Seafood contamination after the BP Gulf oil spill and risks to vulnerable populations: a critique of the FDA risk assessment

Background: The BP oil spill of 2010 resulted in contamination of one of the most productive fisheries in the United States by polycyclic aromatic hydrocarbons (PAHs). PAHs, which can accumulate in seafood, are known carcinogens and developmental toxicants. In response to the oil spill, the U.S. Food and Drug Administration (FDA) developed risk criteria and established thresholds for allowable levels [levels of concern (LOCs)] of PAH contaminants in Gulf Coast seafood.Objectives: We evaluated the degree to which the FDA’s risk criteria adequately protect vulnerable Gulf Coast populations from cancer risk associated with PAHs in seafood.Discussion: The FDA LOCs significantly underestimate risk from seafood contaminants among sensitive Gulf Coast populations by failing to a) account for the increased vulnerability of the developing fetus and child; b) use appropriate seafood consumption rates; c) include all relevant health end points; and d) incorporate health-protective estimates of exposure duration and acceptable risk. For benzo[a]pyrene and naphthalene, revised LOCs are between two and four orders of magnitude below the level set by the FDA. Comparison of measured levels of PAHs in Gulf seafood with the revised LOCs revealed that up to 53% of Gulf shrimp samples were above LOCs for pregnant women who are high-end seafood consumers.Conclusions: FDA risk assessment methods should be updated to better reflect current risk assessment practices and to protect vulnerable populations such as pregnant women and children.     

Olestra: A New Food Additive

In 1987, Procter and Gamble Company (Cincinnati, Ohio) petitioned the US Food and Drug Administration (FDA) to amend the food additive regulations to allow sucrose esterified with fatty acids (olestra) to be used as a replacement for conventional fats. The petitioner later restricted its request for use in savory snacks. FDA considered evidence submitted by the petitioner, the opinions of experts, proceedings from the FDA Food Advisory Committee, and public discussion and concluded on January 25, 1996, that olestra was safe for use in savory snacks (eg, salty snacks such as potato chips, corn chips). Olestra is not toxic, carcinogenic, genotoxic, or teratogenic and is neither absorbed nor metabolized by the body, but may be associated with gastrointestinal tract symptoms such as cramping or loose stools. In addition, olestra affects the absorption of fat-soluble vitamins but does not affect the absorption of water-soluble nutrients. The petitioner's studies concluded that when olestra was consumed with foods containing vitamins A, D, E, or K, the fat substitute could have an effect on the absorption of these nutrients. Therefore, FDA is requiring that fat-soluble vitamins lost through absorption be added back to olestra as follows: 170 IU vitamin A per gram olestra, 12 IU vitamin D per gram olestra, 2.8 IU vitamin E per gram olestra, and 8 μg vitamin K per gram olestra. As part of the conditions of approval FDA is requiring that the food labels of products containing olestra disclose the vitamin compensation and the potential gastrointestinal effects. FDA is also requiring that further studies examining consumption patterns and the effects of olestra on human beings be conducted. J Am Diet Assoc. 1998;98:565–569.     

Licensure of 13-valent pneumococcal conjugate vaccine for adults aged 50 years and older

In 2010, 13-valent pneumococcal conjugate vaccine (PCV13 [Prevnar 13, Wyeth Pharmaceuticals, Inc., a subsidiary of Pfizer, Inc.]) was licensed by the Food and Drug Administration (FDA) and recommended by the Advisory Committee on Immunization Practices (ACIP) for children aged 6 weeks through 71 months for the prevention of invasive pneumococcal disease (IPD) caused by the 13 pneumococcal serotypes included in the vaccine. PCV13 currently is recommended as a 4-dose series for children starting at age 2 months. On December 30, 2011, FDA approved PCV13 for prevention of pneumonia and invasive disease caused by PCV13 serotypes among adults aged 50 years and older. This report summarizes data on the immunogenicity and safety of PCV13 in adults and outlines key additional evidence requested by ACIP to formulate recommendations for its use.     

Impact on human health of hormonal additives used in animal production

The establishment of the impact of environmental compounds or additives with hormone-like activity on human health still requires further investigation, as well as a reexamination of biologic models and experimental methodology employed so far. In 1988, the FAO/WHO Expert Committee on Food Additives Joint with the Federal Drug Administration (FDA) considered that sexual hormone residues usually present in meat do not represent a risk for human consumption. Nevertheless, this resolution seems to be uncertain since the scientific elements employed for this statement may not be adequate. In this review the principal objections to the evidence used to establish the innocuousness of growth promoter hormones are considered.     

