiredthe only difference is the labeling.

THAT is why people – in my opinion – who are purchasing essential oils, need to understand the FDA regulations, whether they *believe* in the FDA or not.

There are also companies which sell essential oils as food flavorings.

The food industry is the largest consumer of essential oils next to the perfume industry. Essential oils sold as food flavorings are often standardized, because foods need to taste the same from batch to batch, year to year. So the industrial use of essential oils requires the ingredient fit a standard, often the ISO standard. So a certain year’s peppermint might be a bit off and so constituents from other essential oils are added to make the oil fit the required profile. But most people in the practices of  aromatherapy  want 100% pure essential oils – as they come off the still – not standardized for consistency. Standardization is considered to be a form of “adulturation” in the aromatherapy world.

And here is where the discussion took a confrontational turn.

Stating the fact that essential oils can and are used safely as food flavorings is not even remotely the same as saying that essential oils can be ingested safely as dietary supplements (or medically for that matter, unless one is properly trained in Aromatic Medicine).

“…I think that it gets confusing because people often refer to GRAS status, so they will say that this essential oil has GRAS status which means that it is generally recognized as safe by the EPA and the FDA. But actually what that applies to is the use of essential oils in food flavorings; specifically this only applies to food flavorings and not to other uses such as medicines. So GRAS status doesn’t mean this essential oil is safe to ingest, it means this essential oil is safe to use in food flavors, which yes does result in ingestion but the word ingestion is where the confusion happens because it is not a way of saying that this is OK to use as a medicine.” Robert Tisserand

There IS no diet which is missing essential oils, no diet which needs to be supplemented with essential oils. PERIOD.

There is no biological reason to ingest essential oils daily, or regularly for dietary or nutritional reasons or to improve the structure or function of the body. The marketing of essential oils for the purpose of improving the structure or function of the body is selling them as SNAKE OIL. It’s a money making scheme and nothing more.

When people use essential oils as food flavorings, they are adding perhaps a drop or two of oregano to an entire pot of spaghetti sauce or a drop of peppermint in an entire batch of chocolate frosting – where it is incorporated into the fats and other ingredients and can be ingested safely. It is never safe or appropriate to drink essential oils in water or add them to sports drinks. People have died from drinking lemon EO in water. It has been covered up, but they have died of liver failure. Other people have been near death in liver failure from ingesting “blends” sold as dietary supplements by MLMs.

This is one of the reasons professional aromatherapists avoid the big two MLMs, not just because both companies have been accused (and scientifically proven in many instances) to have sold adulturated EOs, but because the corporate culture of these companies puts not only their customers at risk, but risks the future for the entire aromatherapy industry.