FDA Misunderstandings

“Is it FDA approved?” One often hears that phrase, but what does it really mean?

By Bill Landers

“Is it FDA approved?” One often hears that phrase, but what does it really mean? In the late 1800s, there was a huge patent medicine industry in this country, peddling often useless and sometimes dangerous nostrums for every conceivable ailment. In 1906, Congress passed the Pure Food and Drugs Act, which created and charged the FDA with (among other things) protecting consumers from fraudulent product claims. It does so by regulating the sale and marketing of drugs and medical devices, not their use.

For instance, suppose you want to sell a toothpaste. Some toothpastes are regulated by the FDA; others are not. It all depends on how it’s going to be marketed. If the labeling and advertisements for your toothpaste proclaim that it cleans and/or whitens the teeth, it would be classified as a cosmetic. Cosmetics are not regulated by the FDA, although they must be made in accordance with certain “Good Manufacturing Practices.”

Now, suppose that you wanted to increase sales by adding a fluoride so you could also say that your toothpaste helps prevent caries. Your cosmetic toothpaste just became a drug. Caries is a disease, and anything that purports to prevent or treat a disease is defined as a drug. The sale of drugs is regulated by the FDA. Even if you did not add fluoride, you still couldn’t say that it prevented caries, because it’s the claim that is regulated, not the product itself.

There are actually two types of FDA certification (“approval” and “clearance”). They are often used interchangeably in ordinary discourse because the outcome is the same — the product has been proven safe and effective. There is an expensive distinction for manufacturers, however. The FDA reserves the term “approved” for new drugs with no prior medical application, like a brand new type of fluoride. New drugs require multiple, long-term (and very expensive) efficacy and safety studies. “Clearance” is used instead of “approval” when a drug is substantially the same as other drugs already approved. In that case, the manufacturer only needs to demonstrate that the drug is functionally equivalent to one previously approved.

Once the FDA grants marketing approval, it can be sold, but only for specific applications. For instance, a fluoridated toothpaste approved for caries prevention could not be promoted for periodontal disease unless it had been specifically approved for that purpose as well.

While manufacturers are prohibited from promoting their products for “off-label” applications, medical professionals are free to use them as they see fit. That’s because the FDA doesn’t regulate the medical professions. They’re regulated by the various state professional practice acts, which typically authorize off-label product use subject to the professional’s expertise and judgment. RDH

BILL LANDERS has been president of OraTec Corp. since 1992. He is also a leading expert on chairside and laboratory periodontal risk assessment technologies, and his essays on periodontal disease have been published in several dental hygiene journals. Mr. Landers is a popular speaker and has presented hundreds of continuing education seminars on the microbiology of periodontal diseases.

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