By Kurt R. Karst – After days of debate and a slew of proposed amendments, the U.S. Senate passed S. 3187, the FDA Safety and Innovation Act, on Thursday afternoon by a roll call vote of 96-1. Senator Bernie Sanders (I-VT), who cast the lone vote against passage, …
By Riëtte van Laack – On May 21, 2012, the FTC posted the 345-page Administrative Law Judge’s ("ALJ’s") Initial Decision in In the Matter of POM Wonderful LLC et al. ("POM") (FTC Docket No. 9344). The ALJ upheld the FTC’s Complaint insofar as the FTC asserted …
By Riëtte van Laack – Last week, the Food Safety and Inspection Service (“FSIS”) issued a proposal to lift the general prohibition against the use of sodium benzoate, benzoic acid, and sodium propionate in meat and poultry. Historically, the use of these substances in meat and …
By Riëtte van Laack – On May 8, 2012, the Food Safety and Inspection Service (“FSIS”) published three sets of regulations mandated by the 2008 Farm Bill: (1) regulations requiring that meat and poultry plants promptly (within 24 hrs) notify FSIS that a contaminated or misbranded …
By Ricardo Carvajal – April was a busy month for nanotechnology at FDA. The agency issued two draft guidance documents worthy of close examination for those with an interest in the use of emerging technologies, including nanotechnology, in the cosmetic and food industries. Further, FDA denied …
By Ricardo Carvajal – The Washington Post recently reported on the delay in getting clearance from the Office of Management and Budget (OMB) for the regulations that would implement the key provisions of the Food Safety Modernization Act. Industry groups and consumer advocates purportedly are baffled, …
By Ricardo Carvajal— The American Bar Association’s Section of Ligation (specifically the Food and Supplements Subcommittee of the Products Liability Committee) is presenting its Second Annual Workshop on Food and Supplements on June 12 in Downers Grove, Illinois. Hyman, Phelps & McNamara, P.C.’s Ricardo Carvajal will …
By Ricardo Carvajal — FDA’s second annual reportable food registry (RFR) report confirms that foodborne pathogens and undeclared allergens continue to account for the vast majority of instances of reportable food. There has been little change in the total number of primary reports submitted (i.e., initial reports …
By Ricardo Carvajal – The USP plans to make available on its website a database of published articles that report “fraudulent activities related to food ingredients,” including foods used as ingredients (e.g., milk, honey, and olive oil). The database will also be included in tabular format …
By Riëtte van Laack – In an April 3, 2012 letter to FDA Commissioner Dr. Margaret Hamburg, Senator Richard Durbin (D-IL) requests that FDA take action against energy drinks containing “exceptionally high” levels of caffeine and other possibly stimulating substances such as guarana and ginseng. Caffeine is …
By Ricardo Carvajal – Warning letters issued by FDA since late February provide an indication of the types of violations that could trigger reinspection fees under the authority provided by the Food Safety Modernization Act (“FSMA”). As we noted in a prior blog posting, FSMA authorized …
By Riëtte van Laack – On March 30, FDA denied a petition submitted by the Natural Resources Defense Council ("NRDC") to ban bisphenol A ("BPA") in food packaging. As FDA explains in its 15-page response, the science NRDC presented in the petition was insufficient to support a conclusion …
By Ricardo Carvajal – Linda Birnbaum, Director of the National Institute of Environmental Health Sciences and the National Toxicology Program, published an editorial discussing the most recent evidence that certain environmental chemicals, including suspected endocrine disruptors such as BPA, “can have effects that would …
By Ricardo Carvajal – The U.S. District Court for the Northern District of Connecticut has ruled that FDA’s qualified health claim (“QHC”) regarding the relationship between green tea and the risk of breast and prostate cancer violates the First Amendment. In a prior posting, we commented …
By Ricardo Carvajal – FDA published its Food Safety Modernization Act ("FSMA") Domestic Facility Risk Categorization for FY2012, which distinguishes domestic high-risk ("HR") food facilities from non-high-risk (NHR) food facilities for purposes of determining frequency of inspection. For now, the determination of whether a facility is …
