Former U.S. Food & Drug Administration (FDA) Associate Chief Counsel Kristin Kaplan joins Shook, Hardy & Bacon, further expanding the firm’s regulatory capabilities. Kaplan has a deep understanding of regulatory issues and the nuances of the government agency after advising FDA for eight years and serving an in-house role at a global leader in animal health. “Her combined FDA insight and in-house experience make Kristin invaluable as we deepen our regulatory capabilities,” said Shook Chair Madeleine McDonough. “It is critical for our clients facing litigation to align with our regulatory team to anticipate and address developing legal developments.” Kaplan counseled FDA on a variety of issues, including new animal drug applications stemming from biotechnology and recalls of foods, animal foods and drugs. She later became Deputy General Counsel for one of the world’s largest animal health leaders, where she provided strategic insight on various issues including regulatory, compliance, and health, safety…
Tag Archives animal feeds
Europol and Interpol have announced the seizure of 320 additional tonnes of "counterfeit and substandard food and beverages" following an operation that involved 83 countries, bringing the operation's seizure total to about 12,000 tonnes. "This year’s operational activities have found a new disturbing trend to address: the infiltration of low-quality products into the supply chain, a development possibly linked to the COVID-19 pandemic," the press release notes. The operation, which focused on dairy foods, olive oil, alcohol and horse meat, also identified counterfeit cereals, grains and derived products as well as coffee, tea and condiments.
The Association of American Feed Control Officials (AAFCO) has issued guidelines on the 2018 Farm Bill and its removal of hemp from the list of controlled substances. "As of April 2019, hemp and hemp products may not be used in animal feed or pet food in the United States," the guidelines state. "In 2015 AAFCO asked the hemp industry to come forward and present information for the scientific review to establish definitions for animal foods made from the industrial hemp plant. We expected information on hemp seed oil, hemp seed meal, and whole hemp seeds. Although there are private companies and organizations working on applications, to date, the industry has not submitted any data showing that ingredients derived from the hemp plant are safe and useful in animal food. AAFCO is encouraging the industry to submit their data promptly." The guidelines also advise that feed with cannabidiol (CBD) is not…
The U.S. Food and Drug Administration (FDA) has announced an amendment to food additive regulations to provide for the use of formic acid and ammonium formate in animal feed and drinking water. Taking effect November 13, 2017, the amendment limits formic acid and salts to 1.2 percent in complete feeds. FDA will accept comments or requests for a hearing until December 13, 2017.
A dairy trade group has filed a lawsuit against Wisconsin’s Department of Natural Resources (DNR) alleging that the agency both exceeded its authority and failed to follow required public rulemaking processes when it set new water pollution control regulations affecting dairy and animal feeding operations. Dairy Bus. Ass’n v. Wis. Dep’t of Nat. Res., No. 2017CV001014 (Wis. Cir. Ct., Brown Cty., filed July 31, 2017). The complaint involves recent administrative rules and guidance issued by DNR related to feed storage leachate runoff and calf hutches. DNR is the state agency tasked with enforcement of the federal Clean Water Act and is responsible for issuing state Pollutant Discharge Elimination System permits (WPDES) to entities that discharge pollutants into state waters. The complaint asserts that the goal of the permit system is “parity” with the Clean Water Act (CWA) and state regulations “shall comply with and not exceed the requirements of the…
Syfrett Feed Co., a Florida manufacturer of medicated animal feeds, has entered into a consent decree to control its production process and comply with federal laws before resuming medicated feed operations. U.S. v. Syfrett Feed Co., Inc., No. 17-14038 (S.D. Fla., order entered May 4, 2017). The court entered the decree after the U.S. Food and Drug Administration (FDA) filed a complaint alleging the company failed to adequately identify and store the drugs it used or prevent contamination of drugs and feeds as well as mislabeled and misbranded feeds. According to the complaint, 17 horses had to be euthanized after eating the company’s horse-pellet food. Syfrett manufactures feeds for cattle, poultry, pigs, sheep, goats and exotic animals, but has agreed to discontinue production of the horse feed connected to the animal deaths. “Animal feed manufacturers that fail to comply with labeling and good manufacturing requirements for medicated animal feeds jeopardize…
The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) has updated its guidelines on the documentation needed to support animal-raising labeling claims, which include “Raised Without Antibiotics,” “Organic,” “Grass-Fed,” “Free-Range” and “Raised with the use of hormones.” Among other things, the agency requires the following information to support such claims: (i) “a detailed written description explaining the controls used for ensuring that the raising claim is valid from birth to harvest or the period of raising being referenced by the claim”; (ii) “a signed and dated document describing how the animals are raised (e.g., vegetarian-fed, raised without antibiotics, grass-fed), to support that the specific claim made is truthful and not misleading”; (iii) “a written description of the product-tracing and segregation mechanism from time of slaughter or further processing through packaging and wholesale or retail distribution”; (iv) “a written description for the identification, control, and segregation of non-conforming animals…
Two horse owners have filed a lawsuit against Archer Daniels MidlandCo. alleging feed produced by its subsidiary, ADM Alliance Nutrition, was contaminated with monensin, a cattle-feed additive poisonous to horses. Berarov v. Archer Daniels Midland Co., No. 16-7355 (N.D. Ill., filed July19, 2016). The plaintiffs argue that ADM knowingly manufactured cattle feed containing monensin in the same facility as its horse feed and supplement production, resulting in cross-contamination between the two. The complaint details the effects of monensin on horses, including equine heart failure and other major organ damage, which the plaintiffs argue can occur with doses as low as 1.38 mg/kg of body weight. In a statement,ADM disputed this toxicity level, arguing that a horse can safely consume 9.5 mg/kg of body mass, according to the complaint. For allegations of negligent misrepresentation, strict product liability, unjust enrichment, breach of warranties and violations of Illinois consumer-protection laws, the plaintiffs seek class…
A consumer has filed a lawsuit alleging that Chipotle Mexican Grill Inc. falsely advertised its food as free of genetically modified organisms (GMOs) despite serving meat products from animals fed GMOs and soft drinks that contain GMO corn syrup. Pappas v. Chipotle Mexican Grill, Inc., No. 16-0612 (S.D. Cal., filed March 10, 2016). The plaintiff alleges violations of California's consumer-protection law and seeks class certification, damages, an injunction, and attorney's fees. The complaint echoes the arguments in a similar California case dismissed without prejudice in February 2016 finding that the plaintiff's definition of GMO was inconsistent. The plaintiff has filed an amended complaint arguing that consumers "reasonably understand today that such claims would mean that Chipotle's menu is 100% free of GMOs and that Chipotle does not serve food sourced from animals that have been raised on GMOs or genetically engineered food." Gallagher v. Chipotle Mexican Grill, Inc., No. 15-3952…
The European Food Safety Authority (EFSA) has issued a scientific opinion assessing any potential risks associated with the use of insect protein in food and animal feed. Concluding that chemical and biological risks depend on production method, the type of substrate used, and insect species, the expert panel specifically notes that “the occurrence of prions—abnormal proteins that can cause diseases such as Bovine Spongiform Encephalopathy (BSE) in cattle and Creutzfeldt-Jakob Disease in humans—is expected to be equal or lower if the substrate does not include protein derived from humans (manure) or ruminants.” The report also calls for more data about the possible accumulation of cadmium, arsenic, lead, mercury, and other heavy metals in farm-raised insects. “EFSA concludes that when non-processed insects are fed with currently permitted feed materials, the potential occurrence of microbiological hazards is expected to be similar to that associated with other nonprocessed sources of protein,” states a…
