The Demise of Artificial Trans Fat: A History of a Public Health Achievement.

Policy Points This article describes a strategic combination of research, advocacy, corporate campaigns, communications, grassroots mobilization, legislation, regulatory actions, and litigation against companies and government to secure a national policy to remove artificial trans fat from the US food system. Sharing lessons we learned can help inform policymakers, academics, policy practitioners, and students across disciplines. Some of our lessons are that system change means that all consumers benefit without the need for individual behavior change; research can both identify opportunities to improve health and support policy adoption; policy efforts can serve as public education campaigns; policy campaigns can drive marketplace changes; and engaging forward-thinking companies can diffuse opposition to passing a policy. CONTEXT: For many decades, partially hydrogenated vegetable oil (PHO), the primary source of artificial trans fat in the American diet, was used widely in processed and restaurant foods. In the early 1990s, studies linked the consumption of artificial trans fat with heart disease. This article details how research and advocacy led to eliminating artificial trans fat from the US food supply. METHODS: We synthesized published studies of the health impact of trans fat, the legislative history of state and local trans fat bills, the Food and Drug Administration's (FDA) regulatory docket on trans fat labeling and its declaration that PHOs are no longer Generally Recognized as Safe (GRAS), and our own files, which included strategy documents, notes from meetings with the FDA staff, correspondence between advocates and the FDA, fact sheets, press releases, news clips, and other materials. FINDINGS: This history of trans fat provides insights into policy strategy and advocacy best practices that resulted in the removal of trans fat from food in the United States, preventing an estimated 50,000 premature deaths a year. The lessons we learned are that system change benefits all consumers without the need for individual behavior change; research can both identify opportunities to improve health through policy and support policy adoption; policy campaigns can serve as public education campaigns; policy can drive changes to products and the marketplace; and engaging forward-thinking companies can help diffuse opposition to passing a policy. Securing this policy required the persistence of scientists and health advocates in first discovering the risks and then using the science to secure policies to mitigate the identified harm. CONCLUSIONS: An understanding of the tactics used to help attain the targeted policies and how challenges were addressed (such as through communications, leveraging an expanding research base and expert reports, showing that a national policy was feasible through voluntary corporate changes and state and local policy, and litigation against companies and government agencies) may provide a model for scientists, students, advocates, and policymakers. We hope this account will inform efforts to address other public health challenges, such as the current threats of excessive exposure to sodium and added sugars, which persist in the US food system.

Policies to solve the salt problem.

Diets high in sodium have long been known to raise blood pressure, which, in turn, increases the risk of cardiovascular disease. Though authoritative recommendations have been made in the past several decades for federal policies and programs to reduce sodium consumption, measures adopted to date have not been effective. We recommend a comprehensive public health approach to reduce sodium in the food supply and prevent thousands of unnecessary deaths and billions of dollars in health-care costs each year.

Self-reported adverse reactions associated with mycoprotein (Quorn-brand) containing foods.

BACKGROUND: Mycoprotein, which is produced by a mold and is the basis of Quorn-brand meat substitutes, is a novel cause of allergic and gastrointestinal reactions, but little information has been available on its associated symptomatology. OBJECTIVE: To describe the nature and frequency of adverse reactions to mycoprotein. METHODS: Self-reports of adverse reactions to mycoprotein were collected via a Web-based questionnaire (www.quorncomplaints.org) and then analyzed. RESULTS: Analysis of 1,752 adverse reactions found that Quorn products caused allergic and gastrointestinal symptoms, with some people experiencing both. Allergic reactions, including urticaria and anaphylaxis, occurred within 4 hours of consumption in 312 people. Of those reactions, 45.8%, 1 fatal, began within 1 hour of exposure. Of those 312 individuals, 188 (60.3%) reported repeated reactions after repeated consumption of Quorn, and 2 people experienced 8 reactions (13 people did not say whether they experienced more than 1 reaction). Quorn foods caused gastrointestinal symptoms, including emesis and diarrhea, within 8 hours of consumption in 1,692 people. Of the gastrointestinal symptoms, 66.6% occurred 46 to 180 minutes after consumption of the products. Symptoms ranged from mild nausea to emesis severe enough to warrant medical attention. CONCLUSION: Mycoprotein may be causing numerous and sometimes life-threatening allergic and gastrointestinal reactions. The acceptance in the food supply of this nonessential ingredient deserves reconsideration.

