Block Exemption Request Differentiates "Label" From "Labeling"

Block Drug's request for an exemption from the OTC labeling final rule complies with provisions of the FD&C Act that differentiate a product's "label" from "labeling," the company says in a Dec. 22 letter to FDA.

The agency denied Block's initial exemption request, submitted Jan. 28, in August, stating all "Drug Facts" information must be visible at the point of purchase; Block proposed including information for its BC analgesic powder on a fold-out flap contained under shrink wrap.

The agency also maintained including labeling information on a product tray could create potential problems since the tray may not be visible to consumers at point of purchase.

In response to FDA's opposition, Block asserts its proposed options provide a "viable and legal alternative to the mandates set forth" in the OTC labeling final rule.

The firm cites section 201(k) of the FD&C Act, which defines the term "label" as a "display of written, printed or graphic matter upon the immediate container of any article." Block then notes section 201(m) defines "labeling" as "all labels and other written, printed or graphic matter upon any article or any of its containers or wrappers, or accompanying such article."

According to the definitions, the firm claims the envelope containing its BC powder is the product label, while the product tray could be considered labeling.

As written in the FD&C Act, "the only specific information statutorily required to be placed on the label is the name and place of business of the manufacturer, packer, or distributor, the net quantity of contents, the established name of the drug, the active ingredients and the inactive ingredients," Block says.

While Block is willing to include this information on the product label, it states "whatever authority FDA does or does not have to require a company to provide the customer with the Drug Facts, the agency cannot require that information to appear on a product's label, as opposed to its labeling."

The Consumer Healthcare Products Association voiced a similar opinion in an October letter to FDA, claiming the agency had erred in denying Block's labeling exemption request (¹ (Also see "Block Drug OTC Small Packaging Denial Mishandled By FDA, CHPA Says" - HBW Insight, 6 Nov, 2000.)).

FDA should consider shelf displays, tear-off leaflets or package inserts as acceptable alternatives for convenience-size OTC drug products, the trade group maintained.

In Block's proposed solution, the product tray would provide all the information FDA has deemed relevant to the consumer at the point of purchase.

The fifth flap, exposed when the shrink-wrap is removed, would allow the consumer to read that same information when actually using the product and would appear in the format and type size required by the regulation.

Additionally, Block addresses FDA's concern that the product tray could be discarded by retailers, noting, "throwing away the tray would surely create an unsightly mess and it is highly unlikely any retailer would choose to do so." The firm says it is willing to place statements on the tray citing its importance.

In its original exemption request, Block also had asked FDA to consider exempting BC's packaging from certain formatting requirements to help it fit the necessary information on the outside of the package.

However, FDA denied the request and suggested Block place information unable to fit on the back of the package on the product's principal display panel. The agency further maintained Block could increase the packages' size.

In its Dec. 22 letter, Block claims denying its exemption request would violate its Fifth Amendment rights, since altering the product's trade dress by placing information on the PDP would "constitute an unlawful taking of private property pursuant to the Fifth Amendment to the Constitution."

In making this argument, Block defines the BC powder's trade dress as its entire PDP, consisting of both the oval BC trademark and the panel's overall composition and design, including size, shape, color, texture and graphics.

"Block has invested considerable resources in developing, establishing and maintaining its trademark and trade dress, the company says, noting it has used the logo for 40 years, the current trade dress for 25 years and current package size for 70-80 years.

As a result, "if FDA denies Block's application, FDA will be disregarding Block's property interest in its trademark and trade dress."