Dietary influences on cognitive development and behaviour in children

There are a number of ways in which food can influence behaviour, including malnutrition, types of diet, eating habits, pharmacological effects, food allergy, fatty acid deficiency and possibly food additives. The range of behaviour affected is also wide, and includes attention, conduct disorder and mood. A particular focus of interest has been the effects of food on hyperactivity in children. There is some initial evidence that fatty acids may influence hyperactivity in children with specific learning disabilities. The findings also suggest that some food additives (colourings, flavourings and preservatives) may increase hyperactivity in children with behaviour problems. For children showing behaviour problems such as hyperactivity the use of dietary manipulation tends to be a more acceptable approach to treatment than the use of drugs. However, there needs to be awareness of the dangers of the use of unsupervised restriction diets with children, and the use of dietary treatments alone is not likely to be sufficient treatment for many children with attention-deficit hyperactivity disorder. A study is currently underway to investigate the possible effects of additives on behaviour in the general population of children.     

Salmonellosis associated with pet turtles--Wisconsin and Wyoming, 2004

Salmonellosis associated with small pet turtles in the United States was a major public health concern in the 1970s. In 1975, the Food and Drug Administration (FDA) banned commercial distribution of small turtles (i.e., those with a carapace of <4 inches). The FDA ban prevents an estimated 100,000 cases of salmonellosis among children each year. However, a recent resurgence in the sale of small turtles has generated concern. In Wisconsin and Wyoming, at least six human cases of salmonellosis have been linked to such turtles. This report describes the investigation into those cases. The findings underscore the need for health and environmental officials to prevent illegal distribution of small turtles and consider patient contact with turtles when investigating salmonellosis cases.     

FDA licensure of and ACIP recommendations for vaccines

Many healthcare providers are not familiar with the Food and Drug Administration (FDA) vaccine licensure process, the Advisory Committee on Immunization Practices (ACIP) vaccine recommendation process, and how FDA vaccine licensure and ACIP recommendations are related. Vaccines for use in the United States military and civilian populations are licensed by the FDA by several potential pathways but use of licensed vaccines in the civilian population should be based on recommendations made by the ACIP. In performing these distinct activities, FDA and ACIP function under different mandates. In this article, we discuss whether the FDA licensure pathways used to approve a vaccine impacts ACIP recommendation categories for vaccines licensed from 2006 to 2016.     

Recommendations regarding the use of vaccines that contain thimerosal as a preservative

On October 20, 1999, the Advisory Committee on Immunization Practices (ACIP) reviewed information about thimerosal in vaccines and received updates from CDC's National Immunization Program and several vaccine manufacturers on the current and anticipated availability of vaccines that do not contain thimerosal as a preservative. The review was prompted by a joint statement about thimerosal issued July 8, 1999, by the American Academy of Pediatrics (AAP) and the Public Health Service (PHS) (1) and a comparable statement released by the American Academy of Family Physicians (2). These statements followed a Congressionally mandated Food and Drug Administration (FDA) review of mercury in drugs and food, which included a reassessment of the use of thimerosal in vaccines.     

Pneumococcal vaccination for cochlear implant candidates and recipients: updated recommendations of the Advisory Committee on Immunization Practices

In October 2002, CDC recommended that all persons with cochlear implants receive age-appropriate pneumococcal vaccination with 7-valent pneumococcal conjugate vaccine (PCV7) (Prevnar), 23-valent pneumococcal polysaccharide vaccine (PPV23) (Pneumovax), or both according to the Advisory Committee on Immunization Practices (ACIP) schedules for persons at high risk. CDC issued these recommendations on the basis of preliminary data suggesting an increased risk for pneumococcal meningitis in persons with cochlear implants. Findings of a recent investigation by CDC, the Food and Drug Administration (FDA), and state health departments support this recommendation. Children aged <6 years with a cochlear implant had a substantially greater risk for having pneumococcal meningitis, compared with children in the general U.S. population of the same age. Some children who are candidates for cochlear implants have pre-existing anatomic factors that might contribute to an increased risk for meningitis; however, the recent study was not designed to assess this association.     

Update on herpes zoster vaccine: licensure for persons aged 50 through 59 years

Herpes zoster vaccine (Zostavax, Merck & Co., Inc.) was licensed and recommended in 2006 for prevention of herpes zoster among adults aged 60 years and older. In March 2011, the Food and Drug Administration (FDA) approved the use of Zostavax in adults aged 50 through 59 years. In June 2011, the Advisory Committee on Immunization Practices (ACIP) declined to recommend the vaccine for adults aged 50 through 59 years and reaffirmed its current recommendation that herpes zoster vaccine be routinely recommended for adults aged 60 years and older.     

