By Ricardo Carvajal – No sooner did FDA hold its advisory committee meeting and public hearing on bioengineered AquAdvantage salmon than Congressional representatives made their displeasure known with the prospect of FDA approval. In addition to signing on to letters of protest to the Commissioner (here …
By Ricardo Carvajal – FDA announced the availability of a draft guidance on acidified food intended to help processors determine whether their products are subject to the current good manufacturing practice ("CGMP") requirements in 21 CFR part 114 and the “Specific Requirements and Conditions for Exemption …
By Ricardo Carvajal – A district court dismissed a complaint alleging consumer fraud in food labeling that highlights the presence of fiber. Plaintiff alleged that defendants violated state consumer fraud laws by failing to disclose that their products contain alleged “non-natural” fibers that “have not …
By Kurt R. Karst – Earlier this week, Senator Patrick Leahy (D-VT) introduced the Food Safety Accountability Act of 2010 (S. 3767). The bill, which follows Sen. Leahy’s Food Safety Enforcement Act of 2010 (S. 3669) introduced earlier this year and the recent egg …
By Ricardo Carvajal – In late August, FDA issued warning letters to Unilever and Dr. Pepper Snapple Group objecting to the use of unauthorized nutrient content claims for antioxidants in the labeling of certain products containing green tea. Similar warning letters addressing other types of …
By Riëtte van Laack – In anticipation of the possible approval of the New Animal Drug Application (“NADA”) for genetically engineered AquAdvantage Salmon (“GE salmon”), FDA announced a public hearing on September 21, 2010, concerning the labeling of food made from such salmon. This is …
By Ricardo Carvajal – In several cases that challenge food marketers’ use of the term “natural” in labeling and advertising, the presiding judges have recently opted to suspend proceedings and seek an administrative determination from FDA as to whether high fructose corn syrup ("HFCS") qualifies …
By Susan J. Matthees – FDA announced yesterday the availability of two new draft guidance documents regarding implementation of the menu labeling provisions of section 4205 of the Patient Protection and Affordable Care Act (“PPACA”). As we reported last month, FDA requested comments on how …
By Diane B. McColl – According to Sharon Benz, Ph.D., Director of the Division of Animal Feeds in FDA's Center for Veterinary Medicine ("CVM"), CVM is moving away from enforcement discretion for new animal feed/pet food ingredients. In a conversation with HP&M's Diane McColl, Dr. …
By Ricardo Carvajal – Late on August 12th, the U.S. Senate Committee on Health, Education, Labor, and Pensions (“HELP”) announced the release its 225-page compromise agreement of the Food Safety Modernization Act (S. 510). The Congressional Budget Office simultaneously released its estimate of the bill, …
By Susan J. Matthees – POM Wonderful is still in court. The maker of POM Wonderful pomegranate juice brought suit against Coca-Cola, alleging the Coca-Cola’s Minute Maid Enhanced Pomegranate Blueberry Flavored 100% Juice Blend is misleading and deceptive to consumers because the name suggests that …
By Ricardo Carvajal – FDA released a report summarizing the first seven months of the agency’s experience with its Reportable Food Registry (for more on recent developments pertaining to the RFR, see our prior posting here). The data summarized by FDA show how the potential …
By Alexander J. Varond* & Diane B. McColl – As noted in our blogpost less than two months ago, the U.S. District Court for the District of Columbia held that FDA acted unconstitutionally in Alliance for Natural Health, US v. Sebelius when the agency limited qualified …
By Ricardo Carvajal – As we discussed in a prior posting, Section 4205 of the Patient Protection and Affordable Care Act requires the display of certain nutrition information by chain restaurants and retail food establishments with 20 or more locations doing business under the same …
By Susan J. Matthees – FDA recently announced that the Agency is seeking public comments on how to implement section 4205 of the Patient Protection and Affordable Care Act of 2010 (“PPACA”), which requires certain restaurants and vending machines to disclose nutrition information. The docket opened on …
