A general postlaunch monitoring framework for functional foods tested with the phytosterol/-stanol case

The regulations and/or directives in force for functional foods primarily focus on the warrant of safety before the particular foods reach the consumer. Aspects that come into the picture after marketing are not structurally and/or regulatory dealt with at this moment. This absence of clear guidelines about responsibility, timing and contents of a postlaunch monitoring (PLM) system hamper the establishment of an internationally standardized and stakeholder-adopted framework. The current paper describes a proposal for PLM and is illustrated with a case study on phytosterols/-stanols.

[1]  J. Weststrate,et al.  Spreads enriched with three different levels of vegetable oil sterols and the degree of cholesterol lowering in normocholesterolaemic and mildly hypercholesterolaemic subjects , 1999, European Journal of Clinical Nutrition.

[2]  P. Jones,et al.  Plant sterols: factors affecting their efficacy and safety as functional food ingredients , 2004, Lipids in Health and Disease.

[3]  P. Hepburn,et al.  Safety evaluation of phytosterol esters. Part 8. Lack of genotoxicity and subchronic toxicity with phytosterol oxides. , 2004, Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association.

[4]  E. V. van Puijenbroek,et al.  Post Launch Monitoring of food products: what can be learned from pharmacovigilance. , 2007, Regulatory toxicology and pharmacology : RTP.

[5]  M. Uusitupa,et al.  Effects of low-fat stanol ester enriched margarines on concentrations of serum carotenoids in subjects with elevated serum cholesterol concentrations , 1999, European Journal of Clinical Nutrition.

[6]  J. Heddle,et al.  Genotoxicity of two fecal steroids in murine colonic epithelium assessed by the sister chromatid exchange technique. , 1987, Mutagenesis.

[7]  R. Friele,et al.  Demographic and lifestyle characteristics of functional food consumers and dietary supplement users , 2003, British Journal of Nutrition.

[8]  Joshua T. Cohen,et al.  A quantitative risk-benefit analysis of changes in population fish consumption. , 2005, American journal of preventive medicine.

[9]  P. Hepburn,et al.  Safety evaluation of phytosterol esters. Part 2. Subchronic 90-day oral toxicity study on phytosterol esters--a novel functional food. , 1999, Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association.

[10]  N. D. Jong,et al.  Potential intake of phytosterols/-stanols: results of a simulation study , 2004, European Journal of Clinical Nutrition.

[11]  C. Jonker,et al.  Moderately elevated plant sterol levels are associated with reduced cardiovascular risk--the LASA study. , 2008, Atherosclerosis.

[12]  T. Nagata,et al.  Rapeseed oil ingestion and exacerbation of hypertension-related conditions in stroke prone spontaneously hypertensive rats. , 2003, Toxicology.

[13]  W. Stargel,et al.  Aspartame: scientific evaluation in the postmarketing period. , 2001, Regulatory toxicology and pharmacology : RTP.

[14]  J. Weststrate,et al.  Safety evaluation of phytosterol esters. Part 4. Faecal concentrations of bile acids and neutral sterols in healthy normolipidaemic volunteers consuming a controlled diet either with or without a phytosterol ester-enriched margarine. , 1999, Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association.

[15]  P. Hepburn,et al.  Safety evaluation of phytosterol esters. Part 7. Assessment of mutagenic activity of phytosterols, phytosterol esters and the cholesterol derivative, 4-cholesten-3-one. , 2002, Food and Chemical Toxicology.

[16]  D. Jonker,et al.  13-week oral toxicity study with stanol esters in rats. , 1999, Regulatory toxicology and pharmacology : RTP.

[17]  S. Mäkelä,et al.  Wood-derived estrogens: studies in vitro with breast cancer cell lines and in vivo in trout. , 1996, Toxicology and applied pharmacology.

[18]  R. Crevel,et al.  Post-market surveillance of GM foods: applicability and limitations of schemes used with pharmaceuticals and some non-GM novel foods. , 2003, Regulatory toxicology and pharmacology : RTP.

[19]  C. Glueck,et al.  Relationships of serum plant sterols (phytosterols) and cholesterol in 595 hypercholesterolemic subjects, and familial aggregation of phytosterols, cholesterol, and premature coronary heart disease in hyperphytosterolemic probands and their first-degree relatives. , 1991, Metabolism: clinical and experimental.

[20]  S. Grundy,et al.  Efficacy and safety of plant stanols and sterols in the management of blood cholesterol levels. , 2003, Mayo Clinic proceedings.

[21]  W. Ratnayake,et al.  Vegetable oils high in phytosterols make erythrocytes less deformable and shorten the life span of stroke-prone spontaneously hypertensive rats. , 2000, The Journal of nutrition.

[22]  D. Howes,et al.  The safety evaluation of phytosterol esters. Part 6. The comparative absorption and tissue distribution of phytosterols in the rat. , 2000, Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association.

