Abstract FDA’s proposed mandatory Generally Recognized as Safe (GRAS) notification rule would create both transitional and recurring costs for companies relying on the GRAS pathway. In its Preliminary Regulatory Impact […] Read More >>
Abstract L-theanine has become one of the most widely used functional ingredients in beverages formulated to support focus, relaxation, and cognitive wellness. As manufacturers continue to expand into ready-to-drink (RTD) […] Read More >>
At a Glance A GRAS dossier is often viewed as a regulatory submission prepared solely to support commercialization in the United States. In reality, a well-developed GRAS dossier can become […] Read More >>
At a Glance A well-prepared self-affirmed GRAS dossier may already contain much of the scientific information needed to support an FDA GRAS notice. However, converting an existing dossier for FDA […] Read More >>
At a Glance On August 10, 2026, HHS announced that FDA had issued a proposed rule that would replace the current voluntary GRAS notification program with a mandatory notification requirement […] Read More >>
Abstract Introduction Developing a proprietary blend can create an important regulatory question: if every component is already Generally Recognized as Safe (GRAS), can the ingredients be combined under one existing […] Read More >>
Abstract For ingredient manufacturers expanding internationally, achieving Generally Recognized as Safe (GRAS) status in the United States is often viewed as a significant regulatory milestone. However, GRAS does not authorize […] Read More >>
Originally expected earlier this year, FDA’s proposed overhaul of the Generally Recognized as Safe (GRAS) notification process has now been pushed to December 2026. While the timeline has shifted, the […] Read More >>
State-level scrutiny of Generally Recognized as Safe (GRAS) substances is no longer limited to New York. While New York’s Food Safety and Chemical Disclosure Act has drawn significant attention because […] Read More >>
Background On January 15, 2025, the FDA revoked authorization for FD&C Red No. 3 (erythrosine) for use in foods, including dietary supplements, and in ingested drugs. The agency followed a […] Read More >>
On July 20, 2022, Health Canada published amendments to the Food and Drug Regulations (FDR), introducing new regulations for supplemented foods as a category. These new regulations continue to protect […] Read More >>
Novel foods are defined as “foods that have not been historically consumed or have been produced using new processes” and are becoming more common in the food industry. Advances in […] Read More >>
Supplemented Foods and Caffeinated Energy Drinks (CEDs) is a growing market within Canada. Primarily products in this category are ready-to-drink (RTD) beverages, Beverages mixes/concentrates or CED. However, temporary marketing authorization […] Read More >>
FDA Issues New Guidance Documents for Nutrition and Supplements The FDA has updated the Nutrition and Supplement Facts Labels. The update was in response to comments received on the draft […] Read More >>
Prop 65, California’s right-to-know law that requires a clear and reasonable warning for chemicals known to cause cancer or reproductive harm, finds that coffee does not require a cancer warning. […] Read More >>
The Food Safety Modernization Act (FSMA) reaches across the entire food industry, not just conventional foods. Stakeholders and consumers rarely think of dietary supplements as foods, even though they are […] Read More >>
In January 2018, the Food Institute hosted a webinar discussing lawsuits that food and beverage manufacturers were being subjected to. These lawsuits were being served to manufacturers of all sizes, […] Read More >>
Service(s) related to this article: Food Safety and Quality With the world seemingly getting smaller and smaller, Food Fraud is one of the most hot-button and pressing issues facing […] Read More >>
Service(s) related to this article: Food Label & Claims, Food & Beverages, Product & Label Development Canada’s Food Guide is getting a makeover, and Health Canada is expected to […] Read More >>
Service(s) related to this article: Dietary Supplement Consulting, Food & Beverages Proposition 65 (Prop 65) in California is not new. Officially coming into effect in 1986 requiring that in the state […] Read More >>
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