Is Food Policy Making Us Sick? What We Know and Where Our Knowledge Stops

"While most UPF categories showed harmful effects, breakfast cereals demonstrated protective properties, which may be explained by several biological mechanisms documented in previous studies."

"The adjusted ORs for inadequate CVH were 1.40 (95% CI: 1.23, 1.60), 1.82 (1.45, 2.29), and 2.57 (1.79, 3.70), respectively, comparing quartiles 2, 3, and 4 with quartile 1 of UPF intake."

"A graded inverse association between %kcal from UPFs and CVH was observed."

"The pattern of association was largely consistent across subgroups."

"If finalized, the rule would require submission of GRAS notices for substances self-determined to be GRAS under the conditions of their intended use in human or animal food, unless an exception applies."

"Since Congress created the GRAS exemption in 1958, manufacturers have been able to independently determine that substances are generally recognized as safe under their intended conditions of use and therefore exempt from mandatory FDA pre-market review."

"Notably, the Proposed Rule would not establish a pre-market approval framework for GRAS substances (and FDA acknowledges that it lacks the authority to do so). Companies may continue to market self-determined GRAS substances before and while FDA reviews the GRAS notice."

"The proposed rule would change that approach by requiring GRAS notifications for most ingredients added to foods marketed in the United States."

"Most additives entering the market since 1970 have done so based upon producer or industry self-determinations of safety rather than by FDA evaluation and approval."

"FDA proposes a 45-day initial evaluation period for determining whether a submission is adequate to file."

"FDA would publish qualifying submissions, but listing would not mean that FDA has reviewed or agreed with the underlying GRAS conclusion."

"would, for the first time, mandate premarket notification for substances determined to be Generally Recognized as Safe (GRAS)."

"Instead, these substances currently reach the market under the FDA’s 1997 Proposed Rule allowing voluntary notification to FDA of the producer’s GRAS self-determination."

"Inclusion on the list would not represent Agency review of GRAS status."

"For full GRAS notices, FDA proposes a 45-day initial filing review and generally would respond within 180 days after filing, subject to two possible 90-day extensions."

"Uses of food substances that are subject to the mandatory notification requirement will be presumed by FDA not to be GRAS unless the notification requirement has been met."

"lack[s] express statutory authority to require companies to submit GRAS notices."

"Under the 1997 Proposed Rule, the FDA reviews not the scientific evidence for proof of safety, but rather the documentation submitted for sufficiency under the statutory criteria for notification."

"The General Accounting Office concluded in 2010 that “because companies are not required to provide information to FDA regarding their GRAS determinations,”"

"The 2026 Agenda entry also does not address how the FDA would handle confidential, trade secret, or otherwise proprietary information in mandatory GRAS submissions."

"There were significant negative interactions between unit sales and TFA news coverage for the two products with the highest TFA content: Crisco shortening and buttered popcorn. The effects dissipated after 3 weeks."

"In 2009, a World Health Organization (WHO) scientific committee recommended the ‘virtual elimination’ of trans fats from all food supplies (1). This recommendation replaced the 2003 joint WHO and Food and UN Agriculture Organization (FAO) report recommendation that advised countries worldwide to limit their population intakes of industrially produced trans-fatty acids (hereafter, trans fats) to le"

"Theirremovalfromtheglobalfoodsupplycouldpreventupto17milliondeathsby2040"

"The use of partially hydrogenated oil in food production and preparation still remains on the US Food and Drug Administration (FDA) Generally Recognized as Safe (GRAS) list (10) despite requests that petitioned the FDA to remove it in 2010 (11)."

"National bans virtually eliminated TFAs from the food supply ( Table 3 ) and local bans were very successful in removing TFAs from fried foods."

"In Eastern Europe (for example, Hungary, Poland and the Czech Republic) where voluntary-only labelling or limited reformulation has occurred, trans fats remain very high in many processed products and quick-serve restaurant meals, compared with acceptable levels in Denmark and Austria where trans fat bans and regulations have been implemented (28)."

"Higher intake was also linked with greater odds of metabolic syndrome and diabetes, along with a 4% higher risk of death from any cause."

"replacing 10% of ultra-processed food intake with the equivalent weight of minimally processed foods was linked to a 2% reduction in the incidence of bowel cancer."

