Center for Food Safety and Applied Nutrition
Center for Food Safety and Applied Nutrition
News Article | April 24, 2017
This seminar on veterinary medicine regulations will provide attendees with a comprehensive understanding of FDA's veterinary drug approval process. The U.S. Food and Drug Administration's Center for Veterinary Medicine or CVM is responsible for the approval of veterinary drug products intended for both family pets and food-producing animals. FDA regulates not all products intended for animal use. Jurisdiction over animal products including licensed biologics such as vaccines is shared with a number of other federal agencies. For example, animal vaccines, animal disease diagnostic devices and some animal biologics are regulated by the U.S. Department of Agriculture's Animal and Plant Health Inspection Service or APHIS; and products such as flea and tick collars are regulated by the Environmental Protection Agency. This two day interactive course will cover: - Premarket approval process - Various sections of a New Animal Drug Application - Strategies for navigating the FDA approval process and for expending product approval - The nature of shared jurisdiction over veterinary products in certain cases. - Understand how the U.S. Food and Drug Administration regulates veterinary drug product. - Understand how FDA's Center for Veterinary Medicine is organized. - Discuss the process by which veterinary drug products are reviewed and approved. - Learn how to open an INAD File and request fee waivers. - Obtain a working knowledge of various sections included within an NADA. - Develop a deep understanding of what is needed to substantiate product characterization, target safety and effectiveness. - Analyze FDA's rules governing chemistry, manufacturing and controls or CMC. - Understand the various components of an animal field study to support product approval. - Discuss the difference between FDA's various user fees and fee waivers. - Identify the elements of an FDA compliant label. - Develop a corporate compliance strategy covering labeling, marketing and advertising. - Problem solving methods to mitigate regulatory enforcement risks. - Explain how jurisdiction is split between various Federal agencies in a certain cases. - Learn how animal feed, veterinary devices, OTC drug products and nutritional supplement are regulated in the U.S. Introduction to Veterinary Drug Approval process - FDA's jurisdiction and Center's relevant to Animal Health - Center for Food Safety and Applied Nutrition (CFSAN) - Center for Drug Evaluation and Research (CDER) - Center for Veterinary Medicine (CVM) - Specifics of CVM - Intro to the FDCA, AMDUCA, ADAA, MUMS, etc and guidance (GFI) - Overview of FDCA and regulations - Introduction to FDA GFI Overview of Veterinary Drug Development Discovery/Acquisition - Preliminary Patent Protection Concerns Submissions - Open INAD File - NADA (8 sections) - 5 Major Technical Sections - Chemistry, Manufacturing and Controls (CMC) - Safety (target animal safety study) - Efficacy (field study) - Human Food Safety (human food safety studies for food-producing animals) - Environmental Impact (EA/CE) - 3 Minor Technical Sections - All other information - Labeling - Freedom of Information Summary (FOI) Brief Description of cGxP (GMP, GLP, &GCP) CMC - API: name, structure, properties - API manufacturing - Clinical Trial material - Final Formulation Target Animal Safety - Content and format - Final Study Reports - Monitoring and Reporting Adverse Drug Events Human Food Safety - Analysis of Drug Residues - Toxicology - Residue Chemistry - Microbial Food Safety - Regulatory Method Relied Upon by Sponsor Effectiveness - Dosage Characterization - Substantial evidence (e.g. dose confirmation and clinical field studies) - All other information related to effectiveness - Proposed effectiveness-related labelling - Effectiveness Guidance Documents - The 7 Major Phases of Animal Field Studies - Planning - Study Initiation - In-life Activities - Site close-out - Data management - Biostatistical analysis - Report Writing Approval Process: Chemistry, Manufacturing Controls, Environmental Impact & Managing Clinical Trials - Environmental Impact - Categorical Exclusions - Environmental Assessments (EA) - Common EA Components - Environmental Impact Statements (EIS) - Labeling - FOI - AOI Animal Drug User Fees and Related Fee Waivers - Veterinary Drug User Fees and Fee Reductions and Waivers - Animal Drug User Fee Act (ADUFA) - Applies to Innovators Only - Animal Generic Drug User Fee Act (ADGUF) - Applies to Generic Manufacturers - ANADA sections - CMC - BE (Safety & Efficacy) - HFS - All others - Types of User Fees - Animal