What Does the FDA Do to Protect Us?

Maybe the better question is, “Can the FDA really protect us?” It’s an enormous undertaking when you think about it. This one regulatory agency is responsible for ensuring the safety of basically everything: from your blood pressure medications, to your IUD, to the chocolate bars you hide from your kids. Yet most Americans haven’t a clue what the FDA does. We blindly trust that it’s all good because—well, we never hear of anything bad happening. But the truth about what goes on at the FDA may surprise you and might even save your life.

I know many people could care less about what really goes on at this level of government. I mean, it’s way more entertaining to binge watch a documentary about a serial killer. Learning stuff is boring. That is until someone you love gets sick, or poisoned, or dies. Government shut downs and budget cuts seriously impact the FDA’s ability to do its job. The program is grossly underfunded compared to other programs like military defense; yet it’s responsible for protecting us from the more immediate threats that lurk in our kitchens and cabinets. That’s not the only issue. There are a few more surprising facts about the FDA that shed some light on why you need to be a little less trusting and a lot more aware.

The FDA is responsible for regulating the safety of all domestic and imported food and drug products. This includes assuring that foods are safe and sanitary; and that products like drugs, medical devices, supplements, and cosmetics are safe for use by the public.

What the FDA Doesn’t Do

What may surprise you is that the FDA is totally dependent on companies to provide data and evidence that prove product safety. Most people assume that the FDA actually does the testing and research. They couldn’t be more wrong. The FDA does not research or test foods, drugs, cosmetics, or medical devices for safety. The agency relies solely on research and testing provided by the company who makes the product. Companies compile their own data and present their findings to the FDA. The FDA then conducts a review of the application, and if approved, a company takes their product to market.

The FDA will only investigate and recall a product if the risk to the public outweighs the benefits. Meaning many people have to die, get sick or injured before the FDA steps in. At least 1-2 drugs and 6-8 medical devices are pulled off the market every year. If you want to play it safe, hold off on using new products. Allow for adequate time (think 2-3 years) for a product to prove it is safe for use. This is especially true when it comes to new drugs and supplements. You’re much better off using generic brand medications which are just as effective, not to mention cheaper.

You should also know that many of the agents that work at the FDA are former employees of the very companies that FDA is charged to regulate. Can you say serious conflict of interest! Therefore, it is not unlikely for an FDA agent to have biases that influence the approval process, cause them to overlook a potential red flag, or delay pulling a product off market.

Unfortunately, recent government legislation continues to promote this type of capitalist co-dependency. The Prescription Drug User Fee Act (PDUFA) requires pharmaceutical firms to pay a fee to get an accelerated review process. These fees account for nearly 94% of the agency’s budget. Yes, that means that the FDA is being funded and kept afloat by the very people they are charged to regulate.

What Can We As Consumers Do?

We must start demanding better for ourselves and hold our government agencies accountable. Don’t ever think that your voice doesn’t matter. As a consumer, your refusal to buy or use a product can be very powerful. And it’s so important to advocate for your rights before they get taken away. Case in point: The Food Safety Modernization Act was signed into law by President Obama on January 4, 2011. Its intent is to strengthen the FDA’s ability to regulate and protect the public. But it also gives the government the right to restrict, limit, prohibit, fine, or jail you and I for growing and selling produce on a home garden or farm. The reason for such intrusive power—to protect us from intentional and accidental food contamination. Hmm, call me crazy, but I’m far more trusting of some lemons from my girlfriend’s backyard then I am of a salad from Chipotle.

 

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