News & Analysis as of

Distributors Federal Food Drug and Cosmetic Act (FFDCA)

Perkins Coie

FDA Publishes Draft Guidance For Submitting Cosmetic Product Facility Registrations and Product Listings Under MoCRA

Perkins Coie on

The U.S. Food and Drug Administration (FDA) issued draft guidance on August 7, 2023, clarifying new requirements for cosmetic facility registrations and product listings under the Modernization of Cosmetics Regulation Act of...more

Husch Blackwell LLP

MoCRA: Is my product a “cosmetic” and who is my “responsible person”?

Husch Blackwell LLP on

Am I making a “cosmetic product”? If you are a manufacturer, packer, importer, or distributor, the first question you should be asking is whether your product falls under the definition of a “cosmetic product,” which...more

King & Spalding

Nearly a Century in the Making: Congress Modernizes FDA’s Regulation of Cosmetics

King & Spalding on

The Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”) was signed into law alongside other reforms to the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) on December 29, 2022, as part of a broader consolidated...more

Faegre Drinker Biddle & Reath LLP

Preemption of Structure/Function Claims

Seen frequently on grocery items, and especially on dietary supplements, structure/function claims describe the role of a nutrient or ingredient in the structure or function of the human body. Examples include “Calcium builds...more

Harris Beach PLLC

FDA and FTC Take Action Regarding Pandemic-Related Products

Harris Beach PLLC on

In response to the COVID-19 pandemic, numerous manufacturers and distributors of products ranging from CBD, to herbal products and supplements, to ingestible silver, began to market their products as those that could...more

Faegre Drinker Biddle & Reath LLP

FDA Warns Companies about Processing, Distributing and Marketing Unapproved Stem Cell Products

The U.S. Food and Drug Administration (FDA) has issued three letters (one warning letter and two untitled letters) over the last two months of 2019 directed at four different companies focused on the processing, distributing,...more

Buchalter

Regulatory and Product Liability Overview for Distributors of Food Products in California

Buchalter on

Welcome to California! California is a great place to live and work, and we are fortunate to call it home. But there is no sugarcoating the fact that California presents unique and daunting challenges to product...more

Sheppard Mullin Richter & Hampton LLP

Forget About Vermont!: Congress Passes GMO “Labeling” Legislation

On July 14, 2016, the House of Representatives passed S.764 creating a National Bioengineered Food Standard. Importantly for food manufacturers and distributors, the law – expected to be signed by President Obama – will...more

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