FDA Aims To Resolve OTC Labeling Issues At Three Upcoming Meetings

FDA will meet with over-the-counter drug and cosmetics trade associations as many as three more times to discuss outstanding concerns regarding the OTC labeling final rule.

The agency already has conducted two "feedback" meetings with the Consumer Healthcare Products Association and the Cosmetic, Toiletry & Fragrance Association to discuss the reg. The final rule was published in the March 17 Federal Register (¹ (Also see "P&G Billing Metamucil As Dual OTC/"Heart Healthy" Dietary Supplement" - Pink Sheet, 9 Nov, 1998.)).

A working group meeting scheduled for Aug. 24 with the two trade organizations as well as the D.C.-based law firm Covington & Burling will consider the issue of trade dress for product packaging.

At a June 29 feedback meeting with the agency, CTFA VP-Legal & General Counsel Thomas Donegan said the trade dress requirements, that type only be black or a dark color printed on white or a light color on the label, were too restrictive and would jeopardize product distinctiveness. He argued many companies rely on their trade dress to distinguish their products from competitors (² (Also see "OTC Label Multiple Columns Suggested For Elongated Packaging By CHPA" - Pink Sheet, 5 Jul, 1999.)).

Donegan suggested the agency follow the Federal Trade Commission's standard of "clear and conspicuous" labeling to determine whether a label is readable and consumer-friendly.

Other issues with the final rule that have been under discussion include omission of the space needed for a Uniform Product Code symbol from the type size requirements and the question of a special package exemption for small product packaging. The concerns may be taken up at the working group meeting tentatively scheduled for Sept. 17. Another meeting has been tentatively set for Nov. 1 to conclude any matters not yet discussed.

In an Aug. 9 letter to CHPA, CTFA and the Uniform Code Council, Division of OTC Drug Products Director Charles Ganley, MD, addresses a number of issues that were discussed at the June 29 feedback meeting.

In response to the CTFA request for small package exemptions, Ganley states the association's proposals "are no different than the comments discussed in the preamble of the final rule....The position of the agency is clearly stated in the preamble and has not changed."

"By granting a general exemption for small packages, the problems associated with the readability of current small OTC packages will persist," Ganley says. That would defeat the purpose of the final rule, he noted, which was to establish "a standardized format for the labeling of all OTC drug products so that the labeling will be easier to read and understand and will provide consistent information in like situations."

CTFA and the Uniform Code Council argued at the June 29 meeting the UPC symbol should not be included in the 60% labeling space requirement of the final rule. UCC Healthcare Director John Roberts maintained bar code graphics are fixed and cannot be rotated or resized. He noted the codes were often rejected when they were too small and recommended they be at least .8% times the standard size.

At the meeting, FDA seemed receptive to the UPC exclusion request. ODE V Director Debra Bowen, MD, said, "Obviously we don't regulate UPC codes, and we're not intending to do that." Both she and Ganley noted the agency was "sensitive to" the issue.

In the Aug. 9 letter, however, Ganley says "manufacturers are already altering the size of the UPC prior to implementation of the labeling final rule" according to the size and shape of the package. "Consequently, it is difficult to argue that the final rule will have a great impact on the size of the UPC because manufacturers already adjust the size based on the shape and size of the package."

"Therefore," Ganley concludes, "the agency finds no basis to give a general exemption to exclude the UPC area from the calculation of the total surface area available to bear labeling."

Using a column format on OTC labels has been of central interest to CHPA. At the most recent meeting, Senior VP and Director of Science & Technology William Soller, PhD, argued multiple columns for elongated packaging should be allowed. He maintained lines containing more than 39 characters are less readable; therefore, if a package has more than that, columns should be an option.

Ganley's letter does not offer an FDA perspective on the use of columns, saying only "the columns format issue is currently under discussion within the agency and will be discussed in a separate communication." CHPA hopes to resolve the matter by the September meeting.