FDA is unregulated and risky

The unregulated Food and Drug Administration may be putting consumers at risk by allowing illegal products to remain on the market.

Okay, maybe that's a little harsh...or is it?

Case #1: FDA sent a warning letter to a company in September 2009 for making H1N1/flu claims on its website. The company seems to have removed the H1N1 term, but still has products promoted for flu, cancer, heart disease, arthritis, cysts, lung disease and the list goes on (click here to see the list). FDA should be held accountable for this ridiculous approach to "enforcement."

Case #2: FDA sent a warning letter to a company in October 2009 for making H1N1/flu claims on its website. The company is still making those claims (click here for a selection of products to prevent H1N1)! And they are offering products for cancer, high blood pressure, fybromyalgia, you name it (click here for the full list, and notice that H1N1 appears twice!)

Case #3: FDA's opening paragraph on its webpage for dietary supplements is one of the most creative truthful but misleading pieces of commentary I have ever read: "FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products (prescription and Over-the-Counter). Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market." On no other section of the many classes of goods that FDA regulates does it start by saying that it does not regulate those products like some other product. There are different regulations for each class of goods: drugs, foods, supplements, medical devices, cosmetics, blood/plasma, radiological devices, etc. This is exactly how one would write this opening paragraph if one wanted it to seem that the agency does not regulate the products or does not have the authority. But who does FDA report to for such misleading and deceptive behavior? Apparently no one.

Case #4: I turned in a website to FDA in December 2009 that was making blatant H1N1 flu claims (click here to see the site, which is still operating the same today). I also blogged about it, and said that I would check back occasionally and report whether FDA had done anything about it. I did receive a response from the agency back in December saying "we will consider whether a violation of the FFD&C Act has occurred and, if so, whether regulatory action is warranted in light of FDA’s enforcement priorities and resources." Apparently the resources just aren't there, because nearly six months have passed and this company is still making money selling H1N1 products. Where is the accountability for FDA?

I can go on and on with literally dozens of examples of how the agency is failing to enforce the law, and I will, but frankly I don't think any more examples are necessary to prove my point that the FDA is unregulated. Perhaps someone in the Senate should introduce a FDA Accountability and Transparency Act so we can find out what is going on within that agency.