"FDA Approved": When It's True and When It's Not.html

What does "FDA approved" really mean?: Internet Scambusters #763

Just because a product you're buying says "FDA approved" doesn't always mean it is.

And even if the approval is genuine, that doesn't necessarily mean the product is safe.

You can't even trust some claims made in certain prescription drug ads, as we explain in this week's issue.

Now, here we go...

Don't be Fooled by "FDA Approved" Claims

You know that reassuring feeling you get when you learn something you're about to swallow -- food or drugs -- or a device you plan to use is "FDA approved"? It must be OK, right?

Well, all may not be as it seems.

The FDA is the U.S. Food and Drug Administration, the government agency responsible for monitoring the safety and effectiveness of a wide range of consumer products.

So, it seems fair to assume that products carrying that "FDA approved" label must be safe and meet any advertising claims.

Although it's illegal to claim something has been approved by the agency when it hasn't, that doesn't stop unscrupulous manufacturers and sellers from making the claim or using vague wording to imply approval.

For example, the FDA doesn't "approve" companies. It only delivers its verdicts on their products.

So, it would be wrong for a company that has FDA approval for a particular product to use that to suggest all of its products have been similarly approved.

Likewise, the agency has authority to inspect certain facilities, such as those providing healthcare and laboratories, and require registration of blood and tissue services. But passing inspections or being registered does not mean the establishment is "FDA approved."

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There's a whole world of difference between being approved by the FDA and being regulated by them.

FDA Guide

In a recent consumer update, the FDA issued a guide to how it regulates products and what it does or doesn't approve.

The key points are:

* The FDA itself doesn't test products before approving them. It bases its decision on the results of tests done by manufacturers. That's important to know.

* Approval sometimes only means the agency decided the benefits of the product outweigh any known risks. It doesn't necessarily guarantee they're safe, much as manufacturers might wish we'd think so.

* Compounded drugs, made by combining the contents of two or more pills into a single dose, are never FDA approved. The agency does not review them.

* The FDA does not approve any type of tobacco product. It does regulate how they are sold and promoted.

* The agency does not approve cosmetics, with the exception of certain color additives. However, the FDA does require that cosmetics should be safe for their intended use.

* It is responsible for approving animal drugs but not animal foods. Food manufacturers are required to conform to FDA and other food health regulations but that doesn't mean these products are "approved."

* Nor does the agency approve so-called "medical foods" -- products used for diets that provide specific nutrients or avoid using certain additives like gluten.

* It doesn't approve dietary supplements, such as vitamin and enhancement pills, either. A reputable manufacturer normally includes a disclaimer on the labeling to the effect that the product is not FDA approved or that any claims of effectiveness have not been evaluated by the agency.

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* The FDA doesn't approve food or nutrition labels on food.

That's quite a list of "things we don't do."

Bad Ads

Another area of concern in relation to the promotion of FDA-controlled products, notably certain prescription drugs, are claims about their safety and effectiveness.

In fact, the agency has a special department -- the Office of Prescription Drug Promotion (OPDP) -- to try to ensure drug makers don't make claims they either can't prove or that are blatantly untrue.

As part of this, a few years back OPDP launched what it called the Bad Ad Program to identify and clamp down on misleading prescription drug marketing, especially to healthcare professionals.

It identified how the makers of even well-known dementia and skin treatment drugs may have misled people by failing to provide balanced information about both the benefits and the risks.

Each year, the Bad Ad Program has received hundreds of complaints, both from professionals and patients, many resulting in violation notices.

One example of a dubious claim would be something like "this drug can achieve results in as little as three days." While it might be true, it could conceal the fact that the majority of patients did not experience a result for perhaps three weeks.

It's very difficult for consumers of prescription drugs to be sure of the accuracy and balance of claims made for their meds -- but it underlines the importance not only of reading manufacturers' claims carefully but also discussing them with your physician -- or pharmacist -- and researching the experience of others online.

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