Sunday, March 9, 2014

The FDA Doesn't Regulate Health

Little man and I went to Wal-Mart today. We were on a mission to pick up a new black ink cartridge for our printer. Since little buddy loves to ride in the cart, I decided to take a little stroll around Wally World. One area I enjoy visiting in particular is the pharmacy section. Some of you may be familiar with my fondness for the store pharmacy aisle. With the proper knowledge, this aisle can be a veritable treasure trove of disease killing power.

There is danger there, however. I can usually find a few chuckles about whatever the latest and greatest over the counter supplement may be. These new products are usually some of the same old things re-branded as something new. As soon as the TV infomercials go out, people dash for the store to pick it up or call their physician demanding to know why they weren't advised to take this amazing new medication.

Many of these supplements are advertised as substances that can improve some form of "health." I've seen advertisements for things that will improve brain health, liver health, immune system health, and even prostate health. Many people don't bat an eye at this phrasing. It's incredible important, though, that little word. When consumers think of the word health, they think of models in jogging clothes that smile and hold up a bottle of whatever product it may be. Do you know what I think of when I see a product designed to improve some type of "health?" Pure junk.

When a regular medication is approved by the FDA, this approval is backed up by clinical studies that prove efficacy in some way. There are also studies reviewed by the FDA that prove the medication is safe. Guess how many safety and efficacy studies the FDA reviews before a dietary supplement hits the market? Zero. Nada. Dietary supplements fall under a completely different set of rules. It is the manufacturer's responsibility to make sure a dietary supplement is safe, not the FDA. Therefore, the FDA reviews nothing and will only step in if some type of adverse event occurs.

When advertising, these supplements are not allowed to say that they do anything specific, such as actually help with your chronic fatigue, because there have been no studies verifying this. They are allowed to use general phrases, however, and "improving health" is a common go to. 

Some of you probably think that I'm being a bit harsh. How do I know that these drugs don't actually work? No studies means you don't know either way, right? Unfortunately not. These manufacturers are in business to make money. Do you know what kind of money they are giving up by not being FDA approved? To put it in perspective, it costs about $1 billion on average to bring an FDA approved drug to the market, and companies like Pfizer and Merck are some of the richest in the world. Think about that. $1 billion up front cost, and they are still making tons of money. If you sell your drug as a dietary supplement, it probably doesn't mean you chose to. It means that you know the FDA won't approve it.

I want to be clear that I'm not disparaging drug companies. Many people don't see or don't take advantage of a lot of the good work that many of these companies do for folks that can't afford different medications. To be fair, very few of the major drug companies are in the dietary supplement business either. Would you jeopardize your reputation and excellent business model by being involved with this? I wouldn't. They already know what I know. What comes out of your GI tract after you take that "gastrointestinal health" pill is exactly equivalent to it's value. Crap.

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