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The Pitfalls and Burdens of Claims

By: Marie Alice Dibon, PharmD
Posted: February 2, 2010, from the February 2010 issue of GCI Magazine.

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Two facts are interesting in this case: There is no threat to consumer safety and many of the claims that the FDA points out to be “illegal” claims are found on many other products currently on the market. They are made in more or less subtle ways, but they are there. So what gives? Why are those products singled out, out of thousands of other products? Consider that, like the lash example, the second example bore claims very similar to an Allergan product—Botox.

According to Steinberg and Associates’ president/founder, and Cosmetics & Toiletries magazine columnist David Steinberg, very simply put, it is a matter of priority.

FDA action is driven first by customer safety, industry’s interest secondly and then pure compliance—with very little means to apply the rules. So FDA actions often simply reflect this order, and are instigated from outside the agency.

“The Botox [like] claim is right in Allergan’s backyard, obviously there was pressure put on the FDA to send the letter,” offers Steinberg. “The exact same thing probably helped the agency pay attention to the [lash] product.”

The bottom line is that, in most cases, consumer’s safety is not endangered by most of the claims that the FDA would consider to be drug claims.b