Home » FDA Regulations for Aromatherapy: Is Your Drug or Cosmetic Product At Risk?
March 30, 2022 by Mason Grandusky
Aromatherapy products contain essential oils with fragrances aimed at achieving certain purposes. Many aromatherapy products are used for cosmetic purposes, but some are intended to be used to improve a health condition, making them drug products.
FDA regulates aromatherapy products according to the intended use of a product. Knowing whether FDA considers your product a drug or a cosmetic is essential to preparing your product for the market.
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Registrar Corp’s Regulatory Specialists can help you determine which FDA regulations your product may be subject to, review your product’s label for compliance, and more.
For more information, call us at +1-757-224-0177, email us at info@registrarcorp.com, or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livechat.
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Keep reading to learn about the key elements that separate an aromatherapy drug from an aromatherapy cosmetic.
Intended Use
The U.S. Food and Drug Administration (FDA) determines the intended use of an aromatherapy product from claims made on the product’s label, on websites, and in advertising. Additionally, FDA may consider how consumers perceive the product should be used based on the product’s reputation. FDA may also determine an intended use due to ingredients that are commonly used for a specific purpose by the industry and consumers.
Aromatherapy Drugs
If a company markets an aromatherapy product as one that is intended to diagnose, cure, mitigate, treat or prevent a disease, FDA regulates it as a drug. Common drug claims for aromatherapy products include treatment of pain, nausea, anxiety, and insomnia.
Even if a company markets the product as a cosmetic, FDA may still consider it a drug if any of the marketing materials suggest the product is a drug. Rather than considering the specific type of product independent of other factors, FDA reviews aromatherapy products on a case-by-case basis. For example, if a fragrance containing essential oils is intended for use as a perfume, it is considered a cosmetic. But, if the marketing claims the fragrance can treat insomnia, it is considered a drug.
FDA regulates drugs more stringently than cosmetics. Drugs must obtain FDA approval for safety and effectiveness and comply with drug listing and labeling requirements, among other regulations. If a company distributes a product as a cosmetic, but marketing for the product suggests it is a drug, the product may be deemed misbranded and subject to FDA enforcement actions. If the non-compliant product is being shipped to the United States, the shipment may be detained at the port of entry.
Aromatherapy Cosmetics
FDA defines cosmetics as products “intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance.” If an aromatherapy product such as a skin moisturizer, body wash, or body scrub, is not intended to affect the structure or any function of the body, it is a cosmetic.
Cosmetic aromatherapy products do not need FDA approval before being marketed. However, the products must be safe for consumers when used according to the directions. Because a cosmetic product does not need prior FDA approval, the company manufacturing the product is responsible for ensuring it is safe and FDA-compliant.
Cosmetic products must meet all applicable FDA regulations for cosmetics, including labeling regulations.
Both or Neither
In some cases, FDA may consider an aromatherapy product to be both a cosmetic and a drug. For example, a cleansing shampoo is a cosmetic. However, if the shampoo claims to have anti-dandruff properties, it is a cosmetic and a drug. In this case, the product is subject to regulations for drugs and cosmetics.
There are also fragrance products that are neither a cosmetic nor a drug by FDA’s definition and are not subject to FDA regulation. These products, including scented candles, laundry detergents, and household cleaners, fall outside the scope of FDA regulation based on their intended use and are regulated by the Consumer Product Safety Commission (CPSC).
Get assistance with FDA compliance.
Registrar Corp’s Regulatory Specialists can help you determine which FDA regulations your product may be subject to, review your product’s label for compliance, and more.
For more information, call us at +1-757-224-0177, email us at info@registrarcorp.com, or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livechat.
Get Assistance
FAQs
FDA regulates aromatherapy products according to the intended use of a product.
Are essential oils considered cosmetics? ›
“Essential Oils” and “Aromatherapy”
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, see “Aromatherapy.” Similarly, a massage oil intended to lubricate the skin is a cosmetic.
What are the FDA regulations for cosmetics? ›
FDA does not pre-approve cosmetic products or ingredients, with the important exception of some color additives. However, cosmetic firms are responsible for marketing safe, properly labeled products; using no prohibited ingredients; and adhering to limits on restricted ingredients.
Is aromatherapy a drug? ›
Aromatherapy is an alternative medicine or integrative therapy that works with conventional medicine treatment. The Food and Drug Administration of the United States guidelines classify essential oils as cosmetics because they are not drugs for treating or prevention of disease.
What is aromatherapy risks? ›
Undiluted aromatic plant oils used over sensitive areas, such as nostrils or on sensitive skin, could irritate or burn the skin. In some cases, there may be an allergic reaction such as a skin rash in susceptible people. Some of the oils that may cause problems include: eucalyptus.
What are the regulations for essential oils? ›
The U.S. Food and Drug Administration (FDA) regulates essential oils by determining whether they're a cosmetic, drug, household item, or something else. Accordingly, they base their determinations on the product's intended use.
What is cosmetic aromatherapy? ›
Cosmetics aromatherapy utilizes certain essential oils for skin, body, face and hair. cosmetic products.
Is fragrance considered a cosmetic? ›
According to FDA regulations, if a product adds fragrance ingredients to make the person more attractive, it's a cosmetic under the law, for instance, perfumes, colognes, and aftershave should all be regulated as cosmetics.
What is considered a cosmetic product? ›
Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, makeup, cleansing shampoos, permanent waves, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product.
What are 4 types of products that the FDA regulates? ›
FDA is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices. FDA also has the responsibility in maintaining the safety of our nation's food supply (human and animal), cosmetics, and products that emit radiation.
The ingredients (except certain colors) and labeling of cosmetics, such as many perfumes, makeup, moisturizers, shampoos, hair dyes, face and body cleansers, and shaving preparations do not require FDA approval.
What is Article 19 of the cosmetics Regulation? ›
Article 19 of the GPSR requires that where economic operators make products available on the market online or through other means of distance sales, the offer of those products shall clearly and visibly indicate at least the following informafion: (a) name, registered trade name or registered trademark of the ...
Is aromatherapy approved by the FDA? ›
The FDA does not regulate essential oils, just like it doesn't regulate herbs or supplements. That means that there is no FDA approval for any essential oil.
What does aromatherapy come under? ›
Aromatherapy is a form of complementary and alternative medicine (CAM). It uses essential oils to manage symptoms or boost your well-being. It's a holistic therapy, meaning it supports your whole self — mind, body and spirit.
Is essential oil a cosmetic? ›
Essential oils are primarily used in natural cosmetics due to their anti-inflammatory, antibacterial and antiviral properties. They also serve as natural preserving agents. Alongside all these benefits, essential oils have a positive effect on the human organism.
Do I need FDA approval to sell essential oils? ›
The FDA does not regulate essential oils, just like it doesn't regulate herbs or supplements. That means that there is no FDA approval for any essential oil.
Does the FDA regulate fragrance? ›
Before entering the US market, fragrance ingredients must meet the US FDA's cosmetic ingredient requirements. Although fragrances and fragrance ingredients are exempt from US FDA approval before entering the market, they must adhere to labelling regulations and ensure consumer well-being during use.
What products does the FDA not regulate? ›
The ingredients (except certain colors) and labeling of cosmetics, such as many perfumes, makeup, moisturizers, shampoos, hair dyes, face and body cleansers, and shaving preparations do not require FDA approval.
Do you need certification for aromatherapy? ›
No mandatory national certification or licensing requirement is established for aromatherapy. As an aromatherapist, you can choose to pursue voluntary certification from the Natural Therapies Certification Board or join the non-profit National Association for Holistic Aromatherapy. Read on for more information.
