On June 26, the FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On June 25, the FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On June 24, the FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The FDA will allow Njoy to market four of its menthol-flavored e-cigarette products in the U.S. after the company applied through the agency's premarket tobacco product application pathway, the first non-tobacco flavored e-cigarette products to be authorized by the agency, it announced June 21. “The FDA will closely monitor how these products are marketed and will act as appropriate if the company fails to comply with any applicable statutory or regulatory requirements,” the agency said, saying it "remains concerned about the risk of youth use of all e-cigarettes -- particularly flavored products that are more appealing to youth." The FDA added that it has received applications for “nearly 27 million deemed products and has made determinations on more than 26 million of these applications,” authorizing 27 tobacco- and menthol-flavored e-cigarette products and devices, including the most recent four for Njoy. Those “manufacturing, importing, selling, or distributing e-cigarettes without the required premarket authorization risk enforcement,” the FDA said.
On June 18, the FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On June 17, the FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On June 14, the FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The FDA issued a final rule revising requirements related to current good manufacturing practice (CGMP), certification, and post-marketing safety reporting and labeling that apply to certain medical gases, it said in a notice released June 17. The final rule also establishes regulations regarding the certification of designated medical gases, and it satisfies the medical gas rulemaking requirements of the Consolidated Appropriations Act of 2017, the FDA said. The rule is effective Dec. 18, 2025, although certain amendments won't go into effect until Feb. 2, 2026.
On June 13, the FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On May 30, the FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of: