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Article: HUMAN DRUGS.
- Article from:
- Warning Letter Bulletin
- Article date:
- December 4, 2000
CopyrightCOPYRIGHT 2000 Washington Information Source, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Health Notification Service, Henderson, NV, Sept. 29 (San Francisco). FDA wrote that labeling associated with the firm's Miracle Wild Yam Cream caused the product to be a drug for which the firm lacked a new drug application (NDA). The letter stated the product label indicated the cream was useful in treating or preventing osteoporosis, depression, ovarian cysts, fibrocystic mastitis and infertility. The agency also noted the presence of progesterone in the topical also qualified it as a new drug. FDA cited the labeling as false and misleading because it suggested that there was substantial scientific evidence that the product was safe and effective ...