In Brief: Natural Hairs warning letter
This article was originally published in The Rose Sheet
Executive Summary
Natural Hairs warning letter: Portland, Maine-based Talk America receives March 18 FDA warning letter stating that labeling for its Natural Hairs hair loss treatment products does not comply with the agency's Hair Grower and Hair Loss Prevention monograph. Labeling for the products, order form, brochure and other Natural Hairs literature contains certain drug-like claims "that represent and suggest that these products are useful in treating or preventing hair loss and in promoting hair growth," the letter states. FDA noted that it is unaware of an NDA supporting use of such claims for the product. The statements in question include "Get back your hair now!" and "The average length of time on the program is six to nine months for a person with thinning and/or bald spots, while someone who is totally bald may require longer treatment time." The products are also misbranded because they lack adequate directions for use, the letter states...