Genomma Lab USA Inc. is straight on the OTC monograph for antifungal products, but the firm is straightening out its process for making sure ads for its Silka athlete's foot treatment comply with the regulation.

In response to a National Advertising Division inquiry on efficacy claims challenged by Bayer Healthcare LLC, the US subsidiary of Mexican firm Genomma Lab Internacional SAB de CVsaid some claims had been discontinued "but continued to air due to a miscommunication in its marketing department in Mexico City."

Genomma said it changed its internal process for approving and posting Spanish-language TV commercials for airing in the US "to prevent further broadcast of the discontinued claims," according to NAD's May 12 report on the review.

However, attorneys for the Advertising Self-Regulation Council's investigative unit said they examined Genomma’s current advertising to determine whether any challenged claims were broadcast.

The attorneys said while the current claim – “one week topical treatment” between the toes with Silka – when combined with the visual images of the treated area healing by day seven was supported, they recommended modifying the ad to remove the language “compared with other OTC products to treat athlete’s foot” and avoid implying that Silka is faster than competing products.

Bayer Markets Canesten In Spanish-Language Markets

Bayer Healthcare markets the Canesten OTC antifungal line including an athlete's foot treatment – creams or powders containing either bifonazole or clotrimazole – in markets including South and Central America but not in the US. It objected to claims including “Silka is 400% faster than other products in alleviating the itching, burning, dryness of athlete’s foot between the toes,” "fastest to cure athlete’s foot or treat athlete’s foot symptom" and "consumers will have not itchiness or burning after seven days" of use.

The Bayer AG business argued Genomma’s TV advertisements for Silka expressly claim a consumer can expect complete relief of itchiness and burning associated with athlete’s foot after seven days and imply, through a visual depiction of clear skin between the toes on day four, "that relief can occur in as few as four days."

The Houston-based firm contended the ads misleadingly and without support convey that Silka is superior to and relieves athlete’s foot faster than competing products. The latest Silka commercial, Bayer said, conveyed a misleading message that the product relieves athlete’s foot after seven days of treatment and is faster than its competitors.

Bayer also noted the FDA antifungal drug OTC monograph prohibits label claims regarding the speed of symptomatic relief and onset of fungicidal activity to ensure claims will not "create the false impression of instant results and discourage consumers from following label instructions for the entire duration of treatment," according to the NAD report.

The firm maintained Genomma’s commercials contravene the monograph guidance on advertising athlete’s foot treatment products and discourage consumers from following the directed course of treatment.

NAD attorneys pointed out the organization "has echoed these concerns when it has reviewed advertising claims that may mislead consumers in a way that could negatively impact their health."

Additionally, Bayer noted in a previous review of claims for another athlete's food brand, Lamasil, containing the same active ingredient as Silka, terbinafine, NAD determined that "all athlete’s foot treatment products take four weeks to effectuate a mycological (absence of fungus) or complete cure of athlete’s foot resulting in the elimination of all symptoms and fungus."

NAD attorneys explained, however, that the prior case concluded it is not misleading for a product which requires one week of treatment to claim to “cure” athlete’s foot within one week, "as a consumer is likely to view the elimination of the major signs and symptoms as well as the end of treatment as a 'cure,' although the fungus might not be 'cured' mycologically until four weeks after treatment began.

They said the voiceover in Silka's ad stating, “one week topical treatment” between the toes combined with the visual images of the athlete’s foot between the toes being healed by day seven, was supported.

Silka Marketer Scratches Monograph Claim Itch In NAD Review

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