Richard B. Newman
Member
CellMark Biopharma, LLC and its CEO have agreed to settle Federal Trade Commission charges that they made false or unsupported claims regarding two health products they marketed as effective treatments for cancer patients’ malnutrition and “chemo fog,” or treatment-related cognitive dysfunction.
According to the FTC’s complaint, CellMark and its CEO violated the FTC Act by deceptively advertising two products for cancer patients. The first, CellAssure, to treat cancer-related malnutrition. The second, Cognify, to treat “chemo fog.”
A one-month supply of CellAssure sold for $248. 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 allegedly 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 allegedly described Cognify as “the world’s first product designed specifically to alleviate . . . chemo fog . . . .”
They also allegedly 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 complaint charges that the company’s “clinically proven” claims were false.
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 its CEO – who is serving time in federal prison for criminal conduct related to the sale of other dietary supplements.
The settlement was announced less than a year after the FDA sent CellMark an advisory letter notifying the company that it must remove claims from its website and other materials indicating that CellAssure could treat or prevent cancer. The FDA stated that the company would need to submit a new drug application for approval in order to make those claims.
Takeaway: The FTC takes claims directed to cancer patients and others battling serious medical conditions quite seriously. Marketers must possess competent and reliable scientific evidence to support health claims and may not misrepresent the results of any study, test or scientific research.
Contact the author if you are interested in learning more about this topic, including the implementation of preventative telemarketing compliance protocols. You can also follow the author in LinkedIn at FTC Defense Lawyer.
ADVERTISING MATERIAL. These materials are provided for informational purposes only and are not to be considered legal advice, nor do they create a lawyer-client relationship. No person should act or rely on any information in this article without seeking the advice of an attorney. Information on previous case results does not guarantee a similar future result. Hinch Newman LLP | 40 Wall St., 35thFloor, New York, NY 10005 | (212) 756-8777.
According to the FTC’s complaint, CellMark and its CEO violated the FTC Act by deceptively advertising two products for cancer patients. The first, CellAssure, to treat cancer-related malnutrition. The second, Cognify, to treat “chemo fog.”
A one-month supply of CellAssure sold for $248. 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 allegedly 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 allegedly described Cognify as “the world’s first product designed specifically to alleviate . . . chemo fog . . . .”
They also allegedly 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 complaint charges that the company’s “clinically proven” claims were false.
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 its CEO – who is serving time in federal prison for criminal conduct related to the sale of other dietary supplements.
The settlement was announced less than a year after the FDA sent CellMark an advisory letter notifying the company that it must remove claims from its website and other materials indicating that CellAssure could treat or prevent cancer. The FDA stated that the company would need to submit a new drug application for approval in order to make those claims.
Takeaway: The FTC takes claims directed to cancer patients and others battling serious medical conditions quite seriously. Marketers must possess competent and reliable scientific evidence to support health claims and may not misrepresent the results of any study, test or scientific research.
Contact the author if you are interested in learning more about this topic, including the implementation of preventative telemarketing compliance protocols. You can also follow the author in LinkedIn at FTC Defense Lawyer.
ADVERTISING MATERIAL. These materials are provided for informational purposes only and are not to be considered legal advice, nor do they create a lawyer-client relationship. No person should act or rely on any information in this article without seeking the advice of an attorney. Information on previous case results does not guarantee a similar future result. Hinch Newman LLP | 40 Wall St., 35thFloor, New York, NY 10005 | (212) 756-8777.
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