The Herbal Consumer

Essential Oils, Part II: Regulation

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EO photoIf you’re interested in using essential oils (EO), it’s important to understand how they’re regulated. Regulations are often a consumer’s best friend, even if they can take some time and effort to sort through and comprehend. Understanding how something is (or isn’t) regulated can help a consumer avoid untrue assumptions, know where there are and aren’t consumer protections, and know what to look for in a product.

How Are EO Regulated?

EO are regulated as either a cosmetic, drug or dietary supplement, depending on how the products are marketed and the directions for their use. The Food and Drug Administration (FDA) oversees the regulations for cosmetics, drugs and dietary supplements. Below are their definitions for each.

Cosmetics

“A product, except soap, intended to be applied to the human body for cleansing, beautifying, promoting attractiveness or altering the appearance” and “…articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance.”

Drugs

“…articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.”

Dietary supplements

“… a product taken by mouth that contains a ‘dietary ingredient’ intended to supplement the diet. The ‘dietary ingredients’ in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders.”

There are a couple of other definitions to keep in mind as well. A structure/function claim describes the role of a substance (i.e. EO) intended to maintain the structure or function of the body. Examples of a structure/function claim are “helps promote sleep” and “supports the immune system.” A disease claim states that the product or ingredient(s) can diagnose, cure, mitigate, treat or prevent disease. Examples of a disease claim are “treats insomnia” and “protects the immune system.”

If the use directions for an EO follow the definition of a cosmetic, it is regulated as a cosmetic. Regulations for cosmetics state they should not to contain any poisonous or deleterious substances that could cause injury with customary and usual use. The cosmetics also cannot contain a “filthy, putrid or decomposed substance” and cannot be “prepared, packed or held under insanitary conditions.” For products that are marketed as a cosmetic, certain information must be included on the label of the product. This includes the name of the product, net quantity of contents, directions for safe use, any required warnings, name and address of the business, list of ingredients, and any other required information. A cosmetic label does not have a specific facts panel the way drugs and dietary supplements do. However, cosmetics, like dietary supplements, do not need FDA pre-market approval (except for any color additives) before they are put on the market. Any FDA enforcement would come after the product has been available for sale.

If an EO follows the definition of a cosmetic and a structure/function and/or disease claim is made on the label or in the advertising, it is considered regulated as a cosmetic and a drug. Keep in mind drugs fall into two categories – prescription and over-the-counter (OTC) and any EO would most likely fall under OTC regulations. Among other requirements, drugs must have FDA approval for safety and effectiveness before they are put on the market. For products that are marketed as OTC drugs, a “drug facts” panel must be included on the label and the product must follow all other regulation label requirements. If the product does not follow the regulations for a drug, the FDA considers it misbranded as a drug and will take action against the company.

If the directions for use for an EO follow the definition of a dietary supplement, it is regulated as a dietary supplement. That means the product can make structure/function claims and must be able to provide relevant evidence that the claim is truthful and not misleading. When making this type of claim, the product must also include the statement, “This/These statements has/have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease” on the label and in the advertising. For products that are marketed as dietary supplements, a “supplement facts” panel must be included on the label. The product cannot make a disease claim or it will be considered a drug and be subject to enforcement action. Dietary supplements do not need pre-approval by the FDA before going to market. There are, however, regulations for supplement production including ingredient and product testing, current good manufacturing practices, quality control measures, labeling, etc., that the manufacturers of the herbal supplements are required to follow.

Terms Used for Marketing EO

There are a few different terms that are used in the marketing of EO. Knowing if and how these terms are regulated can help make navigating the EO marketplace a little easier.

Therapeutic grade

Some EO are used in cooking and baking while others are used therapeutically. Some companies may promote their EO as being of therapeutic grade. The consumer assumption with this term is that the oil is a higher quality, more potent oil. The term “therapeutic grade” is actually an industry/marketing term rather than a term with a regulatory definition. That means whichever company that is using the term can set the definition for the term; there is no regulatory enforceable standard for the term. If a product does have a therapeutic use and is promoted that way, the FDA considers that product to be a drug and it would then fall under the regulations for a drug.

Food Grade

The term “food grade” basically refers to a substance that is produced under good manufacturing practices, and that it’s safe to ingest at recommended amounts. There are quite a few EO that the FDA considers “Generally Recognized as Safe” (GRAS) for intended use in foods. Keep in mind that “recommended amounts” are generally quite small. Just because an essential oil is included on a GRAS list for food doesn’t mean it is safe to ingest in any amount.