[23]  H. V. van Kranen,et al.  Integrated risk-benefit analyses: method development with folic acid as example. , 2008, Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association.

[24]  F. Bellisle,et al.  PASSCLAIM: consensus on criteria. , 2005, European journal of nutrition.

[25]  E M Faustman,et al.  Use of Quality‐Adjusted Life Year Weights with Dose‐Response Models for Public Health Decisions: A Case Study of the Risks and Benefits of Fish Consumption , 2000, Risk analysis : an official publication of the Society for Risk Analysis.

[26]  J. Ashby,et al.  Safety evaluation of phytosterol esters. Part 1. Assessment of oestrogenicity using a combination of in vivo and in vitro assays. , 1999, Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association.

[27]  W. R. Bruce,et al.  Characterization of cytotoxic steroids in human faeces and their putative role in the etiology of human colonic cancer. , 1986, Cancer letters.

[28]  W Slob,et al.  Balancing the risks and benefits of drinking water disinfection: disability adjusted life-years on the scale. , 2000, Environmental health perspectives.

[29]  J. Weststrate,et al.  Plant sterol-enriched margarines and reduction of plasma total- and LDL-cholesterol concentrations in normocholesterolaemic and mildly hypercholesterolaemic subjects , 1998, European Journal of Clinical Nutrition.

[30]  L. Ellegård,et al.  Intake of dietary plant sterols is inversely related to serum cholesterol concentration in men and women in the EPIC Norfolk population: a cross-sectional study , 2004, European Journal of Clinical Nutrition.

[31]  J. V. van Delft,et al.  Genotoxicity evaluation of wood-derived and vegetable oil-derived stanol esters. , 1999, Regulatory toxicology and pharmacology : RTP.

[32]  A. Wolterbeek,et al.  Developmental toxicity study of vegetable oil-derived stanol fatty acid esters. , 1999, Regulatory toxicology and pharmacology : RTP.

[33]  A. Schuit,et al.  Exposure and effectiveness of phytosterol/-stanol-enriched margarines , 2007, European Journal of Clinical Nutrition.

[34]  P. Hepburn,et al.  Safety evaluation of phytosterol esters. Part 3. Two-generation reproduction study in rats with phytosterol esters--a novel functional food. , 1999, Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association.

[35]  N. Grishin,et al.  Accumulation of dietary cholesterol in sitosterolemia caused by mutations in adjacent ABC transporters. , 2000, Science.

[36]  T. Strandberg,et al.  Noncholesterol sterols and cholesterol lowering by long-term simvastatin treatment in coronary patients: relation to basal serum cholestanol. , 2000, Arteriosclerosis, thrombosis, and vascular biology.

[37]  J. Weststrate,et al.  Safety evaluation of phytosterol esters. Part 5. Faecal short-chain fatty acid and microflora content, faecal bacterial enzyme activity and serum female sex hormones in healthy normolipidaemic volunteers consuming a controlled diet either with or without a phytosterol ester-enriched margarine. , 1999, Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association.

[38]  D. Jonker,et al.  Short-term tests of estrogenic potential of plant stanols and plant stanol esters. , 1999, Regulatory toxicology and pharmacology : RTP.

[39]  Anand K. Srivastava,et al.  Identification of a gene, ABCG5, important in the regulation of dietary cholesterol absorption , 2001, Nature Genetics.

[40]  T. Malini,et al.  Effect of beta-sitosterol on uterine biochemistry: a comparative study with estradiol and progesterone. , 1993, Biochemistry and molecular biology international.

[41]  T. Sudhop,et al.  Serum plant sterols as a potential risk factor for coronary heart disease. , 2002, Metabolism: clinical and experimental.

[42]  M. Ocké,et al.  Effectiveness of customary use of phytosterol/-stanol enriched margarines on blood cholesterol lowering. , 2006, Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association.

[43]  M. Law Plant sterol and stanol margarines and health. , 2000, The Western journal of medicine.

[44]  P. Hepburn,et al.  Safety evaluation of phytosterol-esters. Part 9: Results of a European post-launch monitoring programme. , 2006, Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association.

[45]  E. Vartiainen,et al.  Retinol, vitamin D, carotenes and alpha-tocopherol in serum of a moderately hypercholesterolemic population consuming sitostanol ester margarine. , 1999, Atherosclerosis.

[46]  R. Luben,et al.  Plasma levels of plant sterols and the risk of coronary artery disease: the prospective EPIC-Norfolk Population Study Published, JLR Papers in Press, October 30, 2006. , 2007, Journal of Lipid Research.

[47]  S. Taylor,et al.  Postmarketing surveillance of new food ingredients: results from the program with the fat replacer olestra. , 2001, Regulatory toxicology and pharmacology : RTP.