Trends in trans fatty acids reformulations of US supermarket and brand-name foods from 2007 through 2011.

INTRODUCTION: Although some US food manufacturers have reduced trans fatty acids (TFA) in their products, it is unknown how much TFA is being reduced, whether pace of reformulation has changed over time, or whether reformulations vary by food type or manufacturer. METHODS: In 2007, we identified 360 brand-name products in major US supermarkets that contained 0.5 g TFA or more per serving. In 2008, 2010, and 2011, product labels were re-examined to determine TFA content; ingredients lists were also examined in 2011 for partially hydrogenated vegetable oils (PHVO). We assessed changes in TFA content among the 270 products sold in all years between 2007 and 2011 and conducted sensitivity analyses on the 90 products discontinued after 2007. RESULTS: By 2011, 178 (66%) of the 270 products had reduced TFA content. Most reformulated products (146 of 178, 82%) reduced TFA to less than 0.5 g per serving, although half of these 146 still contained PHVO. Among all 270 products, mean TFA content decreased 49% between 2007 and 2011, from 1.9 to 0.9 g per serving. Yet, mean TFA reduction slowed over time, from 30.3% (2007-2008) to 12.1% (2008-2010) to 3.4% (2010-2011) (P value for trend < .001). This slowing pace was due to both fewer reformulations among TFA-containing products at start of each period and smaller TFA reductions among reformulated products. Reformulations also varied substantially by both food category and manufacturer, with some eliminating or nearly eliminating TFA and others showing no significant changes. Sensitivity analyses were similar to main findings. CONCLUSIONS: Some US products and food manufacturers have made progress in reducing TFA, but substantial variation exists by food type and by parent company, and overall progress has significantly slowed over time. Because TFA consumption is harmful even at low levels, our results emphasize the need for continued efforts toward reformulating or discontinuing foods to eliminate PHVO.

Carcinogenicity and regulation of caramel colorings.

2- and 4-methylimidazoles are present as contaminants in caramel colorings manufactured with ammonia catalysts. Both contaminants have been shown to induce cancer in animals and may be present in caramel colorings in amounts that exceed federal guidelines. California requires warning notices on products that could lead to consumption of more than 30 micrograms per day. The US Food and Drug Administration should bar the use of excessively contaminated caramel coloring in food.

Toxicology of food dyes.

BACKGROUND: Food dyes, synthesized originally from coal tar and now petroleum, have long been controversial because of safety concerns. Many dyes have been banned because of their adverse effects on laboratory animals or inadequate testing. CONCLUSIONS: This review finds that all of the nine currently US-approved dyes raise health concerns of varying degrees. Red 3 causes cancer in animals, and there is evidence that several other dyes also are carcinogenic. Three dyes (Red 40, Yellow 5, and Yellow 6) have been found to be contaminated with benzidine or other carcinogens. At least four dyes (Blue 1, Red 40, Yellow 5, and Yellow 6) cause hypersensitivity reactions. Numerous microbiological and rodent studies of Yellow 5 were positive for genotoxicity. Toxicity tests on two dyes (Citrus Red 2 and Orange B) also suggest safety concerns, but Citrus Red 2 is used at low levels and only on some Florida oranges and Orange B has not been used for several years. The inadequacy of much of the testing and the evidence for carcinogenicity, genotoxicity, and hypersensitivity, coupled with the fact that dyes do not improve the safety or nutritional quality of foods, indicates that all of the currently used dyes should be removed from the food supply and replaced, if at all, by safer colorings. It is recommended that regulatory authorities require better and independent toxicity testing, exercise greater caution regarding continued approval of these dyes, and in the future approve only well-tested, safe dyes.

Delayed Finalization of Sodium Targets in the United States May Cost Over 250 000 Lives by 2031.

