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 …
The American Bar Association’s Section of Ligation (specifically the Food and Supplements Subcommittee of the Products Liability Committee) just announced its Fourth Annual Food & Supplements Workshop, scheduled for June 5 in the Minneapolis area. Among the topics to be addressed: Emerging Issues: Surveying the Regulatory …
By Riëtte van Laack – The U.S. Court of Appeals for the District of Columbia Circuit recently declined to stop USDA/AMS implementation of the amended Country of Origin Labeling ("COOL") regulations for beef, pork, and poultry products requiring identification of the country where the animals are …
GMA Science Forum 2014 kicks off on April 6 in Washington, DC. The Forum will feature numerous sessions addressing scientific and regulatory issues of interest to the packaged food industry. A complete agenda is available here. HPM attorneys will help present a half-day introduction to …
By Riëtte van Laack – Defendants Wellness Support Network, and co-owners Robert and Robyn Held, marketed two diabetes products – Diabetic Pack and Insulin Resistance – as medical foods. In 2005 and 2006, FDA issued two Warning letters to them (here and here), claiming the products …
By Ricardo Carvajal – Sabra Dipping Co., LLC ("Sabra") submitted a citizen petition (Dokcket No. FDA-2014-P-0259) asking FDA to establish a standard of identity ("SOI") for hummus. The proposed SOI would define hummus as “the semisolid food prepared from mixing cooked, dehydrated, or dried chickpeas and tahini” with …
By JP Ellison – We previously posted (here and here) about the Supreme Court case that will be argued next month in which the parties are debating the proper interplay between the Federal Food, Drug, and Cosmetic Act (“FDC Act”) and the Lanham Act. Briefly, the issue …
By Riëtte van Laack – Last week, FDA announced the long awaited proposal for revisions to the regulations (here and here) for the format and mandatory information included in the Nutrition Facts Box (“NFB”) and the Supplement Facts Box (“SFB”), and for the calculation of the …
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 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 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 …
