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.”
“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.
(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.)
Originally Published on: Oct 4, 2014 @ 06:03
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?
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.