Drug Application and Supplement Fee - Animal Drug Product Fee - Animal Establishment Fee - Animal Drug Sponsor fee - Types of Fee Waivers and Reductions - Procedures, Timing and FDA Evaluation of Waivers or Reductions - FDA decision on approval Introduction to FDA's Regulation of Veterinary Feed, OTC Drugs and Supplements - Animal Feed - GRAS - Feed Labeling - AAFCO - Veterinary Feed Directive (VFD) - Veterinary OTC Drugs and Nutritional Supplements - Regulatory Agencies - CVM Compliance Policy - CPG 690.150 & CPG 690.100 - Veterinary Medical Devices CPG 655.100 USDA (CVB, APHIS, FSIS) & EPA - USDA's Animal and Plant Health Inspection Service - Virus Serum Toxin Act - Animal vaccines - Animal biologics - Animal disease diagnostic devices - EPA - Flea & Tick Products - Insect Repellants such as Equine Fly Sprays - State Registrations Non-Approval-Related Considerations - Extra-Label Drug Use - Compounding - Noncompliance and Enforcement - FDA Enforcement Authority over Development, Manufacture, Marketing, and Distribution - FDA's Office of Regulatory Affairs (ORA): Responsible for field activities, imports, inspections, and enforcement policy - Local, State, and Tribal governments - CVM's Office of Surveillance and Compliance - Types of Enforcement Actions Importance of Patent Protection: Right to Enforce For more information about this conference visit http://www.researchandmarkets.com/research/h6p6wc/the_veterinary To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/two-day-veterinary-drug-approval-process-and-fda-regulatory-oversight-course-kansas-city-missouri-united-states---june-13-14-2017---research-and-markets-300444055.html
News Article | May 11, 2017
NSF International, a global public health and safety organization that provides food safety and quality assurance services across all food supply chain sectors, announced the recipients of the 2017 NSF Food Safety Leadership Awards today at the 2017 Food Safety Summit in Rosemont, Illinois: 2017 NSF Food Safety Leadership Lifetime Achievement Awards: Jack J. Guzewich, MPH Consultant and Trainer in Foodborne Disease Epidemiology and Food Emergency Response NSF International’s Food Safety Leadership Awards recognize individuals and organizations for real and lasting improvements in food safety. Created in 2004, the awards encourage the development of educational programs, processes and technologies to advance food safety. Each year, an independent panel of food safety experts from academia, industry and the regulatory community reviews nominations from around the world to select the recipients. Nominations are evaluated on the basis of innovation, impact and contribution to the advancement of food safety. “These awards honor the recipients for their contributions to food safety and the protection of public health. The work of Jack Guzewich, David Theno and Lee-Ann Jaykus has contributed to important advances in food safety research, industry innovation and pathogen mitigation. Their leadership and enthusiasm in science-based research, collaboration and information sharing to help solve vital food safety issues embodies the spirit of NSF International’s Food Safety Leadership Awards,” said Kevan P. Lawlor, NSF International President and Chief Executive Officer. Lifetime Achievement Award: Jack J. Guzewich, MPH, Consultant and Trainer in Foodborne Disease Epidemiology and Food Emergency Response Over his 46-year career, Jack J. Guzewich has been a national leader in food safety regulation and the epidemiology of foodborne disease. He is a proponent of environmental assessment including root cause analysis to investigate the causes of foodborne disease outbreaks and food contamination events. Much of his career was spent on investigations to understand how food becomes contaminated with foodborne pathogens and the ecology of pathogens in various environments. Mr. Guzewich directed the New York State Department of Health’s food safety program for 17 years and created the Foodborne Disease Surveillance System (FBDS), an extensive database of reported foodborne disease outbreaks including their contributing factors. FBDS was one of the first systems of its kind and served as a precursor to today’s National Outbreak Reporting System. Mr. Guzewich guided the adoption of New York’s regulation to prohibit bare-hand contact with ready-to-eat foods and worked to include these provisions in the FDA Food Code. He was instrumental in documenting gastroenteritis and Salmonella enteritidis outbreaks associated with shellfish and shelled eggs, respectively, by identifying trends and developing interventions to prevent future outbreaks. As a result, control recommendations implemented by New