OTC Labeling Implementation Date Extended One Year

FDA is extending the OTC drug labeling implementation date to May 2002 to allow time for the agency to develop "forthcoming guidances" regarding a number of outstanding industry concerns.

In Feb. 4 letters, the agency tells CHPA and CTFA that "in recognition of the fact that there are several guidance documents that may prove helpful in the transition to the new format...the agency concludes that an extension of the May 2001 primary implementation date by one year to May 16, 2002...is justified."

In the letter to the Consumer Healthcare Products Association, FDA notes it "intends to outline in a forthcoming guidance several circumstances in which the agency is likely to provide additional time (i.e., a 'deferral')...in which to make such changes."

Although the agency estimates any necessary package size changes "would either be very limited...or could be accomplished by integrating commonly used techniques," it will consider "good faith" product-specific requests for deferrals.

For example, "if a firm requires additional time to complete stability testing on a new immediate container, where it is shown that the existing container could not comply with the new format, the agency would consider a time-limited deferral."

The guidance will discuss how the deferral process would work for manufacturers "who wish to use an extended text mechanism that may require new machinery or new studies, such as a peel-back panel, to meet the requirements of the rule," FDA adds.

Industry concerns regarding the new labeling format on single-use and convenience products also will be addressed by the forthcoming document. A further extension of time based solely on those issues - a request made by CHPA - is not necessary, FDA says.

Another guidance will discuss the requirement that trade secrets and confidential commercial information be submitted and made public at the time of an exemption request. Admitting the rule "does not provide a mechanism for protecting such information from disclosure," the agency says it plans to remedy the problem.

FDA already has addressed several issues brought forth by the trade groups regarding their inability to comply with the reg. In January, the agency issued a technical amendment to the final rule to allow light text on a dark background as long as contrast is apparent (¹ (Also see "OTC Labeling Trade Dress Issues Resolved In FDA Technical Amendment" - Pink Sheet, 10 Jan, 2000.)). The Cosmetic, Toiletry & Fragrance Association had requested trade dress consideration at a number of "feedback" meetings.

Column use also has been reconsidered by the agency. In November, a draft guidance on the use of column format for the "Drug Facts" box on OTC labels was posted on the FDA Web site, www.fda.gov (² (Also see "OTC Labeling Column Format Allowed Under FDA Guidance" - Pink Sheet, 29 Nov, 1999.)). CHPA and CTFA responded to the guidance with comments Jan. 31.

FDA's letter to CHPA also outlines its final decision on the ongoing type size discussion. The agency "does not agree that additional time is needed to consider type size issues," the letter says.

CHPA has argued that 4.5-point type is an appropriate minimum standard for OTC drug labeling, citing studies supporting the readability of type sizes smaller than the 6-point limit set in the final rule.

FDA denied two type size exemption requests in August (³ (Also see "OTC Labeling Exemption Requests For Ophthalmics Denied By FDA" - Pink Sheet, 13 Sep, 1999.)). CHPA asked the agency at a Nov. 23 "feedback" meeting whether small packages could earn a type size exemption and pointed to type size parity among FDA-regulated product labeling. Dietary supplements, for example, are allowed to use a 4.5-point type size.

"The agency considered the labeling specifications for other product categories in developing the final OTC labeling rule," but concludes "the unique demands of OTC drug labeling along with the strong trend in the OTC drug industry" support a 6-point type standard, the letter states.

"A type size larger than that allowed in limited circumstances for other categories of products such as dietary supplements was justified and reasonable," the agency maintains.

FDA also addresses the outstanding issues of trade dress, categorical exemptions for small packages and cosmetic-drug labeling in the letter to CTFA (⁴ (Also see "OTC "Drug Facts" Column Size Flexibility Sought By Industry" - Pink Sheet, 14 Feb, 2000.)).