Adverse Event Reporting for Registered Aromatherapists

BY Arianna Staruch, ND, ACHS Academic Dean

According to the FDA, a dietary supplement is a product intended to supplement the diet, which must be labeled as such and intended for ingestion. Ingredients in dietary supplements can include vitamins, minerals, herbs or botanicals, amino acids, dietary substances used to increase the entire dietary intake, concentrates, metabolites, constituents, extracts, or combination of these ingredients. If ingested, then, essential oils can be considered a dietary supplement and should be treated with the same precaution as more traditional supplements.

For that purpose, Registered Aromatherapists (RAs) should familiarize themselves with the new guidance information released by the FDA regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act. Though this Act does not require reports of adverse effects for foods other than dietary supplements, voluntary submission of reports of "serious adverse events associated with all FDA-regulated foods " are encouraged.

The FDA website defines an adverse event is considered "any health-related event associated with the use of a dietary supplement that is adverse." For RAs who use essential oils internally with their clients, reporting of any adverse events will not only increase general safety but will actively develop a database of current research to help the professional community better understand the potential effects and applications of botanical-based products.

To submit a report of a serious adverse event to the FDA, a MedWatch Form 3500A should be used. This form is also called a FDA Form 3500A. When submitting a form, the submitter is asked to include: an identifiable patient, an identifiable initial reporter, the identity and contact information for the responsible person, a suspect dietary supplement, and a serious adverse event or fatal outcome. (The FDA defines a 'serious adverse event' as one that results in a: death, life-threatening experience, inpatient hospitalization, persistent/significant disability or incapacity, congenital anomaly or birth defect, or an outcome previously listed that requires medical or surgical intervention to prevent.)

References:
http://www.fda.gov/Safety/MedWatch/HowToReport/ucm085568.htm

>> This article first appeared in the Aromatherapy Registration Council September 2009 newsletter. CLICK HERE to download the complete newsletter.

>> Read "Natural perfume making with essential oils" on the ACHS website