09.22.16
Three more warning letter notices have been sent out to beauty companies for claims. The firms most recently flagged by the FDA include Tata’s Natural Alchemy, LLC, Repechage, Ltd. and ZO Skin Health Group.
An Aug. 18 letter was sent to Tata Harper, owner of Whiting, VT-based Tata’s Natural Alchemy, involving Rejuvenating Serum Home & Travel Set, Restorative Eye Crème, Boosted Contouring Eye Mask, Elixir Vitae, Rejuvenating Serum, Be Smitten, and Concentrated Brightening Serum. FDA contends claims made by the company on its website violate (the Act) [21 U.S.C. § 321(g)(1)(C)] because they are articles intended to affect the structure or any function of the human body.
In a letter dated Aug. 1 sent to Lydia Sarfati of Sarkli/Repechage, Ltd., Secaucus, NJ, FDA claimed that the brand’s Hydra 4 Red-Out Calming Cleanser, Hydra 4 Red-Out Serum, and Biolight Brightening Daytime Protection Cream, were also being marketed as drugs because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body.
On Aug. 29, Dr. Zein Obagi was issued a letter that cited ZO Skin Health Group’s Ossential Growth Factor Serum Plus, Ossential Daily Power Defense, and Ossential C-Bright Serum 10% Vitamin C for the same issue.
An Aug. 18 letter was sent to Tata Harper, owner of Whiting, VT-based Tata’s Natural Alchemy, involving Rejuvenating Serum Home & Travel Set, Restorative Eye Crème, Boosted Contouring Eye Mask, Elixir Vitae, Rejuvenating Serum, Be Smitten, and Concentrated Brightening Serum. FDA contends claims made by the company on its website violate (the Act) [21 U.S.C. § 321(g)(1)(C)] because they are articles intended to affect the structure or any function of the human body.
In a letter dated Aug. 1 sent to Lydia Sarfati of Sarkli/Repechage, Ltd., Secaucus, NJ, FDA claimed that the brand’s Hydra 4 Red-Out Calming Cleanser, Hydra 4 Red-Out Serum, and Biolight Brightening Daytime Protection Cream, were also being marketed as drugs because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body.
On Aug. 29, Dr. Zein Obagi was issued a letter that cited ZO Skin Health Group’s Ossential Growth Factor Serum Plus, Ossential Daily Power Defense, and Ossential C-Bright Serum 10% Vitamin C for the same issue.