10.03.16
FDA has issued three more warning letters to companies making claims that the agency contends go to far.
A letter sent to Federico Sanchez, owner of Miami, FL-based Menscience Androceuticals, came following a review of its website http://www.menscience.com/ in May 2016 where the firm is taking orders for an Anti-Aging Formula. FDA says the claims on the company’s’ website establish that the product is a drug under sections 201(g)(1)(B) and/or 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B) and/or 21 U.S.C. § 321(g)(1)(C)] because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or is intended to affect the structure or any function of the human body.
Victoria Fantauzzi and Karen King, founders of La Bella Figura, LLC, Chicago, were also presented with a letter following a review of the company’s website in May. FDA has determined La Bella Figura’s claims surrounding Crema Virtuosa Night Cream, Daily Elements Defense Facial Oil, Jardin de Fleurs Skin Revitalizer and Modern Radiance Concentrate establish that the products are drugs.
In addition, Kathleen Hembree, owner of Healing-Scents, Rockford, IL, was issued a letter following a June 2016 website review. Again, FDA contends claims on the website establish that products the brand is selling are drugs.
A letter sent to Federico Sanchez, owner of Miami, FL-based Menscience Androceuticals, came following a review of its website http://www.menscience.com/ in May 2016 where the firm is taking orders for an Anti-Aging Formula. FDA says the claims on the company’s’ website establish that the product is a drug under sections 201(g)(1)(B) and/or 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B) and/or 21 U.S.C. § 321(g)(1)(C)] because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or is intended to affect the structure or any function of the human body.
Victoria Fantauzzi and Karen King, founders of La Bella Figura, LLC, Chicago, were also presented with a letter following a review of the company’s website in May. FDA has determined La Bella Figura’s claims surrounding Crema Virtuosa Night Cream, Daily Elements Defense Facial Oil, Jardin de Fleurs Skin Revitalizer and Modern Radiance Concentrate establish that the products are drugs.
In addition, Kathleen Hembree, owner of Healing-Scents, Rockford, IL, was issued a letter following a June 2016 website review. Again, FDA contends claims on the website establish that products the brand is selling are drugs.