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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 Nearly two years after FDA issued draft guidance on Labeling of Plant-Based Milk Alternatives andVoluntary Nutrient Statements, on January 6, 2025, FDA releaseddraft guidance document on plant-based labeling,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 Nearly two years after FDA issued draft guidance on Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements, on January 6, 2025, FDA released draft guidance document on plant-based labeling, Labeling Plant-Based Alternatives to Animal-Derived Foods.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 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 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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Apr 16, 2024 | 
thefdalawblog.com | Sophia Gaulkin
On April 10, the Fourth Circuit unanimously affirmed a summary judgment ruling for the Centers for Medicare & Medicaid Services (CMS) regarding the agency’s definitions of “line-extension drug” and “new formulation” for purposes of determining rebates that drug manufacturers may owe the Medicaid Drug Rebate Program (MDRP). Vanda Pharmaceuticals, Inc. v. Centers for Medicare and Medicaid Servs., No. 23-1457 (4th Cir. Apr. 10, 2024).
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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.
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Dec 19, 2023 | 
mondaq.com | Sophia Gaulkin |Riette van Laack |Riëtte van Laack
On November 30, FDA's Center for Veterinary Medicine (CVM)
released a draft guidance, "Using Relative
Supersaturation to Support 'Urinary Tract Health' Claims
for Adult Maintenance Cat Food," to provide recommendations
for how pet food companies manufacturers can use relative
supersaturation (RSS) methodology to support urinary tract health
(UTH) claims for certain adult maintenance cat food.
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Dec 13, 2023 | 
thefdalawblog.com | Riette van Laack |Riëtte van Laack |Sophia Gaulkin
On November 30, FDA’s Center for Veterinary Medicine (CVM) released a draft guidance, “Using Relative Supersaturation to Support ‘Urinary Tract Health’ Claims for Adult Maintenance Cat Food,” to provide recommendations for how pet food companies manufacturers can use relative supersaturation (RSS) methodology to support urinary tract health (UTH) claims for certain adult maintenance cat food.
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Nov 27, 2023 | 
mondaq.com | Sophia Gaulkin |Riette van Laack |Riëtte van Laack
For any of our readers seeking recommendations on which drinks
pair well with turkey this Thanksgiving, certain fruit-flavored
beverages may be off the table. Earlier this month, FDA issued a proposed rule that would revoke 21 C.F.R.
§ 180.30, its interim authorization of the use of
brominated vegetable oil (BVO) in in fruit-flavored beverages.
BVO is a complex mixture of plant-derived triglycerides that
have been reacted to contain atoms of the element bromine bonded to
the molecules.
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Nov 22, 2023 | 
thefdalawblog.com | Riette van Laack |Riëtte van Laack |Sophia Gaulkin
For any of our readers seeking recommendations on which drinks pair well with turkey this Thanksgiving, certain fruit-flavored beverages may be off the table. Earlier this month, FDA issued a proposed rule that would revoke 21 C.F.R. § 180.30, its interim authorization of the use of brominated vegetable oil (BVO) in in fruit-flavored beverages. BVO is a complex mixture of plant-derived triglycerides that have been reacted to contain atoms of the element bromine bonded to the molecules.
