By Ricardo Carvajal – FDA issued a draft guidance for industry that sets out the agency’s expectations for the content of petitions and notifications for exemption from food allergen labeling requirements.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 …
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 …
By Ricardo Carvajal – A putative class action targeting certain food products that declare “evaporated cane juice” (ECJ) as an ingredient was recently stayed based on the doctrine of primary jurisdiction. As noted by the Court, prior decisions have gone both ways on the question of …
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 …
