Under the leadership of U.S. Food and Drug Administration (FDA) Commissioner Dr. Martin Makary, the agency has undergone significant change in the first year of President Donald Trump's second term. As part of the changes...more
For the first time in 26 years, the US Food and Drug Administration (FDA) has proposed adding a new active ingredient to the list of permissible sunscreen actives in the United States....more
Welcome to FDA in Flux — A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies....more
FDA has published a proposed administrative order to include bemotrizinol (BEMT) as an active ingredient in over-the-counter (OTC) sunscreen products under the U.S. sunscreen monograph. The list has remained largely unchanged...more
The U.S. Food and Drug Administration (FDA) on Dec. 11, 2025, announced a proposed administrative order to add bemotrizinol as a new active ingredient to the over-the-counter (OTC) sunscreen monograph. This is the first new...more
The pressure is building for the U.S. Food and Drug Administration (FDA) to take steps to facilitate making more drugs available over-the-counter (OTC) that currently require a prescription. As part of the Congressional...more
On November 12, 2025, President Trump signed H.R. 5371, the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026, into law (P.L. 119-37). In addition...more
In the Continuing Resolution and Appropriations Package (H.R. 5371), enacted into law on November 12, 2025, Congress included several new provisions regarding over-the-counter (OTC) drug and sunscreen products....more
On October 28, 2025, the State of Texas filed a complaint against Johnson & Johnson and Kenvue, Inc. (“Kenvue”)—formerly the consumer health division of Johnson & Johnson, and now in the process of being acquired by...more
The pharmaceutical retailer AvKARE has published a voluntary recall notice for five different types of eye drops previously available through the company’s online store. The recall involves products sold by BRS Analytical...more
As debate intensifies over acetaminophen and autism claims, manufacturers, distributors and health care providers should review coverage options to manage potential liabilities....more
If you or a loved one has been harmed by a defective drug, you may have grounds to file a lawsuit against the manufacturer. ...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
The U.S. Food and Drug Administration announced yesterday that it will require drug manufacturers to change the label to products containing acetaminophen to reflect an alleged association between taking the drug during...more
In recent years, many of the world’s biggest pharmaceutical companies have carved out and spun off their consumer health divisions in an effort to refocus on core strategic areas and free up cash for investment. Here, we...more
Health care is a consistently active area for policymakers on Capitol Hill. This alert highlights five health policy issues to watch as Congress returns from August recess. While the fiscal year 2026 (FY26) appropriations...more
In March 2020, Congress enacted the first Over-the-Counter (OTC) Monograph Drug User Fee program (OMUFA) as part of the CARES Act (P.L. 116 – 136) to modernize the Food and Drug Administration’s regulation of OTC monograph...more
The Texas Legislature was back in full swing last week as the House restored quorum following the return of most Democratic members. With legislative business fully resumed, lawmakers made swift progress on a range of...more
In July 2022, the agency formerly known as the Puerto Rico Auxiliary Secretariat for Regulation and Accreditation of Health Facilities (SARAFS), now the Auxiliary Secretariat for the Regulation of Public Health (SARSP),...more
FDA’s recent focus on potentially harmful color additives in food products has expanded to the pharmaceutical sector. In May 2025, FDA issued a draft guidance titled Replacing Color Additives in Approved or Marketed Drug...more
In a unanimous opinion issued today, the Pennsylvania Supreme Court has ruled that any item that is part of a health care provider’s treatment plan falls within the purview of medical services and the broad-encompassing...more
When was the last time you thought about “data on file” (“DOF”)? Probably not recently, but last week, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) posted an untitled letter (the...more
From medical devices to OTC drugs, preemption to expert preclusion, New York state and federal courts issued decisions in 2024 which further shaped the landscape in the medical and life sciences legal world. To prepare the...more
The US Food and Drug Administration (FDA)’s recently issued final rule establishing application, labeling, and postmarketing reporting requirements for a nonprescription drug product with an “additional condition for...more
As the new year begins, change is afoot inside the Beltway as the 119th Congress gets underway and Washington prepares for President Trump’s second administration. While change is bringing uncertainty on some fronts, health...more