Botanical medicines are regulated by the DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT OF 1994 (DSHEA).
This law clarifies marketing regulations for herbals and reclassifies them as dietary supplements - distinct from food or drugs. Dietary supplements under DSHEA include plant extracts, enzymes, vitamins, minerals and hormonal products that are available to consumers without a prescription.
The DSHEA does NOT require: 1) safety and efficacy studies of a dietary supplement; or 2) standardization codes for manufacture.
TYPES OF HERBAL FORMULATIONS:
Bulk herbs - sold loose to be used as teas;
Extracts - made by pressing herbs with a hydraulic press and soaking in alcohol. or water; excess alcohol or water allowed to evaporate.
Tinctures - liquid extracts of plants in an alcohol base; Capsules/Tablets - contains freeze-dried or powdered herbs or extracts;
Teas - water-based extraction brewed using one ounce (25 grams) of dried herb or two ounces (50 grams) of fresh herb and 500 milliliters of boiling water. Boiling water is poured over the herb and allowed to brew ( 1 to 3 minutes for flowers; 2 to 4 minutes for leaves; 4 to 10 minutes for bark, roots, or hard seeds).
Decoctions - water based extraction brewed from seeds, bark and roots using the same quantity as for tea. The mixture of water and herb is brought to a boil - then simmered for 20 to 30 mintes - after which the mixture is strained and water is added to a volume of 500 milliliters. The lack of regulation in herbal medicines may lead to problems, such as misrepresentation of the potency of the products, inadequate information about how a company drows or processes its' herbs, product safety or active ingredients.
Formulations obviously vary in potency and recommended dosages.