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FDA: HealthWorksUSA ‘Perfect Health’ Claim Imperfect

Marketers of "wellness products" receive FDA warning letter over unauthorized health claims.

Ad Alert

FDA: HealthWorksUSA ‘Perfect Health’ Claim Imperfect

healthworks

Considering what’s posted on the company’s online profile page, you’d think HealthWorksUSA President Dale Jansen would have known better than to market his “wellness products” with unauthorized health claims.

“You won’t hear about stabilized aloe in the news or from your doctor because the FDA won’t allow natural products to make health claims,” reads a section of the company profile page with Jansen’s name and title at the bottom.

healthworksusa manual

Yet, that’s exactly what Jansen did, according to a recent warning letter from the FDA to the HealthWorksUSA president. The letter cites therapeutic claims that classify some of Jansen’s products containing stabilized aloe as drugs, a classification that is illegal without FDA approval.

The challenged claims include one on the cover of the corporate health manual HealthWorksUSA sells to companies (see right) that states, “Heal Yourself of Any Disease.” The unapproved claims also appear on product pages, including one for NutraGel that states, “NutraGel allows you to enjoy the sun longer without damaging your skin.”

The letter states that the claims are made online at www.healthworksusa.net but that site bounces to www.healthworksusa.com. Most of them remained on the site as of this writing.

The recipient of an FDA warning letter generally has 15 days to correct the violations. The HealthWorksUSA missive was shipped out Nov. 24.

For more of our coverage on so-called “wellness products,” click here.


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