To anyone with an interest in that question, FDA’s public meeting later this week is a can’t miss event. Perhaps the most critical issue facing this nascent industry is the need for clarity on which federal agency – FDA or USDA – will exercise jurisdiction …
On June 22, the Food Safety and Inspection Service (FSIS) announced the receipt of a Petition by the Organization for Competitive Markets and the American Grassfed Association to revise FSIS’s policy on “Product of USA” claims so that only U.S. domestic meat and meat products …
The FSMA final rule on intentional adulteration, entitled “Mitigation Strategies to Protect Food against Intentional Adulteration” (IA rule), 21 C.F.R. Part 121, was published in May, 2016. The rule is designed to address hazards that may be intentionally introduced to foods, including by acts of …
Much to our surprise, we found the following recommendation for GRAS Panel members in FDA’s draft Guidance on GRAS Panels issued in November 16, 2017: . . . avoid filling a gap in the available data and information through theoretical considerations and relevant experience – e.g., …
The American Conference Institute (“ACI”), together with the Council for Responsible Nutrition, are sponsoring ACI’s 6th Annual Legal, Regulatory, and Compliance Forum on Dietary Supplements. The conference is scheduled to take place in Ney York, New York from June 18-20, 2018. This “must-attend” event for legal, …
At long last, the Agricultural Marketing Service (AMS) of the USDA has issued the proposed rule for the National Bioengineered Food Disclosure Standard for food products that have been bioengineered. As readers of this blog know, the Agricultural Marketing Act of 1947 was amended on …
USDA announced the publication of its much awaited proposed rule establishing a National Bioengineered Food Disclosure standard as mandated by Congress almost two years ago (for more on that law, see our prior posting here). The rule is scheduled to publish in the Federal Register on …
In 2015, Senators D. Feinstein, R. Durbin and K. Gillibrand asked GAO to investigate the U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) pathogen standards for meat and poultry products and identify any steps that FSIS could make to address food safety. …
In 2014, the Center for Science in the Public Interest (CSPI) filed a Citizen Petition requesting that FDA ban the retail distribution of highly concentrated caffeine marketed as a dietary supplement and specify limits on the forms in which caffeine may be sold. On April …
As we previously reported, the United States Cattlemen’s Association (USCA) filed a Petition with the Food Safety and Inspection Service (FSIS), asking that FSIS establish formal definitions of “meat” and “beef” that exclude what petitioners call lab grown meat and products prepared from plant or …
On April 2, Rep. Frank Pallone, Jr. introduced the Food Labeling Modernization Act (FLMA) of 2018, an updated version of the FLMA of 2015. As we previously reported, the FLMA of 2015 was an updated version of the FLMA of 2013. The FLMA of 2018 differs …
On April 5, 2018, the Institute for Justice (IJ), on behalf of South Mountain Creamery (South Mountain), filed a complaint against the U.S. Food and Drug Administration (FDA) in the U.S. District Court for the Middle District of Pennsylvania, stating that the Agency is violating …
On April 3, 2018, FDA announced that it had issued a mandatory recall order for all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC (Triangle). FDA issued this order based on its finding that several Triangle products contained kratom …
For anyone not familiar with the legal framework governing “organic” claims, first a brief summary. The Organic Food Production Act of 1990 (OFPA) established a process for organic certification by the United States Department of Agriculture Agricultural Marketing Service, National Organic Program (NOP). Under the …
In September 2013, FDA issued a final guidance addressing when, according to FDA, companies need an Investigational New Drug Application (IND) for clinical studies in humans. The final guidance created quite a stir, as it included several sections that had not been included in the …
