Tell me if you’ve heard this one before – the regulatory issues surrounding CBD will be completely resolved after a certain “legislative fix” is passed. Remember all of the articles in December 2018 declaring CBD legal after the passage of the 2018 Farm Bill? Don’t expect Congress or FDA to wave a magic wand and
GRAS
Developments Related to the Compliance Date for FDA’s Final Determination on the GRAS Status of Partially Hydrogenated Oils
By Martin Hahn, Veronica Colas & Samantha Dietle on
As the June 18, 2018 compliance date for the Food and Drug Administration’s (FDA’s) final determination that partially hydrogenated oils (PHOs) are no longer generally recognized as safe (GRAS) approaches, the food industry has undertaken efforts to obtain clarification and flexibility from FDA on several issues related to the compliance date, including (1) clarifying the…
FDA Issues Draft Guidance on Best Practices for Convening a GRAS Panel
By Joe Levitt & Christine Forgues on
On November 16, 2017, the Food and Drug Administration (FDA or the agency) issued a federal register notice soliciting comments on its Draft Guidance for Industry, “Best Practices for Convening a GRAS Panel.”
The Draft Guidance is intended for persons responsible for a conclusion that a substance may be used in food on the basis…
Consumer Groups File Complaint Against FDA for GRAS Final Rule
By Martin Hahn, Joe Levitt & Xin Tao on
On May 22, 2017, the Center for Food Safety (CFS), Breast Cancer Prevention Partners (BCPP), Center for Science in the Public Interest (CSPI), and Environmental Defense Fund (EDF), filed a complaint for declaratory and injunctive relief against the U.S. Food and Drug Administration (FDA) for the agency’s final rule regarding substances that are Generally Recognized…
New Wave of California Proposition 65 Acrylamide 60-Day Notices
By Martin Hahn, Brian Eyink, Xin Tao & Kaitlin Welborn on
Posted in GRAS, Proposition 65
Food companies should be aware of a recent, new wave of Proposition 65 (Prop 65) challenges targeting acrylamide in food. In the past year, private litigants—particularly the Center for Environmental Health (CEH)—have filed numerous 60-day notices indicating their intent to sue food companies that allegedly fail to warn consumers of harmful levels of acrylamide…
FDA Issues Its Final Rule on the Criteria of Substances Generally Recognized as Safe (GRAS) and Voluntary GRAS Notification Program
By Martin Hahn, Xin Tao & Samantha Dietle on
Posted in GRAS
On August 17, 2016, the U.S. Food and Drug Administration (FDA) issued its final rule regarding substances that are Generally Recognized as Safe (GRAS) for use in human and animal foods. This long-awaited final rule, published nearly twenty years after the 1997 proposed rule, clarifies the criteria for when the use of a substance is…