COSMETICS

6724W

Nature=s Acres, North Freedom, WI, June 30 (Minneapolis). ACosmetic type products,@ including various herbal body oils, moisturizers, soaps and bath salts, were regarded as drugs due to labeling claims. GMP deficiencies included the lack of lot numbers, expiration dating, raw material and finished product testing, a quality control unit, a complaint file, SOPs and product specifications. In addition, FDA declared a facial toner noncompliant with the final rule for OTC acne drugs and cited Almond-Sage Scrub Hand Made Soap for a lack of evidence for safety and effectiveness. Both items were deemed unapproved new drugs. The agency also termed all the firm=s products misbranded due to failure to register the establishment and follow drug listing requirements. Premarket submissions and export approval requests may not be approved until the violations are corrected. The inspection dates were not disclosed.