York under his leadership led to national improvements as provided in the 2009 Egg Safety Final Rule. At the FDA’s Center for Food Safety and Applied Nutrition, Mr. Guzewich created and led the Center’s Emergency Coordination and Response program with a strong emphasis on prevention and control of foodborne disease. He developed the FDA procedures for investigating produce farms implicated in outbreaks or contamination events to identify the root causes of contamination, which required an environmental assessment versus a routine inspection. He worked very closely with the CDC’s Environmental Health Specialist Network to help develop the National Environmental Assessment Reporting System which is used by several states to help identify the root causes of foodborne disease outbreaks. He was also instrumental in developing the publication Procedures to Investigate Foodborne Illness and contributed to the first editions of Guidelines for Foodborne Disease Outbreak Response and Guidelines for Foodborne Disease Outbreak Response – Toolkit. “Jack Guzewich is the epitome of a food safety leader,” says Dale L. Morse, MD, Associate Director for Food Safety, Division of Foodborne, Waterborne and Environmental Diseases, CDC. “His career was built on hard work, innovative creation of foodborne illness surveillance networks and databases, application of these networks to identify causes and initiate long-term control recommendations, and educational pursuits to train the next generation of food safety leaders.” Lifetime Achievement Award: David M. Theno, Ph.D., CEO/CBIO, Gray Dog Partners, Inc. Throughout his 40-year career, Dr. David M. Theno’s work set new standards for food safety leadership and management in food production and in the foodservice industry. He has been instrumental in demonstrating how the scientific community and the meat/food industry can work together to solve food safety challenges. Dr. Theno installed the first Hazard Analysis and Critical Control Point (HACCP) program in an animal protein production plant while at Foster Farms in the mid-1980s. His work in the early 1990s at Jack in the Box is widely credited with setting new standards for food safety leadership and management in all aspects of food production. After an Escherichia coli (E. coli) 0157:H7 infection of the chain’s burgers caused a foodborne illness outbreak in the Pacific Northwest, he developed the first comprehensive food safety management plan for a foodservice chain. He also implemented a finished ground beef testing protocol, a comprehensive supply chain auditing system and a “test and hold” protocol for ground beef that is now an industry standard. This management program resulted in a significant reduction of foodborne illness outbreaks in the foodservice industry, and all major foodservice chain organizations today have implemented a food safety management plan based on this program. Serving as a member of the USDA’s National Advisory Committee on Microbiological Criteria for Foods, Dr. Theno was instrumental in changing the way the USDA and the industry look at food safety. He played an essential role in helping guide the beef industry’s research activities to better understand E. coli O157, and helped form the Beef Industry Food Safety Council, which develops and updates food safety practices that are critical for the food industry. Dr. Theno is one of the original authors of the HACCP guidance issued by FDA and USDA/FSIS that is in place today, and has authored numerous scientific and trade publication articles. “David Theno’s leadership through the E. coli outbreaks in the 1990s set the stage for the entire industry to come together in a non-competitive, collaborative effort to employ science-based solutions to tackle emerging pathogenic threats,” says Thomas H. Powell, Ph.D., CAE, Executive Director, American Meat Science Association. “Dr. Theno led the effort to identify and implement viable interventions and spurred research into new intervention strategies. His greatest impact was his unswerving dedication to protecting the consumer and his complete transparency with other industry food safety leaders. He freely shared the valuable insights he gained through the fiery trials on the front lines of the early outbreaks.” Dr. Lee-Ann Jaykus has over 30 years’ experience advancing the science of food safety through applied infection prevention and control science, especially regarding norovirus. She has collaborated on many large, multi-institutional projects on foodborne pathogens and food virology, including developing methods to detect human enteric virus contamination in foods and environmental samples, and better understanding the dynamics