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 The agency issued two draft guidance documents worthy of close examination for those with an interest in the use of emerging technologies, including nanotechnology, in the cosmetic and food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 …
By Ricardo Carvajal – In a letter that includes fun facts about the function of the epiglottis, FDA has warned Breathable Foods, Inc. that its AeroShot product is misbranded. The product’s labeling is alleged to be false and misleading because it contains contradictory statements regarding whether …
By Riëtte van Laack & John R. Fleder – After the Federal Trade Commission (“FTC”) entered consent orders against Nestle and Iovate (see here), prohibiting future claims for respondents’ food and dietary supplements unless they are supported by two well-controlled clinical studies, the industry has been …
By Riëtte van Laack – A coalition of public health associations sent a letter to FDA encouraging the agency to amend its ingredient statement regulation to include the single food ingredient “added sugars” followed by a parenthetical listing of the specific sugars added in descending order of …
By Ricardo Carvajal – Researchers report that in vitro and in vivo experiments conducted with polystyrene nanoparticles indicate that nanoparticle exposure can disrupt iron transport in the gut, and may possibly disrupt absorption of other minerals, as well as vitamins. The in vivo experiments, which were …
