On June 3, FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On June 2, FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On June 1, FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:

FDA has issued its Enforcement Report for June 1, listing the status of recalls and field corrections for food, cosmetics, tobacco products, drugs, biologics and devices. The report covers both domestic and foreign firms.

On May 31, FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On May 27, FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:

FDA will hold a webinar June 14 on its recent move toward a lower lead action level in apple juice and other single-strength juices and juice blends. The agency’s April 27 draft guidance would lower the lead action level to 10 parts per billion for apple juice, and 20 ppb for other juices and blends (see 2204280031). “During the webinar the FDA will provide an overview of the draft guidance and additional information, as well as answer stakeholder questions,” FDA said.

FDA on May 25 released a new small entity compliance guide on its final rule allowing imports of drugs from Canada. The guidance “is intended to help small entities better understand the final rule,” which was published in October 2020 (see 2009290018). It includes information on who and what is eligible for importing under the Section 804 Importation Programs (SIPs) provided for under the final rule, as well as on entry, labeling and testing requirements. Comments on the guide may be submitted at any time, FDA said.

FDA has issued its Enforcement Report for May 25, listing the status of recalls and field corrections for food, cosmetics, tobacco products, drugs, biologics and devices. The report covers both domestic and foreign firms.

FDA recently approved the first foreign infant formulas allowed for import into the U.S. under its new enforcement discretion policy announced earlier this month to address the infant formula shortage, it said May 24. The U.K.’s Kendal Nutricare will send the over 40,000 cans it has in stock of three types of Kendamil infant formula, and the company has estimated it will eventually send about 2 million cans total.