As early as 1652, American colonist

As early as 1652, American colonists recognized the potential for fraud, safety risks, and adulteration of the food supply and passed laws to protect the public.1 Prior to the establishment of the Food and Drug Administration (FDA) by the U.S. Congress in 1938, the U.S. Pharmacopeia (USP) played a strong role in regulating herbals. Standards were published as a result of The U.S. Pharmacopeial Convention, and, thus, the USP became the only quasigovernmental regulation of the purity of medicinal herbs. Compliance was seen by the designation of USP on the label of a product. The National Formulary (NF) was a second and similar publication. Prod- ucts complying with the rules could be designated NF. As medical practice moved from herbal to chemical products, items were deleted from these compendiums.
In 1938, when congress passed the Food, Drug and Cosmetic Act (FDCA) and created the Food and Drug Administration (FDA), authority was mandated to reg-

ulate food and drugs. The FDCA defined both drugs and foods but left plant medicinals undefined. The ambiguity of herbal products led the FDA to generally categorize herbals as (1) generally recognized as safe (GRAS), (2) unsafe or inef- fective, or (3) lack of adequate information to determine safety and efficacy. The nutrition labeling and education act of 1990 mandated labeling of dietary supple- ments and defined health claims. Additional amendments and legislation modified the FDCA and led to the Dietary Supplement Health and Education Act (DSHEA) of 1994. A provision in DSHEA is now being acted on by the USP with the goal of generating informational monographs and standards for manufacture. DSHEA legislation, however, ultimately created an environment for selling unregulated herbal and botanical products in the U.S.
One problem consistently observed in evaluating plant medicines is the definition of herbs and botanicals. The Herb Trade Association in 1976 defined herbs as “a plant, plant part, or extract thereof used for flavor, fragrance, or medicinal purposes.”1 In 1991, the World Health Organization (WHO) defined herbal medicines as follows:

Hasil (Bahasa Indonesia) 1:

Sedini 1652, koloni Amerika mengenali potensi untuk penipuan, risiko keselamatan dan pemalsuan pasokan makanan dan disahkan undang-undang untuk melindungi public.1 sebelum pembentukan Food and Drug Administration (FDA) oleh Kongres AS pada tahun 1938, US Pharmacopeia (USP) memainkan peran yang kuat dalam mengatur herbal. Standar diterbitkan sebagai hasil dari US Pharmacopeial Konvensi, dan, dengan demikian, USP menjadi hanya quasigovernmental peraturan kemurnian obat herbal. Kepatuhan dilihat oleh penunjukan USP pada label produk. Formularium Nasional (NF) adalah sebuah publikasi kedua dan sejenisnya. Prod-ucts mematuhi aturan dapat ditunjuk NF. Karena praktek medis pindah dari herbal produk kimia, item dihapus dari compendiums ini.Pada tahun 1938, ketika Kongres berlalu makanan, obat dan kosmetik Act (FDCA) dan menciptakan Food and Drug Administration (FDA), otoritas diamanatkan reg- ulate food and drugs. The FDCA defined both drugs and foods but left plant medicinals undefined. The ambiguity of herbal products led the FDA to generally categorize herbals as (1) generally recognized as safe (GRAS), (2) unsafe or inef- fective, or (3) lack of adequate information to determine safety and efficacy. The nutrition labeling and education act of 1990 mandated labeling of dietary supple- ments and defined health claims. Additional amendments and legislation modified the FDCA and led to the Dietary Supplement Health and Education Act (DSHEA) of 1994. A provision in DSHEA is now being acted on by the USP with the goal of generating informational monographs and standards for manufacture. DSHEA legislation, however, ultimately created an environment for selling unregulated herbal and botanical products in the U.S.One problem consistently observed in evaluating plant medicines is the definition of herbs and botanicals. The Herb Trade Association in 1976 defined herbs as “a plant, plant part, or extract thereof used for flavor, fragrance, or medicinal purposes.”1 In 1991, the World Health Organization (WHO) defined herbal medicines as follows: