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Jan 24, 2025 | 
mondaq.com | Sophia Gaulkin |Riette van Laack |Riëtte van Laack
Readers of this blog likely are familiar with the ongoing, oftencontentious battle over the labeling of plant-based foods (see,e.g., here, here, and here). Nearly two years after FDA issued draft guidance on Labeling of Plant-Based Milk Alternatives andVoluntary Nutrient Statements, on January 6, 2025, FDA releaseddraft guidance document on plant-based labeling, Labeling Plant-Based Alternatives to Animal-DerivedFoods.
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Jan 20, 2025 | 
thefdalawblog.com | Riette van Laack |Riëtte van Laack |Sophia Gaulkin
Readers of this blog likely are familiar with the ongoing, often contentious battle over the labeling of plant-based foods (see, e.g., here, here, and here). Nearly two years after FDA issued draft guidance on Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements, on January 6, 2025, FDA released draft guidance document on plant-based labeling, Labeling Plant-Based Alternatives to Animal-Derived Foods.
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Jan 20, 2025 | 
mondaq.com | Riette van Laack |Riëtte van Laack
A little over two years ago, the Modernization of CosmeticRegulation Act (MoCRA) was (at long last) enacted. The passing ofthe law which, among other things, amended the Federal Food, Drug,and Cosmetic Act to include requirements for facility registrationand product listing, safety substantiation, adverse eventreporting, and requirements for FDA to issue several newregulations, brought excitement and anxiety.
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Jan 17, 2025 | 
mondaq.com | Sophia Gaulkin |Riette van Laack |Riëtte van Laack
On January 6, 2025, FDA released two final guidance documents onfood allergens: Questions and Answers Regarding Food Allergens,Including the Food Allergen Labeling Requirements of the FederalFood, Drug, and Cosmetic Act (Edition 5), and Evaluating the Public Health Importance of FoodAllergens Other Than the Major Food Allergens Listed in the FederalFood, Drug, and Cosmetic Act.
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Jan 15, 2025 | 
thefdalawblog.com | Riette van Laack |Riëtte van Laack
A little over two years ago, the Modernization of Cosmetic Regulation Act (MoCRA) was (at long last) enacted. The passing of the law which, among other things, amended the Federal Food, Drug, and Cosmetic Act to include requirements for facility registration and product listing, safety substantiation, adverse event reporting, and requirements for FDA to issue several new regulations, brought excitement and anxiety.
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Jan 14, 2025 | 
thefdalawblog.com | Riette van Laack |Riëtte van Laack |Sophia Gaulkin
On January 6, 2025, FDA released two final guidance documents on food allergens: Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5), and Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act.
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Jan 8, 2025 | 
mondaq.com | Riette van Laack |Riëtte van Laack
HP Hyman, Phelps, & McNamara More Hyman, Phelps & McNamara, the largest FDA-focused law firm in the U.S., specializes in comprehensive legal solutions for companies regulated by the FDA and related agencies like the DEA, CMS, and USDA. The firm assists with regulatory compliance, product lifecycle management, marketing compliance, and due diligence, offering practical, responsive, and client-focused legal strategies.
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Sep 18, 2024 | 
thefdalawblog.com | Riette van Laack |Riëtte van Laack
The dietary supplement exclusionary clause is, as its name suggests, a clause in the Federal Food, Drug, and Cosmetic Act (FDC Act) definition of dietary supplement. That clause excludes those ingredients that were first marketed as drug ingredients.
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Jul 8, 2024 | 
thefdalawblog.com | JP Ellison |Riette van Laack |Riëtte van Laack
On Thursday, the 27th of June, the Supreme Court issued its decision in Securities and Exchange Commission v. Jarkesy. The court ruled that the Securities and Exchange Commission (SEC) may not impose fines to penalize securities in its administrative proceedings because that practice violates the Seventh Amendment “right of trial by jury” in all “suits at common law.” This decision likely will impact other federal administrative agencies, including those relevant to our practice.
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Mar 5, 2024 | 
thefdalawblog.com | Riette van Laack |Riëtte van Laack |Sophia Gaulkin
As readers of this blog know, there is a lot of contention about the naming of alternative protein products (APPs), including both plant-based and cell-cultured alternatives for (traditional) animal products. The animal product industry, particularly the beef industry and the dairy industry, has challenged naming of APPs using what they consider to be traditional meat terminology.
