CellMark Biopharma, LLC & CEO Barred From Making Deceptive Claims About The Ability of CellAssure and Cognify to Mitigate Side Effects of Cancer Treatment
On January 11, 2018, the FTC issued a press release concerning the settlement of FTC charges against CellMark Biopharma and CellMark’s CEO, Derek E. Vest, for making false or unsupported claims regarding health products they marketed as effective treatments for cancer-related malnutrition and cancer treatment-related cognitive dysfunction, also known as “chemo fog.”
Deceptive Marketing of CellAssure & Cognify
According to the FTC’s press release:
According to the [FTC’s] complaint, CellMark and its CEO, Derek E. Vest, violated the FTC Act by deceptively advertising two products for cancer patients: CellAssure, to treat cancer-related malnutrition, and Cognify, to treat “chemo fog.” A one-month supply of CellAssure sold for $248 and a one-month supply of Cognify sold for $79.
The FTC alleges that the defendants advertised the two products with a range of deceptive and unsupported health benefits for cancer patients. For example, the defendants described CellAssure as a medical breakthrough solution that “specifically addresses the malnutrition suffered by over 80% of all cancer patients” and claimed that CellAssure treats cancer with its “anti-cancer and anti-tumor properties.”
The defendants described Cognify as “the world’s first product designed specifically to alleviate . . . chemo fog . . . .” They also disseminated a YouTube video featuring a breast cancer patient who claimed that after taking Cognify, she could “remember the names of places and people and things” and started “thinking more clearly.” However, according to the FTC complaint, the defendants did not possess scientific evidence that these products provided any of the claimed benefits.
The proposed final stipulated order settling the Commission’s charges prohibits the defendants from engaging in similar conduct in the future. It requires them to have competent and reliable scientific evidence to support health claims for any product, and bars them from misrepresenting the results of any study, test, or scientific research.
FTC Fights Against Deceptive Marketing of Unproven Cancer Treatments
The FTC’s blog posting related to the FTC’s settlement with CellMark Biopharma and its CEO (“FTC challenges claims that products could treat side effects of cancer treatment”) stated:
Two serious complications of cancer treatment are cachexia (the wasting syndrome some patients experience) and “chemo fog” (the chemotherapy-related cognitive dysfunction that patients often report). CellMark [Biopharma] claimed to have the answer to both problems.
Selling for $248 for a one-month supply, CellAssure was advertised to treat cachexia and cancer-related malnutrition. In addition, according to the FTC, the defendants conveyed to consumers that CellAssure would improve cancer patients’ ability to withstand the rigors of surgery, radiation, and chemotherapy. But that’s not all. The defendants also claimed that the product “exhibits anti-cancer/anti-tumor effects” and that CellAssure’s ingredients had been “clinically proven” to provide the advertised benefits.
Marketed to treat the memory loss and cognitive impairment sometimes reported during and after chemotherapy, a one-month supply of Cognify cost cancer patients $79. According to ads, Cognify would “protect brain cells/neuro-transmitters against toxins,” “improve cognitive functioning, memory, and processing,” and “stimulate the growth of new brain cells” in patients undergoing chemo. The company used a similar “don’t just take our word for it” tactic by claiming that Cognify’s ingredients were “clinically proven.”
But according to the FTC, the defendants didn’t have sound science to back up their promises. What’s more, the complaint charges that the company’s “clinically proven” claims were false. [Emphasis added]
The settlement in the case requires the defendants to have randomized, double-blind, placebo-controlled testing conducted by qualified researchers to support future cancer- or disease-related claims for dietary supplements, foods, or drugs. Other health claims will need “competent and reliable scientific evidence,” as that phrase is defined in the order. The settlement also prohibits misrepresentations about tests, studies, or research.
The terms of the settlement apply just to CellMark and CEO Derek Vest – who . . . is serving time in federal prison for criminal conduct related to the sale of other dietary supplements. But the case reminds marketers just how seriously the FTC takes claims directed to cancer patients and others battling serious medical conditions. [Emphasis added]