NAD Recommends That Health Claims for Theraworx Relief for Muscle and Joint Products Be Discontinued

Manatt, Phelps & Phillips, LLP

Manatt, Phelps & Phillips, LLP

The National Advertising Division (NAD) determined that Avadim Health, Inc., did not provide adequate substantiation for health claims for its Theraworx Relief for Muscle Cramps and Spasm Foam (Theraworx MCS) and Theraworx Relief for Joint Discomfort & Inflammation Foam (Theraworx JDI), which promise consumers that the products relieve and prevent muscle cramps and spasms, including those associated with nocturnal cramps and restless leg syndrome, and relieve joint pain from arthritis as well as moderate to severe joint inflammation.

The claims were challenged by Chattem, Inc., maker of Icy Hot and Aspercreme.

Both of Avadim’s products are homeopathic external muscle and joint relief products. Theraworx MCS has the active ingredient magnesium sulfate, and Theraworx JDI has the active ingredient olibanum. Both come with a compression garment. The NAD stated that there are no Food and Drug Administration (FDA)-approved over-the-counter (OTC) indications for the active ingredients in the products and that these ingredients have not been reviewed or found to be generally recognized as safe by the FDA to diagnose, treat, cure, prevent or mitigate any disease conditions.

The NAD observed that in order to support its claims, Avadim should demonstrate with competent and reliable scientific evidence that its Theraworx MCS product, when used as directed, not only relieves muscle cramps and spasms, including those associated with nocturnal cramps and restless leg syndrome, but also prevents muscle cramps and spasms, and that its Theraworx JDI relieves moderate to severe joint inflammation and pain due to arthritis and overused joints, after controlling for other confounding factors like a placebo effect.

The NAD carefully reviewed the studies submitted by Avadim in support of its health claims for both of its products and determined that the evidence was not a good fit for the claims. Therefore, the NAD concluded that the advertiser did not provide a reasonable basis for the claims and recommended that they be discontinued.

The NAD also recommended that Avadim discontinue its claim that “healthcare professionals recommend” Theraworx products, since Avadim presented no survey evidence of healthcare professionals to show that a substantial portion recommend its products. The NAD further recommended that Avadim discontinue the challenged endorsements by healthcare professionals (such as “Theraworx Relief is better than any product out there for leg cramps or spasms or even muscle soreness”), since there was inadequate support for these claims.

In addition, the NAD recommended that the advertiser avoid making any comparative superiority claims reasonably conveying the message that the products are more effective than other external analgesic OTC products, including the challenger’s Icy Hot and Aspercreme, or prescription medications.

In its advertiser’s statement, Avadim stated that it will appeal the entirety of the NAD’s decision to the National Advertising Review Board (NARB).

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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