AGG produces a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from our Washington, DC office. The June 2015 update is located here. Two items should be of particular interest to Irish and Northern Irish companies whose products fall under US FDA regulation:
1. The Trans-Fat Ban. On June 15, 2015, the U.S. Food and Drug Administration announced a final determination order regarding the use of partially hydrogenated oils (PHOs) in foods manufactured for human consumption, concluding that PHOs are not generally recognized as safe (GRAS) and, therefore, are “food additives” that require prior FDA approval. FDA has implemented a three-year compliance deadline and has ordered that PHOs be removed from foods unless their use is pursuant to an approved food additive petition. Failure to comply with the deadline can lead to FDA enforcement (meaning that Irish or NI-origin food products that do not comply with the new rules after the transition period would be barred from US markets.) I know that Irish and NI food is 100% good-for-you, at least that is what I have been told at Leo Burdock’s and at The George, but I digress. It’s probably worthwhile–especially as food imports to the US from Ireland and Northern Ireland increase–for producers to take a look at this issue and develop a transition plan if needed. See more here.
2. Preemption in Medical Device Product Liability Cases. The issue of preemption in product liability cases involving medical device products continues to evolve. Recently, the U.S. Court of Appeals for the 10th Circuit found that federal law preempts injury and negligence claims, brought under state law, even if the claims arise out of potential off-label promotion by the device manufacturer. This case, although limited to the 10th Circuit, favors device manufacturers. See more here.