Adulterated Androstenedione: What FDAs Action against Andro Means for IndustryReport as inadecuate




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Journal of the International Society of Sports Nutrition

, 1:52

First Online: 18 May 2004Received: 23 April 2004Accepted: 18 May 2004

Abstract

On March 11, 2004, the Food and Drug Administration FDA pronounced that dietary supplement products containing androstenedione were adulterated new dietary ingredients under the Dietary Supplement Health and Education Act of 1994 DSHEA. The FDA issued a press release, held a news conference, and sent warning letters to 23 companies that had manufactured, marketed or distributed the products containing androstenedione. In its warning letters, FDA threatened possible enforcement actions for noncompliance. The authors have looked at the warning letters, statutes, regulations, and media reports to analyze the legal grounds and standards upon which FDA acted against androstenedione and question the appropriateness of the action taken. They have also looked at the negative impact that FDA-s lack of communication and cooperation with Industry is having upon the fitness nutrition industry and the marketing of dietary supplements containing new dietary ingredients. The authors also suggest what might be done to ameliorate this escalating problem including more cooperation between FDA and Industry and more research into the benefits and use of supplement products.

Keywordsandrostenedione sport nutrition dietary supplements DSHEA  Download fulltext PDF



Author: Richard D Collins - Alan H Feldstein

Source: https://link.springer.com/







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