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 >>
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 >>
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 >>
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 >>
Proposition 65, and what you need to know for your products Proposition 65, Prop 65 for short, is the Californian law requiring companies to warn consumers if they may be […] Read More >>
On January 04, 2018, the United States Food and Drug Administration (FDA) announced their position on enforcement discretion for certain Food Safety Modernization Act (FSMA) Regulations. Specifically, […] Read More >>
As consultants, we are often asked by clients about Food Safety Liability. In particular, clients are interested in knowing what risks are associated with failing to comply with certain regulations […] Read More >>
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