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Should the FDA Regulate Natural Supplements and Herbal Remedies?

The truth of the matter is that they already do and have for over two decades. The FDA has always held the authority to conduct random and unannounced inspections of these manufacturing facilities. Under Title 21 of the Federal Code of Regulations (CFR 21), Nutraceutical Companies are held to the same manufacturing standards as those companies who manufacture food products. In an attempt to address the specific issues of dietary supplements, Congress passed The Dietary Supplemental Health and Education Act of 1994 (DSHEA) which made the Nutraceutical manufacturers responsible for ensuring the safety of their products pre-market and the FDA responsible for monitoring them after-market. Good Manufacturing Practices (GMP's) were to be included in the DSHEA; however, the Industry actually had to wait 13 years before these standards were finally published by the FDA.

Given the propensity of the media to continually offer only a one-sided and generally inaccurate depiction of the Nutraceutical Industry as a whole, I feel compelled to defend the Industry here. Reputable manufacturers have employed GMP's for yearseven without the Federal Regulations requiring them to do so. They have labs staffed with Chemists and other highly trained personnel who are tasked with creating the formulations and monitoring all aspects of the product from raw materials to finished goods. Quality Control and Quality Assurance professionals monitor the entire manufacturing process. The Director of Regulatory Affairs acts as liaison between the FDA and the Company and assures that the manufacturing process is in compliance with Federal Regulations from start to finish.

ISO 9000 Certification has become an Industry standard. ISO 9000 is a set of standards for quality management developed and maintained by the International Organization for Standardization. These standards govern all aspects of the manufacturing process from accurate record keeping to the monitoring and continual improvement of the manufacturing process itself. The road to Certification is long and arduous and the completion of these demanding requirements is a source of pride. Not every company that tries actually obtains certification. These Companies are definitely not the "snake oil" salesmen of a century ago.

Opponents of the Industry have a need to dwell on the issue of ephedra and it's time to set the

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