Dietary Component Specifications and Testing
Since the FDA’s dietary supplement cGMP regulations (21 CFR Part 111) were published, specifications and testing have been consistently one of the most frequently cited FDA observations. Specifically, industry continues to face challenges in complying with the specification and testing requirements for dietary supplement components.
HHS, FDA Issue RFI on Deregulatory Plan to Lower Costs and Empower Providers
HHS, FDA Issue RFI on Deregulatory Plan to Lower Costs and Empower Providers May 13, 2025 View on the FDA Website The U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) announced the launch of a public Request for...
Front-of-Package Nutrition Information; Extension of Comment Period
In response to requests for an extension, the FDA is extending the comment period for the proposed rule entitled ‘‘Food Labeling: Front-of-Package Nutrition Information’’ that appeared in the Federal Register of January 16, 2025, by 60 days. Either electronic or...
FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities
May 06, 2025 Today, the U.S. Food and Drug Administration announced its intent to expand the use of unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products intended for American consumers and...