News & Analysis as of

Product Labels Manufacturers Food and Drug Administration (FDA)

Kilpatrick

E.D.N.Y. deals blow to plaintiffs’ claims – including mislabeling, false advertising and RICO claims – in multidistrict litigation...

Kilpatrick on

Takeaway: When it comes to mislabeling and related claims, and especially when human safety is not implicated, express preemption under the federal Food, Drug and Cosmetic Act (FDCA) remains a powerful tool in the hands of...more

J.S. Held

Inside the Healthcare Industry: The Impact of Human Factors & User Experience in Healthcare

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Human Factors and User Experience testing play an important role in healthcare settings and in the development of healthcare products. They can greatly impact the delivery of care, and the patient experience delivered by...more

Troutman Pepper

Virginia Takes Action Against Retailer Selling THC Products

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On September 14, Virginia’s Attorney General (AG) Jason Miyares issued a letter to the registered agent of the Good Vibes Shop, a Radford, VA store, for selling tetrahydrocannabinol (THC) products without proper labeling and...more

Husch Blackwell LLP

MoCRA: Facility Listing and Cosmetic Registration with FDA Direct

Husch Blackwell LLP on

As discussed in the Product Perspective, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents a major shift in cosmetic industry regulations. This article is one of a series of posts diving into each...more

Troutman Pepper

Industry Urges SCOTUS to Consider FDA Graphic Cigarette Warnings

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In August, a group of tobacco companies filed a petition for certiorari at the U.S. Supreme Court, seeking review of a lower court’s holding that the First Amendment does not prohibit the U.S. Food and Drug Administration...more

Integral Consulting Inc.

Can This Product Hurt Me? Assessing Health Risk in Certain Personal Care Products

Personal care products include a wide range of items such as cosmetics, skin care products, hair care products, deodorants, and more. Two of the largest segments of these products are shampoo and hair dye. In 2022, there were...more

Wiley Rein LLP

Time’s Up! Cosmetic Facilities Must Comply With FDA’s New Registration Requirements by July 1

Wiley Rein LLP on

The July 1, 2024 deadline is fast approaching for cosmetic product manufacturers to comply with new registration and listing requirements under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Passage of the...more

Arnall Golden Gregory LLP

Magic’s in the Makeup: FDA Modernizes Cosmetic Product Labeling Requirements

“Can’t be good for my health,” a song lyric from Gwen Stefani and No Doubt’s early 2000s single, “Magic’s in the Makeup,” comes to mind when we think of the Food and Drug Administration’s possible motives for recent...more

Epstein Becker & Green

FDA Releases Updated Directory on Select Dietary Supplement Ingredients

Epstein Becker & Green on

Whether a consumer is taking calcium carbonate for strong bones, magnesium to fall asleep, or high-dose caffeine to stay awake, the U.S. Food and Drug Administration (FDA) does not approve dietary supplements for safety and...more

Blank Rome LLP

FDA Make-Over of Cosmetics Regulations is Not Limited to Cosmetics Businesses

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The Food and Drug Administration (“FDA”) will begin enforcement of the Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”) on July 1, 2024. MoCRA represents the biggest regulatory overhaul for the cosmetics industry...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

McGuireWoods LLP

FDA Publishes Two Key Guidance Documents on Cosmetics Facility Registration and Product Listing

McGuireWoods LLP on

The U.S. Food and Drug Administration (FDA) had a busy end of 2023 regarding cosmetics facility registration and product listing, which are now required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)....more

Morgan Lewis

Register, List, Report, Repeat: FDA Clarifies MOCRA Cosmetics Requirements

Morgan Lewis on

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) brought significant changes for the US Food and Drug Administration’s (FDA’s) regulation of cosmetic products. Recent FDA action, including the issuance of final...more

Beveridge & Diamond PC

MoCRA Update for Starting the Year Off Right

Beveridge & Diamond PC on

Key Takeaways - What Happened: The Food and Drug Administration (FDA) released four updates regarding MoCRA in December....more

Mintz - Health Care Viewpoints

Looking Back and Moving Forward: MoCRA Regulatory Developments Ring in the New Year

A year has passed since Congress enacted the Modernization of Cosmetics Regulation Act (MoCRA) and enhanced the Food and Drug Administration’s (FDA) authority to regulate the cosmetics industry. Although MoCRA implementation...more

Locke Lord LLP

FDA Issues Updates as MoCRA ‎Deadlines Approach

Locke Lord LLP on

As the December 29, 2023 deadline for certain aspects of the Modernization of Cosmetics Regulation Act (“MoCRA”) approaches, FDA has finalized its guidance document governing the registration of cosmetic manufacturing...more

Shook, Hardy & Bacon L.L.P.

FDA to Push Back Enforcement of Certain MoCRA Requirements

The U.S. Food and Drug Administration (FDA) has announced that it intends to delay enforcement of cosmetic product facility registration and product listing requirements under the Modernization of Cosmetics Regulation Act...more

Beveridge & Diamond PC

MoCRA Enforcement Pushed Six Months

Beveridge & Diamond PC on

Key Takeaways - What Happened: FDA announced delayed enforcement for MoCRA facility registration and product listing information....more

Vedder Price

The Deadlines for MoCRA are Rapidly Approaching: Are Cosmetic Manufacturers, Packers and Distributors Ready?

Vedder Price on

The Modernization of Cosmetic Regulations Act of 2022 (MoCRA) is part of the Food and Drug Omnibus Reform Act of 2022 (FDORA) that President Biden signed into law late last year. MoCRA greatly expands the FDA’s oversight...more

Locke Lord LLP

FDA Extends Some MoCRA Deadlines

Locke Lord LLP on

On November 8, 2023, FDA issued a Final Guidance entitled Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing (“FDA Guidance”) extending some upcoming deadlines set forth in the...more

Bergeson & Campbell, P.C.

FDA Seeks Comment on Cosmetics Direct and Forms Regarding Registration of Cosmetic Product Facility and Cosmetic Product Listing

On September 15, 2023, the U.S. Food and Drug Administration (FDA) announced that it is seeking comment on its newly developed draft electronic submission portal (Cosmetics Direct) and paper forms (Forms FDA 5066 and 5067)....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

Quarles & Brady LLP

Brace Yourself: DEA’s Final Rule on Quotas Squeezes Inventory Levels and Signals Further Supply Restrictions

Quarles & Brady LLP on

On August 31, 2023, DEA published a final rule (“Final Rule”) regarding its management of controlled substance and List 1 Chemical (“L1 Chemical”) quotas for DEA-registered manufacturers. The Final Rule largely tracks DEA’s...more

Kelley Drye & Warren LLP

FDA’s Draft Guidance on Cosmetics Registration and Listing: A Good Reminder of End-of-Year Deadlines

Earlier this month, in a step toward implementing the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), FDA issued a draft guidance document titled “Registration and Listing of Cosmetic Product Facilities and...more

BCLP

Part 3 in MoCRA Series: FDA Guidance on Cosmetic Product Listings

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The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is is the most significant expansion of FDA’s authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act was passed in 1938. As we...more

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