Storm clouds gathering above OTC brands

Drug Store News, April 3, 1995 by Mike Troy

Retailers may soon find themselves caught in a struggle between OTC product manufacturers and the Food and Drug Administration (FDA) as the two sides attempt to reach a middle ground on revised labels.

The FDA wants labels that are "consumer friendly," with wording that is easier to understand and comprehend - a reasonable goal considering the technical nature of labeling language and the nation's increasing illiteracy rate.

Many ideas on the table right now would improve labels. Using words that are easier to understand, changing the order of information and enlarging the type size would go a long way toward accomplishing the FDA's objective. Among the beneficiaries: the huge numbers of consumers with limited English skills.

Communication, not regulation

OTC manufacturers support efforts to improve communication (via labels) with consumers, but they are drawing the line at attempts to alter a product's principal display panel (PDP). At stake is whether a product's active ingredient(s) should be listed on the PDP. One proposal would require the active ingredient(s) to be a type size at least half that of the brand name.

Listing common cough/cold product ingredients such as phenylpropanolamine hydrochloride and dextromethorphan hydrobromide or antidiarrheals such as loperamide hydrochloride or bismuth subsalicylate in large type on the front of a package won't make a label "user friendly" or more readable. It will make OTC planograms more confusing. People use Imodium AD because it works - not because they are knowledgeable about loperamide hydrochloride.

The FDA's intention is not to blur the distinction between branded and private label items, but that would be the upshot. OTC brands are already somewhat disadvantaged against PL competitors because manufacturers essentially provide the product's recipe on the label. Listing active ingredients on the front label would further disadvantage brands.

Under the FDA proposal, the consumer's ability to identify brands of choice from among the product options on retail shelves would be reduced, according to Bob Donovan, a senior vice president at Sandoz and chairman of the Nonprescription Drug Manufacturers Association. "Distinguishing one product from another is vital to effective marketing and to competition in the marketplace," he said. "Manufacturers need the flexibility to use at least this one panel for marketing purposes without unnecessary regulatory interference."

Consumers seeking relief from their minor ailments in the drug store's OTC department aren't pharmacists. Labels can certainly be improved, but consumers and retailers would be ill-served by plastering in large type the names of active ingredients on the front of OTC packages.