Wednesday, May 13, 2009

4 Things the FDA Should Go After Besides Cheerios

As reported by the Wall Street Journal, the FDA has decided to go after the makers of Cheerios. You can read their warning letter to General Mills here. The issue the FDA has is not that Cheerios doesn't really lower your cholesterol, but that the language on the box, specifically that eating Cheerios can "lower your cholesterol 4% in six weeks" means that Cheerios is intended for the use of lowering cholesterol, and is therefor a drug. Former FDA chair Dr. David Kessler's book "A Question of Intent" covers this topic nicely. He describes his struggle to try and regulate big tobacco. Since tobacco grows naturally, the argument was that it could not have been intended for a specific use. However, Kessler's fight was to show that the companies manipulated natural tobacco and the way it was delivered to cause an intended response, i.e satisfaction and addiction.

There are other foods that can make health claims, and the FDA's letter to Cheerios points out that soluble fiber products can talk about health benefits, as long as they add an "as part of" clause to the packaging. Though Cheerios has this, they feel the more prominent claim on the box (though not stated in the letter, it's basically their entire marketing campaign) is much stronger.

Since Cheerios does have clinical data to support a 4% reduction in total cholesterol, I am less worried about the stating this, but more concerned about patient's perception about what that does to cardiovascular risk. I have so many patients that are at risk for heart disease, warrant lipid lowering medications by any guideline, and yet are so affraid of medications ask if we give something like Cheerios a try first. The problem is that even though Cheerios may lower your cholesterol by 4%, this probably has no impact on your risk for heart attack or stroke. If you look at all of the cholesterol studies (any drug in any population) it is clear that to derive benefit you need at least around a 25% reduction in bad cholesterol to get any gain. Thus, my problem with Cheerios is not their claim to lower cholesterol, but the implication that this will make a bit of difference when it comes to heart attack or stroke.

However, there are several things that the FDA could focus on that, in my opinion, would serve a much greater purpose.

1. Medications approved not as drugs, but devices, so they seem like they work.

My favorite pharmacist blogger Mr. Medsaver recently gave a great example of this in his post regarding Allergen which is marketed under the names Chloraseptic Allergen Block and Little Allergies. These products are approved by the FDA, not as drugs but as devices. There is actually no active medical ingredients. These products are essentially petroleum jelly that you put under your nose. Their is absolutely no data whatsovere to suggest that these products do anything at all. Yet, patients wanting to help themselves or children who suffer from allergies and are affraid of side effects from actual medication will likely spend millions of dollars this year on a product which has never been shown to be effective, and is likely not. The FDA needs to work on this loop hole.

2. Supplements that imply health claims
To me this is a much greater problem. At you can get Ez Diet Carb Suppressor Capsules which have no real ingredients that have been shown to actually lose weight. The name implies they work, but a claim is not being officially made. At, a reputable supplement company, their Mega Men 50 supplement is a "healthy aging program for men over 50" and should be taken to "support prostate health" "support eye health" and "provides antioxidant protection." The FDA does not consider these claims as serious apparently as Cheerios, because they are stating that they support eye health for example, and not improving your vision. However, I betting that more people spend their dollars on supplements then Cheerios for health improvement. In addition, unlike Cheerios which at least provides breakfast, the evidence for vitamins and supplements are poor. I discuss this more in my previous post Which Vitamin Should I Take?

3. Homeopathic agents that imply anything
Airborne, Head On, etc. Enough said. At least vitamins and supplements have some potential value. These products have no potential benefit, clearly are making claims, and do absolutely nothing. Innocent patients are wasting millions of dollars on these products.

4. e-cigarettes

These products are drugs without question. They ought to be regulated by the FDA and they have not been proven safe in humans. Though the FDA may not be able to do much about products sold over the Internet, e-cigarettes, which are nictoine inhalers marketed as safer alternatives to cigarettes and smoking cessation aids, are being sold in U.S. shopping malls. There sale in the U.S. should be abruptly halted. See more on my previous post.


ecrunner said...

When something like this happens it makes me realize how vulnerable we are to advertising. It seems like the general population knows enough about cholesterol and their health that a cereal should not have this kind of influence. It can be as simple as reading a couple of health stories and watching what you eat... though I guess Cheerios are misleading us all of a sudden.

Mr. MedSaver said...

I find it fascinating that you actually have patients ask you about trying Cheerios first in order to lower their cholesterol.

Also, I agree with you that this really sheds light on a much bigger problem . . . the FDA's stance on foods vs. drugs. It's ridiculous that a company can market sawdust capsules to treat any disease as long as throw in the word "help."

LaceyUnderall said...

While I completely agree the FDA is off it's rocker regarding Cheerios, I must still say that I don't think the ecig should be on your list.

I completely understand based on our first discussion regarding the ecig that you are definitely pro pharmaceutical route... be it patch, gum, pill or puffer. But what about the thousands, and I mean thousands of persons who have switched from tobacco cigarettes to the electronic cigarette?

What about those of us who have completely stopped using nicotine and still use the electronic cigarette? Is the non-nicotine ecig liquid still a drug if there are absolutely no drugs?

If you really want to go after something, your #4 should be the vapor blasters that are being explicitly sold to children (with the same ingredients as the ecig I might add) that look and smoke just like a waterpipe!

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