The Food and Drug Administration will no longer allow use of bisphenol A-based epoxy resins as coatings in infant formula packaging, according to a final rule that takes effect July 12. The agency said it’s removing the approved use from its food additive regulations at 21 CFR 175 because the chemical is no longer used by the industry, and not because of safety concerns. “FDA’s action is based solely on a determination of abandonment and is not related to the safety of BPA,” FDA said in a press release (here). “The agency’s current safety review supports the safety of BPA for use in the manufacture of food contact articles as authorized in the food additive regulations,” it said.
The Food and Drug Administration issued its weekly Enforcement Report for July 10 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
On July 10 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration’s Prior Notice System Interface (PNSI) will be down at approximately 1 a.m. on July 13 due to scheduled maintenance. The system is not anticipated to be back up until 8 a.m. Though PNSI will not be available during this time, the Automated Commercial System (ACS), the Operational and Administrative System for Import Support (OASIS) and the link between ACS and OASIS will remain operational. Prior notice may still be submitted through the Automated Broker Interface, CBP said.
The Food and Drug Administration issued the July Interstate Certified Shellfish Shippers List (ICSSL). The ICSSL is published monthly for the information and use by food control officers, the seafood industry and other interested persons. The shippers listed have been certified by regulatory authorities in the U.S., Canada, Chile, Korea, Mexico and New Zealand under the uniform sanitation requirements of the National Shellfish Program.
The Food and Drug Administration threatened three food manufacturers with import refusal, and said it would collect reinspection fees, for violations of current good manufacturing practice (CGMP) regulations. Chan Yee Jai of Hong Kong (here) and Productos Alimenticios Centroamericanos of Guatemala (here) were both cited for violations of food CGMP regulations at 21 CFR 110, while COVI S.A.S. of France (here) was cited for violations of CGMP for low-acid canned food regulations at 21 CFR 113. A lack of response, or an inadequate response, will result in detention without physical examination at the border for products form each facility, FDA said.
On July 9 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On July 8 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
During the week of July 1-7, the Food and Drug Administration modified the following existing Import Alerts (not otherwise listed on the FDA's new and revised import alerts page) on the detention without physical examination and/or surveillance of:
A new draft guidance is now available on Medical Device Reporting (MDR) adverse event reporting and recordkeeping regulations for manufacturers, said the Food and Drug Administration. Once finalized, the guidance will update FDA policy and clarify the agency’s interpretation of the MDR regulations, it said. The guidance will be available on FDA’s website (here).