On January 20, 2015, the U.S. Food and Drug Administration (FDA or the Agency) announced the availability of two draft guidance documents in the Federal Register: “General Wellness: Policy for Low Risk...more
The final rule prohibits label claims of food products, including dietary supplements, that are “high in,” “rich in,” or an “excellent source of” DHA or EPA and allows some nutrient content claims for ALA.
On April 28,...more
The rule would ban the sale of e-cigarettes, cigars, pipe tobacco, and other products to those under 18; would require warning statements on product packages and in advertisements; and would require manufacturers to register...more
New mandate would apply to major U.S. and international food processors and handlers.
On December 24, the U.S. Food and Drug Administration (FDA or the Agency) issued a proposed rule, Focused Mitigation Strategies to...more
Proposed requirements dictate a substantial upgrade of the current regulatory standard of care.
On October 29, the U.S. Food and Drug Administration (FDA or the Agency) issued a proposed rule—Current Good Manufacturing...more
Agency expands enforcement discretion, focusing its oversight on a discrete subset of mobile apps that present the greatest risk to patients.
On September 23, the U.S. Food and Drug Administration (FDA or the Agency)...more
The Centers for Medicare and Medicaid Services (CMS) issued the final regulations on the U.S. Sunshine Act on February 8, 2013. Transparency Reports and Reporting of Physician Ownership or Investment Interests, 78 Fed. Reg....more
Affected parties should familiarize themselves with proposed rules for safe food processing and handling and on-farm produce safety; comments to FDA are due by May 16....more