Friday, July 22, 2011


"The FDA’s language resembles that of an out-of-control police state"

For some time I've been bothered that, while medicine is heavily regulated and tested by governments, "herbal remedies" and "food supplements" are not. They are covered by basic advertising and packaging laws, but they don't have to be tested carefully and can be made of anything these companies want.

It seems to me that if this is good enough for bee pollen and garlic extract, its good enough for aspirin and xanax; both are going into your system regularly, both are affecting your metabolism. They should either all be tested just as rigorously or treated with the same lax standards. I just don't see the distinction, other than one is more established medicine and the other is more preferred by hippies and mystics.

Most modern medicine we have now came from herbal remedies in the past, such as penicillin and aspirin. So why the distinction?

Recently the FDA contacted Diamond foods and informed them that their walnuts are, in fact, drugs. The letter sent included these lines:
Based on claims made on your firm's website, we have determined that your walnut products are promoted for conditions that cause them to be drugs because these products are intended for use in the prevention, mitigation, and treatment of disease.
Given what I said above, you might think I like that ruling. You'd be wrong.

The problem here is that the FDA is trying to have it both ways. They want to ignore some herbal remedies and claims, and enforce drug rules on others. They want to have drugs under one set of laws and herbal/food supplement materials under another, then pick and choose arbitrarily how they are enforced.

Simply claiming that walnuts contain materials which are in fact beneficial to the human body does not make walnuts a drug. And that's what the FDA is arguing; you have to either call these a drug or stop saying that.

This is a really disturbing pattern that the Obama administration has gone nuts with: agencies unwilling to wait for congress to actually pass laws and simply enforcing their opinions with the weight of law. I have no doubt they've long wanted to do this, just as I have no doubt that President Obama picked really zealous activists of his stripe to head up these agencies. His cabinet is full of academic theoreticians and hard leftists. I just know that previous presidents used to rein these guys in and under President Obama, the executive department has gone nuts, so to speak.

If the FDA wants food supplements or foods to be classified as drugs for declaring health benefits from their use, they should get congress to pass a law, not simply enforce it as if the law exists already. Because they're obviously doing this only to specific chosen targets, not broadly to every company that claims health benefits like "heart healthy" baked chips.


I am Teriffic Man said...

The matter at hand is one of drug or drug-like claims being used to advertise a product. When you do that, the FDA prefers that you submit to the normal drug testing procedures or stop selling the product as advertised.

Diamond is free to contest the letter, or even ignore it entirely. I have no idea if they'd prevail when it goes to court, though.

Christopher R Taylor said...

There's no "prefer" about that letter, and the claims of Diamond Foods are not drug-like. Further, the letter clearly identifies their walnuts as drugs not as "being advertised in a drug-like fashion." And finally, the FDA is not choosing to address every claim in this manner, only a select few.

Tina said...

The FDA has been battling in recent years to take the same kind of control over cosmetics, skin lotions and personal care preparations. There are thousands of tiny manufacturers in the USA making soaps & lotions. They are responsible for using industry standard "Good Manufacturing Practices" and carry liability for their own products. The multi-national lobbyists pressure the FDA to shut down these small businesses, who have banded together to stand up to the big guys.

From what I have seen about it, it seems to use a ruse of restoring the old "truth in advertising" laws without actually doing so: the FDA could say that lipstick is a drug if the seller/manufacturer makes any claim that it acts on the body. The great question is whether this merely prohibits saying it "heals cold sores", or whether that expands to include "gives you kissable lips" is apparently up to the FDA to decide based on the operational politics and PR issues of the day, rather than on common sense, experienced judgment, or even actual lawful definitions.