Laws and Regulations

The practice of aromatherapy has been around for centuries and only in the past few decades has it become popular in the U.S.A.

We invite you to visit this page frequently as we add information critical to your practice from time to time.

Content

  • Licensing
  • FDA Enforcement Actions/Warning Letters

Licensing

Aromatherapy is not a regulated practice in the United States, yet there are certain laws which may affect the way you practice aromatherapy.

For instance, in 2013, the State of Colorado passed Senate Bill 13-215, The Colorado Natural Health Consumer Protection Act supports alternative health care professionals, a “safe harbor health freedom bill.” The intent of this law is to protect consumer choice and, in consideration of the public’s health and safety, to remove technical barriers to access unregulated health care practitioners and appropriate consumer protection.

Pursuant to the introduction of SB 13-215, a 2009 survey showed that over 35% of the U.S. population spends over 33 billion dollars a year on alternative and complimentary medicine and procedures. In Colorado, more than a million and a half people obtain health care services outside the establishment.

What does this mean to the aromatherapist in Colorado engaging in complementary and alternative health care services? The practitioner must fulfill the disclosure duties specified in the law, must not treat a child under two years of age, must recommend that the client have a relationship with a licensed physician, abide by advertising rules, and comply with all provisions of the law.

FDA Enforcement Actions/Warning Letters

On September 22, 2014, the U. S. Food and Drug Administration sent warning letters to dōTERRA and Young Living for a host of violations concerning claims posted on their respective  company websites and social media. The charge? Promoting essential oil products for conditions that cause them to be drugs. 

As a member of the American Herbal Products Association (AHPA), we receive alerts about a variety of violations, this one is exceptional and is a warning for all of us to make sure we are marketing and labeling our aromatherapy products properly in all respects.

If you are interested in learning more on how to market your products correctly and stay away from inadvertent violations obtain the presentation by Robert J. Galamaga, General Counsel, “Labeling: What Are You Selling?” CD #90. This opportunity couldn’t be timelier, we’re fortunate to have this program available at this serious moment.

Resources

AHPA GuidancePolicies – Page 9 contains labeling requirements

FDA Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist

FDA Aromatherapy Discussion

Federal Trade Commission regulates advertising claims

Generally Recognized as Safe (GRAS) – food additives

Safety Data Sheet (SDS)

A Safety Data Sheet (SDS) provides detailed information about a specific hazardous material. This information is important to aromatherapists and suppliers who ship essential oils.

Pursuant to the Occupational Safety & Health Administration, “the Hazard Communication Standard (HCS) requires chemical manufacturers, distributors, or importers to provide Safety Data Sheets (SDSs) (formerly known as Material Safety Data Sheets or MSDSs) to communicate the hazards of hazardous chemical products. As of June 1, 2015, the HCS will require new SDSs to be in a uniform format.”  Please refer to the downloadable documents for more information.  The Quick Card lists the uniform format requirements.

Hazard Communication Safety Data Sheet Quick Card

Hazard Communication Standard Final Rule

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