Opening Lines
Concerning Cosmeceuticals
If you ask FDA about cosmeceuticals, the agency will say that the word doesn't exist. At least not in this country. "Cosmeceutical isn't a term that's recognized under U.S. regulations, although it is in Europe and elsewhere in the world," says Linda Katz, director of FDA's Office of Cosmetics and Colors at the Center for Food Safety and Applied Nutrition. "If you're calling a product a cosmeceutical, FDA assumes that your product is an over-the-counter (OTC) drug."
Despite whether FDA officially sanctions the term, cosmeceutical is an increasingly popular buzzword in the beauty industry. In our cover article, "Cosmeceutical Components," on page 86 of this issue, senior editor Marie Redding reports the latest news in cosmeceutical packaging.
Manufacturers that market, or plan to market, products as cosmeceuticals should mark the date May 16, 2005, in their calendars, if they haven't already done so. That date is the final deadline for the Drug Facts Labeling monograph, by which all cosmeceutical packages must carry FDA's official Drug Facts panel, with a few exceptions for which FDA has stayed the final monograph dates.
For its part, FDA has been working with the industry to help members understand the monograph's requirements. Once again, I attended ICMAD/FDA's Cosmetic Workshop, held February 12 in Santa Monica, CA. At the workshop, FDA representatives provided us with a barrage of valuable information and had attendees create mock labels according to the Drug Facts guidelines. Please believe me when I say that this wasn't an easy task.
You may have already prepared for the final deadline, as the final monograph was first published in March 1999. And you may have already redesigned product labels to include the Drug Facts panel. But you should visit FDA's very informative Web site at www.fda.gov/cder/ offices/otc/drugFacts.htm to also ensure that your labels meet the latest regulations, because FDA has been refining them.
With the final deadline a little more than a year away, label suppliers are seeing an upsurge of business from companies that need to comply with the FDA rule. Michelle Izzi, a sales representative for Ampersand Label Inc., was a fellow attendee at the ICMAD/FDA workshop. She commented briefly to me on how label suppliers, especially those that supply extended-text versions, are handling the business. "I'd say that in the last six months, we've seen a lot more people being more proactive about Drug Facts labeling," she says. "Our customers know that it's going to be a requirement and are dealing with it now so that it's not a burden later."
Marketing a product as a cosmeceutical has its drawbacks and benefits. The drawback, of course, is having to meet FDA's stringent regulations. The benefit is that a cosmeceutical brand can tell customers that its product's beautifying effect on the body is more than skin deep.
Jennifer Kwok
Managing Editor