Essential Oil Label Requirements
High-quality, credible essential oil brands should provide adequate information about their products to help consumers make informed decisions. Adhering to the labeling guidelines below helps ensure that consumers are able to use essential oil products safely and effectively.
USA Essential Oil Label Requirements
In the United States, essential oils may be regulated as a cosmetic, a drug or both, depending on their intended use.1
Cosmetic products sold in the United States are not required to obtain pre-market approval, but must adhere to cosmetic labeling requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA).
Cosmetics may display all required label information on either the principal display panel (PDP) or the information panel. The PDP is the area most likely to be seen by consumers, and is often the outward-facing display. The information panel contains necessary product information but may be located on the side or back of the product.2
The following information must be included on the principal display panel:2
- - Identity statement which includes the product name and use of the product.
- - Net contents, which may be calculated in terms of numerical count, measure, or weight.
Information that must be included on the information panel:2
- - Ingredients, listed in descending order of predominance.
- - Caution statements or warnings which must be placed in a conspicuous manner and include any hazard warnings if products are flammable or pose any other hazard.
- - Name and place of business which may be the disturber, manufacturer or packer. If the address does not belong to the manufacturer, a distribution statement must be included.
- - Material facts, such as directions for safe use.
All required labeling information must be written in English and be legible for consumers to read.
If essential oils are marketed or intended for therapeutic use, they may be regulated as drugs. In the United States, all drugs require pre-market FDA approval and must adhere to a separate set of guidelines and label regulations.1 Before selling essential oils in the USA, it is important to determine if the essential oil would be considered a cosmetic or a drug, to ensure compliant labeling.
Canada Essential Oil Label Requirements
In Canada, essential oils are regulated as natural health products (NHP) under the Natural Health Products Regulations. For products to be legally sold, all NHPs are required to obtain a product license and natural product number (NPN).3
For businesses or individuals to successfully acquire these licenses, each NHP must meet evidence requirements, proper site licensing and good manufacturing practices(GMP) and labeling requirements. Adhering to label regulations allows Canadian consumers to make informed decisions. Whether products are imported or manufactured in Canada, all NHPs must meet specific label regulations.3
All essential oils sold in Canada must include the following information on the label:3
- - Product name.
- - Recommended use, including dose and route of administration.
- - Health Claim or recommended purpose.
- - Full list of medicinal and non-medicinal ingredients.
- - Product license number.
- - Net amount of product in the container.
- - Any risk information including cautionary statements, warnings or possible adverse reactions.
- - Special storage conditions, if required.
Required label information must be displayed in both official languages, English and French.3
Lot Number and Expiration Date
In addition to the previously outlined information, all NHPs must include a lot number that is clearly displayed on the product label. Manufacturers may legally indicate this using ‘Lot number’, ‘lot’, ‘Lot No.’, or ‘(L)’ followed by the corresponding number. This information can also be printed or stamped directly onto the product, as long as it will last the lifetime of the product.4
Essential oils sold in Canada must include a ‘best by’ or expiration date on every product. The expiration date indicates how long the product will maintain its physical characteristics and ingredient purity. While essential oils have a long shelf life, they may expire after repeated or prolonged exposure to oxygen.4
Expiration dates may be placed on the label, or stamped onto the bottle and should be written as ‘Expiration date’, ‘Expiration’ or simply ‘EXP’. At minimum, manufacturers must provide the month and year of expiration and follow common month abbreviations.4
Eucalyptus and Camphor Products
NHPs that contain more than 2.5% camphor or more than 25% eucalyptus must follow specific label and packaging regulations. While products that contain these ingredients have been deemed safe by Health Canada, accidental ingestion of these products can pose a serious risk to children. As such, manufacturers must include the warnings ‘KEEP OUT OF REACH OF CHILDREN, NOT TO BE TAKEN ORALLY’ on the label, as well as directions on how to contact Poison Control in case of ingestion. NHPs containing these doses must be contained in child-resistant packing.4
- United States Food and Drug Administration. (2014, August 22). Aromatherapy. Retrieved March 31, 2017 from https://www.fda.gov/cosmetics/productsingredients/products/ucm127054.htm
- U.S. Food and Drug Administration. (2012, January 23). Labeling regulations. Retrieved April 12, 2017 from https://www.fda.gov/Cosmetics/Labeling/Regulations/default.htm
- Health Canada. (2016, December 8). About Natural Health Product Regulation in Canada. Retrieved April 12, 2017 from http://www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/index-eng.php
- Health Canada. (2013, June 24). ARCHIVED – Labelling Guidance Document. Retrieved April 12, 2017 from http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/labelling-etiquetage-eng.php
- U.S. Department of Agriculture. (2013, May 13). Organic 101: Can GMOs Be Used in Organic Products? Retrieved March 31, 2017 from https://www.usda.gov/media/blog/2013/05/17/organic-101-can-gmos-be-used-organic-products