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New FDA steroid warnings could teach you something

The Food and Drug Administration (FDA) is responsible for everything from the proper labeling of foods to the inspection of mammography facilities. They’re responsible for making sure the “general public” is safe from misrepresented products and that drugs won’t have dangerous side effects.

The FDA was created in 1906 and is under the direct jurisdiction of the federal government of the U.S. Its 2008 annual budget was $2.3 billion and the FDA used every penny of it. As it regulates $1 trillion in consumer goods, it’s probably safe to say that nobody wants to underpay the people who are keeping us safe from, well, just about everything.

This isn’t to say that sometimes companies and products slide by the FDA.

Every month the FDA sends out warning letters to make certain companies aware of violations. Nine letters have been sent out this month alone, to companies all over the country. Many of these letters informed companies that their products are “misbranded” or “unapproved.”

Believe it or not, these letters are actually really important to everyone. If you’re interested in what you’re putting on or into the bodies of yourself and your loved ones, you may want to start checking them out.

These letters highlight specific aspects of FDA law when they are violated. It’s good for consumers because it allows us to be aware of frequently violated sections. With each newly publicized FDA warning there are many things to be learned.

Take, for example, the recent Zicam controversy. Many people claimed to be losing their sense of smell from using Zicam. The FDA gently reminded people that homeopathic drugs aren’t necessarily regulated. What we learned from that is to do our research before taking anything.

By just taking the time to skim any of these letters, you may be surprised at how much you’ll learn. Let’s take a look at the most recent warning letter was sent out on Tuesday to American Cellular Laboratories, Inc. in Pacifica, Calif. (You can check out the actual letter here.) The subject is dietary supplements that have been “misbranded.”

The gist of the letter was this:
– your products are labeled and advertised as something that they’re not
– your steroids are not dietary supplements
– if you say something is a dietary supplement it MUST meet the actual definition of a dietary supplement
– According to the FDA’s Cosmetic Act, a product claiming to be a dietary supplement must have at least one dietary ingredient like a vitamin, mineral, amino acid or any ingredient of the other categories.
– your products are “new drugs” that aren’t generally recognized as safe and effective
– your products are prescription drugs because they have a potentially toxic or harmful effect and must be taken under direct supervision of someone director
– the products’ directions are inadequate

You can stay up-to-date on all of the FDA’s recent warning letters by checking its Web site. Who knows? You may even learn something.

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