Crystal Flush

Crystal Flush’s two-step system – consisting of an antifungal formula (a topical serum) and a “Balance” dietary supplement – is marketed to eliminate toe nail fungus in as little as 21 days. It’s a bold claim given that the antifungal formula is “not effective on the scalp or nails,” according to the product label.

Is bold the right word?

After receiving a tip from a consumer regarding the disclaimer, which seems at odds with how reasonable consumers would likely expect the product to perform based on the marketing, TINA.org found that he is not the only one to notice it.

In a July 2023 Amazon review, a consumer wrote:

Why on the bottle does it say not effective on the scalp or nails? I bought it to get rid of toe nail fungus.

The company did not respond to the Amazon review.

Deceptive FDA marketing

The antifungal formula is also marketed as containing an “FDA-approved” antifungal agent, Tolnaftate 1%. The reality, however, is that the FDA classified this antifungal ingredient as something called a Category 1 GRASE (Generally Recognized As Safe and Effective) drug, and – here’s the important part – only for athlete’s foot, jock itch and ringworm. In fact, the FDA requires that the labeling for products containing Tolnaftate 1% state, “This product is not effective on the scalp or nails.” Hence the company’s disclaimer noted above.

In other words, the FDA has not approved Tolnaftate 1%, never mind Crystal Flush, to treat toe nail fungus.

But Crystal Flush doesn’t stop at FDA-approved claims. It also displays the FDA’s logo in its TV ads, on its website and on bottles of its Balance supplement, in violation of the FDA’s name and logo policy.

“The ‘FDA’ name .. and corresponding logos are trademarks and service marks specifically for the official use of the U.S. Food and Drug Administration and not for use by the private sector or on private sector materials, unless specifically authorized, in writing, by the FDA,” the agency states in its policy, adding:

Unauthorized use of [the FDA’s name or logo] on private sector materials could send a message to the public that the FDA favors or endorses a private sector organization or the organization’s activities, products, services, and/or personnel (either overtly or tacitly), which the FDA does not and cannot do. Unauthorized use of the [FDA’s name or logo] may violate federal law and subject those responsible to civil and/or criminal liability.

Return policy confusion

But wait, there’s more.

While the website advertises a “180-day fungus-free guarantee” in which consumers can “return empty bottles for a full and courteous refund,” there are conflicting terms about how long consumers have to try the product and return it for a refund. The website’s terms and conditions are consistent with the marketing and say consumers have 180 days but the return policy linked at the bottom of the website says consumers only have 60 days to make a return. It’s unclear whether customers are on the hook for the cost of return shipping.

TINA.org reached out to Crystal Flush for comment. Check back for updates.

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