Here’s to an A-MAZE-ing year!

2017 was a bit of a wild year with many twists and turns, stops and starts in the form of FDA actions.  The agency once more delayed enforcement of restaurant menu labeling regulations; now set for May 7, 2018.  The enforcement date for the revised nutrition/supplement facts and serving size regulations was changed to January 1, 2020 (January 1, 2021 for companies with less than $10 million in annual foods sales.)   There were also changes to some of the 7 sets of regulations based on the Food Safety Modernization Act.

It wasn’t all delays with FDA though. The agency also took some big steps forward in catching up to the state of science by publishing guidance documents on medical devices produced by 3D printing (termed “additive manufacturing” by FDA); gene therapies and other regenerative medicine therapies.   FDA also cleared the first medical device accessory for the Apple watch late in 2017.

Other FDA efforts in 2017 involved nanotechnology and labeling of drugs that contain gluten allergens.

Coming up in 2018 are  the ban on the use of partially hydrogenated oils in foods, effective June 18th and fallout from the draft guidance on homeopathic medicines, which is likely to turn the industry upside down.

No doubt much more will follow and FDA Compliance Simplified will be here to help you map your path to success.

All the best to you and yours in 2018!


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