Choosing Supplements - Part 2 of 2 - Quality

Wednesday, December 8, 2010

By Karen Brothers, ND student, NCNM

Part 2 of 2: Supplement Quality

Part 1 of this series described the categories of available supplements. Here, we’ll discuss what factors you should consider when evaluating supplement quality. This may seem daunting, but having a list of criteria simplifies this task and can provide a good comparison tool.

Before we delve into our list, let’s briefly review the regulation and standardization of supplement quality.

The Dietary Supplement Health and Education Act of 1994 (DSHEA) defines dietary supplements as food (not drugs) and requires that they are labeled as dietary supplements. DSHEA also states that manufacturers of dietary supplements are responsible for ensuring the safety of their products before they reach the market and that the information on the product label is accurate and not misleading. The FDA is responsible for taking action against any unsafe supplement on the market.

Good Manufacturing Practices (GMPs) include provisions regarding equipment, sanitation, operations, testing, quality control procedures, complaint handling, and record-keeping in the manufacturing and testing of dietary supplements. GMPs are typically general enough to enable each manufacturer to decide how to best implement the controls to ensure consistency in the identity, purity, strength, and composition of supplements. In the U.S., GMPs are enforced by the FDA under the 1938 Food, Drug, and Cosmetic Act and refer to "current good manufacturing practices" (cGMPs) to remind manufacturers to employ up-to-date technologies and systems to comply with the regulation.

The United States Pharmacopeia (USP) is a non-government authority that sets standards for the quality, purity, strength, and consistency of food ingredients and dietary supplements as well as for prescription and over-the-counter medicines. USP's standards are recognized and used in more than 130 countries.

NSF International is an independent, non-profit organization offering testing of dietary supplements and GMP inspections for supplement manufacturers. The NSF Dietary Supplements Certification program verifies label claims, ensures that there are no ingredients not listed on the label, and ensures that there are no unacceptable levels of contaminants present.

Now that you know a bit about the regulation of supplement quality, we’re ready for our list of quality criteria. To answer the questions posed here, I recommend first looking at the manufacturer’s website for information about their quality practices. Another potential resource is the Emerson Ecologics Quality Program, which provides information about its suppliers’ quality practices.

o Regulations and standards. Which regulations and/or standards does the supplement’s manufacturer adhere to: cGMPs? USP? NSF? Other? Does the manufacturer have a clean record with the FDA (i.e., no citations for unsafe products)?

o Production process. Does the manufacturer produce their supplements in-house, or does it outsource production? If production is outsourced, how does the company verify quality control? What measures does the manufacturer have in place to avoid contamination during manufacturing? Does the company use fillers or binders in its products?

o Raw materials. How/where does the manufacturer source its raw materials? What requirements must the suppliers meet? Are the materials subjected to verification testing? Are the materials organic?

o Testing. What testing methods does the manufacturer employ for identity verification, potency, and contamination (microbes, heavy metals, solvents)? What allergen testing does the company conduct? Does the company conduct testing in-house or by a third party? Is every product lot tested? At what phase(s) of the production process is testing conducted? What tests does the company conduct on the finished product?

While this is not an exhaustive list of questions to consider, you can feel comfortable that you’ve chosen a high quality supplement if your answer to most of the questions is “yes” or involves an impressive list of tests, procedures, requirements, or measures.

posted by Innate Response at

7:40 AM

Choosing Supplements - Part 2 of 2 - Quality

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