I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - FDA Regulated Natural Products: Leveraging IP and Regulatory Requirements to Maximize Possible Return on Investment
This week, the Natural Products Association (NPA) filed a lawsuit against New York State challenging the constitutionality of a new state law prohibiting the sale of over-the-counter diet pills and dietary supplements for...more
CBD and CBD-containing products are ubiquitous, yet there is significant misunderstanding about their regulatory status. CBD is cannabidiol, one of more than a hundred different active compounds that can be derived from the...more
On March 31, 2020, the United States Food and Drug Administration (FDA) issued guidance surrounding notification procedures if a manufacturer suffers a permanent discontinuance or interruption in manufacturing under the...more
If enacted, the law would amend the Federal Food, Drug, and Cosmetic Act (FDCA) to require cosmetic products labeled as “natural” to contain at least 70 percent natural substances, (excluding water and salt) and be made...more
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
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
Senate Committee Proposes Cosmetics Regulation Amendment - The Senate Committee on Health has released a discussion draft of a proposed amendment to the Federal Food, Drug and Cosmetic Act (FDCA) that would establish greater...more
USDA Withdraws Organic Livestock and Poultry Rule - The U.S. Department of Agriculture (USDA) has issued a final rule withdrawing the Organic Livestock and Poultry Practices Rule, leaving existing organic regulations in...more
FDA Issues Draft Guidance for Homeopathic Drug Products - The U.S. Food and Drug Administration (FDA) has issued draft guidance, "Drug Products Labeled as Homeopathic," that would prioritize enforcement and regulatory...more
The use of beauty products is “an understudied source of environmental chemical exposures” with a disparate effect on women of color, George Washington University and Occidental College researchers argue. Ami R. Zota, et al.,...more
Chicago Repeals SSB Tax After Two Months of Enforcement - Chicago officials have voted to repeal a sugar-sweetened beverage (SSB) tax approved in November 2016 by the Cook County Board of Commissioners but delayed by a...more
As plant-based beverages appear on more store shelves, the definition of “milk” has become the center of a dispute involving legislatures, regulators, litigators and industry groups. Shook Partners Katie Gates Calderon and...more
Food for Thought is a review of significant court decisions affecting the food, beverage, dietary supplements and personal care products industry. Although many cases in this edition focus on class certification, others...more
Most of us understand that the facts that give rise to the legal issues we face are sometimes sewn far in advance. This is certainly true in the area of product claims or statements. ...more
The Ninth Circuit Court of Appeals recently addressed preemption in the context of food and cosmetic labeling. Food Manufacturers Can Label Honey as “Honey” - In June, the Ninth Circuit issued an opinion in Brod v....more
In April 2015, the Ninth Circuit held in a cosmetic labeling class action that the Food, Drug, and Cosmetic Act (FDCA) did not expressly preempt state causes of action predicated on federal cosmetics labeling laws and that...more