BACKGROUND: The US Food and Drug Administration (FDA) proposed 2- and 10-year voluntary sodium-reduction targets for >150 packaged- and prepared-food categories in 2016 and finalized the short-term targets in 2021. METHODS: We modeled the health benefits of implementing the newly finalized sodium targets, and the net health losses because of the 4.3-year delay in finalizing the sodium targets in different compliance scenarios in adults aged ≥30, using the National Health and Nutrition Examination Survey (NHANES) 2015 to 2016 cycle. The health impact was estimated by multiplying the projected reduction in population sodium intake by the annual health benefits resulting from every 1000-mg reduction in daily sodium intake. RESULTS: Under certain assumptions, the FDA's finalization of the short-term targets in Oct 2021 and possible finalization of the long-term targets by April 2024 is projected to save up to 445 979 (95% CI, 17 349-787 352) lives in the coming 10 years. The net number of unnecessary deaths because of FDA's delay is projected to be as high as 264 644 (95% CI, 10 295-467 215) according to our prediction. CONCLUSIONS: These findings highlight the enormous health costs due to the FDA's delay in finalizing the sodium-reduction targets, and the great potential health benefits of industry compliance with the FDA's finalization of its short- and long-term targets in the coming 10 years.

Sodium and Health: Old Myths and a Controversy Based on Denial.

PURPOSE OF REVIEW: The scientific consensus on which global health organizations base public health policies is that high sodium intake increases blood pressure (BP) in a linear fashion contributing to cardiovascular disease (CVD). A moderate reduction in sodium intake to 2000 mg per day helps ensure that BP remains at a healthy level to reduce the burden of CVD. RECENT FINDINGS: Yet, since as long ago as 1988, and more recently in eight articles published in the European Heart Journal in 2020 and 2021, some researchers have propagated a myth that reducing sodium does not consistently reduce CVD but rather that lower sodium might increase the risk of CVD. These claims are not well-founded and support some food and beverage industry's vested interests in the use of excessive amounts of salt to preserve food, enhance taste, and increase thirst. Nevertheless, some researchers, often with funding from the food industry, continue to publish such claims without addressing the numerous objections. This article analyzes the eight articles as a case study, summarizes misleading claims, their objections, and it offers possible reasons for such claims. Our study calls upon journal editors to ensure that unfounded claims about sodium intake be rigorously challenged by independent reviewers before publication; to avoid editorial writers who have been co-authors with the subject paper's authors; to require statements of conflict of interest; and to ensure that their pages are used only by those who seek to advance knowledge by engaging in the scientific method and its collegial pursuit. The public interest in the prevention and treatment of disease requires no less.

Effectiveness and Feasibility of Taxing Salt and Foods High in Sodium: A Systematic Review of the Evidence.

Diets high in salt are a leading risk for death and disability globally. Taxing unhealthy food is an effective means of influencing what people eat and improving population health. Although there is a growing body of evidence on taxing products high in sugar, and unhealthy foods more broadly, there is limited knowledge or experience of using fiscal measures to reduce salt consumption. We searched peer-reviewed databases [MEDLINE, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), and the Cochrane Database of Systematic Reviews] and gray literature for studies published between January 2000 and October 2019. Studies were included if they provided information on the impact on salt consumption of: taxes on salt; taxes on foods high in salt, and taxes on unhealthy foods defined to include foods high in salt. Studies were excluded if their definition of unhealthy foods did not specify high salt or sodium. We found 18 relevant studies, including 15 studies reporting the effects of salt taxes through modeling (8), real-world evaluation (4), experimental design (2), or review of cost-effectiveness (1); 6 studies providing information relevant to country implementation of salt taxes; and 2 studies reporting stakeholder perceptions toward salt taxation. Although there is some evidence on the potential effectiveness and cost-effectiveness of salt taxation, especially from modeling studies, uptake of salt taxation is limited in practice. Some modeling studies suggested that food taxes can have unintended outcomes such as reduced consumption of healthy foods, or increased consumption of unhealthy, untaxed substitutes. In contrast, modeling studies that combined taxes for unhealthy foods with subsidies found that the benefits were increased. Modeling suggests that taxing all foods based on their salt content is likely to have more impact than taxing specific products high in salt given that salt is pervasive in the food chain. However, the limited experience we found suggests that policy-makers favor taxing specific products.

