Who Regulates Essential Oils? FDA, EU and Other Rules
In the US an essential oil is regulated by how it is marketed, as a cosmetic, a drug or a consumer product. This page also summarizes EU cosmetics rules and what we could not read.
Content last updated . This page has not been medically reviewed.
Safety first. Supplements can cause side effects and interact with medicines. Read mushroom safety and interactions before you use any mushroom product.
Safety first. A product being legal to sell is not proof that it is safe for you. Do not swallow essential oils, and keep them away from young children and pets. See Essential oil safety.
United States: the same oil, different categories
| If the product is... | The FDA describes it as... | Source |
|---|---|---|
| A perfume or cologne meant only to smell good | A cosmetic | [2] |
| Meant to treat or prevent disease, or affect the body's structure or function | A drug | [2] |
| A baby lotion claiming to moisturize and to relieve colic | Both a cosmetic and a drug | [2] |
| An air freshener, scented candle, laundry detergent or household cleanser | Regulated by the Consumer Product Safety Commission | [2] |
A massage oil that only lubricates skin is a cosmetic. If it is claimed to relieve aches or relax muscles, apart from the massage itself, it is a drug or possibly both. [1] "Helps you sleep" and "eases pain" are examples of drug claims. [2] The wording of the claim, not the plant, sets the category. [2]
What the cosmetic rules do and do not require
Cosmetic products and ingredients, apart from color additives, do not need FDA premarket approval. [3] Companies that make or market cosmetics have a legal responsibility to ensure their products are safe. [3] The FDA can act against products on the market that break the law, but it is not authorized to order a cosmetic recall. [3] Recalls are voluntary actions by manufacturers or distributors. [3]Drugs are different: they must meet requirements, such as FDA approval for safety and effectiveness, before sale. [2]
Labels and "natural"
Retail cosmetics must list ingredients, but under US regulations fragrance and flavor ingredients can be listed simply as "Fragrance" or "Flavor." [1] The FDA says it has no regulations defining "natural" or "organic" for cosmetics. [2] Advertising claims fall to the Federal Trade Commission rather than the FDA. [2] Read more in Essential Oil Quality and Labels and Therapeutic Grade claim checked.European Union: cosmetics rules
The European Commission calls Regulation (EC) No 1223/2009 the main framework for finished cosmetic products placed on the EU market. [4] It requires a product safety report before a product is placed on the market. [4] The Commission also states that cosmetics marketed in the EU must be registered in the cosmetic products notification portal before sale, and that EU countries are responsible for market surveillance. [5] The Commission's list of legislation includes a 2023 amendment on the labelling of fragrance allergens and common criteria for justifying cosmetic claims. [4]We read the Commission's pages, not the legal texts, so we do not list which individual oils or allergens are covered.
Other countries
Not described in the sources we read: Canada, the United Kingdom, Australia and other countries. We tried to read national regulator pages and could not open them this session. One 2025 review says countries have developed safety guidelines for fragrances covering skin sensitization and allergy and that there are differences and efforts to harmonize. [6] If you live outside the US or EU, check your national health or consumer regulator.What this means for a reader
- A label that says "aromatherapy" does not tell you the product was reviewed for safety or effectiveness.
- Health claims on a bottle suggest the maker intends a drug use, which brings drug rules. [2]
- Report reactions using Side Effects, Allergic Reactions and Reporting.
- Supplement rules are separate; see How Supplements Are Regulated. The claims behind marketing are tested on Essential Oil Claims Checked.
Frequently asked questions
Are essential oils regulated?
Yes, as products, by intended use. The FDA says the term "essential oils" itself has no regulatory definition. [1]
Does the FDA approve essential oils?
Cosmetics do not need FDA approval before sale. [3] Drugs do. [2] Which one a bottle is depends on the claims made.
Can a company list "fragrance" instead of each oil?
Under US regulations fragrance and flavor ingredients can be listed simply as "Fragrance" or "Flavor." [1] The EU has an amendment on labelling of fragrance allergens. [4]
Who checks advertising for essential oils?
The FDA says advertising claims are regulated by the Federal Trade Commission, while the FDA regulates labeling. [2]
Is "organic" or "natural" on an oil label regulated?
The FDA says it has no regulations defining either word for cosmetics. [2] See Organic, Wildcrafted and Origin Claims.
References
- U.S. Food and Drug Administration. Fragrances in Cosmetics. Content current as of 02/28/2022. Read 2026-10-22.
- U.S. Food and Drug Administration. Aromatherapy. Content current as of 09/08/2023. Read 2026-10-22.
- U.S. Food and Drug Administration. FDA Authority Over Cosmetics: How Cosmetics Are Not FDA-Approved, but Are FDA-Regulated. Content current as of 11/18/2025. Read 2026-10-22.
- European Commission. Cosmetics: Legislation. Read 2026-10-22.
- European Commission. Cosmetics (Internal Market, Industry, Entrepreneurship and SMEs). Read 2026-10-22.
- Rana P, Pathania D, Gaur P, et al. Regulatory frameworks for fragrance safety in cosmetics: a global overview. Toxicol Res. 2025 (review; abstract read). Read 2026-10-22.