FDA Regulatory Status
On June 18, 2008 pHlex I and pHlex II went under a comprehensive formulary safety assessment by Dr. Robert Scheuplein, Toxicologist and Veteran Director of the Office of Toxicology Sciences at FDA’s Center for Food Safety and Applied Nutrition. Dr. Scheuplein has assessed that both pHlex I and pHlex II are “Generally Recognized as Safe (GRAS) in accordance with FDA assessment guidelines.
On January 3, 2013 pHlex-HAR, pHlex-CR, and pHlex SAR were formulated in accordance with the same standards as both pHlex I and pHlex II. pHlexaPeel certifies that pHlex-HAR, pHlex-CR, and pHlex SAR are “Generally Recognized as Safe (GRAS) in accordance with FDA assessment guidelines. Later this year, pHlexaPeel will contract the services of Dr.Robert Scheuplein to better satisfy the assessment of pHlex-HAR, pHlex-CR and pHlex-SAR and will publicly post the assessment results.