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BakerHostetler

[Podcast] FDA-Regulated Products Supply Chain Disruptions: Industry Perspective

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Supply chain disruptions have become a significant challenge for the U.S. FDA-regulated products industry, affecting the availability of pharmaceuticals, medical devices, and food. These disruptions are caused by various...more

Gardner Law

The Value of MDUFA

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Anyone who has submitted a medical device for pre-market review knows the financial investment it takes to for FDA to conduct its review. Under the Medical Device User Fee Amendments (MDUFA), certain submissions, including...more

Venable LLP

FDA Regulatory Updates for Summer 2025: Food, Supplements, and Cosmetics

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Recent actions by the Food and Drug Administration (FDA or Agency) reflect a sharpened scrutiny in areas where public health and safety may be critical, but a more relaxed approach in areas where it views innovation may be...more

Gardner Law

FDA Signals Interest in Defining Ultraprocessed Foods

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In June 2025, the U.S. Food and Drug Administration announced it is evaluating whether to formally define the term ultraprocessed food (UPF)—a move that could influence future labeling regulations, public health guidance, and...more

Akin Gump Strauss Hauer & Feld LLP

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

Holland & Knight LLP

Red Flags Over Red 40: Heightened Regulatory Scrutiny on Use of Artificial Food Dyes

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The regulatory landscape for consumer-packaged goods (CPG) brands is shifting, with artificial food dyes emerging as a central focus of both state and federal scrutiny. Recent actions by the federal and state governments,...more

MG+M The Law Firm

Bitter Aftertaste: PFAS Found in US Beer

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The Environmental Science & Technology Journal found in a 2025 study that 95% of 23 tested beers brewed across the United States contain varying levels of per- and polyfluoroalkyl substances (PFAS). PFAS are synthetic...more

Jones Day

Georgia Limits Liability for Pesticide Manufacturers

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This week, Georgia's governor signed a new pesticide labeling and liability act (SB 144) ("Act"), amending state law to limit the scope of pesticide manufacturer liability for failure to warn and aligning the state standards...more

Troutman Pepper Locke

PFAS Regulatory Landscape Update — The Message? Stay Tuned.

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The Environmental Protection Agency (EPA) has announced several actions in recent weeks that shed light on the Trump administration’s approach to PFAS regulation....more

Cozen O'Connor

HHS Advocates Mandated Placebo-Controlled Trials for New Vaccines: Implications for Clinical and Regulatory Practice

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The Department of Health and Human Services (“HHS”) recently proposed a policy that would require all new vaccines to undergo placebo-controlled clinical trials prior to FDA approval. The proposal, while controversial, is...more

Mintz - Intellectual Property Viewpoints

Regulation, Enforcement, and Associated Challenges of the ENDS Industry: Part I

In 2016, the U.S. Food and Drug Administration (FDA) began regulating all manufacturers, retailers, and distributors of electronic nicotine delivery systems (ENDS) with following the agency’s promulgation of the Final Deeming...more

Bergeson & Campbell, P.C.

NSF Announces PFAS-Free Certification for Nonfood Compounds and Food Equipment Materials 

On March 24, 2025, NSF announced the release of NSF Certification Guideline 537: PFAS-Free Products for Nonfood Compounds and Food Equipment Materials (NSF 537). The press release states that to be certified, nonfood compound...more

Butler Snow LLP

Turnabout is Fair Play – “Junk Science” Litigation Aftermath: Requisite Retractions and Dubious Do-Overs

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Do plaintiffs’ experts get to put junk science before juries more often than their opinions are excluded? The answer is a resounding “probably.” Even in light of the December 2023 amendment to Federal Rule of Evidence and its...more

Bergeson & Campbell, P.C.

EPA Will Extend Deadline for Reporting Health and Safety Data for 16 Chemicals

The U.S. Environmental Protection Agency (EPA) announced on March 6, 2025, that it plans to issue a rule “soon” to extend the reporting deadline for a rule under Section 8(d) of the Toxic Substances Control Act (TSCA)...more

MG+M The Law Firm

Expanding PFAS Liability: City of Savannah, Georgia's Wake-Up Call

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The legal landscape surrounding per- and polyfluoroalkyl substances (PFAS) is rapidly evolving, with industrial users now facing heightened risks, even if they never directly manufactured these chemicals. This shift is...more

Cozen O'Connor

Purdue Pharma to Pay $7.4 Billion to Settle Thousands of Opioid-Related Lawsuits

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New York AG Letitia James, along with a bipartisan coalition of 15 other state AGs and additional parties, has reached a settlement in principle with members of the Sackler family and Purdue Pharma, Inc., to resolve...more

Hogan Lovells

EU bans BPA in Food Contact Materials: what does it mean for industry?

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Jacqueline Mailly and Anastasia Vernikou of Hogan Lovells and Grégoire Paquet outline the details of the EU regulation introducing a ban on Bisphenol A (BPA) in food contact materials and its implications for industry. On 20...more

Williams Mullen

Environmental Notes - January 2025

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EPA late last year finalized rules banning use of trichloroethylene (TCE) in the United States and certain consumer uses of perchloroethylene (PCE) under the Toxic Substances Control Act (TSCA). Both chlorinated chemical...more

Williams Mullen

TCE and PCE Eliminated from Most Uses

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EPA late last year finalized rules banning use of trichloroethylene (TCE) in the United States and certain consumer uses of perchloroethylene (PCE) under the Toxic Substances Control Act (TSCA). Both chlorinated chemical...more

DLA Piper

Maine DEP Proposes Currently Unavoidable Use Procedures for PFAS in Products Law

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Maine’s Department of Environmental Protection (DEP) recently published a proposed rule prescribing procedures and criteria for determining Currently Unavoidable Uses (CUU) of intentionally added per- and polyfluoroalkyl...more

McGuireWoods LLP

FDA Bans Red Dye No. 3 in Food and Drugs, Sets Deadlines for Manufacturers to Reformulate

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On Jan. 15, 2025, the U.S. Food and Drug Administration revoked its authorization for the use of Red Dye No. 3 in food and ingested medications. Red Dye No. 3, chemically known as erythrosine, is a synthetic color additive...more

Clark Hill PLC

Red Dye No 3: Old Data Induces New Ban

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On January 16, 2025 the federal Food and Drug Administration (FDA) issued notice requiring manufacturers to reformulate their products removing Red Dye No. 3 by January 15, 2027 for food (21 CFR §74.303) and January 18, 2028...more

BakerHostetler

Navigating FDA’s Guidance on Validation and Verification of Analytical Testing Methods for Tobacco Products

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The Food and Drug Administration (FDA) recently issued a final guidance document, Validation and Verification of Analytical Testing Methods Used for Tobacco Products. This nonbinding guidance provides tobacco product...more

Morrison & Foerster LLP

FDA Issues Action Levels for Lead in Baby Food

On January 6, 2024, the U.S. Food and Drug Administration (FDA) issued its final guidance establishing action levels for lead in processed food intended for babies and young children. This is the first FDA guidance directly...more

Stinson LLP

Bottom of the Ninth: Forever Chemical Bans Take Effect in 2025. What's in Your Team Apparel?

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There has been a significant uptick in class action litigation related to sustainability claims, which will only increase after bans in California and New York on forever chemicals in apparel go into effect January 1, 2025....more

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