P&G, McNeil Should Tone Down Phenylephrine Cough-Cold Claims – NAD

The National Advertising Division has advised Procter & Gamble and McNeil Consumer Healthcare that they should not be misleading when they emphasize distinct differences between competing products in their advertising claims.

In separate decisions it released in July, the Council of Better Business Bureaus unit ruled on P&G's complaint against McNeil's' advertising claims for Tylenol Cold Multi-Symptom Nighttime and on McNeil's complaint against P&G's NyQuil Multi-Symptom Cold/Flu Relief ad claims.

NAD found McNeil provided a "reasonable basis" for claiming Tylenol treats more cold symptoms than NyQuil Multi-Symptom.

However, NAD recommended July 9 McNeil modify its claims that its product "helps relieve more of your worst cold symptoms."

"The fact that Tylenol contains a decongestant and NyQuil does not, does not mean that Tylenol will be more effective at treating other cold symptoms," NAD said.

NAD recommended July 13 P&G use the phrase "six to eight" hours or "up to eight" hours in its NyQuil Multi-Symptomads instead of eight hours of cough relief.

P&G said it will take recommendations into account in future ads. McNeil disagreed with ad modifications, but said it will make changes in future ads.

The complaints came after the firms launched versions of their products reformulated with phenylephrine after federal and state restrictions were implemented on retail sales of OTC pseudoephedrine-containing products (¹ , p. 5).

In challenging Tylenol Nighttime claims, P&G said the ads falsely state the product is superior to NyQuil in relieving consumers' worst cold symptoms and helping them sleep.

The Cincinnati-based firm contested claims made in the ad suggesting consumers who use the reformulated NyQuil Multi-Symptomwill get less relief for congestion than they had with the previous formulation and that the new version contains no decongestant ingredient.

The firm said Tylenol Nighttime contains less cough suppressant - the only ingredient for which the FDA expressly allows sleep or rest claims - per dose than NyQuil Multi-Symptom.

Further, P&G said in the Tylenol Nighttime ads McNeil incorrectly interpreted FDA's monograph for OTC nasal decongestant products. The firm said the monograph allows a claim that Tylenol treats congestion, but not a claim that people who use NyQuil Multi-Symptom will remain congested, as the television commercial message states.

McNeil asserted its Tylenol Nighttime claims are "straight-forward" and reflect an accurate ingredient comparison because its product contains a decongestant while the P&G product does not. The Ft. Washington, Pa.-based wholly owned subsidiary of Johnson & Johnson said this distinction establishes a legitimate ingredient advantage over NyQuil Multi-Symptom.

In its complaint, McNeil said P&G overstated the benefits of its product by implying dosing would provide eight hours of relief from all cold symptoms.

FDA regulations, according to McNeil, state 30 mg of dextromethorphan is indicated for six to eight hours of relief, not eight hours.

McNeil argued the eight-hour sleep claim for NyQuil Multi-Symptomis false and misleading because the product does not relieve any other cold symptoms for eight hours.

McNeil also pointed out NAD has consistently held that drug firms are not allowed to overstate the benefits or efficacy of a product in its advertising claims.

In response to the McNeil challenge, P&G said duration claims in its ads are substantiated and its product contains enough cough suppressant to relieve cough symptoms for up to eight hours.

"The dose parameters for each are codified in a regulation of the FDA which requires labeling claims of six to eight hours for the dose of cough suppressant in NyQuil" Multi-Symptom, P&G said.

The firm said the same FDA regulation explicitly authorizes sleep-aid claims for OTC drugs that contain cough suppressants.

- Robert W. Mitchell ([email protected])