Posted 12 January 2018
By Michael Mezher
The US Federal Trade Commission (FTC) on Thursday announced it has reached a settlement with CellMark Biopharma related to the company's claims about marketing efforts to sell two of its unapproved products.
The settlement comes less than a year after 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. FDA said that the company would need to submit a new drug application (NDA) for approval in order to make those claims.
In a complaint filed Tuesday by FTC, the agency alleged that CellMark made unsubstantiated and deceptive claims about CellAssure, which the company promoted "to treat cancer-related malnutrition" and Cognify, which was billed as a treatment for "chemo brain" and other types of cognitive impairment related to cancer treatment.
According to FTC, CellMark sold the unapproved products CellAssure for $248 for a one-month supply and Cognify for $79 per month.
In settling the complaint, CellMark is not admitting or denying the allegations made by FTC, but under the terms of the order the company and its employees are barred from making future misleading claims about products to treat, cure, mitigate or prevent cancer or related symptoms. Any future medical claims, the order stipulates, must be backed by "competent and reliable scientific evidence."
The settlement also specifically does not bar the defendants from making representations about FDA-approved products so long as the claim is in line with the product's approved labeling.
FTC Statement, Complaint, Order