Essential Oil Labels: What You Need to Know

Essential Oils Labeling Guide

Certain claims on your essential oils can get you into trouble

The U.S. Food and Drug Administration (FDA) regulates essential oils by determining whether they’re a cosmetic, drug, household item or something else. They base their determinations on the product’s intended use. To help guide you through these regulations, we’ve taken a closer look at what you need to ensure your essential oil labels are compliant before you order or print your labels.

One way the FDA determines your intended use is by the claims you make on your essential oil labels. For example, if your label states or implies that your product can cure, treat or prevent illness the FDA will treat your product as a drug, which requires a development and approval process.

You must follow FDA regulations for your product’s intended use or face FDA non-compliance penalties that can be catastrophic for a small business. These penalties can include:

– Warning letters (which are public record and can damage your business’s reputation)

– Seizure of your product

– Injunction (a court order to do or stop doing a specific action)

– Criminal prosecution

– Fines up to $500,000

Make sure the intended use of your essential oils is clear

Product labels are crucial for communicating the intended use of your essential oils. The FDA can also take into consideration your packaging, website copy, and marketing materials such as social media posts, blog articles, and ads.

From a logistics standpoint, your labels and packaging are the most important thing to get right the first time. Let’s say you make a drug claim about your cosmetic essential oils and you receive an FDA warning letter. Changing your entire line of product labels is expensive and time-consuming. Whereas digital content can be changed quickly and easily. So it’s a good idea to focus on your labels and packaging first.

FDA essential oil categories

Essential oil products fall into three basic categories based on their intended use according to the FDA: cosmetics, drugs, and household items/something else. It’s possible for products to be categorized as both a cosmetic and a drug. This means they must follow both sets of FDA rules.

Cosmetic- Essential oils or essential oil products applied topically with any of the following goals are considered cosmetic: 1) temporarily changing and/or improving the appearance of face, skin, nails, or hair, 2) cleansing the body, and 3) perfuming the body.

Drug- Essential oils or essential oil products claiming to 1) treat, cure, or prevent a condition, illness, or disease, 2) permanently alter the state of the body, and/or 3) affect a function of the body. Can be applied topically, ingested, or inhaled.

“Claims that a product will relieve colic, ease pain, relax muscles, treat depression or anxiety, or help you sleep are drug claims.”

-Food and Drug Administration

Household item/other- Household items include essential oils or essential oil products that are used for cleaning surfaces and/or sprayed or diffused in the air for fragrance. “Other” uses include diffusing or inhaling for spiritual and/or mental well-being.

Spiritual benefits of essential oils include things like enhancing mediation practices or helping set intentions. Similarly, using essential oils to regulate moods and emotions, such as inspiring positive thoughts, falls under use for mental well-being.

If your small business isn’t prepared to follow FDA drug development and approval procedures, it’s important that your product messaging clearly focuses on cosmetic, spiritual, or mental uses.

Examples of messaging for FDA classification

Messaging ExamplesFDA Category
Hydrating essential oil face serum temporarily reduces the appearance of fine lines & wrinkles.Cosmetic
Anti-aging essential oil face serum smooths wrinkles.Cosmetic & Drug
Put yourself in the mood to relax with our lavender essential oil bath soak. Woody and floral, this lavender essential oil bath soak is perfect for use at bedtime.Household/Other
Our tea tree oil shampoo reduces dandruff-causing bacteria on your scalp.Cosmetic
Our tea tree oil shampoo eliminates dandruff. (Dandruff is a form of seborrheic dermatitis, which is a disease.)Drug
Eucalyptus essential oil in your diffuser can freshen the air in your home by reducing airborne bacteria that may cause unpleasant odors.Household/Other
Eucalyptus essential oil in your diffuser purifies the air for allergy, asthma, and cold relief. Breathe easier with eucalyptus essential oil in your diffuser.Drug

Label requirements for essential oils by FDA category

This section will help you determine the information you will need on your essential oil labels.

Essential oil label information required by the Fair Packaging and Labeling Act regardless of usage:

  • Product identity (name of the item)
  • Net quantity of contents (including metric measurements)
  • Name and place of business (manufacturer or distributor)

Information required for cosmetic essential oils or essential oil products:

  • Declaration of ingredients (in descending order of predominance)
  • Warning/caution statements

Additional requirements for essential oil products deemed a drug by the FDA:

  • Alternative ingredients list order
  • Specific ways to deal with blended ingredients

Recommended best practices for essential oil labels:

  • Brand name
  • Recommended use/benefits*
  • Extraction method
  • Disclosure of material facts (anything a reasonable person might consider significant such as expiration date, manufacturing date or batch codes)

*Including the recommended use/benefits on your essential oil labels can benefit your business in two key ways: 1) moving customers through the consideration phase towards a purchase 2)  making usage clear for FDA classification.

