Monday, December 15, 2008

Labeled

In my previous observation, I mentioned the phrase "pharmaceutical benefit" when discussing nutritional products and condition-specific marketing. There is a fine line between marketing a nutraceutical such as a functional food or a dietary supplement and making health claims.
  1. The label - and by "label" I mean the marketing extension of the label, including Internet content and other forms of marketing - must not in any way convey that the product can cure or prevent a condition or disease.
  2. Once a nutraceutical is presented to a consumer in a way that implies it can cure or prevent a condition or disease, the product enters the realm of a prescription drug in the minds of consumers and the U.S. Food and Drug Administration.

While the majority of Americans are now using nutraceuticals, they face a major problem: the market is flooded with products for which unsubstantiated medical-health claims are being made. The industry and FDA are working to create a free flow of information on product safety, but more work is needed to bridge industry with regulators.

This afternoon, I read a news report on this subject that centered on Minnesota-based Wilderness Family Naturals, an organic ingredients supplier of dietary supplements and food products, which allegedly made disease claims on the labels of their brands. FDA has clearly begun to take action against companies that make such claims; in this case, FDA alleges Wilderness Family product labels played up potential health benefits for specific conditions and diseases such as cancer, diabetes, heart disease, chronic fatigue syndrome, HIV, AIDS, and arthritis.

I dare to make an analogy...

***

During my first high school football practice, I failed to heed repeated warnings while attempting to play defensive back and stood up straight (as opposed to staying low and keeping my knees bent).

The result?

My shoulderpads were pushed into my throat and I landed on my back.

"You just got labeled!" cried the junior varsity coach.

***

I believe the same battle cry is being heard in the nutraceutical badlands of Minnesota.

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