In the lab: do supplement manufacturers validate their products with research?

• Author: Lewis, Di
• Position: Techknowledge

From the multivitamins in the cabinet to the protein powder in a workout drink, products of the dietary supplement industry are everywhere. Most people know there are looser regulations for dietary supplements, or nutraceuticals, than for drugs. But few know what goes into getting these products on the shelf.

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The current rules on dietary supplements date back to 1994, when the Dietary Supplement Health and Education Act (DSHEA) was put into place. Under the DSHEA, the manufacturer has the responsibility to ensure product safety before going to market. Unless the product contains a new dietary ingredient--any ingredient not id use by 1994--the Food and Drug Administration (FDA) does not need to approve products. The FDA does regulate the claims nutraceutical companies make and can act if they make misleading claims or put out unsafe products.

A few local companies say there are businesses that give everyone a bad name by rushing poor products to the shelf to capitalize on trends. But many supplement companies do extensive testing to ensure their products work in the way they are intended.

The R&D Process

"I think there's an ethical responsibility to do some kind of research to prove that what you designed does something useful" says Brett West, director of Noni benefits research at Tahitian Noni. "Anyone can put a product out in three months, but it doesn't mean it's effective because a lot of that is based off of others1 research."

Agel's Noah Westerlund agrees. Agel usually takes anywhere from a year to two years to get a new product on the market. Most of that time is spent on research.

Westerlund, vice president of marketing, says the research department begins with a health problem, like joint pain. After identifying the target of the supplement, they look at the ingredient list approved by the FDA and what ingredients show promise in solving the problem. Then the research and development department goes to work testing different formulas, ultimately making sure they're safe and effective by looking at blood absorption levels and symptom changes.

Tahitian Noni's process is similar.

The company generally goes through a three-part process: in vitro, lab research; in vivo, pre-clinical safety studies; and human clinical trials. While none of those steps are required in the United States for most products, West says it is both the responsible thing to do and required by many markets outside the country, like the...