"Swapping just 10 percent of ultra-processed food by weight for minimally processed options was tied to a 2 percent lower colorectal cancer rate."

"However, we also found no association between total ultra-processed food intake and bowel cancer incidence."

"tying each extra 100 grams of ultra-processed food a day to a higher risk of heart disease, cancer and death overall"

"we have used N-[4-(5-nitro-2-furyl)-2-thiazolyl]formamide (FANFT) as initiator and sodium saccharin (SAC) or tryptophan as promoters."

"For example, if sodium saccharin is administered to rats after ulceration of the bladder, even without prior administration of an initiator, bladder carcinoma develops."

"Light microscopic changes and an increase in labeling index were seen at all time points in rats fed 7.5% sodium saccharin, but not at the lower doses."

"no tumors resulted if either promoter was given without initiation with FANFT."

"In addition, a multistage carcinogenesis process has been demonstrated for the rat bladder using MNU or FANFT as initiators, and dietary sodium saccharin, sodium cyclamate, or tryptophan as promoters."

"This study demonstrates that the hyperplastic response of the urothelium to sodium saccharin administration varies with dose and time, and that observation by scanning electron microscopy is the most sensitive of the three methods evaluated for detecting these changes."

"Had any evidence been found that would have led EFSA’s expert Panel to reconsider the safety of aspartame, a re-evaluation would have been immediately initiated."

"administration of SAC to animals with a rapidly proliferating bladder mucosa, induced by ulceration, pellet insertion, or in utero, resulted in bladder tumor induction, even without prior initiation with FANFT."

"Prospective cohort study with dietary intake assessed every four years using food frequency questionnaires."

"higher consumption of meat/poultry/seafood based ready-to-eat products (hazard ratio for highest versus lowest fifth 1.44, 1.20 to 1.73; P for trend<0.001) and sugar sweetened beverages (1.21, 1.01 to 1.44; P for trend=0.013) among men"

"ready-to-eat/heat mixed dishes among women (1.17, 1.01 to 1.36; P for trend=0.02) was associated with increased risk of colorectal cancer; yogurt and dairy based desserts were negatively associated with the risk of colorectal cancer among women (hazard ratio 0.83, 0.71 to 0.97; P for trend=0.002)"

"the positive association was limited to distal colon cancer (72% increased risk; hazard ratio 1.72, 1.24 to 2.37; P for trend<0.001)"

"In substitution models, the CAF increased to 9.67% (4.36; 14.85) for colon cancer and 7.30% (3.05; 11.48) for CRC incidence."

"NutriNet-Santémortalityanalysisusedpercentageofweightinits"

"reported that the modest overall association (HR ≈ 1.04)"

"In 2015, the Expert Panel of the Flavor and Extract Manufacturers Association (FEMA) initiated a program for the re-evaluation of the safety of over 250 natural flavor complexes (NFCs) used as flavor ingredients."

"The re-evaluation of NFCs is conducted based on a constituent-based procedure outlined in 2005 and updated in 2018 that evaluates the safety of NFCs for their intended use as flavor ingredients."

"In 1960, the Flavor and Extract Manufacturers Association (FEMA) Expert Panel began a program to assess the safety of flavor ingredients for their intended use in human food."

"In 2015, the Expert Panel of the Flavor and Extract Manufacturers Association (FEMA) initiated a re-evaluation of the safety of over 250 natural flavor complexes (NFCs) used as flavor ingredients."

"The procedure relies on a complete chemical characterization of the NFC intended for commerce and organization of each NFC's chemical constituents into well-defined congeneric groups."

"The Expert Panel has a long history of publishing the criteria used in their safety assessments of flavoring substances for food (Smith et al. 2005a; Smith et al. 2005b; Cohen et al. 2018a)."

"The FEMA Expert Panel affirmed the GRAS status of Peppermint Oil (FEMA 2848), Spearmint Oil (FEMA 3032), Spearmint Extract (FEMA 3031), Cornmint Oil (FEMA 4219), Erospicata Oil (FEMA 4777), Curly Mint Oil (FEMA 4778), Pennyroyal Oil (FEMA 2839), Buchu Leaves Oil (FEMA 2169), Caraway Oil (FEMA 2238) and Dill Oil (FEMA 2383) and determined FEMA GRAS status for Buchu Leaves Extract (FEMA 4923), Peppe"

"The safety of the NFC is evaluated using the well-established and conservative threshold of toxicological concern (TTC) concept in addition to data on absorption, metabolism and toxicology of members of the congeneric groups and the NFC under evaluation."

