Options under the Dietary Supplement Health and Education Act
The complex regulatory status of TCM suggests parallels with dietary supplements and dietary supplement ingredients. Americans
and other Western consumers typically link TCM herbal ingredients with dietary supplement herbal ingredients. Health food
stores or the dietary supplement aisles at drug or grocery stores include a wide variety of botanicals, both in raw form and
in concentrated or extracted fractions.
Current regulations for dietary supplements under the Dietary Supplement Health and Education Act of 1994 (DSHEA) provide
the lowest barrier to market entry (5). In brief, submission of a new dietary ingredient (NDI) to FDA's Office of Nutritional
Products, Labeling, and Dietary Supplements (ONPLDS) as a Notification (NDIN) requires a safety data package that is relatively
straightforward.
DSHEA states that a dietary supplement that contains an NDI shall be deemed adulterated under section 402(f) of the Act [21
USC 342(f)] unless it meets one of two requirements: the dietary supplement contains only dietary ingredients that have been
present in the food supply as an article used for food in a form in which the food has not been chemically altered; or a history
of use or other evidence of safety establishes that the dietary ingredient when used under the conditions recommended or suggested
in the labeling of the dietary supplement will reasonably be expected to be safe. Further, the manufacturer or distributor
of the dietary ingredient or dietary supplement must provide FDA with certain safety information. Such safety information
can include citations to published articles on the basis of which the manufacturer or distributor has concluded that a dietary
supplement containing the dietary ingredient can reasonably be expected to be safe.
If a dietary ingredient has not been present in the food supply, vendors must show why they believe that consumption of an
NDI can reasonably be expected to be safe under the conditions recommended in the labeling. FDA has not published guidance
defining the specific information required to demonstrate safety but has made clear its position that there should be a "reasonable
expectation of safety" when the product is used. The manufacturer is therefore responsible for determining what information
provides the basis for the safety conclusion.
Standards for TCM–USP's role
Standardization of any new ingredient is of paramount importance. Appropriate specifications to demonstrate quality and purity
(and impurities at acceptable levels) are critical in obtaining a successful response from a GRAS Expert Panel, from FDA's
Center for Food Safety and Applied Nutrition during a follow-up GRAS Notification, or from ONPLDS in response to an NDIN.
Since its inception, USP has worked to provide accurate names for medicinal products, standardized procedures to test them,
and reference standards that independent parties can use to ensure their identity, strength, and purity (1). In modern times,
USP has asserted that "the elements of the monograph are sufficient to identify the compendial article and to control its
quality in the marketplace. The activity can bring a private consensus developed between a regulatory agency and applicant
into the open and allows public scrutiny and endorsement" (6). USP's expanding catalog of official reference standards enables
dietary supplement, food ingredient, and pharmaceutical scientists worldwide to test an article in commerce against a reference
standard or certified reference standard to ensure that the product is not adulterated (7).
USP also verifies the identity, strength, purity, and quality of dietary supplement finished products, dietary supplement
ingredients, and pharmaceutical ingredients. Products and ingredients that pass USP verification requirements—including a
GMP audit, product and ingredient testing, and manufacturing documentation review—are awarded use of the USP Verified mark,
which helps assure consumers that products provide the expected value.
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