Last week’s issuance of a request for information (RFI) in the Federal Register by the FDA and the US Department of Agriculture (USDA) marks the first step in the administration’s effort to address health concerns associated...more
In June 2025, the US Food and Drug Administration (FDA) announced a major update to its General Food Labeling Requirements Compliance Program—the first overhaul of this program since 2010. This program guides FDA inspectors...more
The US Food and Drug Administration recently announced a major initiative to strengthen oversight of food additives and other food-related chemicals. The agency described this as a “stronger, more systematic review process”...more
The White House on May 5, 2025 issued an executive order requiring the US Food and Drug Administration to find ways to facilitate the opening of new drug manufacturing sites in the United States while also increasing the...more
The Alcohol and Tobacco Tax and Trade Bureau (TTB) has published a pair of proposed rules that if finalized could significantly reshape alcohol beverage labeling in the United States. In a move aimed at improving transparency...more
The US Food and Drug Administration (FDA) is confronted with significant challenges in its inspection processes due to recent layoffs. Among other effects, the latest reduction in force of full-time FDA employees is raising...more
Ingredient suppliers and food manufacturers face an uncertain supply chain landscape in which “generally recognized as safe” (GRAS) self-determinations may be more closely scrutinized. The US Department of Health and Human...more
The recent reductions in the US Food and Drug Administration’s workforce are poised to have a substantial impact on drug and biologic development programs. This LawFlash discusses strategies to optimize interactions with the...more
With the continuing cuts to US Food and Drug Administration (FDA) staffing, the pharmaceutical and biotechnology industries are communicating increasing concern about potential product development impacts. While these cuts...more
Only weeks after being confirmed, the Department of Health and Human Services (HHS) secretary has advised food companies to remove artificial colors from their food products. He recently met with several major food brand...more
3/25/2025
/ Department of Health and Human Services (HHS) ,
Dietary Supplements ,
Enforcement Actions ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Safety ,
Public Health ,
Regulatory Agenda ,
Regulatory Requirements ,
State and Local Government
FDA issued a Voluntary Sodium Reduction guidance in October 2021, aimed to help Americans reduce average daily sodium intake over the next two and a half years. The guidance suggests voluntary sodium reduction targets for...more
The month of May was buzzing with good news for the edible insect industry, but this emerging food trend still faces regulatory uncertainty in the United States....more
The coronavirus (COVID-19) pandemic continues to impact the biopharmaceutical industry. In a recent guidance, Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency (the...more
From the beginning of the coronavirus (COVID-19) pandemic, FDA actively provided guidance to members of the drug and biologic industries, including sponsors, investigators, pharmacies, and compounders....more
7/1/2020
/ Biologics ,
Biosimilars ,
CGMP ,
Clinical Trials ,
Coronavirus/COVID-19 ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Life Sciences ,
National Institute of Health (NIH) ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Regulatory Requirements ,
Research and Development