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

Natural PerfumeMaking with Essential Oils

BY Dorene Petersen, ACHS President

Looking for a natural perfume? A fragrance that does not contain a collection of synthetic chemicals, which place a burden on your liver and other detoxifying organs. Wander through any perfume counter at the local department store and your olfactory system is bombarded with aromas. Some have names you recognize like gardenia, jasmine, or even rose. But, if you take a closer look at these perfume formulas, it is unlikely you will find anything resembling plant-sourced material even though they may use the term “natural” or “nature identical.” Don’t be fooled. These terms do not mean the perfume was blended from essential oils or absolutes, which are all distilled, expressed, or dissolved from plant leaves, flowers, stems, roots, or seeds in a solvent base.

Unlike perfumes made from plant-based materials, most perfume counter perfumes are made from a combination of synthetic chemicals, derived from petroleum. These ingredients allow perfumers to create an array of fragrances that are either unavailable or difficult to obtain in nature. Of course they are less expensive, too.

However, there is growing public awareness about the relationship between synthetic ingredients—potential toxins—and health challenges. To maintain optimal health, natural perfume blending is a healthy green alternative. These perfumes are made from high-quality essential oils, which are known to have therapeutic health benefits and are truly natural. In this context, the term “natural” refers to plant-sourced perfumes. The plants are grown or wildcrafted naturally and, preferably, grown organically (without synthetic pesticides) and sustainably whenever possible.

>>To read the full-length article and more articles from the Aromatherapy Registration Council newsletter, CLICK HERE

>> To learn more about natural products manufacturing and aromatherapy, check out the American College website