Wintergreen (Gaultheria procumbens) essential oil
EPA Reason for Regulation: Chemical in Commerce
Synonym: Wintergreen oil
List Name: Inert Ingredients in Pesticide Products
“Ingestion can cause severe poisoning and death, Lethal doses with children at 10 ml, adults at 30 ml.” – Guenther, volume II, page 640
Natural Wintergreen Essential Oil contains 97-99% methyl salicylate. While this is not exactly same as aspirin (the chemical name for aspirin is acetylsalicylic acid) all salicylates do tend to be teratogenic in elevated doses.
Members of the International Federation of Aromatherapists take a “vow” not to use Wintergreen essential oil.
“In 1967, an ADI (acceptable daily intake) for methyl salicylate was set at 0.5 mg/kg body weight by the Joint FAO/WHO Expert Committee on Food Additives, and this was reviewed in 2001. The same ADI was adopted by the Council of Europe Committee of Experts on Flavoring Substances. The Health Canada maximum for methyl salicylate is 1% in topical products (Health Canada Cosmetic Ingredient Hotlist, March 2011).” Robert Tisserand
“How does it work?
Wintergreen leaf contains an aspirin-like chemical (methyl salicylate) that may 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. For medical use, 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.
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 aspirin allergy, 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.” — WebMD
“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!”
TITLE 21–FOOD AND DRUGS
CHAPTER I–FOOD AND DRUG ADMINISTRATION DEPARTMENT 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.)