On April 22, 2025, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) announced a major initiative to voluntarily phase out “petroleum-based synthetic dyes” (i.e., synthetic...more
On April 21, 2025, it was reported that the U.S. Department of Health and Human Services (HHS) has released a media advisory describing the Food and Drug Administration’s (FDA) intention to remove petroleum-based synthetic...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
New Trump Administration tariffs on Canada, Mexico, and China. On February 1, 2025, President Donald Trump signed three Executive Orders instituting sweeping new tariffs on all goods imported from Canada, Mexico, and China,...more
The US Food and Drug Administration (FDA) has released its proposed rule on front-of-package (FOP) nutrition labeling. Announced on January 14, 2025, the proposed rule would add a requirement to include an informational box...more
The Drug Supply Chain Security Act (DSCSA) (section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 USC §360eee – 1) was introduced in response to several drug contamination, counterfeiting, and diversion...more
FDA issues final guidance on lead in baby food. FDA has issued its Final Guidance on Action Levels for Lead in Processed Food Intended for Babies and Young Children as part of its Closer to Zero initiative to reduce dietary...more
On December 17, 2024, Iowans for Alternatives to Smoking & Tobacco, Inc., Global Source Distribution, LLC, and others filed a complaint and motion for a preliminary injunction in federal district court against the Iowa...more
Our Food, Beverage & Agribusiness Team unpacks what companies need to know about the Food and Drug Administration’s final rule on “healthy” food labeling....more
Throughout 2024, the U.S. Food and Drug Administration (FDA) endeavored to curb sales of unauthorized electronic nicotine delivery systems (ENDS) in the U.S. In light of persistent demand for flavored ENDS — nearly all of...more
The U.S. Food and Drug Administration (FDA) has announced a final rule updating the definition of the nutrient content claim “healthy.” To qualify as “healthy” under the updated definition, food products must contain a...more
On December 5, 2024, just in time for the holidays, the U.S. Food and Drug Administration (“FDA” or the “Agency”) released a draft guidance titled “Expedited Program for Serious Conditions: Accelerated Approval of Drugs and...more
On November 21, the FDA sent its proposed rule on front of package (FOP) nutrition labels to the White House Office of Management and Budget (OMB). FOP labeling has been prioritized by the agency as part of a National...more
This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape. FDA seeks input on human food export certification program. Companies that...more
FDA Releases Guidance for Voluntary Qualified Importer Program - The U.S. Food and Drug Administration (FDA) has released guidance with revisions to the Food Safety Modernization Act Voluntary Qualified Importer Program...more
This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications....more
In October, the Oregon Court of Appeals ruled that a law restricting the packaging of e-cigarettes violates the state constitution’s free speech protections. The decision illustrates the utility of free speech arguments...more
The U.S. Codex Office will hold a public meeting on November 14, 2024, to receive public comments on agenda items and U.S. positions for the Codex Alimentarius Commission, held November 25-30, 2024, in Switzerland. Issues to...more
On July 12, 2024, the FDA provided small dispensers—those employing 25 or fewer full-time pharmacists or pharmacy technicians—with an exemption from the Drug Supply Chain Security Act’s (“DSCSA”) enhanced drug distribution...more
On September 17, 2024, the Journal of Exposure Science and Environmental Epidemiology (JESEE) published a paper on the potential human exposure to food contact chemicals (FCCs). Led by a research team at the Food Packaging...more
On October 9, 2024, the Food and Drug Administration (“FDA”) issued a document that provides exemptions to the enhanced drug distribution security requirements (enhanced requirements) required by section 582(g) of the Food,...more
BBB National Programs’ National Advertising Division has recommended that Gruma Corp. discontinue and modify certain claims on its tortilla products. Olé Mexican Foods, Inc., a competitor, challenged Gruma's packaging claims....more
On August 29, 2024, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued an untitled letter to AbbVie, Inc. (AbbVie) regarding a promotional, direct-to-consumer (DTC) television...more
In a previous blog on the use of psychedelics to treat mental health disorders, we reported that the US Food and Drug Administration (FDA) granted breakthrough therapy designation to MDMA (a.k.a., ecstasy) in 2017 as part of...more
A New York woman has filed a putative class action alleging Mondelez Global LLC's Nabisco Whole Grain Premium Saltine Crackers' “whole grain” labeling is misleading because the main flour ingredient is non-whole grain...more