By Ricardo Carvajal – In a prior posting, we reported on a lawsuit brought by Jensen Farms (Jensen) against its auditor Primus Labs (Primus) alleging that Primus had been negligent in the conduct of its audit – negligence that allegedly contributed to the 2011 outbreak of …
By Jennifer M. Thomas – In another confirmation of the Lanham Act’s reach following on the heels of the Lexmark decision, the U.S. Supreme Court ruled today that POM Wonderful LLC’s (“POM’s”) Lanham Act suit against Coca-Cola Co. (“Coke”) over juice product labeling is not precluded …
By Riëtte van Laack – In Quesada v. Herb Thyme Farms, Inc., Plaintiff Quesada alleged that Herb Thyme Farms, Inc. (Herb Thyme) lied about the nature of its “Fresh Organic” line of herbs. According to Plaintiff, Herb Thyme misrepresented its “Fresh Organic” products as 100% percent …
By Kurt R. Karst – On May 29th, the U.S. House of Representatives Committee on Appropriations voted 31-18 during a mark-up session to send to the House floor its version of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015, along …
By Ricardo Carvajal – FDA filed a motion to dismiss the lawsuit brought by the Center for Food Safety challenging the legality of FDA’s GRAS notification program (for background information on the lawsuit, see our prior posting here). In its supporting memorandum, FDA argues that plaintiff …
By Riëtte van Laack – FDA’s proposed rule regarding nutrition labeling (see our previous post here) will have far-reaching consequences that may not be obvious. For example, FDA intends to make major changes in its approach to defining and measuring dietary fiber – changes that could …
By Riëtte van Laack – In 2011, the National Organic Program (“NOP”) of the USDA announced the availability of a draft guidance for “Made with Organic” claims. Of the four categories of organic claims (“100% organic,” “organic,” “made with organic,” “x% organic”), this category of organic …
By Ricardo Carvajal – FDA issued a draft guidance for industry that sets out the agency’s expectations for the content of petitions and notifications for exemption from food allergen labeling requirements. To date, such petitions and notifications have met with very limited success – a situation …
By Riëtte van Laack – The FDC Act, as amended by the Dietary Supplement Health and Education Act (“DSHEA”) of 1994, excludes from the definition of dietary supplement any article that is approved as a new drug and any article “authorized for investigation as a new …
By Ricardo Carvajal – FDA issued a final rule that prohibits nutrient content claims for the omega-3 fatty acids DHA and EPA, as well as certain nutrient content claims for ALA. The final rule carries through on the proposed rule issued in November 2007 with no …
By Riëtte van Laack – Legislation that would require labeling of genetically engineered or bioengineered foods (generally referred to as “GMOs”) has been proposed in various states. If enacted, these state laws may expose companies to a patchwork of different GMO labeling requirements. On April, 10, 2014, …
By Ricardo Carvajal & Diane B. McColl – When GAO issued its 2010 report criticizing FDA’s oversight of the GRAS exception, we were motivated to respond first in short form in a blog post, and then in long form through a Washington Legal Foundation Legal Backgrounder. …
By Riëtte van Laack – In 2006, the American Beekeeping Federation and honey industry groups petitioned FDA (Docket No. FDA-2006-P-0207) to adopt a standard of identity for honey. In 2011, FDA denied this petition because it concluded that no standard of identity was needed. FDA asserted …
By Riëtte van Laack – Does the same standard that applies when regulators require label statements that “correct a deception,” such as false advertising, also apply when they require label statements for other purposes based on the interests of the government? This issue will be before …
By Jennifer M. Thomas & James P. Ellison – Hyman, Phelps & McNamara, P.C. (HP&M) filed comments on April 7 concerning FDA’s Guidance document, Investigational New Drug Applications (INDs) — Determining Whether Human Research Studies Can Be Conducted Without an IND (the “Guidance”). HP&M has previously blogged …
