Tuesday, September 22, 2009

Part Two in AgLaw/BioLaw's series on the FDA

I tried to put up a comment last week asking the author what she thought about the rather tenuous link between high cholesterol and heart disease, but it wasn't approved. That's splitting hairs, though, because the point is not whether high cholesterol really does cause heart disease but whether products can claim that they can lower your cholesterol without subjecting themselves to FDA regulation.


Tuesday, September 22, 2009

Post Two of a Series: The Relationship Between the Level of Regulation under the FDCA and the Health Status of a Product’s Targeted Population

The first post of this series began by asking whether functional foods should be regulated as drugs if they claim to treat abnormal health conditions. For example, was it appropriate for the FDA to characterize Cheerios as a drug as a result of its advertising claim that “you can Lower Your Cholesterol 4% in 6 weeks?” An abnormally high level cholesterol level is a serious risk factor for disease and those with high cholesterol levels are in an abnormal state of health. By virtue of its claims to help this group of unhealthy consumers with their struggle to return to a normal state of health, should the manufacturer of Cheerios be required to undergo the FDA's premarket approval process to show that eating Cheerios is effective in lowering cholesterol as claimed?

The answer to this question may become more apparent by looking at another category of products that claim to help unhealthy people return to a normal health status – weight loss products.

Click here to read the rest.

1 comment: