Topics discussed at the recent Food & Drug Law Institute’s (FDLI) Enforcement, Litigation and Compliance Conference included FDA Center leaders’ enforcement priorities, interagency enforcement actions, the implications of increasing globalization, and the diversion of controlled substances. Among the highlights: Joseph Rannazzisi, Deputy Assistant Administrator in DEA’s Office of Diversion Control, said due diligence is the… Continue Reading
Tag Archives: Enforcement
FDA Suspends Sunland’s Registration; First Use of New Suspension Authority
On November 26, the Food and Drug Administration (FDA) suspended the food facility registration of Sunland, Inc., a producer of nuts, and nut and seed spreads. Notably, this is the first time FDA has used its registration suspension authority, which was established by Section 102(b) of the FDA Food Safety Modernization Act (FSMA). Significantly, this… Continue Reading
Updates from FDLI’s Advertising & Promotion Conference and the Pharmaceutical & Regulatory Compliance Congress
Recently, industry leaders, members of the FDA bar, and government officials convened at the Food & Drug Law Institute’s (FDLI’s) Advertising & Promotion Conference and the Pharmaceutical & Regulatory Compliance Congress. Topics included policy updates and enforcement priorities from FDA’s centers, Office of Inspector General (OIG) and Department of Justice (DOJ) current and future enforcement… Continue Reading
California AG Sends Enforcement Letter to Developers of Popular Mobile Apps
On Tuesday, October 30, the Office of California Attorney General Kamala Harris issued a press release confirming that it had begun “formally notifying” mobile device application (“app”) operators that they are out of compliance with the notice provisions of the California Online Privacy Protection Act of 2003 (“CalOPPA”). Those companies — many of which are major marketers — now… Continue Reading
DOJ and EU Working Together on IP Issues
DOJ antitrust chief Joe Wayland revealed in an interview (subscription required) this week that the US and EU are working together to coordinate their enforcement approach regarding the acquisition and use of intellectual property — particularly standard essential patents (SEPs). The comments come as the European Commission is engaged in at least two significant investigations… Continue Reading
FDA’s Changing Culture: What Food Companies Need to Know
The Food and Drug Administration (FDA) is undergoing a major culture change, and nowhere is that impact being felt more than in the food industry. While visibly preparing new regulations to implement the Food Safety Modernization Act (FSMA), the agency has quietly become much more inspection-oriented and enforcement-minded, even under its historic authorities. Here is… Continue Reading