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Label Management
February 17, 2022
April 2, 2024

Bottle Labels for Essential Oils: Don’t Forget About FDA Regulations

Mrignayni Pandey

Bottle Labels for Essential Oils: Don’t Forget About FDA Regulations

February 17, 2022
April 2, 2024
Mrignayni Pandey


The essential oil market of the U.S. is a highly competitive one, but also has a lot of scope for growth. Reportlinker says that the U.S. essential oil market is expected to grow at a 7% CAGR during 2021-26, in terms of revenue.

To capture this expanding market, your essential oil brand needs to create an impact in the minds of your buyers. You need to stand out among your competitors, so that buyers come back to your brand for more.

But how?

Labels and packaging are the first thing customers notice about your brand, and that’s where you can make the difference. Labels can be your channel to communicate the value your essential oil provides.

While it is obvious that you would like to pour in your creativity into your labels to attract more buyers, complying with all the FDA guidelines is also necessary.

So, in this article we bring for you some points to remember for your labels and the FDA guidelines that you must not forget.

Let’s get started.

Disclaimer: This blog post derives information from the U.S. Food and Drug Administration (FDA) website and is updated as of March 1st, 2024. Do refer to the FDA website for final and updated information regarding regulations.  Artwork Flow is a software designed to streamline compliance for brands, not a service providing legal or regulatory advice.

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What do you need the essential oil label to do?

When you design the labels for your essential oil bottles, make sure that you have in mind the purpose that your label must fulfill. Here are certain things that your labels need to do without fail.

1. To comply legally

The label must contain all the information as mentioned in the FDA guideline. The failure to do so can result in heavy fine penalties, product seizures and even criminal prosecution. All this can negatively impact your business.

The creative designing on the labels and packaging must be done taking all rules into consideration. The claims made by the essential oil must be stated clearly on the label. Refrain from making any unsupported claims about the essential oil, especially in the case of essential oils of drugs category. 

FTC issues strict warning letters to brands that make such unsupported claims, like in the case of some brands that claimed that their essential oils can potentially cure Covid-19.

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Source:  youngliving.com

2. To build your brand

Your label must help you get picked by a customer. But why a buyer will pick your brand from the shelf largely depends on the design of your labels. So, creating a strong impression becomes very necessary.

An essential oil bottle, being usually small in size, provides less space for more information to be provided after legal compliance. Hence, you must try to give information like the fragrance or the flower, fruit or plant from which it is extracted through colors and images.

Source: Utama Spice Bali

3. To communicate product information

The basic function of a label is to communicate information related to the product to its buyers. Clear and direct statements of the constituents makes it easier for the customers to place trust in your brand.

Some brands use this communication to their benefit by telling their customers about the organic and natural composition of their essential oils. They take this opportunity to show their unique blending process or a unique quality that only their product provides.

Source: nvgraphicdesign.com

Essential oil categories and FDA regulations

FDA classifies essential oils into 4 categories and lays rules according to the category they fall in. These categories are based on the ‘intended use’ of the essential oil. 

Intended Use

Your product label must clearly communicate the intended use of the essential oil. The intended use is determined by the FDA based on the claims made for the use of the essential oil on the label, packaging, website and advertisements. 

1. Drugs

Any product that intends to cure or reduce the symptoms of a disease, or helps in preventing a disease, or intends to affect the structure or function of the body is said to be a drug.

If the essential oil or a product containing the essential oil claims to do any of the above then it falls into the category of drugs. Even if the ingredients and fragrances are plant derived, they are not exempted. 

The essential oil or product falling into this category must be approved by the FDA before being released in the market. It must comply with the labeling guidelines of the essential oils as well as the guidelines for drugs.     

Source: healthline.com
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2. Cosmetic

A product that intends to make a person more attractive or clean the body comes under the category of cosmetic.

An essential oil or a product with essential oil that claims to do so will fall under this category. Soaps, lotions or creams with essential oils or face and body oils, all come under this category.

For labeling, these products must comply with the guidelines of the FDA set for any cosmetic product and the guidelines for essential oils. But these products do not need any approval from the FDA before being released into the market.

Source: mydd.com

3. Both

Any product that intends to be of therapeutic use as well as of cosmetic use is said to be both a drug and a cosmetic. 

If any essential oil or a product containing it has both these qualities then they fall under this category. For example, if an essential oil cleans the skin as well as heals skin rashes, then it is both a drug and a cosmetic.

The labels of these products must comply with the FDA guidelines of drugs as well as cosmetics. Since they are also drugs, you will need to get it approved by the FDA before releasing it in the market.

Source: Simply earth

In case of products containing cannabis extracts, you need to follow a different set of guidelines. Here’s an article that talks about it in detail. 

4. Something else

Other products containing essential oils like detergents, scented candles, air fresheners or disinfectants come under this category. They are usually used for fragrance or cleaning. CPSC regulates some of the fragrance products. 

Source: Cosmopolitan

What to include on the labels?

According to the FTC’s Fair packaging and labeling act, the following information must be included to essential oil labels regardless of their type.

  • Name of the product and the brand
  • The net quantity of the product
  • Details of the manufacturer or the distributor.

Other information depends on the type of essential oil. Here’s what you must include in your essential oil labels.

Cosmetic essential oil 

  • List of ingredients in decreasing order of concentration
  • Warning statement

Drug essential oil

  • List of alternative ingredients
  • Blended ingredients information

Here’s what more you should include.

  • Extraction method
  • Batch number, manufacturing date, expiration date etc.
  • Benefits and uses
  • Brand logo
  • Bar code
  • Certifications
Source: yourboxsolution

Wrapping up

Managing labels of different bottle sizes, designing compliant yet creative labels and minimizing approval time can be tough. However, tools like Artwork flow have made it simpler than ever before.

With features like easy collaboration, smart checklists and robust workflows, you can streamline all your label management and brand asset management on one platform in an easy and compliant way. So, get started with a demo by the Artwork Flow team and make your label management process hassle free.

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