The limits of two-year bioassay exposure regimens for identifying chemical carcinogens.

BACKGROUND: Chemical carcinogenesis bioassays in animals have long been recognized and accepted as valid predictors of potential cancer hazards to humans. Most rodent bioassays begin several weeks after birth and expose animals to chemicals or other substances, including workplace and environmental pollutants, for 2 years. New findings indicate the need to extend the timing and duration of exposures used in the rodent bioassay. OBJECTIVES: In this Commentary, we propose that the sensitivity of chemical carcinogenesis bio-assays would be enhanced by exposing rodents beginning in utero and continuing for 30 months (130 weeks) or until their natural deaths at up to about 3 years. DISCUSSION: Studies of three chemicals of different structures and uses-aspartame, cadmium, and toluene-suggest that exposing experimental animals in utero and continuing exposure for 30 months or until their natural deaths increase the sensitivity of bioassays, avoid false-negative results, and strengthen the value and validity of results for regulatory agencies. CONCLUSIONS: Government agencies, drug companies, and the chemical industry should conduct and compare the results of 2-year bioassays of known carcinogens or chemicals for which there is equivocal evidence of carcinogenicity with longer-term studies, with and without in utero exposure. If studies longer than 2 years and/or with in utero exposure are found to better identify potential human carcinogens, then regulatory agencies should promptly revise their testing guidelines, which were established in the 1960s and early 1970s. Changing the timing and dosing of the animal bioassay would enhance protection of workers and consumers who are exposed to potentially dangerous workplace or home contaminants, pollutants, drugs, food additives, and other chemicals throughout their lives.

Prevalence of Artificial Food Colors in Grocery Store Products Marketed to Children.

Artificial food colors (AFCs) in foods and beverages may be harmful to children. This study assesses the percentage of grocery store products marketed to children that contain AFCs, by category and company. The research team collected product and food-color information about 810 products in one grocery store in North Carolina in 2014. Overall, 350 products (43.2%) contained AFCs. The most common AFCs were Red 40 (29.8% of products), Blue 1 (24.2%), Yellow 5 (20.5%), and Yellow 6 (19.5%). Produce was the only category that did not have any AFCs. The highest percentage of products with AFCs was found in candies (96.3%), fruit-flavored snacks (94%), and drink mixes/powders (89.7%). Forty-one of the 66 companies marketed products containing AFCs. Given concerns about health effects of AFCs and high proportions of high-AFC categories, clinicians, parents, food companies, and the government can take steps to support children's healthy eating and development by reducing AFCs in children's diets.

Lifting the veil of secrecy from industry funding of nonprofit health organizations.

Those who provide information about scientific issues and science policy normally present themselves as being objective and "scientific." This article describes a range of health charities, professional associations, nonprofit advocacy organizations, and industry-created organizations that receive significant funding from industry. In some cases, industry appears either to influence an organization's positions or to limit an organization's freedom to speak out on matters of interest to the funders. Nonprofit organizations need to consider the potential influence on their independence if they accept funding from interested companies and trade associations.

Carcinogenicity of saccharin in laboratory animals and humans: letter to Dr. Harry Conacher of Health Canada.

We appreciate this opportunity to provide input to the Health Protection Branch's (HPB's) review of the artificial sweetener saccharin. Concerns with regard to the safety of saccharin are of great public health significance and of great interest to the public because saccharin is consumed by tens of millions of people, including children and fetuses. Any evidence of carcinogenesis--and there is ample such evidence--of such a widely used chemical should spur health officials to minimize human exposure to it. It is worth noting that on October 31, 1997, the Board of Scientific Counselors of the National Toxicology Program, a unit of the National Institute of Environmental Health Sciences (NIEHS), voted not to delist saccharin from its Report on Carcinogens.