of virus transmission through the food chain. She serves as the Scientific Director of the USDA-NIFA Food Virology Collaborative (NoroCORE), a team of 30-plus scientists representing 18 academic and government institutions working to develop improved tools, skills and capacity to understand and control foodborne virus disease risks. Under Dr. Jaykus’ direction, NoroCORE has worked closely with companies, trade organizations, government regulators and public health entities to identify and address the most important food virology problems, and translate results into real-world processes and actions. These include cultivating human norovirus which had eluded scientists for 50 years, developing a risk-modeling program for tracking norovirus that can calculate disease risk and screen strategies for managing contamination in food service and health care facilities, confirming that alcohol-based hand sanitizers cannot completely inactivate norovirus and working to modify FDA Food Code recommendations to facilitate norovirus control. In her academic career, Dr. Jaykus has taught graduate and undergraduate courses in food microbiology and safety, mentored over 30 graduate students and post-doctoral research associates, and authored over 150 publications. “I have never met a scientist or food safety professional as enthusiastic and competent as Dr. Jaykus is in defining the issues, developing key needs, initiating the means to fill gaps and translating findings quickly into industry applications,” says Hal King, Ph.D., President/CEO of Public Health Innovations LLC. “Her work will lead to improved methods to prevent norovirus foodborne disease infections around the world, and she has elevated our nation’s food safety competencies across all sectors of the food chain.” Editor’s note: For more information on the NSF Food Safety Leadership Awards or to schedule an interview with an NSF International food safety expert, contact Liz Nowland-Margolis at media(at)nsf.org or +1 734-418-6624. About NSF International: NSF International (nsf.org) is a global independent organization that writes standards, and tests and certifies products for the food, water and consumer goods industries to minimize adverse health effects and protect the environment. Founded in 1944, NSF is committed to protecting human health and safety worldwide. NSF International is a Pan American Health Organization/World Health Organization Collaborating Center on Food Safety, Water Quality and Indoor Environment. NSF International provides expertise and accredited food services across all supply chain sectors, including agriculture, animal feed and welfare, produce, processing, distribution, dairy, seafood, quality management software, retail and restaurants. Services include Global Food Safety Initiative, foodservice equipment and nonfood compounds certification, HACCP validation and inspection, label claims verification and certification, DNA and food package testing, product and process development, food fraud consulting and training, and organic and Certified Transitional certification through Quality Assurance International (QAI).
Flynn T.J.,Center for Food Safety and Applied Nutrition |
Ferguson M.S.,Center for Food Safety and Applied Nutrition
Toxicology Letters | Year: 2010
Women are more susceptible than men to acute liver injury from drugs and other xenobiotics. The biological mechanisms for this sex difference are unknown, but known sex differences in steroid hormone levels and immune response could play a role. A human hepatocyte cell line, HepG2, was cultured for 8 days in either a male hormone, female hormone, or sex hormone-free medium. The cells were then exposed to a mixture of pro-inflammatory cytokines (interleukin (IL)-1β, IL-6, TNFα) for 72. h to simulate acute inflammation. Cell viability (total DNA) and various metabolic functions (reactive oxygen species (ROS), neutral and polar lipid (PL) accumulation, mitochondrial membrane potential, cytochrome P450 (CYP) activities) were measured fluorometrically. Acute phase proteins (albumin, IL-1ra) were measured in the culture medium by ELISA. This model gave both significant hormone only effects (ROS, PL accumulation) and cytokine only effects (total DNA, CYP1A, neutral and PL accumulation, albumin, IL-1ra) consistent with known biological responses. Significant hormone-cytokine interactions were observed for several endpoints (total DNA, ROS, neutral and PL accumulation, albumin). These findings suggest that sex hormones and pro-inflammatory cytokines can interact to alter liver metabolism in ways that may contribute to the marked sex difference in susceptibility to chemical-induced acute liver injury. © 2010.
Trumbo P.R.,Center for Food Safety and Applied Nutrition
The American journal of clinical nutrition | Year: 2016
The US Food and Drug Administration (FDA) regulates the addition of iodine to infant formulas, the iodization of salt, and the addition of salt and iodine to foods. The required amount of iodine in infant formulas is based on caloric content, and the label must provide the iodine content per 100 kcal. Cuprous iodide and potassium iodide may be added to table salt as a source of dietary iodine at a maximum amount of 0.01%; if added, the label must indicate that the salt is iodized. Table salt to which iodine has not been added must bear the statement, "This salt does not supply iodide, a necessary nutrient." If a nutrient is to be appropriately added to a food for the purpose of correcting a dietary insufficiency, there should be sufficient scientific information available to demonstrate a nutritional deficiency and/or identify a public health problem. Furthermore, the population groups that would benefit from the proposed fortification should be identified. If iodine is added to a food, the percent Daily Value of iodine must be listed. There are no FDA regulations governing ingredient standards for dietary supplements. As a result, some dietary supplements include iodine and others do not. If a supplement contains iodine, the Supplement Facts label must list iodine as a nutrient ingredient. If iodine is not listed on the Supplement Facts label, then it has not been added. There are similarities between the FDA, which establishes US food regulations and policies, and the Codex Alimentarius (Codex), which develops international food standards and guidelines under the aegis of the FAO and the WHO. Both the FDA and Codex call for the labeling of table salt to indicate fortification with iodine, voluntary labeling of iodine on foods, and a Daily Value (called a Nutrient Reference Value by Codex) of 150 μg for iodine. © 2016 American Society for Nutrition.
News Article | November 20, 2015
CHICAGO (Reuters) - A battle over whether the U.S. government should require special labels for genetically modified foods is set to heat up after a type of salmon on Thursday became the first biotech animal approved for human consumption. Activists who argue that the farm-raised salmon poses risks to the environment and public health say its clearance by the U.S. Food and Drug Administration (FDA) will galvanize opponents to press for the fish to be labeled as genetically engineered. Friends of the Earth and other environmental groups plan to send letters to the FDA and members of Congress calling for a law that requires labels. The groups have already successfully lobbied major companies like and Kroger Co and Safeway Ltd [MRWAY.UL] to say they will ban GMO salmon from their stores. "The labeling battle is a particularly big deal," said Dana Perls, food and technology campaigner for Friends of the Earth. "People have a right to know what they're eating." Companies that produce food with genetically modified (GMO) ingredients worry that mandated labels could reduce consumer demand and increase costs. The first supplies of GMO salmon, which will be engineered by AquaBounty Technologies Inc to grow faster than conventional fish, will likely arrive in U.S. supermarkets in two years or more, after being raised in facilities in Canada and Panama, Chief Executive Ronald Stotish told Reuters. He said the company will follow the FDA's rules, which do not require special labeling because the agency says the salmon is nutritionally equivalent to conventional, farm-raised Atlantic salmon. If a company opts to label GMO salmon, the agency suggested wording such as, "This salmon patty was made from Atlantic salmon produced using modern biotechnology." Sellers of other salmon may want to label products as being not genetically engineered (GE) if they "want to assist consumers in avoiding confusion about the limited scope of fish products on the market that are genetically engineered," the FDA said. The agency is accepting public comments on its voluntary labeling guidelines for 60 days starting on Nov. 23. "We recognize that some consumers are interested in knowing whether food ingredients are derived from GE sources," said Susan Mayne, director of the FDA's Center for Food Safety and Applied Nutrition. The FDA's clearance of GMO salmon "will energize people to fight and demand more labeling," said Michael Hansen, senior staff scientist for the Consumers Union, who opposed the approval. In July, the U.S. House of Representatives passed a hotly debated measure that blocks any mandatory labeling of foods made with genetically engineered crops, including pre-empting a state law set to take effect next year in Vermont. The vote was a victory for food and agricultural companies that say mandatory labeling would burden them with unwieldy costs and requirements. Since 2005, a state law in Alaska has required GMO fish to be "conspicuously labeled," although the measure never needed to be used. Fishermen would like to see a similar federal law so that consumers know what they are eating, said Tyson Fick, communications director for the Alaska Seafood Marketing Institute. More grocery store bans on GMO salmon would help ensure that customers do not unknowingly eat the fish, said Patty Lovera, assistant director for Food & Water Watch. "It's an imperfect way, but it's what they leave us with when they don't require labeling," she said about the government.
