FDA Regulations - Keeping You Safe - Fact or Fiction?

GREENSBORO, NC -- Here's a fact or fiction about sunscreen. The FDA knows every ingredient in that bottle. It turns out that's fiction That got us thinking, if a product is regulated by the FDA, why doesn't the agency know about all the ingredients?

You know the FDA as the agency that oversees food and drugs, but they have you covered from head to toe - literally. The FDA regulates shampoo, chapstick, vitamins sunscreen and anti-fungal solutions for your toenails, not to mention contact lenses, hearing aids, and cigarettes.

But when we say the FDA has you covered, it might not mean what you think. The agency makes a lot of rules for product makers to follow, but has little power to make sure companies are actually following the rules.

Sunscreen: The FDA rules created industry-wide definitions for SPF, broad spectrum and water proof. But the agency isn't allowed to the test products to see if a product's labels are accurate. The manufacturers have to test but they don't have to report the results to the FDA.

And guess what? Consumer Reports found the labels aren't always accurate. The magazine tested 20 sunscreens and only two provided the SPF protection promised on their packages. Jamie Kopf with Consumer Reports says, "We can't say why our test results differ from the manufacturers'. In some cases we found the SPF was off by just a little. But two sunscreens were off by much more."

Dietary supplements: They are not subject to safety and efficacy testing, and there are no approval requirements. The FDA can take action against dietary supplements only after they are proven to be unsafe. Manufacturers of dietary supplements are permitted to make specific claims of health benefits, referred to as "structure or function claims" on the labels of these products. They may not claim to treat, diagnose, cure, or prevent disease an must include a disclaimer on the label.

FDA would like to know whenever the use of a dietary supplement causes you to have a serious reaction or illness, even if you're not certain that the product was the cause, and/or you did not visit a doctor or clinic.Report it through the FDA's Safety Reporting Portal.

Cosmetics: Under the law, cosmetic products and ingredients do not need FDA premarket approval, with the exception of color additives. Neither the law nor FDA regulations require specific tests to demonstrate the safety of individual products or ingredients. The law also does not require cosmetic companies to share their safety information with FDA.


  • Just because you can buy it on a store shelf, doesn't mean it can't hurt you.
  • When you get ready to buy a product, don't accept it on face value. Check it out. Go online - see if consumer reports or someone else reputable reviewed it. Or see if problems have been reported.

The FDA does try to gain the power to test products before they hit the shelves but so far either Congress or the industry has blocked the move.


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