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Standard reference materials for foods and dietary …

INDUSTRY NEWSS tandard reference materials for foods and dietary supplementsKatherine E. Sharpless&Jeanice Brown Thomas&Steven J. Christopher&Robert R. Greenberg&Lane C. Sander&Michele M. Schantz&Michael J. Welch&Stephen A. WiseReceived: 31 January 2007 /Revised: 2 April 2007 /Accepted: 20 April 2007 / Published online: 30 May 2007#Springer-Verlag 2007 AbstractWell-characterized certified reference materialsare needed by laboratories in the food testing, dietarysupplement, and nutrition communities to facilitate compli-ance with labeling laws and improve the accuracy ofinformation provided on product labels, so that consumerscan make good choices.

INDUSTRY NEWS Standard reference materials for foods and dietary supplements Katherine E. Sharpless & Jeanice Brown Thomas & Steven J. Christopher & Robert R. Greenberg & Lane C. Sander & Michele M. Schantz &

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1 INDUSTRY NEWSS tandard reference materials for foods and dietary supplementsKatherine E. Sharpless&Jeanice Brown Thomas&Steven J. Christopher&Robert R. Greenberg&Lane C. Sander&Michele M. Schantz&Michael J. Welch&Stephen A. WiseReceived: 31 January 2007 /Revised: 2 April 2007 /Accepted: 20 April 2007 / Published online: 30 May 2007#Springer-Verlag 2007 AbstractWell-characterized certified reference materialsare needed by laboratories in the food testing, dietarysupplement, and nutrition communities to facilitate compli-ance with labeling laws and improve the accuracy ofinformation provided on product labels, so that consumerscan make good choices.

2 As a result of the enactment of theNutrition Labeling and Education Act of 1990 and theInfant Formula Act of 1980, the National Institute ofStandards and Technology (NIST) worked to develop aseries of food -matrix Standard reference materials (SRMs)characterized for nutrient concentrations. These includeSRM 1544 Fatty Acids and Cholesterol in a Frozen DietComposite, SRM 1546 Meat Homogenate, SRM 1548aTypical Diet, SRM 1566b Oyster Tissue, SRM 1846 InfantFormula, SRM 1946 Lake Superior Fish Tissue, SRM 1947 Lake Michigan Fish Tissue, SRM 2383 Baby FoodComposite, SRM 2384 Baking Chocolate, SRM 2385 Slurried Spinach, and SRM 2387 Peanut Butter.

3 With theenactment of the dietary Supplement Health and EducationAct of 1994, NIST has been working to develop suites ofdietary supplement SRMs characterized for active andmarker compounds and for toxic elements and pesticides,where appropriate. An updated SRM 1588b Organics inCod Liver Oil, a suite of ephedra-containing materials (SRMs 3240 3245), a carrot extract in oil (SRM 3276), anda suite of ginkgo-containing materials (SRMs 3246 3248)are available. Several other materials are currently inpreparation.

4 dietary supplements are sometimes providedin forms that are food -like; for these, values may also beassigned for nutrients, for example SRM 3244 Ephedra-Containing Protein Powder. Both the food -matrix anddietary supplement reference materials are intended primar-ily for validation of analytical methods. They may also beused as primary control materials in assignment of valuesto in-house (secondary) control materials to confirmaccuracy and to establish measurement traceability to reference materialIntroductionThe Infant Formula Act of 1980 and the Nutrition Labelingand Education Act of 1990 (NLEA) [1,2] were the originaldriving forces behind the National Institute of standards andTechnology s(NIST s) introduction of food -matrix standardreference materials (SRMs)

5 With values assigned fornutrients. (A reference material is a material or substanceone or more of whose property values are sufficientlyhomogeneous and well established to be used for thecalibration of an apparatus, the assessment of a measurementmethod, or for assigning values to materials [3]. A certifiedreference material (CRM) is a reference material , accom-panied by a certificate, one or more of whose property valuesare certified by a procedure which establishes traceability toan accurate realization of the unit in which the propertyvalues are expressed, and for which each certified value isaccompaniedbyanuncertainty at a stated level ofconfidence [3].)

6 CRMs produced by NIST are known asSRMs.) NLEA requires that labels on processed foodsdistributed in the US specify the amount of total fat,Anal Bioanal Chem (2007) 389:171 178 DOI ; No of PagesK. E. Sharpless (*):J. B. Thomas:S. J. Christopher:R. R. Greenberg:L. C. Sander:M. M. Schantz:M. J. Welch:S. A. WiseAnalytical Chemistry Division,National Institute of standards and Technology,100 Bureau Drive Stop 8390,Gaithersburg, MD 20899-8390, USAe-mail: fat, cholesterol, total carbohydrate, dietary fiber,sugars, protein, vitamin A, vitamin C, sodium, calcium, andiron contained in a single serving.

7 In addition to this, theFood and Drug Administration published a final rule thatamended labeling regulations so thattransfatty acids alsomust be declared on the label, effective January 1, 2006 [4].The manufacturer may voluntarily provide informationabout any other vitamin, mineral, or nutrient to assist theconsumer in maintaining a healthy diet. The Infant FormulaAct requires that nutrients contained in infant formula fallwithin a specified range or above a specified minimum. Inresponse to these laws NIST began to produce food -matrixSRMs with values assigned for organic nutrients; beforethis approximately fifteenfood-matrix materials wereavailable ( , SRM 1549 Non-Fat Milk Powder, SRM1567 Wheat Flour, SRM 1577 Bovine Liver) but they werecharacterized solely for element content.

8 Several referencematerials developed by Agriculture Canada and distributedby NIST were also available with values assigned forelements [5]; values for proximates (fat, protein, carbohy-drate) in six of these materials were added after they wereoriginally released [6]. With regard to materials containingtransfatty acids, SRMs 1846 Infant Formula and 1946 Lake Superior Fish Tissue have reference values of and for (E)-9-octadecenoic acid(elaidic acid) as the triglyceride. The certified value of 4%in SRM 1846 is equivalent to g in 16 g material , theapproximate amount that would be used to prepare a100 mL (4 oz) bottle for a baby if this material wereintended for that purpose.

9 (Note that atransfatty acidconcentration greater than g per serving requires that anon-zero value be provided on the nutrition label; concen-trations below g per serving can be shown as 0 g [4]).Two additional laws that affect the food community werepassed more recently. The dietary Supplement Health andEducation Act of 1994 (DSHEA) defines dietary supple-ments and regulates them as foods ; it requires that productsbear a supplements facts panel similar to the nutrition factspanel required by NLEA for food labeling [7].

10 In addition,DSHEA states that the US food and Drug Administration(FDA) will issue good manufacturing practices (GMPs) forthe dietary -supplement industry [7]. Manufacturers will berequired to evaluate the identity, purity, quality, strength, andcomposition of their dietary supplements ingredients andfinished products, in part, by use of SRMs as laboratorycontrols [8]. Accurate label information will enable public-health agencies to draw conclusions about the use ofindividual dietary supplements and enable consumers to makesound choices.


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