Essential oil label design requirements and best practices

Now we will help you determine what your essential oil labels should look like and where information should be placed. First things first, any product should include a company logo and a consistent design theme. Consistent use of your logo and design elements will help you expand your branding and make your small business more memorable.

Essential oil products with cosmetic and/or drug uses have additional rules that apply to the principal display panel (PDP) of your packaging/label. The PDP is the part of the label that is most likely shown for retail and must take up a significant portion of the label.

The FDA provides a Cosmetic Labeling Guide with full regulations for cosmetic labels and a very useful compliance guide for labeling over-the-counter (OTC) drugs.

Here is a good example of an essential oil label used for spiritual practice and mental well-being by enjoying aromatically in a diffuser or applying topically as a personal fragrance (cosmetic):

Downloadable PDF on Essential Oil Label guidelines.

What essential oil labels are right for you?

Designing the perfect essential oil label means nothing if the label gets damaged or falls off. Standard paper labels are inexpensive but can easily be ruined by oil drips or wet hands. Labels made from durable waterproof film are oil-resistant and necessary to ensure your product looks fantastic and your labels remain intact.

Avery offers a huge selection of health & beauty labels that are perfect for essential oils, and easy to design online with free essential oil label templates. Avery WePrint custom printed labels come on rolls or sheets, and custom sizes are available at no extra cost. There are also no setup fees or plate charges, a big plus if you have a growing business.

You can also order our blank labels sold online by the sheet if you don’t need a large number of labels and prefer to do it yourself. There are no minimum orders and more than 3,100 size, shape, and material combinations you can choose from. If you want to use Avery labels that are sold in retail packs, we recommend our 2″ x 2″ waterproof square labels for small bottles or our 9-3/4″ x 1-1/4″ waterproof labels for packaging larger essential oil products, like bath soaks and lotions.

If you have any questions or need help choosing the right labels, please feel free to call our California-based Customer Care Center at (800) 942-8379.  Or let us know in the comments below and we’ll respond within 24-48 hours.

Please note, the contents of this article and related articles on avery.com/blog are for informational purposes only, are general in nature, and are not intended to and should not be relied upon or construed as a legal opinion or legal advice regarding any specific issue or factual circumstance.

6 thoughts on “Essential Oil Labels: What You Need to Know”

  1. Hi. I currently use a body lotion and skin oil product on my baby where the ingredient says
    “Fragrance (essential oil blend)” i’m trying to look up the FDA requirements around this wording. What could this possibly mean?

    1. Hi Kalina,
      As far as we know (however, we aren’t attorneys), there are no FDA requirements around that particular wording. What it generally means is that they used several different essential oils to create the fragrance for the product rather than using synthetic fragrances. We hope this helps.

  2. Thank you for this helpful info! As far as labeling names for the blends of oils created, is it similar to cautiously wording as ingredients are? I’m looking at some of my “names” of my diy products wondering if it should be worded differently as well. I want to label them toward cosmetics side for uses.

    1. Hi Julie,
      Great question. Yes, Jojo would recommend erring on the side of caution for naming both ingredients and blends. For example, “Fresh as a Daisy Undereye Blend” or “Well-Rested Undereye Blend” vs. “Anti-Aging Undereye Blend” or “Lavender Bedtime Blend” vs. “Sleep Enhancing Lavender Blend”. We hope this helps, let us know if we can help in any other way. Thank you for reading.

  3. Hello.
    I am interested in custom labels for essential oils spray bottles (50 ml) and rollers (10ml) to sell in the US.
    I am aware of regulations for labeling essential oils. I would like some advice to create the label accordingly. The labels need to be oil proof/waterproof. The rollers and bottles are frosted amber glass.
    The products consist of Coconut Oil and Essential Oils.

    I would like to receive a quote for custom clear labels for rollers (10ml) and spray bottles (50ml).

    1. Elena,
      We need some more specifics from you to help you out. Can you please reach out to our Customer Care Team at (800) 942-8379 Monday to Friday 6am – 5pm PT. They’re based in California and would be happy to help you find the perfect essential oil labels for your products. You can try professionally printed labels or blank printable labels depending on what you need. And your satisfaction is always 100% guaranteed. So please reach out to us so we can help you.
      Melanie

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