Jun 28, 2024 | Dietary Supplements, FDA and USDA Regulatory Update, Foods
Earlier this year, the FDA released the draft and final guidance topics that are a priority for the agency’s Foods Program to complete during 2024. Since January, the FDA has issued the following guidances that were on the list: New Dietary Ingredient (NDI)...
Apr 3, 2024 | Drugs, FDA and USDA Regulatory Update
FDA announced the fiscal year 2024 OTC-Monograph Drug User Fee rates in the Federal Register Vol 89, No. 62 published 29 March 2024. These fees cover FDA’s FY2024 which runs from October 2023 through September 2024. The facility fees for FY 2024 are due on 3 June...
Apr 3, 2024 | Dietary Supplements, FDA and USDA Regulatory Update
Today, the U.S. Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry titled “New Dietary Ingredient Notification Master Files for Dietary Supplements.” This draft guidance responds to the dietary supplement industry’s...
Apr 1, 2024 | FDA and USDA Regulatory Update, Foods
On March 20, 2024, the US FDA issued a new import alert for human food products with detectable levels of chemical contaminants that may present a safety concern to human health. The Import Alert 99-48, Detention without Physical Examination of Foods Due to Chemical...
Mar 28, 2024 | FDA and USDA Regulatory Update, Tobacco
Database Lists Tobacco Products—Including E-Cigarettes—That May Be Legally Marketed Today, FDA launched the Searchable Tobacco Products Database, a new user-friendly list of tobacco products—including e-cigarettes—that may be legally marketed in the United States. The...
Mar 12, 2024 | FDA and USDA Regulatory Update
FDA proposes to revise the existing regulations regarding the content and format of labeling for approved or conditionally approved new animal drugs to provide for a more comprehensive set of requirements in one location in the Code of the Federal Register (CFR)....
