• Paustenbach and Associates understands that personal injury litigation around nitrosamine impurities in foods, pharmaceuticals, and consumer products has been escalating for the past 3-4 years. (paustenbachandassociates.com)
  • We recommend that those who have detected nitrosamine impurities in their foods, consumer products, or pharmaceuticals conduct a thorough health risk assessment in order to fully characterize the possible health risks. (paustenbachandassociates.com)
  • Nitrite occurs in the environment, in food and water, and is produced endogenous-ly. (inchem.org)
  • As there was no quantitative evidence of the endogenous formation of carcinogenic N- nitroso compounds at the levels of intake of nitrite and nitrosatable precursors achievable in the diet, a quantitative risk assessment of nitrite on the basis of endogenously formed N- nitroso compounds was considered to be inappropriate. (inchem.org)
  • The human gastrointestinal (GI) tract, a site enriched with nitrate and nitrite from our diets, emerges as a significant crucible for endogenous NA genesis. (synthinkchemicals.com)
  • The EWG reported that "even low levels of nitrosamines on raw apples, or in apple juice and applesauce could potentially pose a risk to human health" (EWG, 2014), without acknowledging the quantity formed in the digestive tract due to nitrite intake from various foods. (paustenbachandassociates.com)
  • When dietary nitrate is not available, the excretion of total nitrate calculated in health volunteers was much larger than the amount of intake, indicating that nitrate and nitrite could be formed by endogenous synthesis. (dusseight.com)
  • Nitrosamines are a class of chemicals and have generally been shown to be carcinogenic in laboratory animals (NTP, 2016) at certain doses. (paustenbachandassociates.com)
  • 1 Nitrosamines can be carcinogenic and genotoxic and, in the food industry, can compromise a food product's quality and safety. (foodsafetytech.com)
  • Certain biogenic amines, notably spermidine and putrescine, have been spotlighted as precursors of specific volatile nitrosamines. (synthinkchemicals.com)
  • Humans are regularly exposed to nitrosamines or their precursors through consumption of a wide variety of foods (in addition to apples) and consumer products, although the major source of human exposure to nitrosamines is via endogenous production in the human digestive tract (NTP, 2016). (paustenbachandassociates.com)
  • The endogenous production of nitrate was mainly in intestine mucosa tissues [36]. (dusseight.com)
  • Dietary nitrate (10 mmol/L soldium nitrate in drinking water) can partly improve age-related hypertension and metabolic activities in mice through a decrease of endogenous NO generation via inhibition of NADPH oxidase and modulation of angiotensin (ANG) II receptor expression [39]. (dusseight.com)
  • Beyond the external sources like food and medicines, there's a silent, endogenous exposure to NAs that often goes unnoticed. (synthinkchemicals.com)
  • The magnitude of this endogenous exposure is nothing short of astonishing. (synthinkchemicals.com)
  • To date, there have been no epidemiological studies that have linked human exposure to nitrosamines via food consumption, or by endogenous production in the digestive tract to cancer even though the stomach can form up to 1,000-fold greater doses than those are eaten via food or drugs. (paustenbachandassociates.com)
  • N-nitroso compounds (NOCs), or nitrosamines, have once again made headline news as their occurrence in some pharmaceuticals has led to high profile product recalls in the United States. (foodsafetytech.com)
  • One nitrosamine in particular, N-nitrosodimethylamine (NDMA), is a highly potent carcinogen, traces of which are commonly detected in foods and may be used as an indicator compound for the presence of nitrosamines. (foodsafetytech.com)
  • Carbon Sequestration: We are evaluating the formation of nitrosamine and nitraminecarcinogens from amine-based carbon capture, as well as techniques to destroy any of these byproducts that form. (stanford.edu)
  • Tobacco-specific nitrosamines (TSNAs) were present in all samples at ng/mL levels. (mdpi.com)
  • and via consumption of nitrates in the diet (present in many vegetables due to natural mineral deposits in the soil), which react with bacteria and acids in the stomach to form nitrosamines. (foodsafetytech.com)
