OTC Labeling Column Format Allowed Under FDA Guidance

A two-column format for required information on OTC drug labels can be used by placing multiple "Drug Facts" boxes on each side of a product package, FDA states in a draft guidance posted on the agency's Web site the week of Nov. 22.

The guidance for industry, entitled "Labeling OTC Drug Products Using a Column Format," addresses one of the central issues raised by industry in response to FDA's final rule on the revised labeling requirements for over-the-counter drugs sold under an approved NDA or monograph.

"The final format for the 'Drug Facts' box generally favors a vertical, linear presentation, to enhance draft readability and facilitate product comparisons," the guidance says. "Except for the presentation of active ingredient and purpose information...and the use of a table to present complex dosing information...the final format does not allow required information to be separated into columns within a given 'Drug Facts' box."

"However," the draft continues, "the rule does allow for the use of an alternative column format that can help to maximize available labeling space and, in some instances, improve readability. Specifically, this guidance describes how more than one 'Drug Facts' box or enclosure can appear on each side of a package or container to allow for the use of columns."

The guidance provides industry with at least a partial victory on the columns topic. Leading industry's push on the issue, the Consumer Healthcare Products Association urged FDA in a May 6 letter to allow the use of columns "for and within" the "Drug Facts" box ("The Tan Sheet" May 17, p. 14). The trade group reiterated its position at a June 29 "feedback" meeting with the agency ("The Tan Sheet" July 5, p. 3).

In both instances, CHPA suggested multiple columns would be a "significant space saver" that in turn would allow more SKUs to meet the requirements under the final rule's standard format and modified format.

The trade group requested the ability to divide the entire "Drug Facts" box into multiple columns or use a column format for just the "Warnings" section. The agency's position on information within the "Drug Facts" box seems to rule out a multiple column approach for a specific section.

CHPA also favored the optional use of three columns for long rectangular boxes - a request FDA appears to agree with as the guidance provides scenarios for such products.

With regard to packages designed under the standard labeling format, the final rule "can accommodate the use of more than one 'Drug Facts' box on each side of a package container, or the use of side-by-side 'Drug Facts' boxes on a wrap-around label (e.g., the label of a bottle of cough syrup)," the draft guidance states.

"Such a presentation generally is consistent with the rule, provided it is done in a manner that allows for the clear and legible presentation of all required labeling information," FDA adds. "In cases of elongated packages (such as toothpaste and topical ointment packages), the column format may noticeably improve readability."

The guidance provides several recommendations, as well as an accompanying mock label, aimed at helping companies that are deciding whether to employ the column layout on a product label.

In cases where two or more "Drug Facts" boxes are used on one side of a package, the first box or column "should be left justified and should bear the title 'Drug Facts,'" the guidance says. Two columns positioned side-by-side may share a common vertical barline extending from the top to the bottom of the box.

"When multiple 'Drug Facts' boxes or columns appear on the same side of a container, the columns should be approximately the same size," the guidance continues. All columns following the initial "Drug Facts" box should bear the title "Drug Facts (continued)," and a visual icon, such as an arrow, should be positioned at the bottom of each column to mark continuation of the information to the next column.

Under the final rule, "Active Ingredient" information is intended to be left justified, while the "Purpose" information is right justified. The rule requires this information "be presented in a manner that readily associates each active ingredient with its purpose," FDA notes.

"Accordingly, when multiple 'Drug Facts' boxes or columns are used, it is important that the columns be wide enough to allow the active ingredient and purpose information to appear on the same horizontal line," the agency points out.

Finally, the draft reminds companies considering the use of columns in the standard labeling format that the "continuation of the required labeling onto multiple 'Drug Facts' boxes or columns must be done in a manner that retains the order and flow of headings, subheadings and information, as required" by the OTC labeling final rule.

Small packages that cannot meet the requirements of the standard labeling format - defined as those in which 60% of available labeling is needed to include FDA required information - may use a modified labeling format outlined in the final rule.

Products using the modified format are allowed to omit the box "or similar enclosure" outlining the "Drug Facts" box if the "Drug Facts" information is distinguished from the rest of the labeling by color contrast.

"In such a case," the guidance states, "if more than one 'Drug Facts' box or column is used on the same side of a package, or side-by-side on a wrap-around label, the columns should be separated by adequate vertical common space of a contrasting color." The guidance illustrates its points through an accompanying example of a modified labeling format.

Barlines and hairlines should begin and end where the text begins and ends and should not extend into the common space between the columns, the agency notes.

The columns draft guidance is the first public, written direction on the revised OTC labeling standards since the final rule was published in the March 15 Federal Register ("The Tan Sheet" March 15, pp. 3-10).

Numerous issues have been discussed between FDA and industry since the reg's release, both in written correspondence and through a series of working group meetings on specific topics.

At the most recent session, which covered the process for exemptions to the labeling rule and related confidentiality matters, Division of OTC Drugs Director Charles Ganley, MD, announced the timely release of the guidance, noting additional guidances on certain issues of industry concern will follow (see story, p. 5).