On October 15, the U.S. Food and Drug Administration (FDA) issued the final guidance “Distinguishing Medical Device Recalls from Medical Device Enhancements.” This guidance revises and finalizes the draft version that...more
In recent months, the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has issued draft and final guidance documents at a relatively fast pace. To assist interested parties, we have...more
The proposal, if adopted, will require new recordkeeping by both processing establishments and retail facilities that grind raw beef products....more
The draft guidance also enables some health IT manufacturers to avoid the device tax.
The Food and Drug Administration (FDA) took an unusual step on June 20 by issuing new draft guidance that states its intent to not...more
The Supreme Court holds that competitors may bring Lanham Act claims challenging food and beverage labels that are regulated by the FDA....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
The first major overhaul of the Nutrition Facts panel in more than 20 years focuses on serving sizes, calories, and a refreshed design.
The Food and Drug Administration (FDA or the Agency) on February 27 announced the...more
Manufacturers seeking to enter the medical food market face increased challenges.
The Food and Drug Administration (FDA or the Agency) has issued several Warning Letters to manufacturers of medical foods...more
FDA “reminds” manufacturers of the requirements for food and dietary supplement ingredients and finalizes long-awaited liquid dietary supplement guidance.
On January 14, the U.S. Food and Drug Administration (FDA or...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
Food industry should be aware of new risks associated with whistleblower protections for food and beverage company employees.
On June 6, one of the first whistleblower lawsuits under the Food Safety Modernization Act...more
Agency implements rule requiring companies to disclose information regarding the use of certain industrial chemical substances commonly used in natural gas and oil well drilling....more
Recall notification suggests the agency is ready and willing to use its new, enhanced enforcement authority.
On February 13, the U.S. Food and Drug Administration (FDA) began its first enforcement action under the...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