On June 18, the US Food and Drug Administration (FDA) released for public comment a proposed method for ranking chemicals present in the food supply to determine which should be prioritized for post-market safety assessments....more
On April 22, at the direction of US Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr., both the US Food and Drug Administration (FDA) and HHS published identical statements announcing the...more
Key Insights for Pharma Manufacturers Regarding the AKS -
In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General...more
4/29/2025
/ Abbreviated New Drug Application (ANDA) ,
Anti-Kickback Statute ,
Compliance ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
New Regulations ,
Pharmaceutical Industry ,
Popular ,
Regulatory Requirements
2025 will be a transformational year for the beverage and food industry, which has already been dramatically impacted by shifting market trends and profound policy changes. Here are the top five topics influencing the...more
3/25/2025
/ America First Trade Policy ,
Artificial Intelligence ,
Beverage Manufacturers ,
Department of Health and Human Services (HHS) ,
Employer Liability Issues ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Safety ,
International Trade ,
PFAS ,
Regulatory Agenda ,
Regulatory Requirements ,
Supply Chain ,
Tariffs ,
Trump Administration
On March 10, the US Department of Health and Human Services (HHS) announced that newly confirmed HHS Secretary Robert F. Kennedy Jr. has directed acting US Food and Drug Administration (FDA) Commissioner Dr. Sara Brenner to...more
On January 6, the US Food and Drug Administration (FDA) published in the Federal Register a notice announcing its determination that 35 previously authorized Food Contact Notifications (FCNs) for food contact substances...more
1/9/2025
/ Compliance ,
Enforcement ,
Final Rules ,
Food and Drug Administration (FDA) ,
Hazardous Substances ,
PFAS ,
Product Packaging ,
Public Health ,
Regulatory Requirements ,
State and Local Government ,
Toxic Chemicals
California Bans Several FDA-Authorized Food Additives; New York May Soon Follow -
On October 7, California Governor Gavin Newson signed into law AB-418, the California Food Safety Act, which completely bans, on safety...more
On October 7, California Governor Gavin Newson signed into law AB-418, the California Food Safety Act, which completely bans, on safety grounds, the use in food of four additives that are considered safe by the US Food and...more
On July 21, 2023, the US Food and Drug Administration (FDA) issued a letter denying a request that it reconsider its decision from May 2022 that it would not prohibit the use of eight phthalates as food-contact substances. At...more
A lawsuit by anti-fluoridation activists has forced the early release of a long-awaited government report on fluoride and its possible association with neurodevelopment and cognition while the report is still in draft form...more
FDA joins industry groups in opposing Prop 65 cancer listing for BPA -
Chemical Watch -
The US Food and Drug Administration has joined a pair of industry trade groups in opposing the potential listing of bisphenol A as...more
On September 28, 2022, the Food and Drug Association announced a proposed rule to redefine the implied nutrient content claim term “healthy” to more closely reflect current nutrition science and Federal dietary guidelines....more
The Food and Drug practice at ArentFox Schiff has received numerous inquiries from clients about long COVID, so we decided to ask our in-house scientist, Robert Edwards, Ph.D., Director of Regulatory Science, to prepare an...more
On November 18, 2021, just a few days before the Omicron variant suddenly revealed itself to the world, the preliminary results of two Phase III clinical trials were announced by AstraZeneca, bringing new hope to high-risk...more
On February 24, 2021, we first reported on the most significant variants of the novel coronavirus then emerging across the globe and here in the United States.
In that Alert, we included the prediction by the Centers for...more
It covers both single-use (disposable) and reusable products for use by workers and by the general public.
ASTM International, formerly the American Society for Testing and Materials, is a premier international standards...more
FDA has been monitoring the emergence of novel coronavirus mutations and variants and their potential for impacting the results of currently authorized COVID-19 tests.
On February 22, FDA issued a new Guidance for...more
The presence in the blood of antibodies specific to the novel coronavirus may help identify those who were unknowingly exposed to the virus but remained asymptomatic, those who were symptomatic but have fully recovered, and,...more
The latest clinical data casts doubt on the safety and efficacy of these antimalarial drugs for treatment of COVID-19, and both the FDA and an Expert Panel of the NIH have just warned against their use outside of clinical...more
On March 31, Health & Human Services Secretary Alex Azar announced the creation of a new FDA program, the Coronavirus Treatment Acceleration Program (“CTAP”), designed to speed up the development of life-saving treatments...more
Arent Fox continues to monitor the FDA activities and scientific reports on COVID-19 and the novel coronavirus.
On March 24, FDA announced that it would allow the use of convalescent plasma from recently recovered COVID-19...more
In a letter dated March 28, FDA announced it was issuing an Emergency Use Authorization for oral formulations of chloroquine phosphate and hydroxychloroquine sulfate for the treatment of COVID-19.
The drugs are to be...more
Food Safety
On March 9, the European Food Safety Authority announced that there is no evidence that food is a source or transmission route for coronavirus. FDA has taken the same position, both in a stakeholder briefing held...more