  • Detection technology for quantitating the amount of nitrosamines (ppm levels) in a sample had not advanced in nearly 40 years-until recently. (foodsafetytech.com)
  • Developers of crop protection products are required to verify the absence of nitrosamines or quantify the amount at ppm levels to ensure they are within the accepted guidelines. (foodsafetytech.com)
  • One global producer of agrochemicals uses a custom version of the TEA to verify the absence of nitrosamines or quantitate the amount of nitrosamines (ppm levels) in its active ingredients. (foodsafetytech.com)
  • The Nitrosamine (NA) issue, often termed the "Saga," has been a focal point of attention for both the pharmaceutical sector and regulatory entities over the past half-decade. (synthinkchemicals.com)
  • Another Nitrosamine Issue: Apples listed on EWG's "Dirty Dozen. (paustenbachandassociates.com)
  • The situation escalated with the 2021 recall of Chantix (varenicline) due to the presence of a nitrosamine drug-substance-related impurity (NDSRI) named nitrosovarenicline. (synthinkchemicals.com)
  • The presence of nitrosamines must be traced and risk-managed along the food's journey from farm to fork. (foodsafetytech.com)
  • In the United States there are limits for NDMA or total nitrosamines in bacon, barley malt, ham and malt beverages, yet there are currently no regulatory limits for N-nitroso compounds (NOC) in foods in the EU. (foodsafetytech.com)
  • Human exposure to N-nitrosamines also occurs by nitrosation of amines in the body, via their acid or bacterial catalyzed reaction with nitrite, or by reaction with products of nitric oxide generated during inflammation or infection. (nih.gov)
  • Also, hopefully, the agencies start doing their own due diligence on endogenous nitrosation, the TD50s of complex nitrosamines, and think twice before recommending that products be removed from the market. (usp.org)
  • This paper uses N-nitrosamine carcinogenesis as an example. (nih.gov)
  • A second approach toward prevention of N-nitrosamine carcinogenesis is inhibition of this endogenous N-nitrosamine formation. (nih.gov)
  • potential for occupational exposures based on high production volume · evidence of occupational exposures based on TLV and other literature documentation · universal potential for general population exposures based on endogenous and exogenous occurrence in many consumed products and environmental media · lack of chronic toxicity data. (nih.gov)
  • Glycosides of GLUCURONIC ACID formed by the reaction of URIDINE DIPHOSPHATE GLUCURONIC ACID with certain endogenous and exogenous substances. (lookformedical.com)
  • The t-AI should not be used as a target for development of validated analytical methods to quantify new nitrosamines since the long-term limits adopted by CHMP might ultimately be lower than the t-AI. (usp.org)
  • Developers of crop protection products are required to verify the absence of nitrosamines or quantify the amount at ppm levels to ensure they are within the accepted guidelines. (foodsafetytech.com)
  • N-nitroso compounds (NOCs), or nitrosamines, have once again made headline news as their occurrence in some pharmaceuticals has led to high profile product recalls in the United States. (foodsafetytech.com)
  • In the United States there are limits for NDMA or total nitrosamines in bacon, barley malt, ham and malt beverages, yet there are currently no regulatory limits for N-nitroso compounds (NOC) in foods in the EU. (foodsafetytech.com)
  • Diminishing human exposure to these carcinogens is one approach to prevention of cancer, and this has been accomplished in many instances, although exposure to N-nitrosamines in tobacco products is still unacceptably high. (nih.gov)
  • The new Q&As 21 is clear in the statement that the Non-clinical Working Party (NcWP) and the CHMP are the final instances to decide on control options for the nitrosamine in the finished product. (usp.org)
  • Human exposure to preformed N-nitrosamines occurs through the diet, in certain occupational settings, and through the use of tobacco products, cosmetics, pharmaceutical products, and agricultural chemicals. (nih.gov)
  • Suspicion of carcinogenicity is based on reported potential to be converted endogenously to nitrosamines and is further supported by some positive data for short-term genotoxic effects, including positive results in E. coli , mouse lymphoma, and rat inhalation dominant lethal assays, evidence of DNA methylation, and comutagenic effects. (nih.gov)