Buyers beware when it comes to toenail treatments for onychomycosis (otherwise known as toenail fungus). Over the years, there have been many misleading statements made by advertisers of toenail fungus treatments promising “miracle cures,” all the while peddling snake oil. We recently penned an article on how the FDA is cracking down on illegal claims made by diabetic foot care products. Yet, we’re finding the same is true of toenail fungus foot care products as well.
Fungi-Nail received a stern warning from the FDA for making misleading statements regarding the effectiveness of their product.
Image Source: Target.com
FDA Warns The Makers Of Fungi Nail Toenail Fungus Treatments
A 2005 letter from the FDA to Kramer Labs warned that their marketing materials contained several misleading statements that were in violation of the law. On their website, they claim that “Fungi Nail Brand is the strongest topical anti-fungal medication available without a prescription.” They also include information about athlete’s foot, jock itch, and ringworm that “thrive on the hair, finger and toenails.”
These statements imply that the product is intended to treat fungal nail infections, the FDA argues — despite a small disclaimer that states the product is “not effective on the scalp or nails.” While the product has received approval to treat ringworm, athlete’s foot, and jock itch, it has not been cleared to treat nail fungus (as the product cannot penetrate the nail) or scalp fungus.
“We sent you a Warning Letter on March 4, 1996, regarding the Fungi-Nail product,” the FDA added. “Since that time, you have added additional promotional material and labeling claims that further cause your products to violate the Act. You must take prompt action to correct the violations identified in this letter. Failure to do so may result in enforcement action without further notice.”
Lamisil’s “Digger” character sought to make toenail fungus a topic discussed in more doctors’ offices across America, but it also led consumers to believe oral antifungals came without risk.
Image Source: TotalPict.com
FDA Cracks Down On Lamisil, Too
In December 2003, the FDA let Novartis know that their advertising for Lamisil toenail fungus treatment was not direct enough about the risks associated with their product. They admitted they had trouble keeping up with and enforcing prescription drug ads in what had become a $117 billion industry, but promised to “become more vigilant in its enforcement responsibility.”
By law, television ads have to spell out the interactions and side effects of all drugs. Novartis was asked to pull the ads for Lamisil that included the famous character “Digger” because the ads were “false or misleading” by overstating the drug’s efficiency, minimizing risk information, and making “unsubstantiated superiority claims.” The company pledged to find ways to make their ads comply with the law.
Zeta Clear makes some fanciful claims about the effectiveness of their topical toenail fungus remedy.
Image Source: Zetaclear-Review.net
If It Sounds Too Good To Be True… It Probably Is!
The Winona Daily News cautions consumers to avoid “spending an arm and a leg on a toe with only a modest hope of success.” They mention brands like Zetaclear, for instance, which claims that toenail fungi “live beneath your nails” — which isn’t really true. Fungus infects the cells of the nail plate, the paper clarifies.
Furthermore, the ads state, “If you want to kill the fungus and get clear nails again, using powerful anti-fungal ingredients like natural undecylenic acid and tea tree oil as found in Zeta Clear nail solution are critical.” Winona Daily News makes the case that fancy language like “powerful,” “cure,” and “all natural” sway consumer emotions, without really providing backup evidence to these loose and fast claims.
Do Try To Be Patient, But Don’t Believe The Hype!
It’s important to keep in mind that neither topical, nor oral, treatments can “cure” nail fungus. Oral pills stand a slightly better chance at working since they attack living fungal tissues in the body, rather than trying to penetrate into dead nail cells. But at best, clearance rates are as high as 70%, with a very real possibility of relapsing. Tiny spores can easily live in old dirty footwear, on nail clippers and in socks. No matter which treatment you try over the next year, the use of SteriShoe UV shoe sanitizer can eradicate up to 99.9% of the microbes living in your footwear to decrease the likelihood of a toenail fungus relapse. We don’t make any fanciful claims we can’t prove with lab data!
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