Natalie Rainer on Food and Drug Administration (FDA)

Microplastics Under the Microscope: Federal and California Proposals Target Microplastics

On 17 July 2025, a bipartisan bill aimed at uncovering the potential human health implications of exposures to microplastics in the food and water supply was introduced into Congress. Introduced by Rep. Janelle Bynum (D-OR),...more

7/24/2025 / California , Chemicals , Environmental Policies , Food and Drug Administration (FDA) , Healthcare , New Legislation , Proposed Legislation , Public Health , Regulatory Reform , Toxic Chemicals

Litigation Minute: Tough to Swallow: Increased State Regulation of and Attention on Contaminants in Food

What You Need to Know in a Minute or Less - Until recently, state regulators largely deferred to the US Food and Drug Administration (FDA) to scrutinize and regulate contaminants in food, such as heavy metals. In the past...more

5/13/2025 / Class Action , Contamination , Food and Drug Administration (FDA) , Food Labeling , Food Manufacturers , Food Safety , Litigation Strategies , Proposed Legislation , Proposition 65 , State and Local Government , Toxic Chemicals

FDA Proposes Front-of-Package Labeling Requirements

On 14 January 2024, the US Food and Drug Administration (FDA) issued a proposed rule to be published on 16 January, which, if finalized, will require a front-of-package (FOP) nutrition label on most packaged foods. This FOP...more

1/27/2025 / Consumer Protection Laws , Final Rules , Food and Drug Administration (FDA) , Food Labeling , Product Labels , Product Packaging , Proposed Rules , Public Health , Regulatory Requirements , Rulemaking Process

FDA Revokes Authorization for the Use of Red Dye No. 3 in Food and Ingestible Drugs

On 15 January 2025, the US Food and Drug Administration (FDA) announced that it will revoke the color additive authorization for use of FD&C Red No. 3 in food (including dietary supplements) and ingestible drugs. This ban...more

1/24/2025 / California , Cancer , Drug Safety , Federal Food Drug and Cosmetic Act (FFDCA) , Final Rules , Food and Drug Administration (FDA) , Food Manufacturers , Life Sciences , Pharmaceutical Industry , Regulatory Requirements

FDA Affirms Its Decision to Remove 25 Plasticizers From the Food Additive Regulations

In a continuation of the US Food and Drug Administration's efforts to conduct post-market reviews evaluating the continued use and safety of chemicals authorized in its regulations, the agency is removing decades-old...more

12/2/2024 / Chemicals , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Plastics , Toxic Chemicals

Obtaining Clearances Through FDA's Food Contact Notification Program

The US Food and Drug Administration’s (FDA) formal regulation of food packaging began in 1958 with the Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act. Since that time, the FDA has employed various...more

9/10/2024 / Environmental Assessments , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Food Contamination , Food Manufacturers , Food Products . , Food Safety , Product Packaging , Regulatory Oversight , Safety Standards

FDA Weighs in on Microplastics and Nanoplastics in Food

In a development that is expected to complicate many litigation challenges alleging that the presence of low levels of microplastics in food is inherently unsafe, officials from the US Food and Drug Administration (FDA or...more

7/30/2024 / Corporate Counsel , Food and Drug Administration (FDA) , Food Safety , Plastics , Public Health , Regulatory Oversight , Risk Assessment

Litigation Minute: Beauty From Within and the Confusing Claims Landscape

What You Need To Know In A Minute Or Less - The current industry trend “beauty from within” refers to a focus on wellness—namely physical, mental, and lifestyle—and its impact on beauty. Oral supplements that consumers can...more

3/15/2024 / Advertising , Cosmetics , Dietary Supplements , FDA Warning Letters , Federal Food Drug and Cosmetic Act (FFDCA) , Federal Trade Commission (FTC) , Food and Drug Administration (FDA) , Marketing , Pharmaceutical Industry , Risk Mitigation

An Overview of the US Food and Drug Administration's Legislative Goals (Part I)

In anticipation of the US Food and Drug Administration (FDA) budget request for Fiscal Year (FY) 2025, this alert provides an overview of the agency’s most recent priorities as outlined in FDA’s FY 2024 budget, found here....more

1/26/2024 / Animal Drugs , Federal Food Drug and Cosmetic Act (FFDCA) , Food & Drug Regulations , Food and Drug Administration (FDA) , Food Labeling , Food Manufacturers , Generic Drugs , Imports , Pharmaceutical Industry , Pharmaceutical Patents , Policies and Procedures , Product Labels , Public Health , Regulatory Oversight , Regulatory Standards

Natalie Rainer

K&L Gates LLP

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