April 3, 2012

Updated 3/7/20

Herb folks are probably familiar with the acronym GRAS, which stands for “generally recognized as safe.” I often hear students, practitioners and even big-time teachers & leaders in the field casually calling certain herbs GRAS, implying that this should set our minds at ease when it comes to safety issues. Let’s take a closer look at what GRAS really means.

GRAS Defined

GRAS is a term defined by the Federal Food, Drug, and Cosmetic Act, and it refers specifically to food additives. Most substances used as food additives must go through an extensive and expensive review process before being approved by the FDA. The Food, Drug & Cosmetic Act provides an exemption to this process for ingredients that have been historically used and that would be recognized by scientific experts as safe for their intended purposes. An example of this might be the use of basil or oregano in pasta sauces.  The official definition:

Any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive.

Things that might be excluded from the definition of “food additive” include pesticides, dietary supplement ingredients, color additives, etc.

GRAS & Herbal Medicine

There are many medicinal herbs on the GRAS list –  you’ll find everything from buchu (Barosma betulina) to violet (Viola odorata) there (see this link for the current list).  However, the FDA specifically states that dietary supplements are excluded from GRAS status – they cannot be considered GRAS. This makes sense, because the GRAS designation is specific to food additives, which are generally used in much smaller doses than medicinal herbs.

Many of the herbs on the GRAS list are benign and quite safe; most reasonable people would consider medicinal doses of herbs like alfalfa (Medicago sativa), lemon balm (Melisssa officinalis) and elder (Sambucus niger) safe for use in the general population. However, there are a few that don’t necessarily meet this criteria. For example, wormwood (Artemesia spp.), walnut husks (Juglans nigra) and wild cherry bark (Prunus serotina) are all considered GRAS. Anyone with a moderate background in herbal medicine would know that each of these herbs carries specific cautions or contraindications; they should not be considered generally safe in medicinal doses for most people. [Note that I’m not arguing that these herbs should not be used medicinally, only that they should be used with caution.]

In summary, GRAS has nothing to do with medicinal herbs. We cannot use this designation to imply safety in this context; doing so is misleading to clients & consumers and makes herbalists and other practitioners look misinformed. I do believe that many medicinal herbs are generally safe for the larger population, even more so  when used under the guidance of an experienced practitioner, but stating that an herb is “GRAS” does not provide any information about herbal medicine safety. Let’s rely on historical, academic & research-based data to inform safety decisions and leave GRAS to the food additive folks.

Fore more info about from the horse’s mouth, check out this Frequently Asked Questions About GRAS.

About Camille Freeman, LDN, RH (she/her)

Hi there! I'm a clinical herbalist and licensed nutritionist specializing in fertility and menstrual health. I run the Monday Mentoring community of practice and also offer continuing education programs for highly-trained herbalists and nutritionists (Check out this year's Deep Dive!). I'm also a professor in the Department of Nutrition at the Maryland University of Integrative Health, where I teach physiology, pathophysiology, and mindful eating.

~ More to Explore ~

Sign up for weekly Practitioner Notes from Camille.

Tips, resources, & encouragement for herbalists & nutritionists, delivered to your inbox most Thursdays.