CQRM / MARCH 2024 BULLETIN
LATEST FDA ALERTS & UPDATES
FDA Announces Voluntary Phase-Out of PFAS In Food Packaging
The FDA reported on Wednesday that manufacturers will no longer be permitted to sell grease-proofing products with Per and Polyfluoroalkyl Substances (PFAS) for use in food containers and packets on the American market. Dietary exposure to PFAS from approved food contact uses will be eliminated at the conclusion of the voluntary market phase-out of these compounds in food packaging paper and paperboard.
Jim Jones, the Deputy Commissioner for Human Foods, highlighted the FDA's and industry's efforts to reach this significant milestone in public health protection in a statement he made in response to the release. Jim Jones was appointed in the summer of 2023 to serve as the first Deputy Commissioner for Human Foods. The new position was slated to advance priorities for a proposed unified Human Foods Program (HFP).
Learn more about the HFP here:
FDA Warns of Higher-Than-Expected Risk of Device Failure (Hintermann Series H3 TAR)
The Hintermann Series H3 Total Ankle Replacement (TAR) system, made by DT MedTech LLC, has been found to have a higher-than-expected risk of device failure, according to data compiled by FDA. This was made known to patients, caregivers, and healthcare providers last Thursday.
Hintermann Series H3 TAR system's interim post-approval study (PAS) results and other real-world data are being assessed by the U.S. Food & Drug Administration. Their investigations indicate a higher failure rate (i.e., revisions or removals of metal components, at least 16.1%) for patients with the Hintermann Series H3 TAR system in relation to the implanted device than in the premarket clinical investigations (9.9%).
Read the alert here:
https://www.fda.gov/medical-devices/safety-communications/hintermann-series-h3-
total-ankle-replacement-has-higher-expected-risk-device-failure-fda-safety
FDA Confirms Contamination From Lead In Some Cinnamon Applesauce
The FDA confirmed that the lead and chromium previously found in the cinnamon are from lead chromate on Thursday, updating the advisory for the Investigation of Elevated Lead & Chromium Levels in Cinnamon Applesauce Pouches.
The FDA obtained the cinnamon from the manufacturer in Ecuador, Austrofoods, and performed additional analysis of the cinnamon. Lead chromate has historically been added illegally to several spices to make them heavier and more colorful, which raises the adulterated spices' market value. The FDA's primary assumption is still that this was probably an act of adulteration with financial motivation.