Food Composition Databases: Does It Matter to Human Health?

Food provides humans with more than just energy and nutrients, addressing both vital needs and pleasure. Food habits are determined by a wide range of factors, from sensorial stimuli to beliefs and, once commanded by local and seasonal availability, are nowadays driven by marketing campaigns promoting unhealthy and non-sustainable foodstuffs. Top-down and bottom-up changes are transforming food systems, driven by policies on SDGs and by consumer’s concerns about environmental and health impacts. Food quality, in terms of taste, safety, and nutritional value, is determined by its composition, described in food composition databases (FDBs). FDBs are then useful resources to agronomists, food and mechanical engineers, nutritionists, marketers, and others in their efforts to address at maximum human nutrient needs. In this work, we analyse some relevant food composition databases (viz., purpose, type of data, ease of access, regularity of updates), inspecting information on the health and environmental nexus, such as food origin, production mode as well as nutritional quality. The usefulness and limitations of food databases are discussed regarding what concerns sustainable diets, the food ‘matrix effect’, missing compounds, safe processing, and in guiding innovation in foods, as well as in shaping consumers’ perceptions and food choices.     

Qualified Health Claims for Calcium and Colorectal,Breast, and Prostate Cancers: The U.S. Food and Drug Administration's Evidence-Based Review

In 2003, the United States Food and Drug Administration (FDA) received a health claim petition for calcium supplements and reduced risk of colorectal, breast, and prostate cancers. Health claims characterize the relationship between a substance (food or food component) and disease (e.g., cancer or cardiovascular disease) or health-related condition (e.g., hypertension) and require premarket approval for the labeling of conventional foods and dietary supplements by the FDA. This review describes how the FDA used the evidence-based review system to evaluate the scientific evidence for these proposed health claims. FDA found no credible evidence to support health claims for calcium and a reduced risk of breast and prostate cancers. The agency did find limited evidence for the relationship between calcium intake and colorectal cancer risk.     

Missing from the table: role of the environmental public health community in governmental advisory commissions related to Marcellus Shale drilling

Background: The Marcellus Shale is a vast natural gas field underlying parts of Pennsylvania, New York, West Virginia, Virginia, and Maryland. Rapid development of this field has been enabled by advances in hydrofracking techniques that include injection of chemical and physical agents deep underground. Response to public concern about potential adverse environmental and health impacts has led to the formation of state and national advisory committees.Objectives: We review the extent to which advisory committees formed in 2011 by President Obama and governors of the states of Maryland and Pennsylvania contain individuals with expertise pertinent to human environmental public health. We also analyze the extent to which human health issues are of concern to the public by reviewing presentations at the public meeting of the Secretary of Energy Advisory Board (SEAB) Natural Gas Subcommittee formed by the U.S. President’s directive.Results: At a public hearing held by the SEAB Natural Gas Subcommittee 62.7% of those not in favor of drilling mentioned health issues. Although public health is specified to be a concern in the executive orders forming these three advisory committees, we could identify no individuals with health expertise among the 52 members of the Pennsylvania Governor’s Marcellus Shale Advisory Commission, the Maryland Marcellus Shale Safe Drilling Initiative Advisory Commission, or the SEAB Natural Gas Subcommittee.Conclusions: Despite recognition of the environmental public health concerns related to drilling in the Marcellus Shale, neither state nor national advisory committees selected to respond to these concerns contained recognizable environmental public health expertise.     

Prevention and control of influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2011

This document provides updated guidance for the use of influenza vaccines in the United States for the 2011-12 influenza season. In 2010, the Advisory Committee on Immunization Practices (ACIP) first recommended annual influenza vaccination for all persons aged ≥6 months in the United States. Vaccination of all persons aged ≥6 months continues to be recommended. Information is presented in this report regarding vaccine strains for the 2011-12 influenza season, the vaccination schedule for children aged 6 months through 8 years, and considerations regarding vaccination of persons with egg allergy. Availability of a new Food and Drug Administration (FDA)-approved intradermally administered influenza vaccine formulation for adults aged 18 through 64 years is reported. For issues related to influenza vaccination that are not addressed in this update, refer to the 2010 ACIP statement on prevention and control of influenza with vaccines and associated updates.     

