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The Top 5 Good Manufacturing Practices Nonconformances
Despite a struggling economy, the US nutritional products industry was estimated to have reached 117 billion dollars in 2010, a 6% growth over the previous year. With 65% of US adults, roughly 150 million people, labeling themselves as supplement users , the opportunity for nutritional product manufacturers has not gone unnoticed. In fact, the number of nutritional supplements on US store shelves has surged from 4,000 to an estimated 75,000 since the Dietary Supplement Health and Education Act, or DSHEA, was passed in 1994.
This fantastic growth and proliferation of new products has created new challenges for the industry in terms of standardizing safety and quality, not to mention the regulatory hurdles that come with a globalized supply chain. To establish quality-control standards for US nutritional products, the US Food and Drug Administration introduced Good Manufacturing Practices (GMP) regulations in 2007. GMPs require that the processes by which nutritional supplement ingredients are produced are safer and free of possible contamination. This includes all aspects of the manufacturing process, from raw material control to finished product release, as well as training of personnel, qualification and validation of testing equipment and methods, product traceability and facility maintenance.
Why does this matter to a Europe-based nutritional product manufacturer? As of last year, every organization that wishes to participate in the booming US nutritional products industry must demonstrate compliance to these GMP regulations. Although European nutritional product manufacturers are no strangers to meeting rigorous regulations, they have the unique challenge of demonstrating compliance to both EU and US regulations, which have few similarities.
The cost of noncompliance is steep and many manufacturers are still struggling to comply as evident by a 42% increase in warning letters issued by the US FDA in 2010 . Noncompliance with US GMPs can trigger a number of undesirable outcomes: public warning letters, products labeled as adulterated, seizure by authorities, injunction from manufacturing, and damage to brand and company reputation.
This article is available in full in the Winter 2011 issue of Nutraceuticals Now