The past few days people have been cracking jokes that the FDA found time to slap General Mills for it’s heart health claim on Cheerios. I’ve heard people comment about the fact that consumers should know the difference between a food and a drug and doesn’t the FDA have better things to do? Well, actually it isn’t that simple in our litigious society. Picture this scenario: a man stops taking his statin drugs because he sees the Cheerios claim that it can “lower cholesterol by 4% in 6 weeks.” Man has a heart attack. Family sees dollar signs and sues General Mills claiming that the man was led to believe that he could stop taking his cholesterol lowering medication and eat his Cheerios and lead a happy, low cholesterol life.
I’m all for people being held personally accountable for their health but the FDA has to make clear distinctions between food and drugs so that the above scenario doesn’t happen and so that people who just don’t get it won’t be “led” in the wrong direction by marketing hype. By stating that Cheerios can “lower cholesterol by 4% in 6 weeks” – well, that is a drug claim. Big Pharma companies spend plenty of money on research to be able to prove that their drugs are clinically effective. Food products on the other hand do not go through the same rigorous clinical testing.
Give the rise in drug costs, healthcare mess and opportunity for food companies to make money on functional foods, you can expect the lines between drug and food to get even more blurry in the future. A functional food is one that has an added benefit (plant sterols in your orange juice for instance). And, as you have probably noticed, more and more of these products are dawning store shelves. Currently, functional foods are regulated in the same way all foods are. However, the FDA may impose more regulations on functional foods in the future to save people from their own stupidity (ahem, see example above) and save companies from having to hire more lawyers than R&D folks.
good topical post