Essential Oils and GRAS (Generally Recognized as Safe) According to the FDA


We often see companies or individuals use the phrase or statement that “this essential oil is FDA approved for ingestion”. However, GRAS is not a list of ‘safe to ingest’ essential oils or anything else. GRAS is a list of items that companies and experts in their fields have petitioned the FDA to allow or say that they are “Generally Safe Within Certain Conditions” and to be used as food additives. (1)

Because of the strict conditions and testing one must pass to get an item approved, it is extremely difficult to get on the list and although “essential oils” are on the list, there are no essential oils on the list that are approved for ingesting.

The GRAS list can be found on the FDA website. The list states “Essential Oils, Oleoresins (solvent-free), and natural extractives (including distillates) that are generally recognized as safe for “their intended use, within the guidelines of section 409 of the Act. (2)

This is where the problem arises with companies claiming their essential oils are approved for as GRAS. It appears that these companies and individuals making these claims are overlooking section 409. Whether this is because they have read and do not understand what it means, have not bothered to read it or have read it and it does not fit their mantra, this section is an incremental part of GRAS .

The “Section 409 of the Federal Food, Drug and Cosmetic Act” provides that a substance added to food is unsafe unless the substance conforms to the terms of the exemption for investigational use, or unless the substance is in conformance with a regulation describing the conditions under which the substance may be safely used or unless the substance is generally recognized as safe (GRAS). Although it is impractical to list all the substances that are GRAS, FDA has identified numerous substances which, when used for their specified uses and in accordance with good manufacturing practice, are GRAS. See 21 CFR Part 182, 184 and 186. According to 21 CFR 182.1 (b), the following good manufacturing practices are applicable to GRAS substances: (3)

“A food additive is defined in Section 201(s) of the FD&C Act as any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristic of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use); if such substance is not GRAS or sanctioned prior to 1958 or otherwise excluded from the definition of food additives.” (4)

  1. The quantity of the substance added to food must not exceed the amount reasonably required to accomplish the intended technical effect.

  2. Any substance intended for use in or as food must be of appropriate food grade and must be prepared and handled as a food ingredient.

With this in mind, let’s break it down for you:

  • Anyone sitting at home pouring eo’s into their water or ingesting them orally has already violated the term of GRAS. The practice is considered unsafe by the FDA and poison control.

  • GMP (good manufacturing practices) is a designation given to labs, food producers, government facilities, etc. that undergo rigorous training, and regulations in order to handle these materials and use them in food products. It is extremely difficult, highly costly, and time consuming to get certified as GMP. Each time one of these additives is used in food it is under the guidelines of the petition originally filed with the government.

  • These are trained experts in food creation and testing. Who (and I cannot stress this enough) have been trained and worked with these additives for 15 plus years and again are experts. Unless you work for a company that is GMP certified and does food testing, I discourage you from ingesting essential oils. It is dangerous and risky to your health. And any company or representative of an essential oil company that says otherwise is potentially breaking the law and poisoning whomever they are encouraging to ingest oils. And the mantra “certain oils can be taken internally with no problem” is not safe and if this is told to you, run in the other direction.

“Additional information on GRAS can be found on the GRAS Notification Program page.”

How Can You Help?

Injury Reporting

Because companies ignore the laws put in place to protect people, the databases that are kept on essential oil related injuries are on a rise each year. Poison control phone calls are increasing do to misuse from misguidance. The long-term injuries will eventually catch up with those that ignore these warnings and continue to ingest. You can help by reporting injuries from essential oils.

Where Can Someone Report Adverse Events?

  1. In the USA, consumers and health professionals can report adverse events electronically on essential oils by visiting the FDA’s MedWatch site at https://www.accessdata.fda.gov/scripts/medwatch/

  2. In the UK, the equivalent body is the MHRA, and their website can be accessed at https://www.gov.uk/report-problem-medicine-medical-device

  3. In Canada, essential oil reactions can be reported to Health Canada, by visiting http://health.canada.ca/en/health-canada/services/consumer-product-safety/advisories-warnings-recalls/report-incident-involving-consumer-product-a.html

  4. In Australia, adverse events can be reported to the Therapeutic Goods Administration https://www.tga.gov.au/reporting-problems

Resources:

  1. https://www.fda.gov/food/food-ingredients-packaging/food-additives-petitions

  2. https://www.ecfr.gov/cgi-bin/text-idx

  3. https://www.fda.gov/food/food-ingredients-packaging/generally-recognized-safe-gras

  4. https://www.fda.gov/food/food-ingredients-packaging/food-ingredient-packaging-term

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