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Manufacturers Food and Drug Administration (FDA) Labeling

Searcy Denney Scarola Barnhart & Shipley

Exploring Treatment Options for Exactech Shoulder Issues: Surgery vs. Non-Surgical Approaches

The U.S. Food and Drug Administration (FDA) has issued a Safety Communication advising healthcare providers to stop implanting Equinoxe Shoulder System joint replacement devices manufactured by Exactech. The Safety...more

Hogan Lovells

FDA Announces Significant Changes for Pre-Market Animal Feed Ingredient Reviews

Hogan Lovells on

In an August 8 press release, the US Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) announced that it does not intend to renew its longstanding memorandum of understanding (MOU) with the Association...more

Davis Wright Tremaine LLP

Six Key Takeaways on Dietary Supplement Regulation, 30 Years Post-DSHEA

Dietary supplement industry leaders and regulators gathered in Salt Lake City in June to examine the current status of the Dietary Supplement Health and Education Act of 1994 (DSHEA), 30 years after that legal building block...more

Troutman Pepper

TTB Seeking Public Input on Potential Alcoholic Beverage Labeling Changes

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As we previously reported, the Treasury Department released a 2022 report on Competition in the Markets for Beer, Wine, and Spirits (the Competition Report) recommending, in part, that the Alcohol and Tobacco Tax and Trade...more

Nutter McClennen & Fish LLP

Product Liability 2023 Year in Review

Massachusetts federal and state courts issued several important product liability decisions in 2023. Nutter’s Product Liability practice group reviewed these cases and report on their significant holdings as follows ...more

BakerHostetler

FDA Issues Final Guidance on Registration and Listing of Cosmetic Product Facilities and Products

BakerHostetler on

Last month the United States Food and Drug Administration (“FDA”) issued its final guidance (“Guidance”) for the industry on cosmetic product facility registrations and product listings, as required by the Modernization of...more

Wilson Sonsini Goodrich & Rosati

FDA Cracks Down on Unapproved Eye Products

On September 12, 2023, the U.S. Food and Drug Administration (FDA) issued warning letters to eight companies, including two major drugstore retail chains, for their involvement in the production or promotion of unapproved...more

BakerHostetler

Transforming Cosmetics Regulation: FDA’s Mandatory Compliance Shift for Safer Beauty

BakerHostetler on

On August 7, 2023, the U.S. Food and Drug Administration (FDA, the Agency) published draft guidance aimed at assisting cosmetics companies with achieving and maintaining compliance with new cosmetic product facility...more

Troutman Pepper

U.S. District Court Vacates FDA Deeming Rule With Respect To Premium Cigars

Troutman Pepper on

On August 9, 2023, Judge Amit P. Mehta of the US District Court for the District of Columbia issued his decision vacating the decision of the Food and Drug Administration (“FDA”) to “deem” premium cigars covered by FDA’s 2016...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation and Regulatory Update - July 2023 #2

LEGISLATION, REGULATIONS & STANDARDS - FDA Issues Update on Sesame Allergen Labeling - The U.S. Food and Drug Administration (FDA) has released an FDA Voices “Catching Up with Califf” update that addresses the...more

Sheppard Mullin Richter & Hampton LLP

FDA Draft Guidance Signifies Acceptance of the Term “Milk” to Describe Plant-Based Alternatives

The Food and Drug Administration (FDA) has released draft guidance for the labeling of plant-based milk alternatives, which could have a significant impact on the way these products are marketed and sold. The proposed...more

Foley Hoag LLP

Product Liability Update - January 2023

Foley Hoag LLP on

MASSACHUSETTS - Massachusetts Federal Court Holds State Law Claims Alleging Misleading “Rapid Release” Labeling Of OTC Acetaminophen Tablets Preempted By Federal Food, Drug, And Cosmetic Act, As Tablets’ Dissolution Rate...more

MoFo Life Sciences

Congress Expands FDA Authority Over Cosmetics Regulation

MoFo Life Sciences on

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was passed by the U.S. Congress as part of the omnibus Consolidated Appropriations Act enacted on December 29, 2022 and will grant the U.S. Food and Drug...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

Hogan Lovells

Modernization of U.S. cosmetics regulation will be phased in over time - A detailed overview and preliminary analysis of the new...

Hogan Lovells on

On December 29, 2022, U.S. President Biden signed into law the "Consolidated Appropriations Act, 2023," which includes the Modernization of Cosmetics Regulation Act of 2022 (MOCRA). MOCRA reflects the most significant...more

Gardner Law

Transatlantic Legal-Regulatory Update: Live from the Heart of Silicon Valley

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US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more

Dechert LLP

Not Prescription, Not Merely Over the Counter: FDA Proposes a Novel Category of Drugs

Dechert LLP on

In June of this year, FDA announced a proposed rule that would permit approval for nonprescription drug products with an Additional Condition for Nonprescription Use—a category of nonprescription drugs where FDA determines...more

Alston & Bird

Bringing Dietary Supplements to Market: Key Requirements and Best Practices

Alston & Bird on

Whether you are looking to enter the market or grow your footprint in the industry, you need to know what regulations are relevant and how to prepare to bring a dietary supplement to market. ...more

Cozen O'Connor

California Splits from the FDA: CBD Now Permitted in Food, Beverages and More

Cozen O'Connor on

On Wednesday, October 6, 2021, California Governor Gavin Newsom signed into law Assembly Bill 45 (AB-45) that “prohibit[s] restrictions on the sale of dietary supplements, food, beverages, cosmetics, or pet food that include...more

Vicente LLP

California Now Permits the Manufacture and Retail Sale of Hemp-Derived Products — Including CBD

Vicente LLP on

On October 6, 2021, Governor Newsom signed AB-45 into law. The bill, which takes effect immediately, permits the sale of food, beverages, dietary supplements, pet products, and cosmetics containing hemp-derived ingredients,...more

Searcy Denney Scarola Barnhart & Shipley

FDA: Blood Volume Expanders Present Severe Risks for Patients

On July 7, 2021, the U.S. Food and Drug Administration (FDA) issued new warnings regarding hydroxyethyl starch (HES) blood volume expanders. Specifically, the FDA is now requiring manufacturers to update the safety labels for...more

Dechert LLP

FDA’s Proposal For Listing Materials on Medical Device Labeling: Considerations for Industry

Dechert LLP on

Key takeaways - FDA is soliciting feedback on a proposed framework to change medical device labeling to require long-term devices to identify all constituent materials that might come into contact with human tissue and to...more

Alston & Bird

Food & Beverage Digest - April 2021

Alston & Bird on

Welcome to the latest edition of the Food & Beverage Digest, our roundup of court cases and regulations affecting the food, beverage, agribusiness, and cosmetics industries. This month, someone moved someone’s smoked...more

King & Spalding

GSK v. Teva and Induced Infringement by AB-Rated Generics: Where Are We Now?

King & Spalding on

The Federal Circuit’s October 2020 split decision in GSK v. Teva made waves throughout the pharmaceutical industry and among Hatch-Waxman litigators.  In the broadest reading, some see the majority opinion as rendering any...more

BakerHostetler

Companies Entering the Disinfectant and Sanitizer Markets Should Proceed With Caution

BakerHostetler on

As COVID-19 swept across the country in March 2020, it became abundantly clear to anyone who visited a grocery store that the United States was facing a severe shortage of essential products. Among some of the more noticeable...more

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