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EU Health Claims Update EFSA Guidance

Last month saw the publication of 63 opinions on 442 ‘generic’ claims in the EU, the majority of which (around 80%), were rejected mainly because of the poor quality of the information submitted. Now, EFSA has published three draft guidance documents aimed at giving further detail on what it does require. These documents are open to consultation until the end of August…

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USA – The safety of new dietary ingredients

Supplement manufacturers are required to submit safety information to the federal government before placing a new product on the market. However as evidenced by Daniel Fabricant, director of the Division of Dietary Supplement Programs at the Food and Drug Administration (FDA), this often does not happen. Dr Fabricant estimates that some 60,000 ingredients are sold as dietary supplements in the United States, but…

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US FDA compliance and enforcement actions online

The U.S. Food and Drug Administration (FDA) announced that it is disclosing more information about inspections and court actions, and now has a web portal on its enforcement activities as part of Phase II of the agency’s transparency initiative. These actions are being taken to make FDA’s enforcement and compliance-related activities more accessible, downloadable, and searchable online…

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