Botanical products regulation

Botanical product quality and safety can also be influenced by regulatory status, which varies from country to country (46). In some countries, botanical products are regulated as medicine and are subject to mandated... 

Scientific Issues Impacting Regulation of Botanical Products.229... 

In terms of botanical products, where does a dietary supplement fit into the spectrum of use in the United States See Figure 13.9. The same botanical parent can yield derivative products that can be marketed and therefore regulated in many categories (Figure 13.10). In the United States, botanicals can be regulated as (1) foods conventional foods, functional foods, spices, dietary supplements (2) drugs ... 

FIGURE 13.11 In terms of approval, marketing, and regulation of a botanical product, the details of application, ingestion and expected benefits dictate possible niches of product development. 

SCIENTIFIC ISSUES IMPACTING REGULATION OF BOTANICAL PRODUCTS... 

A drug product that contains the same active constituent as a botanical product would be regulated according to different paths, as long as they are marketed with different intent. The combination of caffeine with any other stimulant, such as ephedrine alkaloids2, may not be sold as an OTC drag product (20). However, dietary supplement products that contain ma huang (a source of ephedrine) and natural product stimulants such as kola nut (50% caffeine) are permitted on the market under DSHEA. 

FDA"s evolving role in the regulation of botanical products as medicinal agents. To date there is no clear FDA policy with respect to this issue. 

Simon JE. Domestication and production considerations in quality control of botanicals. In Eskinazi D, Blumenthal M, Farnsworth NR, Riggins CW, eds. Botanical Medicine - Efficacy, Quality Assurance and Regulation. Larchmont, NY Mary Ann Liebert Inc., 1999 133-137. 

Essential oils are also influenced by legislation that regulates specific products that may contain these oils, e,g,. the U.S. Food, Drug, and Cosmetic Act and the European Community Cosmetic Directive. Essential oils would not be anticipated to be of environmental concern, considering that they originate from botanical sources, Thus, natural processes exist to degrade essential oils and recycle their components effectively in the environment,... 

A number of botanicals, flavoring substances, and natural substances long used in wines have been regulated. It is mandatory that product should be free from thujone (In Europe, maximum admissible thujone concentrations are 0.5 mg/kg in food and beverages, 5-35 mg/kg in alcoholic drinks, and 25 mg/kg in food products containing sage Schmandke, 2005.)... 

The United States Congress passed the Dietary Supplement Health and Education Act (DSHEA) in 1994. It describes a dietary supplement as a product (other than tobacco) that (1) is intended to supplement the diet, (2) contains one or more dietary ingredients (including vitamins, minerals, herbs, other botanicals, amino acids, and other substances) or their constituents, (3) is intended to be taken orally as a pill, capsule, tablet, or liquid, and (4) is labeled as a dietary supplement on the front panel. This means that dietary supplements are regulated as foods within the meaning of the act and such products do not require pre-market notification or registration except for new dietary ingredients (NDIs). 

There are several limitations that lead to potential for patient harm with the current regulation of herbals under the DSHEA. First, botanical nomenclature is not standardized. Common names for herbals may vary depending on the region of the country. A single herb may have more than a dozen common names (e.g., echinacea), or one common herbal name may refer to several different species (e.g., yellowroot and snakeroot). To avoid confusion, the American Herbal Products Association (AHPA) has published Herbs of Commerce, a text of more than 500 herbs with the preferred common name, Latin binomial, and appropriate synonyms. 

Pierce, A., Laird, S. and Malleson, R. (2002). Annotated collection of guidelines, standards and regulations for trade in non-timber forest products (NTFPs) and botanicals. Version 1.0. - New York, Rainforest Alliance. Retrieved from... 

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