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Regulatory Requirements › Labeling › Compliance

BakerHostetler

FDA Issues Draft Guidance on Replacing Color Additives in Drug Products

BakerHostetler on

On May 27, 2025, the Food and Drug Administration (FDA) released a new draft guidance, “Replacing Color Additives in Approved or Marketed Drug Products” (Guidance), that outlines regulatory expectations for manufacturers and...more

Gardner Law

FDA Guidance for Labeling Plant-based Products

Gardner Law on

The FDA has developed draft guidance addressing confusion and legal action over the naming and labeling of plant-based alternatives to eggs, seafood, poultry, meat and dairy (excluding plant-based milk, e.g. oat milk). FDA is...more

Husch Blackwell LLP

Say Goodbye to the Red Dye: Legal Implications Following the FDA’s Recent Ban

Husch Blackwell LLP on

On January 16, 2025, the U.S. Food and Drug Administration (FDA) announced a significant regulatory change by revoking the authorization for use of Red Dye No. 3 in food (including dietary supplements) and ingested drugs. As...more

Sheppard Mullin Richter & Hampton LLP

Name That Chemical: California Adds New Requirement for Prop 65 Short-Form Warnings

Sheppard Mullin Richter & Hampton LLP on

Short-form warnings for products that may expose consumers to chemicals on California’s Prop 65 list must now include at least one chemical name to qualify for Prop 65’s “safe harbor” protections—with one caveat. Businesses...more

Perkins Coie

FDA Releases Draft Guidance on the Labeling of Plant-Based Foods

Perkins Coie on

The U.S. Food and Drug Administration (FDA) recently published draft guidance on the Labeling of Plant-Based Alternatives to Animal-Derived Foods (Draft Guidance). The Draft Guidance recommends best practices for naming...more

Husch Blackwell LLP

California’s Proposition 65 Short-Form Warnings Now in Effect

Husch Blackwell LLP on

California’s Office of Environmental Health Hazard Assessment (OEHHA) issued a notice of proposed amendments to Proposition 65 in October 2023 that significantly modify the information businesses are required to provide in...more

Skadden, Arps, Slate, Meagher & Flom LLP

The Commercial Potential – and Practical Challenges – of Marketing OTC Drugs With ‘Additional Conditions for Nonprescription Use’

Skadden, Arps, Slate, Meagher & Flom LLP on

The Food and Drug Administration’s (FDA or Agency) final rule on Additional Conditions for Nonprescription Use (ACNU) paves the way for some drugs that are currently available only with a prescription to switch to OTC where a...more

Hogan Lovells

Naming and Labelling of vegan and vegetarian products – it's what it says on the tin

Hogan Lovells on

There is an ever-increasing number of consumers who are following a vegetarian or even vegan diet – and with this comes a wide range of vegetarian and vegan foods that can now be found in many supermarkets and restaurants....more

Foley & Lardner LLP

Scientific Information on Unapproved Uses of Medical Products: FDA’s Final Guidance on Firm Communication to Health Care Providers

Foley & Lardner LLP on

The U.S. Food and Drug Administration (FDA) recently announced final guidance for firms in the medical device and product industry titled, “Communications From Firms to Health Care Providers Regarding Scientific Information...more

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