Regulation, Standardization, Quality Control- Oh My!

The Difference Between Quality Control and Standardization with Essential Oils

In my homepage blog, I discussed the importance of essential oils quality and safety. Essential oils are regulated by their intended use in the United States; therefore, they can be regulated under the category of cosmetics, fragrances, or “others.” This makes consistency and quality an important consideration when using them for wellness purposes.

In this blog, I want to help you understand the differences between standardization and quality more. Let’s first look at an industry which has both, pharmaceuticals. I reviewed several reasons previously on how standard of care does not necessarily mean it is without risk. For example, medications are regulated, have standardization, and quality, yet still can lead to medical errors, side effects, and toxicities.

In regards to safety of regulated, standardized, and approved drugs, the FDA (Food and Drug Administration) states the following limitations on their own site in approval of safety for drugs (bold emphasis mine):

• FDA provides guidance to companies during the various phases of the human clinical trials. Even so, the number of people in a clinical trial of a new drug is usually small in comparison to the number of people who may take the drug if it reaches the market. This makes it difficult to detect rare side effects.
• Even though data from human trials are analyzed by a team of experts before a drug is approved, it can be impossible to anticipate all bad reactions–especially very rare safety risks–unless they had also happened with use of a similar drug.
• Complicating matters is the fact that after they are approved, drugs are often taken by sick people who are on other medications at the same time, making it difficult to predict how they will react to the drug. And the drug’s effect on the patient may change over the course of years.
• There are hundreds of thousands of adverse events reported via MedWatch each year, but this reporting system is voluntary and there are serious drug reactions that are never reported.
• Because the nation’s healthcare system is not integrated, there is no standard way to track the adverse effects of a medicine in any given health system or across different health systems. Health insurance databases can be helpful in this regard, but they are only accurate as long as a patient has the same job and is enrolled with the same insurance system since many people are insured through their employer. This limits FDA’s ability to monitor the safety of medications taken over many years. However, FDA, through its Sentinel Initiative, is currently working to develop capabilities to use data from different health systems to better understand the safety of drugs in clinical practice.

Interesting, isn’t it?

Standardization in Essential Oils

Currently, there are some sets of standards and certifications regulating essential oils through the agencies of ISO (which is the International Organization for Standardization) and the Association Française de Normalisation (AFNOR).

According to the ISO website: “ISO is an independent, non-governmental international organization with a membership of 161 national standards bodies. Through its members, it brings together experts to share knowledge and develop voluntary, consensus-based, market relevant International Standards that support innovation and provide solutions to global challenges.”

AFNOR is the French national organization for standardization and its International Organization for Standardization member body. They develop their international standardization activities, information provision, certification and training through a network members of the association. According to their website,

AFNOR, the French standardization organization, directs and coordinates the establishment of national standards (NF) and participation in the definition of European standards (EN) and International standards (ISO and IEC). It is the French member of European and international non-governmental standards organizations such as CEN and CENELEC in Europe, and ISO and IEC internationally. Thanks to the investment of all the players in the French economy, AFNOR is one of the most influential members of these organizations, strategically and technically.

The Quality Caveat with Standards and Essential Oils

Unfortunately, ISO standards exist for only approximately 50 EOs. According to a source I had with one well known company, the ISO standards for EOs were created, in most cases, because an AFNOR standard existed. If an EO meets the ISO/AFNOR standard, it will probably be a high quality oil; however, this is not always the case. There is a difference between standards and quality. Standardizations can imply quality, but they don’t necessarily have. They can exist solely for consistency in labeling and selling across manufacturers. The AFNOR does claim to seek to ensure quality.

To complicate matters more, different companies consider different constituents as “quality” essential oils. This may make them not “standardized” but still “quality” in regards to raw materials, distillation technique, testing, manufacturing, and distribution.

The bottom line– know and trust your supplier and ask about quality control, then do some of your own research.

Read more about essential oil safety on my homepage here and get more references.

References:

Food and Drug Administration. Aromatherapy. FDA Web site: http://www.fda.gov/Cosmetics/ProductsIngredients/Products/ucm127054.htm. Accessed December 28, 2015.

Food and Drug Administration. Fragrances in Cosmetics. FDA Web site: http://www.fda.gov/Cosmetics/ProductsIngredients/Ingredients/ucm388821.htm. Accessed December 28, 2015.

Food and Drug Administration. CFR – Code of Federal Regulations Title 21. FDA Web site: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=182.20

Food and Drug Administration. How FDA Evaluates Regulated Products: Drugs. FDA Web site: http://www.fda.gov/AboutFDA/Transparency/Basics/ucm269834.htm

Food and Drug Administration. Pharmaceutical Quality/Manufacturing Standards (CGMP). FDA Web
site: http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/guidances/ucm064971.htm

International Standardization Organization. ISO/TC 54 – Essential oils. ISO Web site:
http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_tc_browse.htm?commid=48956..

Association of French Normalization Organization. Standards- All Published Standards. AFNOR Web site: http://www.afnor.org/en/profiles/activity area/industry/normes/normes/%28limit%29/25/%28page%29/2

Association of French Normalization Organization. ISO 9001 Certification – Quality. AFNOR Web
site: http://www.afnor.org/en/certification/smq001#p17578

Association of French Normalization Organization. Normes. AFNOR Web site: http://www.boutique.afnor.org/recherche/resultats/categorie/normes/ics/huiles-essentielles-71.100.60%20?utm_source=portail&utm_medium=referral&utm_campaign=editions.