What US laws regulate essential oils and their sales and marketing?

It depends 100% on the intended use.

Essential oils are regulated as Cosmetics, Foods, Drugs, or as Household Products (regulated by the Consumer Product Safety Commission, not the FDA, because they are not foods or drugs). Essential oils sold as pesticides are regulated by the EPA.  Essential oils sold as food flavors must be listed by the FDA as “GRAS” (generally recognized as safe) ingredients – and are those essential oils which are generally recognized by experts as safe, based on their extensive history of use in food before 1958 or based on published scientific evidence; these products are labeled as food flavors not dietary supplements. Examples of household products are essential oils sold to scent candles or to use as ingredients in consumer products like scenting cleaners or room fragrance. We focus here on essential oils as regulated by the FDA.

COSMETICS

Most essential oil suppliers and aromatherapy companies legally market and intend their essential oils and aromatherapy products to be used for Cosmetic use. That is why the labels of reputable companies say “For External Use Only.”

To learn more:

Cosmetic Regulations: fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074162.htm

Aromatherapy: fda.gov/Cosmetics/ProductsIngredients/Products/ucm127054.htm


DRUGS

But sometimes they are intended to be used as Drugs. In most cases, this makes them misbranded drugs (illegal).

“Some fragrance products that are applied to the body are intended for therapeutic uses, such as treating or preventing disease, or affecting the structure or function of the body. Products intended for this type of use are treated as drugs under the law, or sometimes as both cosmetics and drugs.”

“Statements on labels, marketing claims, consumer expectations, and even some ingredients may determine a product’s intended use.”

INTENDED USE “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals” [FD&C Act, sec. 201(g)(1)] are DRUGS.

How is a product’s intended use established? fda.gov/cosmetics/guidanceregulation/lawsregulations/ucm074201.htm

“Essential Oils” and “Aromatherapy”: ““essential oils” are commonly used in so-called “aromatherapy” products. If an “aromatherapy” product is intended to treat or prevent disease, or to affect the structure or function of the body, it’s a drug.

To Learn More: fda.gov/Cosmetics/ProductsIngredients/Products/ucm388821.htm#essential


DIETARY SUPPLEMENTS (FOOD)

What about Internal Use? Aren’t essential oils a subcategory of Herbal Medicine?

Yes – they can be  used as Herbal Medicine. However they are NOT FDA APPROVED as Herbal Medicine.  So if someone were to decide to use them as drugs (medicine), they should always consult with a licensed MD or ND who has advanced education in aromatic medicine, or with a Qualified Aromatherapist whose scope of practice, as determined by State Law, includes giving medical advice and who has sufficient training in the use of essential oils as aromatic medicine by internal use.

Essential oils and products which contain essential oils are sold as dietary supplements (aka nutritional supplements) and marketed under the Dietary Supplement Health and Education Act of 1994 (DSHEA).

“The term “dietary supplement” – “(1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: “(C) an herb or other botanical;”

fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/significantamendmentstothefdcact/ucm148003.htm

“A dietary supplement is a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet. The “dietary ingredients” in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. “

“a product sold as a dietary supplement and promoted on its label or in labeling* as a treatment, prevention or cure for a specific disease or condition would be considered an unapproved–and thus illegal–drug.”

“Why do some supplements have wording (a disclaimer) that says: “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease”? This statement or “disclaimer” is required by law (DSHEA) when a manufacturer makes a structure/function claim on a dietary supplement label.” fda.gov/food/dietarysupplements/qadietarysupplements/

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