By Wes Siegner – The following organizations filed joint comments on November 26, 2013 voicing strong opposition to the food provisions of FDA’s final IND Guidance and requesting that FDA reopen the comment period to permit comment on the food provisions of the guidance, which FDA …
By Ricardo Carvajal, Diane B. McColl & JP Ellison – The Center for Food Safety filed suit in the DC District Court challenging FDA’s allegedly “unlawful action of exempting substances that are [GRAS] from regulation as food additives under a proposed rule for more than fifteen …
By Ricardo Carvajal – FDA entered into a consent decree with the Center for Food Safety that specifies new deadlines for the agency’s submission of final rules implementing FSMA to the Federal Register for publication. The consent decree marks the latest chapter in a case that …
By Ricardo Carvajal – FDA published a notice announcing the availability of a Draft Approach for Designating High-Risk Foods, and asking for comments and information to help the agency refine that approach. Designation of a food as a High-Risk Food (HRF) would trigger additional recordkeeping requirements intended …
By Riëtte van Laack – On Friday, February 7, 2014, the FTC filed its long-awaited brief in the D.C. Circuit action concerning POM Wonderful LLC’s (“POM’s”) advertising for its pomegranate products (see our previous post here). Not surprising, the FTC asserts that POM’s ads were deceptive. First, …
By Riëtte van Laack – FDA published a proposed rule to implement the Sanitary Food Transportation Act of 2005 (“SFTA”) in the Federal Register on February 5. FDA also published Questions and Answers related to the sanitary transportation of human and animal food. Enacted in 2005, the …
By Wes Siegner – On January 21 we posted on FDA’s unusual decision to reopen the comment period for the final guidance on INDs with respect to food and cosmetic research. Subsequently we learned that 60 university department heads submitted a comment to FDA’s Final IND …
Hyman, Phelps & McNamara, P.C. is participating in the Food and Drug Law Institute's Food Week 2014 being held February 10–13 in Washington, D.C. This program provides an opportunity for food law, regulation and policy stakeholders to gather practical guidance on cutting-edge issues and hear …
By Riëtte van Laack – On December 26, FDA sent Warning Letters (here and here) to Accera, Inc. and NVN Therapeutics. Accera Inc. markets a product, Axona, as a medical food “for the clinical dietary management of the metabolic processes associated with mild to moderate Alzheimer’s …
By Ricardo Carvajal – The Institute of Medicine (“IOM”) published a summary report of the workshop on caffeine in food and dietary supplements that IOM convened last August at FDA’s request. As noted in the introduction to the summary, the summary presents statements, recommendations, and opinions …
By Wes Siegner – On September 18, we alerted food researchers that FDA had added new language to a final IND guidance that would require FDA approval of an investigational new drug application (IND) for many food studies now conducted without the burden of filing an IND, …
By Riëtte van Laack – On January 13, FDA announced the availability of two guidances concerning beverages and liquid dietary supplements: “Distinguishing Liquid Dietary Supplements from Beverages” and “Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements.” Both guidances are derived from FDA’s 2009 …
By JP Ellison – We previously reported that Pom Wonderful had sought Supreme Court review of the 9th Circuit’s decision that POM’s labeling-based claims against Coke’s Minute Maid products could not proceed under the Lanham Act because such labeling was the province of the FDA and the …
By Riëtte van Laack – On January 7, the FTC announced an initiative “Operation Failed Resolution” stating that it wants to protect consumers against deceptive weight loss claims. Among other things, the FTC announced actions against four companies for advertising fad weight-loss products, issued an updated …
By Ricardo Carvajal – As we noted in a prior posting, several courts have stayed or dismissed class actions based on the doctrine of primary jurisdiction in cases that raise the question of whether a GMO-containing food can properly be labeled as “natural.” In response to …
