Telledant LLC, a Miami-based online distributor of dietary supplements, was issued a joint Warning Letter on September 28, 2010 by the U.S. Federal Trade Commission (FTC) and the U.S. Food and Drug Administration (FDA). In the Warning Letter, the FTC and FDA warn Telledant, LLC that its marketing and claims for a variety of products are in violation of federal laws and regulations.
More specifically, the agencies allege that Telledant, LLC is marketing unapproved “new drug” products through its numerous websites, which include: http://www.biogetica.com, www.fixdisease.com, www.guantumcure.com, www.fixherpes.com and www.quantumfix.com. The Warning Letter states that therapeutic claims on these “websites establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease.”
Further, the agencies warn that under the FTC Act, it is unlawful to “advertise that a product can prevent, treat, or cure human disease,” or “to make or exaggerate such claims, whether directly or indirectly, through the use of a product name, website name, metatags, or other means, without rigorous scientific evidence sufficient to substantiate the claims.”
The Warning Letter goes on to cite several specific products and claims identified during the investigation, while clarifying that the list is not exhaustive as “[t]he unlawful disease treatment and prevention claims. . .were too numerous to list.” Telledant, LLC has 15 days to respond to the FDA and FTC with a corrective action plan that adequately addresses the numerous deviations cited in the letter, as well as others.
Because a Warning Letter can negatively affect consumer confidence and sales, many companies choose to work with an experienced FDA attorney to develop an effective corrective action plan that adequately addresses the agency’s concerns. A qualified FDA attorney, can be instrumental in preventing further damage to your business reputation, as well as averting more serious FDA action in the future. Ann Marie Gaitan, the chair of the FDA & FTC practice group at Gaitan Morales, is experienced at responding to Warning Letters, preparing corrective action plans, negotiating with the agencies and ensuring continued compliance into the future.
If you have questions about FDA and/or FTC regulatory actions, you may contact Ann Marie Gaitan at firstname.lastname@example.org or 305.329.1467.