By Wes Siegner & Paul M. Hyman – The term “medical food” was first defined by statute in the Orphan Drug Act Amendments of 1988. The medical food category is closely related to the already existing category of “foods for special dietary use,” authorized by …
By Riëtte van Laack – As previously reported here, in July, the American Meat Institute and several international meat industry organizations filed a lawsuit in an effort to stop the Agricultural Marketing Service ("AMS") of the USDA from implementing the Country of Origin Labeling ("COOL") rule, …
By Etan J. Yeshua – Three months after announcing a strategic research plan to support its regulatory agenda, FDA's Center for Food Safety and Applied Nutrition ("CFSAN") this week announced its regulatory priorities for 2013 and 2014, giving those in the food, dietary supplement, and cosmetic …
By Ricardo Carvajal – In a number of recent class actions, a central allegation has been that a marketer misled consumers by labeling as “all natural” a food that contains a genetically modified organism ("GMO"). Defendants usually invoke the doctrine of primary jurisdiction in an …
By Ricardo Carvajal – Is the word “source” (just “source” – not “good source” or “excellent source”) a nutrient content claim? FDA seems to think so, as reflected in a paragraph in this warning letter that escaped our attention when it issued in March 2011. FDA …
By Ricardo Carvajal – In poring over FDA’s recently issued proposed rule on Accreditation of Third Party Auditors (see our prior post here), one thing that caught our eye is FDA’s discussion of FSMA’s notification requirement for auditors. That requirement is embedded in new § 808(c)(4) …
By Wes Siegner – In response to a history of FDA illegal restriction of the marketing of dietary supplements in the 1980s and early 1990s, Congress amended the Federal Food, Drug, and Cosmetic Act (“FDC Act”), passing by unanimous consent the Dietary Supplement Health and Education …
By Etan Yeshua – Earlier this week, FDA provided new insight into its interpretation of the definition and regulation of medical foods — a legal category established by the Orphan Drug Act of 1988, incorporated into the Federal Food, Drug, and Cosmetic Act in 1990, and …
By Ricardo Carvajal – Fred Kummerow, a Professor Emeritus at University of Illinois, sued FDA for failing to respond to his citizen petition (Docket No. FDA-2009-P-0382) asking the agency to ban partially hydrogenated oils containing artificial trans fat. The citizen petition was submitted in August …
By Riëtte van Laack – The Organic Foods Production Act requires that the U.S. Department of Agriculture (“USDA”) establish national standards for the production and handling of organic products to assure that agricultural products marketed as organic meet consistent uniform standards. USDA established the National Organic …
By Ricardo Carvajal – FDA published a final rule implementing the directive in the Food Allergen Labeling and Consumer Protection Act ("FALCPA") to define the term “gluten-free” (and other terms that FDA regards as equivalent, namely “no gluten,” “free of gluten,” and “without gluten”). The threshold …
By Kurt R. Karst – Now that we've put the theme from The Jeffersons in your head . . . . On August 2, 2013, FDA will officially announce in a series of Federal Register notices the Fiscal Year 2014 (“FY 2014”) user fee rates under …
By Riëtte van Laack – In March 2012, in a consumer action against Jamba Juice, filed in California, plaintiffs asserted, among other things, that steviol glycosides should not be considered natural because of the “chemical processing” used to extract them. Earlier this month, another lawsuit concerning …
By Ricardo Carvajal – Last Friday, FDA released two additional proposed rules that are fundamental to the agency’s implementation of the Food Safety Modernization Act (FSMA): Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (FSVP rule) and Accreditation of Third-Party Auditors/ …
By Riëtte van Laack – In a lawsuit filed in federal court, meat industry representatives have challenged the constitutionality of Country of Origin Labeling (“COOL”) regulations as amended by USDA’s Agricultural Marketing Service (“AMS”) in May of 2013. To understand the origin of the lawsuit, it …
