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FDA Proposes Comprehensive Current Good Manufacturing Practices Regulations for Dietary Supplements

On 13th March 2002, the FDA issued proposed regulations that would establish standards governing the manufacturing practices that producers of dietary supplements and dietary ingredients must follow (1). For over 30 years the FDA has recognised that manufacturing standards for the products it regulates are a valuable, if not essential, tool for assuring product quality and integrity. The hallmark of the FDA's regulation of good manufacturing practices (GMPs) is the recognition that establishing the basic standards and principles governing product manufacture is essential in helping to ensure that a common level of rigour and attention accompanies the production of products throughout a given industry. In the pharmaceutical and medical device arenas, the FDA has codified these standards into binding regulations, that is regulations possessing the same force and effect as does a law. Dietary supplement manufacturers have to date been subject only to the 'umbrella' GMP regulations governing food in general (2). The umbrella food GMP regulations are not binding and do not have the force and effect of law. Force of law GMP regulations do attend some 'special' foods however, notably seafood and low-acid canned foods (3).
Background

In passing the Dietary Supplement Health and Education Act of 1994 (DSHEA), Congress granted the FDA specific authority to promulgate GMPs for the dietary supplement industry. This grant of authority was tempered by a clear Congressional desire to not unnecessarily burden the supplement industry. Hence the statute provides that good manufacturing practice regulations for dietary supplements should be 'modelled' on the current good manufacturing practices for food and should not impose standards for which there is no current and generally available analytical methodology. Clearly, Congress was concerned that GMPs like those applicable to the pharmaceutical and medical device industries could result in burdensome, unnecessary costs on the dietary supplement industry. It is also clear however, that Congress recognised a need for and the value of the uniform imposition of good manufacturing practice standards in the dietary supplement industry.


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By Fred Degnan, Outside General Counsel, American Nutraceutical Association and Partner at King & Spalding, Washington, DC

Fred Degnan, a Partner in King & Spalding's FDA Practice Group, served as the FDA's Associate Chief Counsel for Foods and as an Associate Chief Counsel for Enforcement. His 11-year career at the FDA included extensive experience with food and drug issues including safety, nutrition and health, labelling, GMP, packaging, biotechnology and the use of risk assessment and risk management in the regulation of the safety of food components. He was FDA's Attorney Liaison with DEA and Chairman of the Interagency Council on Drug Control. He also had substantial litigation and enforcement responsibilities and appeared on behalf of the FDA in over 30 states.

Mr Degnan specialises in food law and handles a wide array of food safety, good manufacturing practice and labelling issues. He represents several large multinational food companies, a number of domestic food producers and several international science-based nonprofit associations. Mr Degnan also serves as General Counsel to the Food and Drug Law Institute.

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Fred Degnan
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