Chattem supplement claims

For Echinex and Propalmex dietary supplements cited as unapproved new drug claims by FDA in April 20 warning letter. Claims for Echinex, an echinacea supplement, include that it supports or boosts "the body's natural resistance against infection" and "viruses and bacteria won't slow you down." For Propalmex, a saw palmetto product, statements include: "Most men over 45 experience a gradual increase in the prostate size at some time during or after middle age. Due to the fact that the prostate surrounds the urinary tract, an enlarged prostate can lead to an obstruction of urinary flow...can mean discomfort in urination or increased night-time urination," and "Propalmex can help to support prostate health and promote free urinary flow." The company, which is preparing a response, did not previously receive a "courtesy" letter on the claims. Chattem acquired the supplement products in June 1997 as part of its Sunsource purchase