JHEIMBACH LLC

Port Royal, VA, United States

JHEIMBACH LLC

Port Royal, VA, United States
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Sanders M.E.,Dairy and Food Culture Technologies | Akkermans L.M.A.,University Utrecht | Haller D.,TU Munich | Hammerman C.,Shaare Zedek Medical Center | And 9 more authors.
Gut Microbes | Year: 2010

The safety of probiotics is tied to their intended use, which includes consideration of potential vulnerability of the consumer or patient, dose and duration of consumption, and both the manner and frequency of administration. Unique to probiotics is that they are alive when administered, and unlike other food or drug ingredients, possess the potential for infectivity or in situ toxin production. Since numerous types of microbes are used as probiotics, safety is also intricately tied to the nature of the specific microbe being used. The presence of transferable antibiotic resistance genes, which comprises a theoretical risk of transfer to a less innocuous member of the gut microbial community, must also be considered. Genetic stability of the probiotic over time, deleterious metabolic activities, and the potential for pathogenicity or toxicogenicity must be assessed depending on the characteristics of the genus and species of the microbe being used. Immunological effects must be considered, especially in certain vulnerable populations, including infants with undeveloped immune function. A few reports about negative probiotic effects have surfaced, the significance of which would be better understood with more complete understanding of the mechanisms of probiotic interaction with the host and colonizing microbes. Use of readily available and low cost genomic sequencing technologies to assure the absence of genes of concern is advisable for candidate probiotic strains. The field of probiotic safety is characterized by the scarcity of studies specifically designed to assess safety contrasted with the long history of safe use of many of these microbes in foods. © 2010 Landes Bioscience.


Sanders M.E.,Dairy and Food Culture Technologies | Heimbach J.T.,JHeimbach LLC | Pot B.,Institute Pasteur Lille | Tancredi D.,University of California at Davis | And 4 more authors.
Gut Microbes | Year: 2011

The topic of "Health Claims Substantiation for Probiotic and Prebiotic Products" was discussed at the 8th annual International Scientific Association for Probiotics and Prebiotics (ISAPP) meeting. The topic is especially timely considering that the regulatory review process for health benefit claims on probiotic and prebiotic products in Europe has not resulted in a single claim being approved (120 negative opinions on probiotic claims and 19 negative opinions on prebiotic claims through February 2011). This situation in Europe and elsewhere has driven companies to seek clarity on a research path that would stand up to scientific scrutiny as well as satisfy regulatory demands for health claim substantiation. It can be challenging to negotiate rigid regulatory distinctions, such as between health and disease, when these states are more realistically represented by continua. One research approach focused on improved homeostasis is explored as a statistically robust approach to measuring physiological parameters in healthy populations, which are the required target for food and supplement claims. Diverse global regulatory frameworks complicate this issue, and harmonization of different approaches globally would simplify requirements for industry, decrease consumer confusion and improve the scientific framework for the research community to set up appropriate research pathways. This report highlights key points from this discussion. © 2011 Landes Bioscience.


Sanders M.E.,International Scientific Association for Probiotics and Prebiotics | Klaenhammer T.R.,North Carolina State University | Ouwehand A.C.,DuPont Company | Pot B.,Institute Pasteur Of Lille | And 12 more authors.
Annals of the New York Academy of Sciences | Year: 2014

Commercial probiotic strains for food or supplement use can be altered in different ways for a variety of purposes. Production conditions for the strain or final product may be changed to address probiotic yield, functionality, or stability. Final food products may be modified to improve flavor and other sensory properties, provide new product formats, or respond to market opportunities. Such changes can alter the expression of physiological traits owing to the live nature of probiotics. In addition, genetic approaches may be used to improve strain attributes. This review explores whether genetic or phenotypic changes, by accident or design, might affect the efficacy or safety of commercial probiotics. We highlight key issues important to determining the need to re-confirm efficacy or safety after strain improvement, process optimization, or product formulation changes. Research pinpointing the mechanisms of action for probiotic function and the development of assays to measure them are greatly needed to better understand if such changes have a substantive impact on probiotic efficacy. © 2014 New York Academy of Sciences.


