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FDA, HHS and USDA Serve Up Ultra-Processed Food RFI

On July 25, the U.S. Food and Drug Administration (FDA), in collaboration with the U.S. Department of Health and Human Services (HHS) and U.S. Department of Agriculture (USDA), unveiled the highly anticipated joint request...more

FDA Green Lights Another Natural Food Color

This week, the U.S. Food and Drug Administration (FDA) granted another color additive petition, approving the use of Gardenia (Genipin) in various food and beverage products. This marks the fourth naturally-derived color...more

HHS to Launch Campaign Promoting Wearable Devices

On June 24, 2025, in a hearing before the U.S. House of Representatives Committee on Energy and Commerce, the Secretary of Health and Human Services (HHS), Robert F. Kennedy Jr. revealed that his department plans to soon...more

MAHA Commission Report on Children’s Health Takes Aim at Ultra-Processed Foods and Medication Practices, Among Other Targets

Yesterday, the White House’s Make America Healthy Again (MAHA) Commission, led by the Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. released its inaugural health report titled, Make Our...more

HHS, FDA Announce Multiple Initiatives on Food Safety, Quality and Compliance Fronts

In the past week, the U.S. Food and Drug Administration (FDA), in collaboration with the Department of Health and Human Services (HHS) announced three new initiatives related to food safety and food supply chain transparency....more

MAHA Picks Up Momentum with the President’s Make America Healthy Again Commission

On February 13, the Senate approved Robert F. Kennedy Jr.’s nomination to serve as Secretary of Health and Human Services and the White House shortly thereafter issued an Executive Order establishing the Make America Healthy...more

Just Prior to Leadership Change, FDA Announces Public Workshops to Advance Dialogues on HCT Product Development and Optimizing...

In the final stretch of the Biden administration, the Food and Drug Administration (FDA) laid the groundwork for continued engagement with the public on two challenging areas of product development, each of which is of high...more

In Waning Days of the Current Administration, FDA Announces Red No. 3 Ban

On January 15, 2025, FDA announced an order revoking the listings providing for the use of the color additive FD&C Red No. 3 in both foods (including dietary supplements) and ingested drugs. The order is in response to a 2022...more

FDA Unveils Draft Guidance on Developing Drugs and Biological Products for Weight Reduction

On January 7, the FDA made available draft guidance on the development of drugs and biological products for weight reduction within the Center for Drug Evaluation and Research intended for reduction and long-term maintenance...more

FDA Issues RFI on PFAS in Seafood

On November 19, 2024, FDA issued a request for information (RFI) on per-and polyfluoroalkyl substances (PFAS) in seafood. Specifically, the agency is seeking scientific data and information from the seafood industry and other...more

President-elect Trump Makes More HHS Personnel Moves: Dr. Marty Makary Tapped to Lead FDA

In recent days, President-elect Trump has made progress in announcing the names of various individuals he intends to nominate to serve in some of the most senior and influential leadership positions at the Department of...more

FDA Announces New Director of the Center for Devices and Radiological Health

Dr. Michelle Tarver is a visionary public health executive, board-certified in ophthalmology with a doctorate in epidemiology, who serves as the Director of the Center for Devices and Radiological Health (CDRH). She has spent...more

FDA’s Proposed Rule on Laboratory Developed Tests: One Small Change to Regulatory Language That Would Mark a Giant Leap in Lab...

On October 3rd, the Food and Drug Administration (FDA) published its widely anticipated proposed rule on the regulation of laboratory developed tests (LDTs). Last year, Congress failed to pass the Verifying Accurate,...more

Food for Thought: FDA Proposes New Vision for the Human Foods Program

On January 31, 2023, the U.S. Food and Drug Administration (FDA) announced a proposal to restructure the agency’s human foods program. FDA regulates almost 80 percent of the nation’s food supply and this work is a cornerstone...more

Preparedness Policy Takes Shape: PREVENT Pandemics Act Enacted Ahead of PAHPA Reauthorization

On December 29, 2022, the President signed into law the Prepare for and Respond to Existing Viruses, Emerging New Threats and Pandemics Act (PREVENT Pandemics Act) as part of the Consolidated Appropriations Act, 2023 (P.L....more

FDA Offers Some Clarity (But Few Concessions) on Off-Label Communication of Medical Products

Among the flurry of policies the Food and Drug Administration (FDA) released in the waning days of the Obama administration are several documents that seek to clarify the agency’s positions on communications about medical...more

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