Comparative Account of Quality Management and Regulatory Aspects of Products with Health Claims: Existing Approaches and Future Challenges for Probiotics and Herbal Products

Abstract This chapter reviews regulatory frameworks for plant sterol containing functional foods in various jurisdictions including Europe, North America, South America, Asia and, Australia/New Zealand. Included is a discussion on approval of plant sterols as novel food ingredients in some countries, as well as details on the type of health claims permitted in the marketing and sale of foods enriched with plant sterols within each jurisdiction. Based on the abundance of clinical trial data, many countries around the world have now approved the use of claims relating the cholesterol-lowering effect of plant sterols, further attesting to their value as functional food ingredients.

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Harmonization of accreditation to ISO15189

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm-2017-0820 ◽

2018 ◽

Vol 56 (10) ◽

pp. 1637-1643 ◽

Cited By ~ 10

Author(s):

Marc H.M. Thelen ◽

Wim Huisman

Keyword(s):

Quality Management ◽

Quality Standard ◽

Laboratory Medicine ◽

Management Systems ◽

Current Position ◽

Quality Management Systems ◽

International Standard ◽

Future Challenges

Abstract Over the years, ISO15189 has established itself as the international standard for quality management systems for all fields in laboratory medicine. As a result, also accreditation to this standard has increased in international adaptation. As a consequence, its impact grows as governments make the standard obligatory and/or national funding systems require ISO15189 accreditation for reimbursement. All these trends amplify each other. This overview aims to specify how ISO15189 has gained its current position as the harmonized quality standard that is not affected by borders between scientific (sub)fields nor between nations. From there, future challenges, opportunities and risks are addressed.

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Quality management in IgE-based allergy diagnostics

LaboratoriumsMedizin ◽

10.1515/labmed-2016-0013 ◽

2016 ◽

Vol 40 (2) ◽

Author(s):

Jörg Kleine-Tebbe ◽

Lars K. Poulsen ◽

Robert G. Hamilton

Keyword(s):

Quality Management ◽

Control Measures ◽

Serological Tests ◽

Technical Performance ◽

Medical Laboratories ◽

Future Challenges ◽

Allergy Diagnostics ◽

Allergen Sources ◽

The Usa ◽

Diagnostic Work

Abstract:Assays for total and allergen-specific (s) IgE are essential serological tests in the diagnostic work-up of immediate type hypersensitivity reactions and atopic diseases. Technical performance characteristics and clinical utility of IgE tests have been published in international guidelines. In the USA and in Europe, IgE tests are mainly performed by accredited medical laboratories and in Germany they are also performed by allergists carrying an OIII-limited license. Both have to perform continuously internal and external quality control measures including proficiency trials twice a year (in Germany). Due to the heterogeneity of the assay’s core allergen reagents, complex extracts and more recently defined allergenic molecules, and heterologous assay calibration, the results of qualitative and quantitative sIgE tests from different diagnostic manufacturers can vary considerably. Proficiency trial results are subsequently grouped according to each assay type. Passing acceptance criteria depend on national rules and regarding quality management. Future challenges include a more valid quantification of sIgE which would allow true comparisons with the international units for total IgE, and the use of harmonized allergen reagents for the most important allergen sources, which have hampered inter-assay comparability in the past.

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Assessing Herbal Products with Health Claims

Critical Reviews in Food Science and Nutrition ◽

10.1080/10408398.2012.726661 ◽

2013 ◽

Vol 55 (13) ◽

pp. 1918-1928 ◽

Cited By ~ 6

Author(s):

Silvia Lapenna ◽

Raymond Gemen ◽

Jan Wollgast ◽

Andrew Worth ◽

Petros Maragkoudakis ◽

...

Keyword(s):

Health Claims ◽

Herbal Products

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ACE2 as therapeutic agent

Clinical Science ◽

10.1042/cs20200570 ◽

2020 ◽

Vol 134 (19) ◽

pp. 2581-2595

Author(s):

Qiuhong Li ◽

Maria B. Grant ◽

Elaine M. Richards ◽

Mohan K. Raizada

Keyword(s):

Therapeutic Agent ◽

Renin Angiotensin System ◽

Peptide Hormone ◽

Experimental Models ◽

Electrolyte Balance ◽

Ang Ii ◽

Angiotensin Converting Enzyme 2 ◽

Beneficial Effects ◽

Overwhelming Evidence ◽

Future Challenges

Abstract The angiotensin-converting enzyme 2 (ACE2) has emerged as a critical regulator of the renin–angiotensin system (RAS), which plays important roles in cardiovascular homeostasis by regulating vascular tone, fluid and electrolyte balance. ACE2 functions as a carboxymonopeptidase hydrolyzing the cleavage of a single C-terminal residue from Angiotensin-II (Ang-II), the key peptide hormone of RAS, to form Angiotensin-(1-7) (Ang-(1-7)), which binds to the G-protein–coupled Mas receptor and activates signaling pathways that counteract the pathways activated by Ang-II. ACE2 is expressed in a variety of tissues and overwhelming evidence substantiates the beneficial effects of enhancing ACE2/Ang-(1-7)/Mas axis under many pathological conditions in these tissues in experimental models. This review will provide a succinct overview on current strategies to enhance ACE2 as therapeutic agent, and discuss limitations and future challenges. ACE2 also has other functions, such as acting as a co-factor for amino acid transport and being exploited by the severe acute respiratory syndrome coronaviruses (SARS-CoVs) as cellular entry receptor, the implications of these functions in development of ACE2-based therapeutics will also be discussed.

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