Medical Device Link.

Originally Published PMPN March 2004

NEWS

ICMAD and FDA Give a Crash Course in Drug Facts Labeling

Over-the-counter (OTC) drug labeling regulations and how they apply to the cosmetic and personal care industry was the main focus at the ICMAD/FDA 24th annual Cosmetic Workshop. Hosted by FDA and the Independent Cosmetic Manufacturers and Distributors (ICMAD; Palatine, IL) association, the seminar took place February 12 at the DoubleTree Guest Suites in Santa Monica, CA. The workshop also covered other hot topics such as international regulatory developments.

The Drug Facts Labeling segment was timely as the deadline for FDA’s final monograph for OTC drug labeling approaches. By May 16, 2005, all OTC drug labels must include FDA’s standardized Drug Facts panel. While this rule focuses on drug products, FDA also considers cosmetic products that make claims to physiologically alter the body’s structure to be OTC drugs. Thus, the packaging for such cosmetics products must include the Drug Facts panel.

Often, whether a product is categorized as an OTC drug depends on the claims that the brand makes about it. FDA defines an OTC drug as a product that physiologically affects the body’s structure. By contrast, cosmetics are defined as products that clean, beautify, promote the attractiveness of, or alter the appearance of the body. If, for instance, a company states that a facial product “removes fine lines,” it would be considered an OTC drug. Conversely, if it were described as “diminishing the appearance of fine lines,” it could be classified as a cosmetic. Marketers should be aware that FDA can check brands’ Web sites and marketing materials to ensure that claims are consistent with packaging.

FDA speaker Allen R. Halper from the Office of Cosmetics and Colors Center for Food Safety and Applied Nutrition said that FDA recently issued its first warning to a company whose labels didn’t meet regulations.

FDA also announced that it has stayed the final monograph deadlines for some products. Robert Eshelman of the OTC Drugs Team at FDA’s Center for Drug Evaluation and Research said that those products include products for which annual sales are less than $25,000; packages that contain no more than two doses of an OTC drug; and packages that are so small that the Drug Facts panel would occupy more than 60% of the package’s total available surface area for labeling.

Halper gave a detailed presentation on what information the Drug Facts panels should contain. According to the final monograph, the panel must include a detailed list of active ingredients, a description of the product’s uses, warnings, directions, and a list of inactive ingredients. The panel must be visible to consumers on packaging at the point of retail. Warning statements must appear on both primary and secondary packaging. In addition, the panel’s format, font style, and type size must be standardized. For some ingredients, FDA specifies special warnings. For instance, it suggests a specific sunburn alert statement that should appear on packaging for products containing alpha hydroxy acids.

For marketers concerned with how the Drug Facts panel will interfere with their labels’ decoration, FDA has made some adjustments to its ruling. FDA announced that the Drug Facts panel doesn’t need to appear on a plain white background, as previously stated. Companies can choose whatever background color they want, as long as the color contrasts with the required black-ink text.

At the workshop, FDA’s representatives organized an exercise during which groups of attendees were charged with designing a mock Drug Facts label according to the monograph’s regulations. Based on the ingredients of the product assigned, each group had to decide whether to market its product as an OTC drug or a cosmetic product. 

For more information on FDA’s OTC drug labeling requirements, visit www.fda.gov/cder/offices/otc/drugFacts.htm.  

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