Organic

Organic is another term that is used with marketing EO. The term “organic” is not regulated by the FDA but by the United States Department of Agriculture (USDA) through the National Organic Program (NOP). “Organic” seems to have a fluid definition within our society. Many believe that it means that the product is free of chemicals and is safe. The NOP defines “organic” as:

… a labeling term that indicates that the food or other agricultural product has been produced through approved methods. These methods integrate cultural, biological, and mechanical practices that foster cycling of resources, promote ecological balance, and conserve biodiversity. Synthetic fertilizers, sewage sludge, irradiation, and genetic engineering may not be used.

The USDA definition for “organic” is geared more for food, animal feed and fiber products. The grey area for this regulation is cosmetics/personal care products. This can include EO when they are marketed as a cosmetic and personal care products containing EO. These types of products were not initially included in the NOP regulations. According to a 2009 recommendation from the National Standards Organic Board, there was an effort to add personal care products to the regulation. To date that has not happened. What this means is that the USDA does not have any authority over any cosmetic, body care product or personal care product that does not claim to specifically meet the USDA organic standard. A product of this nature can claim to meet a private or industry definition/standard for organic instead, if it chooses to do so. That definition/standard may or may not be equal to the USDA standard. There are independent “organic” logos that are specifically geared to personal care products. A couple of these include the NSF/ANSI 305 and Oregon Tilth logos. These companies set their own standards and definitions for the term “organic” and have a process for verifying that the product meets those standards and definitions.

Aromatherapy

The practice of aromatherapy is not regulated in the U.S. and aromatherapy practitioners are not required to be licensed either. Often you will see someone who is licensed in another field (i.e. massage therapy, esthetics, acupuncture) offering aromatherapy. A number of different schools offer training for aromatherapy. There are three professional organizations for aromatherapists:, the National Association for Holistic Aromatherapy, the Alliance of International Aromatherapists and the International Federation of Professional Aromatherapists. Each organization has a code of ethics and standards for certification and education for its members. Also, within the professional standard, there are levels of education and qualifications. With each organization a consumer can compare the code of ethics and education standards, and look up to see if an individual practitioner is a member.

So What’s a Consumer to Do?

When shopping for EO, you may need to do a little sleuthing to determine if it’s being marketed as a cosmetic, drug or dietary supplement. Look to see if there is a “drug facts” or “supplement facts” panel on the label. Any types of claims (i.e. structure/function or disease) made on the label or in advertising can also give you a clue, provided the company is following regulations. Drugs must be pre-approved by the FDA for safety and effectiveness before they can be marketed. To find out if an EO marketed with drug claims (i.e. structure/function or disease) is FDA-approved, contact FDA’s Center for Drug Evaluation and Research (CDER), at druginfo@fda.hhs.gov.

Cosmetics and dietary supplements do not need FDA pre-approval before being available on the market. Dietary supplements are required to be produced using current good manufacturing practices as well as other regulations. Cosmetics must also be produced using good manufacturing practices and also must follow labeling requirements. Dietary supplements must meet the NOP standards in order to be marketed as “organic.” Cosmetics can be marketed as “organic” either under the NOP definition, if it meets the criteria, or under a private (non-governmental) definition/standard for organic. If purchasing organic EO is important to you, you will need to do a bit of research on the different standards/definitions and decide which ones best fit your values.

Understanding the regulations can also help you determine which companies are following the rules. Companies that have multiple FDA warning letters and other enforcement actions can be difficult to trust. Consumer trust is valuable and every company should be working hard to earn it. The FDA website has a page for health fraud recalls and health fraud warning letters. You can also go to the main page and search on a company name.

In working on this article, finding FDA regulations specifically for dietary supplements was much easier than trying to find them for EO. There is little specific to EO the way it is for dietary supplements even though they are both herbal products. Often consumer protection regulations are created or enhanced AFTER there is a major consumer issue. The popularity of EO has only recently begun to grow. As EO become more widely sold and used, the potential for consumer protection issues and further regulation will grow as well.

Next article Essential Oils Part III: Safety

Links to Learn More

FDA website – FDA Authority Over Cosmetics

FDA website – Regulations Related to Cosmetics

FDA website – OTC (Nonprescription) Drugs

Consumer Healthcare Products Association website – Regulation of OTC medicines

FDA website – Subchapter B – Food for Human Consumption, part 111 Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements

NIH Office of Dietary Supplements website – Dietary Supplement Health and Education Act of 1994

FDA website – Subchapter B – Food for Human Consumption, part 182 Substances Generally Recognized as Safe

USDA website – Organic Standards

USDA website – Cosmetics, Body Care Products and Personal Care Products

NSF website – Guidance on Formulation and Marketing of Organic Dietary Supplements Under the National Organic Program

Alliance of International Aromatherapists website

International Federation of Professional Aromatherapists website

National Association for Holistic Aromatherapy website