Nicholas Hall’s OTC.NewDirections: FDA rulings in Medical Devices and Dietary Supplements


Two areas we focus on in our latest OTC.NewDirections bulletin are new regulations for dietary supplements and medical devices. In Canada, quality assurance measures are being introduced for Natural Health Products, while across the border in the US, the FDA has issued guidance to help marketers distinguish between liquid dietary supplements and beverages.

As for medical devices, again North America dominates the news, with the FDA updating its requirements for marketers of paediatric devices and issuing draft guidance on OTC self-monitoring blood glucose tests. Additionally, the FDA has also published draft guidance on the format and content of computational modelling and simulation reports for marketers looking to submit medical device for consideration.

In scientific news, our round-up of the latest healthcare studies from the past fortnight shows a heavy emphasis on Type 2 diabetes research. Research into omega-3, flavonoids and Chinese herbal medicine, Tianqi, all shows a possible link between use of these supplements and reduced risk of developing Type 2 diabetes.

More information on these studies and the scientific round-up can be found in this fortnight’s issue of OTC.NewDirections.

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