By Ricardo Carvajal – The Center for Food Safety and the Center for Environmental Health filed suit in the Northern District of California to compel FDA and the Office of Management and Budget (“OMB”) to implement several major provisions of the Food Safety Modernization Act (“FSMA”). …
Hyman, Phelps & McNamara, P.C.’s Diane McColl will present at USP’s 2012 Science & Standards Symposium, which is dedicated to functional foods and dietary supplements. The conference will address scientific and regulatory issues from an international perspective, and will feature speakers from USP and NIH’s …
By Riëtte van Laack – The Organic Food Products Act of 1990 (“OFPA”) established national standards for the marketing of certain agricultural products marketed as organically produced. It directed USDA to issue regulations specifying the requirements for certification and labeling of organic agricultural products. In promulgating …
By Riëtte van Laack – The U.S. Government Accountability Office ("GAO") released a report on FDA’s food recall process prepared in response to a congressional directive in the Food Safety Modernization Act ("FSMA"), which provided FDA with mandatory recall authority for foods. In evaluating FDA’s implementation, the …
By Ricardo Carvajal – According to an informal policy, FDA considers the use of the term “natural” in food labeling to mean that nothing artificial or synthetic (including colors regardless of source) is included in, or has been added to, the product that would not normally …
By Riëtte van Laack – The Animal Drug User Fee Amendments of 2008 (“ADUFA”) directs FDA to prepare and publish annual summaries of antimicrobial animal drugs sold or distributed for use in food-producing animals. The data are derived from information submitted by sponsors of antimicrobial new …
By Riëtte van Laack – The Patient Protection and Affordable Care Act of 2010, in part, amended the FDC Act by adding Section 403(q)(H) requiring restaurants and similar retail food establishments (“SRFEs”) that are part of a chain with 20 or more locations to provide calorie …
By Wes Siegner – The article “‘Medical Foods’ and Supplements for Brain Health Advance” that recently appeared in The Wall Street Journal provides important insights into a growing industry that is focused on offering a wider range of healthcare options. However, the article contains common misconceptions …
By Ricardo Carvajal – FDA published a Federal Register notice announcing the filing of Rep. Edward J. Markey’s food additive petition asking the agency to amend its regulations “to no longer provide for the use of Bisphenol A (BPA)-based epoxy resins as coatings in packaging for …
By Ricardo Carvajal – We raised this question at the recent ABA Section of Litigation Food & Supplements Second Annual Workshop as a way of commenting on emerging threads of resistance to the imposition of greater food safety-related requirements at all levels of government, but especially …
By Ricardo Carvajal – In several letters issued to trade associations on June 18th (for an example, see here), FDA stated that it “will expect to enforce compliance” with the preventive controls provision in section 103 of the Food Safety Modernization Act ("FSMA") and the foreign …
By Ricardo Carvajal – In a relatively rare example of a request for regulatory action intended to benefit a specific racial or ethnic group, a coalition of businesses and nonprofits submitted a food additive petition (see here and here) asking FDA to amend the food additive regulation …
By Diane B. McColl - The days of having to deal with those pesky adhesive labels on citrus fruit may be over. FDA has announced a final rule approving the use of a carbon dioxide laser for etching information, such as product code, on the surface of …
By Ricardo Carvajal - FDA denied a citizen petition submitted by the Corn Refiners Association ("CRA") which asked FDA to authorize the use of “corn sugar” as a common or usual name for high fructose corn syrup ("HFCS"), and to amend certain regulations that reference “corn …
By Kurt R. Karst – After a round of congratulatory speeches, the U.S. House of Representatives passed H.R. 5651, the FDA Reform Act of 2012, as amended, on May 30th by a vote of 387-5. Unlike the U.S. Senate, which passed its version of the bill …