FDA's review of scientific evidence for health claims

Under the Federal Food, Drug, and Cosmetic Act health claims on foods or dietary supplements must be authorized by the FDA. Health claims describe the relationship between a food, food component, or dietary supplement and reducing the risk of a disease or health-related condition. Under interim guidance and enforcement discretion, certain qualified health claims have been provided for on foods and dietary supplements; these claims contain language to qualify the quality and strength of scientific evidence to support the claim because they are not based on significant scientific agreement, which is the standard for health claims authorized by the Federal Food, Drug, and Cosmetic Act. In order to meet its statutory responsibility for evaluation of health claims, the agency has developed guidelines for review of scientific evidence in support of a health claim.     

Food Additives Associated with Gut Microbiota Alterations in Inflammatory Bowel Disease: Friends or Enemies?

During the 21st century, the incidence and prevalence of inflammatory bowel disease (IBD) is rising globally. Despite the pathogenesis of IBD remaining largely unclear, the interactions between environmental exposure, host genetics and immune response contribute to the occurrence and development of this disease. Growing evidence implicates that food additives might be closely related to IBD, but the involved molecular mechanisms are still poorly understood. Food additives may be categorized as distinct types in accordance with their function and property, including artificial sweeteners, preservatives, food colorant, emulsifiers, stabilizers, thickeners and so on. Various kinds of food additives play a role in modifying the interaction between gut microbiota and intestinal inflammation. Therefore, this review comprehensively synthesizes the current evidence on the interplay between different food additives and gut microbiome alterations, and further elucidates the potential mechanisms of food additives–associated microbiota changes involved in IBD.     

Artificial food dyes and attention deficit hyperactivity disorder

Attention deficit hyperactivity disorder (ADHD) is one of the most common behavioral disorders in children. Symptoms of ADHD include hyperactivity, low frustration tolerance, impulsivity, and inattention. While the biological pathways leading to ADHD are not clearly delineated, a number of genetic and environmental risk factors for the disorder are recognized. In the early 1970s, research conducted by Dr. Benjamin Feingold found that when hyperactive children were given a diet free of artificial food additives and dyes, symptoms of hyperactivity were reduced. While some clinical studies supported these findings, more rigorous empirical studies conducted over the next 20 years were less positive. As a result, research on the role of food additives in contributing to ADHD waned. In recent years, however, interest in this area has revived. In response to more recent research and public petitions, in December 2009 the British government requested that food manufacturers remove most artificial food dyes from their products. While these strictures could have positive effects on behavior, the removal of food dyes is not a panacea for ADHD, which is a multifaceted disorder with both biological and environmental underpinnings.     

FDA licensure of diphtheria and tetanus toxoids and acellular pertussis adsorbed,hepatitis B (recombinant), and poliovirus vaccine combined, (PEDIARIX) for use in infants

On December 13, 2002, the U.S. Food and Drug Administration (FDA) licensed a combined diphtheria and tetanus toxoids and acellular pertussis adsorbed (DTaP), hepatitis B (HepB) (recombinant) and inactivated poliovirus vaccine (IPV), DTaP-HepB-IPV (PEDIARIX, SmithKline Beecham Biologicals, Rixensart, Belgium) for use in infants ages 2, 4, and 6 months. All components in the combined vaccine are recommended for routine use by the Advisory Committee on Immunization Practices (ACIP), the Committee on Infectious Diseases of the American Academy of Pediatrics, and the American Academy of Family Physicians. Combination vaccines decrease the number of vaccine injections.     

THE USE OF CHEMICALS IN FOOD PRODUCTION, PROCESSING, STORAGE AND DISTRIBUTION

A lucid account of the nature and uses of food additives, precautions concerning the uses of additives, the benefits and risks and the regulatory responsibilities of various government agencies involved has been prepared by the Subcommittee on Food Technology of the Food Protection Committee, National Academy of Sciences. Pertinent excerpts from this report are presented below.     

FDA approval of expanded age indication for a tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine

On July 8, 2011, the Food and Drug Administration (FDA) approved an expanded age indication for the tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Tdap) Boostrix (GlaxoSmithKline Biologicals, Rixensart, Belgium). Originally, Boostrix was licensed in 2005 for persons aged 10 through 18 years, but in 2008, FDA approved an expanded age indication for Boostrix to include persons aged 19 through 64 years. FDA has now expanded the age indication to include persons aged 65 years and older. Boostrix is now licensed for use in persons aged 10 years and older as a single-dose booster vaccination. This notice summarizes the indications for use of Boostrix. Recommendations of the Advisory Committee on Immunization Practices (ACIP) for Tdap vaccines have been published previously. Publication of revised Tdap recommendations within the next year is anticipated.