News & Analysis as of

Food and Drug Administration (FDA) Personal Care Products Pharmaceutical Industry

Kelley Drye & Warren LLP

Two Class Actions Take a ShOt at Substantiation for Lemme’s GLP-1 Daily Supplement

Two new class action complaints, both captioned Robins v. Lemme Inc., were filed in in California Superior Court and the Southern District of New York on February 19 and March 9, respectively....more

Searcy Denney Scarola Barnhart & Shipley

The Role of the FDA in Regulating Eye Drops to Prevent Contamination

Contaminated eye drops present serious risks. Not only can they cause blindness and other serious medical conditions, but they have also been linked to at least four cases of premature death caused by severe bacterial...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

Shook, Hardy & Bacon L.L.P.

Congress Gives FDA Oversight Over Cosmetics, Punts on Dietary Supplement Reforms

In a year-end $1.7 trillion spending package in late December, Congress voted to increase FDA's oversight of cosmetics and their ingredients. A portion of the bill titled the Modernization of Cosmetics Regulation Act requires...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - March 2022

Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more

McDermott Will & Schulte

Detailed Summary of Federal Requirements for Production of Hand Sanitizing Products

To meet the growing need for hand sanitizing products, various federal agencies including the Alcohol Tobacco Tax and Trade Bureau (TTB), Federal Drug Administration (FDA), Health and Human Services (HHS) and Congress have...more

Shook, Hardy & Bacon L.L.P.

Dietary Supplement & Cosmetics Legal Bulletin l June 2019

LEGISLATION, REGULATIONS & STANDARDS - FDA Study Finds Sunscreen is Absorbed into Bloodstream - JAMA has published a study conducted by researchers at the U.S. Food and Drug Administration (FDA) Center for Drug...more

Hogan Lovells

FDA Doubles Down on MUsT Studies for Sunscreens and Issues Final Guidance on Absorption Studies that Will Likely Be Needed for...

Hogan Lovells on

On May 10, 2019, FDA published a notice of availability for a final guidance document on Maximal Usage Trials (MUsT studies) for topically applied active ingredients being considered for OTC drug monographs, including...more

Hogan Lovells

With the Statutory Deadline Approaching, FDA Issues a Proposed Sunscreens Rule

Hogan Lovells on

On February 26, FDA published the proposed rule, “Sunscreen Drug Products for Over-the-Counter Human Use,” which describes the conditions under which Over-the-Counter (OTC) sunscreen monograph products are generally...more

Shook, Hardy & Bacon L.L.P.

Dietary Supplement & Cosmetics Legal Bulletin l November 2018

LEGISLATION, REGULATIONS & STANDARDS - Personal Care Products Legislation Introduced in Congress - Rep. Janice Schakowsky (D-Ill.) has introduced the Safe Cosmetics and Personal Care Products Act of 2018, which would...more

Shook, Hardy & Bacon L.L.P.

Dietary Supplement & Cosmetics Legal Bulletin | June 2018

LEGISLATION, REGULATIONS & STANDARDS - Hawaii Bans Two Sunscreen Ingredients - The Hawaii legislature has passed a law that will prohibit the sale or distribution of sunscreen containing oxybenzone and octinoxate after...more

Shook, Hardy & Bacon L.L.P.

Dietary Supplement & Cosmetics Legal Bulletin | April 2018

FDA Issues Guidance on Concentrated Caffeine - The U.S. Food and Drug Administration (FDA) has released guidance clarifying that "dietary supplements containing pure or highly concentrated caffeine in powder or liquid...more

Shook, Hardy & Bacon L.L.P.

Dietary Supplement & Cosmetics Legal Bulletin | December 2017

Sen. Hatch Introduces New Bill Regulating Cosmetic Safety - Sen. Orrin Hatch (R-Utah) has introduced legislation aiming to modernize cosmetics regulation, proposing amendments to the Federal Food, Drug and Cosmetic Act...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - April 2016

Arnall Golden Gregory LLP's (AGG) Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s...more

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