Trumbo P.R.,Center for Food Safety and Applied Nutrition |
Rivers C.R.,Center for Food Safety and Applied Nutrition
Nutrition Reviews | Year: 2014
A systematic review of the evidence for an association between sugar-sweetened beverages and risk of obesity was conducted. This review focused specifically on the role of sugar-sweetened beverages in obesity risk, taking into account energy balance. For the purpose of this review, scientific conclusions could not be drawn from the intervention studies that evaluated the relationship between sugar-sweetened beverage intake and obesity risk. Results of observational studies that examined the relationship between sugar-sweetened beverage intake and obesity risk that were adjusted for energy intake and physical activity were inconsistent for each of the three age groups evaluated (children, adolescents, and adults). From this review, evidence for an association between sugar-sweetened beverage intake and obesity risk is inconsistent when adjustment for energy balance is made. © 2014 International Life Sciences Institute.
Hildebrandt S.,Center for Food Safety and Applied Nutrition |
Hildebrandt S.,College Park
Analytical and Bioanalytical Chemistry | Year: 2010
Fish are a common cause of allergic reactions associated with food consumption, with parvalbumin being the major allergenic protein. Some fish-hypersensitive patients tolerate some fish species while being allergic to others. Reliable detection methods for allergenic fish species in foods are necessary to ensure compliance with food allergen labeling guidelines to protect fish-allergic consumers. The objective of this project was to develop a multi-analyte detection method for the presence of fish in food. Therefore, conserved parvalbumin exon sequences were utilized for the design of universal PCR primers amplifying intron DNA and small regions of exons flanking the enclosed intron from even very distantly related fish species. An assay for the identification of eight fish species was developed using xMAP™ technology with probes targeting species-specific parvalbumin intron regions. Additionally, a universal fish probe was designed targeting a highly conserved exon region located between the intron and the reverse primer region. The universal fish assay showed no cross-reactivity with other species, such as beef, pork, lamb, chicken, turkey, and shrimp. Importantly, with the exception of one notable case with fish in the same subfamily, species-specific detection showed no cross-reactivity with other fish species. Limits of detection for these eight species were experimentally estimated to range from 0.01% to 0.04%, with potential to increase the detection sensitivity. This report introduces a newly developed method for the multiplex identification of at least eight allergenic fish species in food, which could conceivably be extended to detect up to 100 species simultaneously in one sample. © 2010 US Government.
Etheridge S.M.,Center for Food Safety and Applied Nutrition
Toxicon | Year: 2010
Paralytic shellfish poisoning (PSP) is the foodborne illness associated with the consumption of seafood products contaminated with the neurotoxins known collectively as saxitoxins (STXs). This family of neurotoxins binds to voltage-gated sodium channels, thereby attenuating action potentials by preventing the passage of sodium ions across the membrane. Symptoms include tingling, numbness, headaches, weakness and difficulty breathing. Medical treatment is to provide respiratory support, without which the prognosis can be fatal. To protect human health, seafood harvesting bans are in effect when toxins exceed a safe action level (typically 80 μg STX eq 100 g-1 tissue). Though worldwide fatalities have occurred, successful management and monitoring programs have minimized PSP cases and associated deaths. Much is known about the toxin sources, primarily certain dinoflagellate species, and there is extensive information on toxin transfer to traditional vectors - filter-feeding molluscan bivalves. Non-traditional vectors, such as puffer fish and lobster, may also pose a risk. Rapid and reliable detection methods are critical for toxin monitoring in a wide range of matrices, and these methods must be appropriately validated for regulatory purposes. This paper highlights PSP seafood safety concerns, documented human cases, applied detection methods as well as monitoring and management strategies for preventing PSP-contaminated seafood products from entering the food supply. © 2010.
