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PubMedDate not supplied

Using epidemiology to regulate food additives: saccharin case-control studies.

The increasing use of nonnutritive sweeteners and the widely publicized 1969 ban on cyclamate led to additional investigations in rodents of the carcinogenic potential of saccharin. Preliminary results of a long-term feeding study indicated formation of bladder tumors in rodents, and collective experimental evidence has demonstrated that high doses of the synthetic sweetener saccharin can cause bladder cancer in rodents. Based on the results of that and other rodent studies indicating an increased risk of bladder cancer associated with saccharin, the Commissioner of the Food and Drug Administration announced the agency's intention to propose a ban on saccharin. This intention was made known in April 1977 under the Delaney Clause of the Food, Drug, and Cosmetic Act. The clause essentially states that no additive shall be deemed safe if it is found to induce cancer in man or animals, or if it is found, after tests appropriate for the evaluation of the safety of food additives, to induce cancer in man or animals. Also in 1977, a group of epidemiologists began to assess the available epidemiologic information to determine the potential human risk. This report describes the assessment of several human epidemiologic studies available then and the results of more recent epidemiologic studies.

Epidemiologic Methods↗
PubMedDate not supplied

Adverse reactions to food additives.

There are thousands of agents that are intentionally added to the food that we consume. These include preservatives, stabilizers, conditioners, thickeners, colorings, flavorings, sweeteners, antioxidants, etc. etc. Yet only a surprisingly small number have been associated with hypersensitivity reactions. Amongst all the additives, FD&C dyes have been most frequently associated with adverse reactions. Tartrazine is the most notorious of them all; however, critical review of the medical literature and current Scripps Clinic studies would indicate that tartrazine has been confirmed to be at best only occasionally associated with flares of urticaria or asthma. There is no convincing evidence in the literature of reactivity to the other azo or nonazo dyes. This can also be said of BHA/BHT, nitrites/nitrates and sorbates. Parabens have been shown to elicit IgE mediated hypersensitivity reactions when used as pharmaceutical preservatives; however, as with the other additives noted above, ingested parabens have only occasionally been associated with adverse reactions. MSG, the cause of the 'Chinese restaurant syndrome' has only been linked to asthma in one report. Sulfiting agents used primarily as food fresheners and to control microbial growth in fermented beverages have been established as the cause of any where from mild to severe and even fatal reactions in at least 5% of the asthmatic population. Other reactions reported to follow sulfite ingestion include anaphylaxis, gastro intestinal complaints and dermatological eruptions. The prevalence of these non asthmatic reactions is unknown. The mechanism of sulfite sensitive asthma is also unknown but most likely involves hyperreactivity to inhale SO2 in the great majority of cases; however, there are reports of IgE mediated reactions and other sulfite sensitive asthmatics have been found with low levels of sulfite oxidase; necessary to oxidize endogenous sulfite to sulfate.

Angioedema↗
PubMed2002

Current developments in food additive toxicology in the USA.

A recently published proposal (Fed. Reg. 66 (2001) 4706) for mandatory submission of information on all plant-derived bioengineered foods fed to humans or animals will be reviewed. Under this proposal, information such as data on identity, level and function of the introduced substance(s); an estimate of dietary exposure; allergenic potential of the protein; data relevant to other safety issues that may be associated with the substance; selection of a comparable food; historic uses of comparable food; composition and characteristics of bioengineered food versus those of the comparable food should be provided. In addition, characterization of the parent plant; construction of the transformation vector and introduced genetic material along with number of insertion sites and genes; data on the genetic material and any newly inserted genes for antibiotic resistance should be submitted with the notification. The Interagency Coordinating Committee for Validation of Alternative Methods (ICCVAM) was identified by the U.S. Congress as the organization to review and validate new alternative toxicological test methods for 14 U.S. government agencies. Validated and accepted alternative toxicity tests will be incorporated into toxicity testing recommendations for regulatory agencies.

Animals↗