Herbs and GRAS (Generally Regarded As Safe)

The use of herbs in pregnancy is commonly sought to provide wellness for the health of the mother and unborn child. It is important to know what agents are considered safe for pregnancy! Overall there have been few studies have been done to measure the effects of various herbs on pregnant women or fetuses.

One key thing when understanding the safety ratings is to pay attention to what type of use the rating is for. 

As an example, the rating for rosemary is considered Likely Safe when used ingested in typical amounts commonly found in foods. (Rosemary has a Generally Recognized as Safe (GRAS) status in the US.) However, when considering pregnancy, rosemary has been considered Possibly Unsafe when used orally ingested in medicinal amounts due to its potential of having uterine and menstrual flow stimulant effects, thus it is considered best to avoid using it. Safety of the topical use of rosemary during pregnancy is unknown. This is a prime example of how the method of use of the herb changes its safety rating. As we know that rosemary sprinkled in your tomato sauce is not a risk to you and your baby. However, if you were to use rosemary in a large dose, like that used in medicinal amounts, pregnancy is a concern. Similarly, pregnancy concerns are raised for herbs such as garlic, sage, ginger, and turmeric when used in large or concentrated doses, but are considered safe when used in amounts found in food. Another example is garlic that is primarily used for cardiovascular health and relief of cough, colds, and rhinitis (Dr. Bielory publication - Complementary and Alternative Treatments in Asthma, Allergy and Immunology) . Adverse effects commonly include gastrointestinal disturbances, change in body odor through the sweat and breath, and rarely allergic reactions or hypoglycemia. 

One of the scoring systems to consider is the "GRAS" score which is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act) (U.S. FDA Source - GRAS (Generally recognized as Safe) , “…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 excepted from the definition of a food additive.”

Consideration of GRAS has been taken into effect when developing Sinusol® Breathe Easy for use in pregnancy. The essential oils in Sinusol® Breathe Easy include eucalyptus, menthol, cinnamon, mint, benzoin, birch oil, pine oil, camphor and benzoin. (Source FDA Code of Federal Regulations Title 21