News Article | September 29, 2016
The U.S. Food and Drug Administration (FDA) is looking for comments from the public to redefine "healthy," a term that commonly appears on many food product labels in the country. The FDA said on Sept. 28, that redefining "healthy" will help people a great deal in making their food choices according to public health recommendations, which could encourage food industries to produce quality products. Nutrition experts and many food companies claim that the current guidelines enacted decades ago are no longer in accordance with present dietary advice. The agency noted that manufacturers can list products as "healthy" on food labels, in accordance with the existing regulatory definition, while new guidelines are being prepared. The issue started after Kind Snacks, the fruit-and-nut snack bars maker, petitioned FDA for the first time in relation to the federal limitations on fat content. People look at product labels to get nutritional facts while making the decision to buy. Therefore, terms like "healthy," "good source" and "low in fat" matter a lot because they guide people in making choices accordingly. To be deemed healthy, food products must follow appropriate and up-to-date guidelines. For example, recent public health recommendations are more concerned about the type of fat present in the food products than the amount of fat. As such, manufacturers can only claim their food products are healthy if they contain fat within the allowable limits. When label guidelines are updated, they will have information on added sugars, the topic of one of the most recent health recommendations. The guidelines will also focus on nutrient content, particularly those that people don't get in sufficient amounts like potassium and vitamin D. The FDA is organizing various public forums to give people an avenue for their comments, with the comment period starting on Sept. 28 and ending on Jan. 26, 2017. Additionally, comments may be left online at Regulations.gov. Those who wish to mail in their comments may also do so, but written comments have to be identified with the docket number FDA-2016-D-2335. "While we are working on the 'healthy' claim, we also will begin evaluating other label claims to determine how they might be modernized," wrote Douglas Balentine, director of the Office of Nutrition and Food Labeling at FDA's Center for Food Safety and Applied Nutrition. "We want to give consumers the best tools and information about the foods they choose, with the goal of improving public health," he added. © 2017 Tech Times, All rights reserved. Do not reproduce without permission.
News Article | April 2, 2016
The Food and Drug Administration today proposed a new limit for the level of arsenic allowed in infant rice cereal. After an extensive study of arsenic levels in food, the FDA proposed a limit of 100 parts per billion (ppb) for inorganic arsenic in infant rice cereal. The agency's testing has shown that most infant rice cereals now on the market (around 80 percent) already meet, or are close to meeting, this requirement, the FDA said. The agency has already set limits for levels of inorganic arsenic in drinking water and apple juice, but the new proposal, if finalized, would be the first limit for arsenic in food. Arsenic is an element found naturally in soil and water, but rice plants tend to absorb more arsenic than do other crops. What's more, infants consume much more rice than adults relative to their weight, mostly because babies eat infant rice cereal, the FDA said. "Our actions are driven by our duty to protect the public health and our careful analysis of the data and the emerging science," Susan Mayne, director of the FDA's Center for Food Safety and Applied Nutrition, said in a statement. "The proposed limit is a prudent and achievable step to reduce exposure to arsenic among infants." Inorganic arsenic is a known carcinogen, and higher levels of exposure over a lifetime may increase the risk of bladder and lung cancer. The FDA estimates that exposure to inorganic arsenic in rice products causes an extra four cases of lung and bladder cancer over a lifetime, for every 100,000 people in the United States (which is less than 1 percent of the nation's lung and bladder cancer cases). [Why Is Arsenic Bad for You?] Studies have also linked exposure to inorganic arsenic in infants to decreased performance on certain developmental tests. The FDA recommends that people eat a well-balanced diet to minimize the potential health effects of consuming too much of any one food. The agency recommends that parents feed their infants iron-fortified cereals, including rice, oat, barley and multigrain cereals. Rice cereal should not be the only source of nutrients for a baby, the agency said. Copyright 2016 LiveScience, a Purch company. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.