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A Hard Thing To Do!

Posted Sep 14 2008 8:03pm

Having started a company formulating and selling nutritional supplements, I have discovered that one of the hardest things to do is to tell people in a factual, straightforward way exactly what specific nutritional ingredients can actually do for you.

The dietary supplements/nutraceuticals industry is regulated by the FDA, and to some degree the FTC (Federal Trade Commission). The Dietary Supplement Health and Education Act ( DSHEA ) was created in 1994 to bring some regulation to an "anything goes" industry. Like any law, there are pros and cons.

The upside of DSHEA is that it gives the FDA authority to go after the literally thousands of companies selling sub-standard products with slick websites that make totally outrageous claims of miracle cures, and when you peel back the curtain there are 1 or 2 people working out of an apartment or a garage. This is good regulation!

The downside is that DSHEA limits so severely what you can say (or more specifically what you CANNOT say) when you are trying to sell your products. The general rule of thumb is that you cannot make a "structure function claim" (i.e. "ABC cures XYZ") because this would be a drug claim and the FDA must have sufficient scientific evidence to approve drug claims. It doesn't matter if ABC has actually cured XYZ in many patients, you still can't say it until the FDA says so.

For example, much research clearly shows that niacin, a common B vitamin will lower cholesterol. But can you say that? Not if you are selling the product. That would be a drug claim. You are only allowed to say that your niacin product will "support cardiovascular health." And even then, you have to back that statement up with scientific evidence, which by the way, IS a good thing! (As Jigsaw's chief formulator Dr. Yadu likes to say, "Let science do the walking.")

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