Finley J.W.,Louisiana State University | Soto-Vaca A.,Louisiana State University | Heimbach J.,JHeimbach LLC | Rao T.P.,Taiyo Kagaku Company | And 3 more authors.
Journal of Agricultural and Food Chemistry | Year: 2013

Guar gum and partially hydrolyzed guar gum (PHGG) are food ingredients that have been available for many years. PHGG is the partially hydrolyzed product from guar gum obtained from the Indian cluster bean (Cyanopsis tetragonolopus). The gum (CAS Registry No. 9000-30-0) is composed of galactomannan, a gel-forming polysaccharide with a molecular weight ranging from 200 to 300 kDa. The intact and partially hydrolyzed forms have multiple food applications. The intact material can be used to control the viscosity, stability, and texture of foods. PHGG is highly soluble and has little physical impact on foods. Both forms are indigestible but are excellent sources of fermentable dietary fiber. The caloric value of intact guar gum is accepted as 2.0, whereas the caloric value of PHGG has not been firmly established. It is the goal of this paper to review the chemistry, safety, in vivo effects, and caloric value of PHGG. © 2013 American Chemical Society.


Kumar H.,University of Turku | Salminen S.,University of Turku | Verhagen H.,National Institute for Public Health and the Environment RIVM | Verhagen H.,University of Ulster | And 6 more authors.
Current Opinion in Biotechnology | Year: 2015

Novel probiotics and prebiotics designed to manipulate the gut microbiota for improving health outcomes are in demand as the importance of the gut microbiota in human health is revealed. The regulations governing introduction of novel probiotics and prebiotics vary by geographical region. Novel foods and foods with health claims fall under specific regulations in several countries. The paper reviews the main requirements of the regulations in the EU, USA, Canada and Japan. We propose a number of areas that need to be addressed in any safety assessment of novel probiotics and prebiotics. These include publication of the genomic sequence, antibiotic resistance profiling, selection of appropriate in vivo model, toxicological studies (including toxin production) and definition of target population. © 2014 Elsevier Ltd.


PubMed | University of Turku, Bio K Plus International Inc., University of Barcelona, JHeimbach LLC and 4 more.
Type: | Journal: Current opinion in biotechnology | Year: 2015

Novel probiotics and prebiotics designed to manipulate the gut microbiota for improving health outcomes are in demand as the importance of the gut microbiota in human health is revealed. The regulations governing introduction of novel probiotics and prebiotics vary by geographical region. Novel foods and foods with health claims fall under specific regulations in several countries. The paper reviews the main requirements of the regulations in the EU, USA, Canada and Japan. We propose a number of areas that need to be addressed in any safety assessment of novel probiotics and prebiotics. These include publication of the genomic sequence, antibiotic resistance profiling, selection of appropriate in vivo model, toxicological studies (including toxin production) and definition of target population.


Heimbach J.T.,JHeimbach LLC | Egawa H.,DSP Gokyo Food and Chemical Co | Marone P.A.,Product Safety Laboratories | Bauter M.R.,Product Safety Laboratories | Kennepohl E.,Equinox Scientific Services
International Journal of Toxicology | Year: 2013

Forty male and 40 female Crl:SD® CD® IGS rats were fed diets containing 0, 40 000, 80 000, or 120 000 ppm tamarind seed polysaccharide (equivalent to 3450.8, 6738.9, or 10 597.1 mg/kg bw/day and 3602.1, 7190.1, or 10 690.7 mg/kg bw/day for males and females, respectively) for 28 days. Animals were observed for adverse clinical signs, body weight, feed consumption, hematology and clinical chemistry parameters, urinalysis values were recorded, and at the end of the study the rats underwent a full necropsy. Functional Observational Battery (FOB) and Motor Activity (MA) tests were performed on all animals. There were no mortalities, no clinical or ophthalmologic signs, body weight, body weight gain, food consumption and food efficiency, FOB or MA findings associated with the administration of tamarind seed polysaccharide. Initial statistically significant decreases in body weight gain and food consumption resolved after the first week and were considered the result of reduced palatability. There were no adverse changes in hematology, coagulation, clinical chemistry or urinalysis parameters in male or female rats considered the result of test substance administration. At necropsy, there were no macroscopic, histopathological findings, estrus cycle, or organ weight changes deemed related to administration of the test substance. Under the conditions of this study and based on the toxicological endpoints evaluated, the no-observed-adverse-effect level (NOAEL) for tamarind seed polysaccharide in the diet was the highest concentration tested of 120 000 ppm (equivalent to 10 597 mg/kg bw/day and 10 691 mg/kg bw/day for male and female rats, respectively). © 2013 The Author(s).