"Recently, the Panel has seen an increase in complex mixtures or natural flavoring complex applications and has reviewed its criteria regarding botanical species verification."

"Six NFCs from the Myroxylon and Cinnamomum genera, Balsam Oil, Peru (FEMA 2117), Tolu Balsam Extract (FEMA 3069), Cassia Bark Extract (FEMA 2257), Cassia Bark Oil (FEMA 2258), Cinnamon Bark Extract (FEMA 2290) and Cinnamon Bark Oil (FEMA 2291) were evaluated and affirmed as generally recognized as safe (GRAS) under their conditions of intended use as flavor ingredients."

"In 2018, the FEMA Expert Panel published an update to its approach to the safety evaluation of natural flavor complexes (NFCs)"

"the Panel has concluded that the information produced from currently available in silico tools cannot be used as a substitute for in vitro and in vivo metabolic and toxicological information within the context of FEMA GRAS applications."

"Data provided in a 2022 color additive petition submitted to the FDA included two chronic feeding studies showing that male rats exposed to high levels of FD&C Red No. 3 developed cancerous tumors via a rat-specific hormonal mechanism."

"However, since cancer is a known effect in male rats upon ingestion of the dye, application of the Delaney Clause requires that the authorization for FD&C Red No. 3 be revoked."

"In 2011, California listed 4-MEI as a carcinogen under the Safe Drinking Water and Toxic Enforcement Act of 1986, which is better known as Proposition 65"

"The U.S. National Toxicology Program (NTP) assessed the carcinogenicity of 4-MEI in male and female mice and rats using two-year feeding studies in 2007, concluding that there was “clear evidence of carcinogenic activity in male and female mice”"

"Based on the NTP studies, the International Agency for Research on Cancer classified 4-MEI as Group 2B, or “possibly carcinogenic to humans”, indicating sufficient evidence of carcinogenicity in experimental animals while no human data were available"

"The OEHHA denied these claims on the basis of available evidence regarding the mode of carcinogenic action of 4-MEI"

"Similar statements are made regularly by the beverage industry, which submitted these claims to the OEHHA when the agency set the NSRL for 4-MEI under Proposition 65"

"Erythrosin darf in Europa ausschließlich für die Produktion von Cocktailkirschen, in Sirup eingelegten Kirschen und kandierten Kirschen verwendet werden."

"that the lack of a clastogenic potential provides support for the non-genotoxic mechanism of the carcinogenicity"

"FDA bans Red No. 3, artificial coloring used in beverages, candy and other foods."

"On the basis of this information, in 2000, NTP and the United States Department of Health and Human Services removed saccharin from the list of substa..."

"Following a formal review by NTP, saccharin was delisted from the 10th Report on Carcinogens, because the rodent cancer data are not sufficient to mee..."

"The high levels of urinary protein characteristically produced by male rats may partially explain"

"These conditions include a urinary pH greater than 6.5, increased urinary sodium concentration, increased urine volume, decreased urine osmolality, and presence of urinary crystals or precipitate"

"as evidenced by a dose-related increased incidence of benign or malignant urinary-bladder neoplasms at dietary concentrations greater than 1%"

"This decision is based on the perception that the observed urinary-bladder tumors in rats arise by mechanisms not relevant to humans"

"Following its growth, saccharin faced significant controversy, primarily due to studies in the 1970s that linked it to bladder cancer in lab rats."

"Although the Price et al. [ 58 ] study, which formed the basis of the 1970 United States ban, reported increased bladder tumors in rodents fed a high-dose cyclamate-saccharin mixture, the interpretation of these results was subsequently considered unreliable"

"Many studies on rodents have shown that saccharin can cause cancer of the urinary bladder, especially in males."

"These findings led to mandatory warning labels on products containing saccharin and regulatory bans in several countries."

"including the presence of urinary tract calcification and bladder parasites in the animals with tumors, both conditions known to contribute to the development of bladder tumors"

"In 1977, the FDA proposed that saccharin be banned because of the studies showing that it causes cancer in animals."