Safety Classes
Class 1:
Herbs that can be safely consumed when used appropriately.
. History of safe traditional use
. No case reports of significant adverse events with high probability of causality
. No identified concerns for use during pregnancy or lactation
. No innately toxic constituents
. Toxicity associated with excessive use is not a basis for exclusion from this class
. Minor or self-limiting side effects are not bases for exclusion from this class
Class 2:
Herbs for which the following use restrictions apply, unless otherwise directed by an expert qualified in the use of the described substance: 2a: for external use only.
. Toxicity demonstrated with crude preparation taken orally at traditional dose
. Adverse event data in humans with probability of causality of toxicity (eg. hepatotoxicity, nephrotoxicity, neurotoxicity) associated with oral use
2b: Not to be used during pregnancy
. Traditional use contraindicates
. Traditional use as an abortifacient or uterine stimulant
. Relevant adverse even data in humans exist and have probability of causality
. Data in animals suggesting teratogenicity or other adverse effects on the fetus or mother, with reasonable application to humans
. For plants with common food uses, standard dose is in excess of typical food amounts
2c: Not to be used while nursing
. Traditional use contraindicates
. Relevant adverse event data in humans exists and has probability of causality
. Potential hepatotoxicity or neurotoxicity
. Bioavailability of constituents of concern in breast milk has been demonstrated
2d: Other specific use restrictions as noted
. Information exists that use may be unsafe for specific populations
. Dosage level outside of a standard range known to cause adverse effects
Class 3
Herbs to be used only under the supervision of a qualified expert. The following labeling is recommended for Class 3 herbs:
“To be used only under the supervision of an expert qualified in the appropriate use of this substance.”
Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of the substance.
. Narrow therapeutic range
. Identified safety concerns in many populations
Interaction Classes
Class A Herbs for which no clinically relevant interactions are expected.
. No case reports of suspected interactions with probability of causality
. No clinically relevant interactions in human pharmacological studies, if any,
Class B Herbs for which clinically relevant interactions are biologically plausible
. Human or animal pharmacological study data suggest potential for clinically relevant interaction.
. Multiple case reports have suggested a potential interaction concern.
. Cell culture or biochemical assays establish a basis for biologically plausible mechanism of interaction.
Class C Herbs for which clinically relevant interactions are know to occur
. Human pharmacological study has demonstrated interaction with a specific drug or supplement.
. Human pharmacological study has demonstrated clinically relevant effects on drug metabolizing enzymes or drug transporter proteins.
. Case reports of suspected interactions have a probability of causality.
All of our safety information is from:
The Botanical Safety Handbook. Second Edition. Edited by: Zoë Gardner, Michael McGuffin. Expert Advisory Council: Roy Upton, Soaring Bear, David Winston, Daniel Gagnon, Aviva Romm, Tieraona Low Dog, Mary Hardy, Lyle Craker
