Block Drug OTC Small Packaging Denial Mishandled By FDA, CHPA Says

FDA mishandled its decision to deny Block Drug a small packaging exemption by assuming off-label information could not be easily read and interpreted by consumers, the Consumer Healthcare Product Association maintains in Oct. 3 comments to the agency.

FDA appeared to assume that shelf containers could not be considered outer packaging since the in-store displays are often not placed within a reasonable distance to read labeling, the trade group says. If the shelf displays are not visible, CHPA adds, the retailers, not product manufacturers, are guilty of misbranding.

Block filed for exemption of BC analgesic powder in August 1999; FDA initially had held off on announcing its decision until confidential information was either removed or opened to the public record. Block waived its right to confidentiality to speed up the review process (¹ (Also see "OTC labeling" - HBW Insight, 11 Sep, 2000.)).

One of several options Block made in its proposal for BC powder involved using a fold-out flap listing required labeling information unable to fit in the current format. Since the fold-out flap could not be read until the outer wrapping is removed, the same information also would appear on a shelf display.

Tear-off leaflets or packaging inserts also should be considered by FDA as acceptable labeling alternatives for convenience-size OTC drug products, CHPA says. The group requested to meet with FDA to discuss the issue, but a meeting date has not yet been set.

The Block case was used as an example by CHPA to reiterate industry's argument that FDA should be more flexible when considering exemptions to the OTC drug labeling rule. To date, Zee Medical is the only company FDA has granted a deferral (² ).

With regards to exemptions from the OTC labeling rule, FDA "has ample authority to provide the requested relief for convenience-size OTC drug products" under the FD&C Act as long as "certain standards are met," CHPA contends. The Cosmetic, Toiletry and Fragrance Association has made a similar case for cosmetics and cosmetic-drugs.

As long as labeling "on the carton or other outer container" includes the "proprietary name and established name (if any) of the drug, the lot or control number, and the name of the manufacturer, packer or distributor," the remaining information may appear in supplemental form for small packages, CHPA maintains.

The trade group notes examples of small packages that have been exempt from standard labeling requirements include analgesics or lozenges sold in tins, and typically accompanied by package inserts. The Sucrets line of throat lozenges, now marketed by Heritage, was long sold in such a container.

Placing labeling information on the exterior retail package "is not an inflexible requirement," CHPA continues, adding "leaflets with a package are permitted under the small package regulations, and there is no question their use is permissible for convenience sizes."

Numerous "Draft Proposed Convenience-Size Exemption[s]" for products "typically marketed" in small sizes are also contained in CHPA's letter. Products addressed include antacid liquids/solids, analgesic liquids/solids, laxative liquids/solids and topical products such as antifungals and external analgesics.

Among the suggested exemptions common to the options listed for each of the 19 OTC product categories are requests that labeling be allowed to omit the full listings of indications, warnings, directions for use and inactive ingredients.

For instance, CHPA proposes that for antacids, "Warnings visible at the point of purchase may be limited to specialty warnings and those under the 'Do not use' heading, provided that a prominent and conspicuous instruction" to see an insert or attached leaflet appears, and "all required warnings are available when the package is opened."

CHPA suggests most important sections can be briefly dealt with in this manner, while a "See inside for full Drug Facts" statement or similar direction would point consumers to an insert or shelf display where leaflets with the full "Drug Facts" information is available.

The trade association also requests exemptions from format requirements such as barlines, font sizes and other visual standards, noting "horizontal barlines and hairlines...may be omitted," the "Drug Facts" heading and others may be smaller or omitted and a "paragraph format may be used" to disseminate information.

The category-specific suggestions appear to respond to FDA's decision to address small package exemptions through the monograph process instead of through an overarching exemption (³ (Also see "OTC Small Package Exemptions To Be Handled Via Monograph Process - FDA" - HBW Insight, 14 Feb, 2000.)).