OTC Label Final Rule Exemptions By Product Class Urged By CTFA

FDA should issue OTC labeling rule exemptions by class rather than by product from requirements in the final reg, Cosmetic, Toiletry & Fragrance Association VP-Legal and General Counsel Thomas Donegan requested during an OTC "feedback" meeting with FDA. The meeting was held in Rockville, Md. April 23.

The association exec asserted that both the agency and manufacturers could save "an enormous amount of resources" if FDA were to allow "broader exemptions as opposed to requiring individual requests for each SKU."

CTFA and the Consumer Healthcare Products Association requested the meeting to address questions about and concerns with FDA's March 17 final OTC labeling rule ("The Rose Sheet" March 15, pp. 18-22). CTFA had asked for a complete exemption of cosmetic-drugs, arguing such products do not have dosage limitations and thus do not have safety concerns. FDA denied the request.

A preliminary survey of CTFA member companies' abilities to comply with the labeling revisions suggests "30% to 60%" of cosmetic-drug SKUs "cannot comply with the rule as written," Donegan maintained, calling the percentage "unacceptably high." For a larger member company, the percentage would amount to "some 400 to 800 SKUs," he added. CTFA fears the percentage will be the norm for all cosmetic-drug companies.

Considering competition among companies and the short time period in which a firm launches a product, Donegan asked FDA what arrangements the agency has made "or is planning to make to be able to accommodate a response to" an exemption request.

"I don't think it's appropriate for the agency" to prevent companies from being able to compete in the market or to develop new packaging, Donegan maintained. If an exemption is required, "there needs to be a procedure where [companies] can get fast answers."

Confidentiality of exemption requests also is a concern, Donegan said. If a company "is executing a new marketing plan, they can't put that out there on the public record for all their competitors to see and still have the competitive advantage that they are seeking."

Regarding exemptions, the rule states: "FDA, on its own initiative, or in response to a written request from any manufacturer, packer or distributor, may exempt or defer, based on the particular circumstances presented, one or more specific requirements set forth...on the basis that the requirement is inapplicable, impracticable, or would be contrary to public health or safety."

CHPA Senior VP and Director of Science & Technology William Soller, PhD, noted that "preliminary estimates" suggest 20% to 40% of member companies' products may not meet the requirements of the labeling rule. "This is too large a percentage to have for a rule," he maintained.

The mock-up labels provided in the final rule "appear to be unrealistic," Soller said, noting CHPA has been "test driving" the FDA examples and has found the agency's calculation of available "real estate" on a label to be an overestimate (see related story, p. 9).

Using FDA's estimate that 92% of the SKUs in the OTC universe will be able to fit the new requirements on labels, Soller noted that left "about 8% or so that will not fit." According to that percentage, 8,000 OTCs would have to be exempted from the final rule.

Therefore, Soller continued, "if you were to receive about 8,000 letters for exemption," it would take about 57 weeks to process those filings. "Even if it's not routinely granted, you still need to review these expeditiously to get back to companies and act on them...I think some discussion is worthwhile on this particular point."

FDA Division of OTC Drugs' Cazemiro Martin suggested a manufacturer wishing to request an exemption should include "several draft labeling examples" that the agency could accept as an alternative to the requirement. "Show us what you are thinking, show us what your...people have done to try to resolve the issues of whether or not your labels can fit," he urged. "If there are disagreements, we certainly have in the agency a variety of processes that will address the appealing of various decisions."

Office of Drug Evaluation V Director Robert DeLap, MD/PhD, concluded, however, "I'm not a big fan of having large numbers of exemptions. I think if the principle is that there needs to be information provided to consumers to make good choices of products, then...we need to find ways to minimize the times when we don't give that information to consumers."