Competitors, FTC, EPA Take Aim at Antimicrobial Ads

Date: Feb 01, 2000

As if all the confusion about the overlapping jurisdiction between the Federal Food and Drug Administration (FDA) and the Enviromental Protection Agency (EPA) is not enough, the growth in the number of antimicrobials products also is leading to an increase in germ-killing claims about those products.

Predictably, the result is an increase in regulatory and legal challenges about the validity of advertising claims. With interest in antimcrobial-treated packaging rising, it is important to remember some basic rules on advertising.

First, there are lawsuits by competitors to consider. While only EPA can enforce the requirements of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the US Court of Appeals in Denver, CO, recently found that a Lanham Act §43(a) false advertising action involving a registered pesticide was preempted only partially by FIFRA, and that a false statement of EPA approval is actionable under the Lanham Act.

In this case, a competitor of a manufacturer of an antimicrobial pesticide cleaner for hard surfaces in medical and dental facilities sued, alleging that the cleaning product falsely represented that the EPA had approved its product for certain uses.

Specifically, the complaint alleged that EPA had cleared the product for use for one day after mixing, but the manufacturer made claims that it's product was effective for seven days after mixing.

The court dismissed one count, asserting that the label violated EPA standards and saying it was simply an attempt to enforce FIFRA labeling requirements. It allowed, however, the Lanham Act claim. In this regard, the court concluded that this count (namely, that the label statements deceived consumers into believing that EPA had approved the manufacturer's one-week effectiveness claim) would not be preempted.

Similarly, the court held that a valid Lanham Act §43(a) false advertising claim was presented by the assertion that the manufacturer's representations that its product could be used for seven days after mixing was factually false. Both were, therefore, actionable under the Lanham Act.

Then there is the Federal Trade Commission (FTC) to consider. The FTC staff has concerns about the proliferation of antimicrobial-treated products and related claims. In September the FTC published a proposal consent order with Conopco Inc. and its division, Unilever Home & Personal Care USA; the order addressed antimicrobial claims that Vaseline® Brand Intensive Care® Lotion Antibacterial Hand Lotion "stops germs longer than washing alone," "keeps hands safe from germs for hours," and similar claims. The issue, as the FTC saw it, was simple. Although triclosan, the active ingredient in the product, can reduce the number of germs on a user's hands, the FTC said that the degree and duration of the germ protection in the hand lotion had not been scientifically established.

The FTC also said that triclosan had not been proven effective against many disease-causing germs, including cold and flu viruses. The proposed order required that Conopco possess and rely upon competent and reliable scientific evidence when making any express or implied germ-killing claims for this or any other antimicrobial product. It is worth noting that informal discussions with the FTC staff suggest that more actions are underway targeting manufacturers making claims about antimicrobial-treated products.

Last, but by no means least, there is EPA itself to consider. Any person who makes or sells a product that claims, states, or implies (by labeling or otherwise) that it is a pesticide product can be subject to EPA jurisdiction. EPA has the authority to investigate advertising claims that suggest that a product has a pesticidal effect, whether or not the product is registered.

Despite the preemptive provision of FIFRA, makers of antimicrobial-treated products, including manufacturers of antimicrobial-treated food packaging, must remain vigilant to be sure that the products and product ingredients meet not only EPA and FDA requirements, but that labels, advertising, and marketing for such products can be substantiated scientifically. FTC or competitor suits are possible for false claims, and EPA action is possible if advertising claims go beyond approved label claims.

Reproduced with the permission of Paper, Film & Foil CONVERTER magazine (312.726.2802). Copyright © 2000 by Intertec Publishing. All rights reserved.

For further information about this article, please contact Sheila A. Millar at 202.434.4143 or by e-mail at millar@khlaw.com.