Safety Considerations in Supplement Formulation

Is safety really being considered? Do we understand the nature of these newly incorporated minerals into daily preparations? Valence state is critical for some of the known toxicants, such as chromium (Cr) VI versus Cr III. Valence and solubility are factors in absorption and distribution, and systemically target organs or sensitive tissues. Should arsenic or mercury be added or allowed, while at the same time be limited or avoided? What about additivity or synergy among similar moieties or elements? Copper, silver and gold are all IB transition metals, but are they all needed, and what are the effects if all are present? How many of these ingredients are strictly for marketing purposes (the cachet of platinum or horny goat weed for its subliminal visual)?

A baseline for safety should look at ingredients’ monographs, which have been scientifically developed via an independent, rigorous and transparent process. Valid monographs, such as those developed by the U.S. Pharmacopoeia (USP), contain relevant and specific information related to identity, analytical testing methodologies, acceptance criteria, impurities, active constituents, packaging and labeling information. Physical reference standards, i.e., purified and analyzed chemical compounds are used as a “chemical yardstick” to ensure each batch of product coming off of the assembly line is the same and as pure as the previous batch.

The monographs found in USP’s National Formulary (USP-NF) are not static. There are changes in format, inclusion criteria, specifications, analyses, and a myriad of innovative products and processes. Volunteer experts, many of them internationally-based, convene in person and electronically to deliberate on the elements of a particular industry-submitted ingredient monograph. When an ingredient is deemed safe, or safe enough to be used at a specified exposure, then the expert committee swings into action. Of primary importance is identity: it must be characterized so a consistent and unambiguous material is tied to specifications, analytical tests for purity and impurities, acceptance criteria and limits on unwanted/unavoidable elements, etc. New ingredients are continually being presented for systematic review, coming not just from current research and development activities among American dietary supplement entrepreneurs, but also from the collections of traditional medicines in China, India and elsewhere.

Creativity and innovation are not suspect and should not be treated unfairly. They are the leading edge of global safety determinations, clinical evaluations, agricultural practices to standardize and consistently provide a cognizant genus/species, and provide consumers with products and ingredients that may ameliorate many human problems. However, safety must be the first and most differentiating threshold for evaluation and incorporation—not the post-mortem when increasing adverse-event reports spotlight a problem.

James C. Griffiths is the vice president of food and dietary supplement standards and Darrell R. Abernethy is chief science officer at the U.S. Pharmacopeia (USP.org).

Editor's Note: Looking to learn more about USP's Dietary Supplements Compendium? Join USP's Gabriel Giancaspro, Ph.D., on Tuesday, April 29, at 10 a.m. at SupplySide East for a compare/contrast session. Get registered and learn more online at SupplySideShow.com.

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