Marone P.A.,Virginia Commonwealth University | Heimbach J.T.,JHeimbach LLC | Nemzer B.,VDF FutureCeuticals Inc. | Hunter J.M.,VDF FutureCeuticals Inc.
Food and Chemical Toxicology | Year: 2016

A branded calcium fructoborate product, a nature-identical calcium salt of bis (fructose) ester of boric acid found in plants and a natural source of boron in the human diet and sold under the trade name FruiteX-B® Brand Calcium Fructoborate (“FrxB”), was evaluated in a 90-day dietary toxicity study and two genotoxicity studies. In the 90-day study, four groups of 10 male and 10 female Crl:SD CD® IGS rats were fed diets with FrxB admixtures of 0.56, 1.12, and 1.68% dietary concentration, providing mean overall daily intakes of FrxB in male rats of 385.8, 774.9, and 1161.3 mg/kg bw/day, and 392.1, 784.4, and 1171.1 mg/kg bw/day in female rats. There were no mortalities, no clinical or ophthalmologic signs, body weight, body weight gain, food consumption, food efficiency, Functional Observational Battery (FOB), or Motor Activity (MA) findings associated with the administration of FrxB. There were no adverse changes in hematology, coagulation, clinical chemistry, or urinalysis parameters in male or female rats considered the result of test substance administration. At necropsy, there were no macroscopic, histopathological findings, or organ weight changes deemed related to administration of the test substance. Under the conditions of this study, based on the toxicological endpoints evaluated, the no-observed-adverse-effect level (NOAEL) for FrxB in the diet was 1161.3 and 1171.1 mg/kg bw/day in male and female rats, respectively. Bacterial mutagenicity studies and a micronucleus test using Chinese hamster V79 cells demonstrated no mutagenic or genotoxic potential of the tested brand of calcium fructoborate. © 2016 Elsevier Ltd


Heimbach J.T.,JHeimbach LLC | Marone P.A.,Eurofins | Hunter J.M.,VDF FutureCeuticals | Nemzer B.V.,VDF FutureCeuticals | And 2 more authors.
Food and Chemical Toxicology | Year: 2010

The fruit of the coffee plant, Coffea arabica, has high phenolic antioxidant and phytonutrient content and could be a beneficial food ingredient. However, the fruit has historically been discarded for the favored harvesting of the coffee bean alone. CoffeeBerry® products are derived from the whole fruit and include a ground whole powder, a water extract, and a more recently developed water-ethanol extract. The safety of CoffeeBerry® products was evaluated in three genotoxicity studies, three short-term oral toxicity studies, and a 90-day dietary toxicity study. Bacterial mutagenicity studies and a micronucleus test using murine peripheral cells demonstrated that none of the three products showed mutagenic or genotoxic potential. In the short-term studies, despite palatability issues, female rats showed a tolerance for whole powder and ethanol extract at doses up to 8800. mg/kg. bw/day. Male rats also exhibited palatability issues and tolerated lower doses of approximately 4000. mg/kg. bw/day ethanol extract via gavage and approximately 2100. mg/kg. bw/day whole powder or water extract in the diet. When fed in the diet to Sprague-Dawley rats for 90. days, ethanol extract showed no adverse effects at dietary concentrations of up to 5% (approximately 3446 and 4087. mg/kg. bw/day for male and female rats, respectively). © 2010 Elsevier Ltd.


PubMed | JHeimbach LLC
Type: Journal Article | Journal: International journal of toxicology | Year: 2013

Forty male and 40 female Crl:SD CD IGS rats were fed diets containing 0, 40,000, 80,000, or 120,000 ppm tamarind seed polysaccharide (equivalent to 3450.8, 6738.9, or 10 597.1 mg/kg bw/day and 3602.1, 7190.1, or 10,690.7 mg/kg bw/day for males and females, respectively) for 28 days. Animals were observed for adverse clinical signs, body weight, feed consumption, hematology and clinical chemistry parameters, urinalysis values were recorded, and at the end of the study the rats underwent a full necropsy. Functional Observational Battery (FOB) and Motor Activity (MA) tests were performed on all animals. There were no mortalities, no clinical or ophthalmologic signs, body weight, body weight gain, food consumption and food efficiency, FOB or MA findings associated with the administration of tamarind seed polysaccharide. Initial statistically significant decreases in body weight gain and food consumption resolved after the first week and were considered the result of reduced palatability. There were no adverse changes in hematology, coagulation, clinical chemistry or urinalysis parameters in male or female rats considered the result of test substance administration. At necropsy, there were no macroscopic, histopathological findings, estrus cycle, or organ weight changes deemed related to administration of the test substance. Under the conditions of this study and based on the toxicological endpoints evaluated, the no-observed-adverse-effect level (NOAEL) for tamarind seed polysaccharide in the diet was the highest concentration tested of 120,000 ppm (equivalent to 10,597 mg/kg bw/day and 10,691 mg/kg bw/day for male and female rats, respectively).

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