RESUMEN
Infant formula is one of the most regulated foods in the world. It has advanced in complexity over the years as a result of numerous research innovations. To ensure product safety and quality, analytical technologies have also had to advance to keep pace. Given the rigorous performance demands expected of these methods and the ever-growing array of complex matrixes, there is the potential for gaps to exist in current Official MethodsSM and other recognized international methods for infant formula and adult nutritionals. Food safety concerns, particularly for infants, drive the need for extensive testing by manufacturers and regulators. The net effect is the potential for an increase in time- and resource-consuming regulatory disputes. In an effort to mitigate such costly activities, AOAC INTERNATIONAL, under the direction of the Infant Formula Council of America-a trade association of manufacturers and marketers of formulated nutritional products-agreed to establish voluntary consensus Standard Method Performance Requirements, and, ultimately, to identify and publish globally recognized, fit-for-purpose standard methods. To accomplish this task, nutritional reference materials (RMs), representing all major commercially available nutritional formulations, were (and continue to be) a critical necessity. In this paper, various types of RMs will be defined, followed by review and discussion of their importance to the infant formula industry.
Asunto(s)
Industria de Alimentos/normas , Fórmulas Infantiles/normas , Análisis de los Alimentos , Estándares de ReferenciaRESUMEN
Food-related laws and regulations have existed since ancient times. Egyptian scrolls prescribed the labeling needed for certain foods. In ancient Athens, beer and wines were inspected for purity and soundness, and the Romans had a well-organized state food control system to protect consumers from fraud or bad produce. In Europe during the Middle Ages, individual countries passed laws concerning the quality and safety of eggs, sausages, cheese, beer, wine, and bread; some of these laws still exist today. But more modern dietary guidelines and food regulations have their origins in the latter half of the 19th century when the first general food laws were adopted and basic food control systems were implemented to monitor compliance. Around this time, science and food chemistry began to provide the tools to determine "purity" of food based primarily on chemical composition and to determine whether it had been adulterated in any way. Since the key chemical components of mammalian milk were first understood, infant formulas have steadily advanced in complexity as manufacturers attempt to close the compositional gap with human breast milk. To verify these compositional innovations and ensure product quality and safety, infant formula has become one of the most regulated foods in the world. The present paper examines the historical development of nutritional alternatives to breastfeeding, focusing on efforts undertaken to ensure the quality and safety from antiquity to present day. The impact of commercial infant formulas on global regulations is addressed, along with the resulting need for harmonized, fit-for-purpose, voluntary consensus standard methods.
Asunto(s)
Análisis de los Alimentos/historia , Análisis de los Alimentos/normas , Fórmulas Infantiles/historia , Fórmulas Infantiles/normas , Inocuidad de los Alimentos , Historia del Siglo XV , Historia del Siglo XVI , Historia del Siglo XVII , Historia del Siglo XVIII , Historia del Siglo XIX , Historia del Siglo XX , Historia del Siglo XXI , Historia Antigua , Historia Medieval , Humanos , Lactante , Control de Calidad , Estándares de ReferenciaRESUMEN
Eleven subjects completed a clinical trial to determine the safety/tolerability of freeze-dried black raspberries (BRB) and to measure, in plasma and urine, specific anthocyanins-cyanidin-3-glucoside, cyanidin-3-sambubioside, cyanidin-3-rutinoside, and cyanidin-3-xylosylrutinoside, as well as ellagic acid. Subjects were fed 45 g of freeze-dried BRB daily for 7 days. Blood samples were collected predose on days 1 and 7 and at 10 time points postdose. Urine was collected for 12 hours predose on days 1 and 7 and at three 4-hour intervals postdose. Maximum concentrations of anthocyanins and ellagic acid in plasma occurred at 1 to 2 hours, and maximum quantities in urine appeared from 0 to 4 hours. Overall, less than 1% of these compounds were absorbed and excreted in urine. None of the pharmacokinetic parameters changed significantly between days 1 and 7. In conclusion, 45 g of freeze-dried BRB daily are well tolerated and result in quantifiable anthocyanins and ellagic acid in plasma and urine.
Asunto(s)
Antocianinas/farmacocinética , Ácido Elágico/farmacocinética , Frutas/química , Adulto , Antocianinas/sangre , Antocianinas/orina , Área Bajo la Curva , Cromatografía Líquida de Alta Presión , Estreñimiento/etiología , Ácido Elágico/sangre , Ácido Elágico/orina , Femenino , Liofilización , Frutas/efectos adversos , Glucósidos/sangre , Glucósidos/orina , Humanos , Masculino , Espectrometría de Masas/métodos , Tasa de Depuración Metabólica , Factores de TiempoRESUMEN
An alkaline hydrolysis/liquid chromatography (LC) method was developed for determination of isoflavones in ready-to-feed soy-based infant formula. The method consists of a 15 min methanol extraction, 10 min alkaline hydrolysis, HCl neutralization, gravity filtration, aqueous dilution, and 50 min LC analysis with UV detection at 262 and 250 nm to quantify 6 isoflavone analytes: daidzin, glycitin, genistin, daidzein, glycitein, and genistein. The concentration averages for 10 commercial batches (microg aglycone/g formula) were daidzein, 6.12 +/- 1.23; glycitein, 1.19 +/- 0.16; genistein, 12.8 +/- 2.35; and total, 20.1 +/- 3.61. Validation experiments demonstrated extraction completion and analyte stability to alkaline hydrolysis. Spike recoveries ranged from 97.6 to 104.1%, and a series of accuracy assessments showed that isoflavone concentration determined by the method was within 5% of the true value. The relative standard deviation values for repeatability ranged from 0.4 to 2.2% (n = 10), and from 0.3 to 2.7% (n = 4) for intermediate precision. Isoflavone peak purity was verified by comparing sample and standard peak area ratios (262/250 nm). The limits of detection and quantitation (microg/ formula) ranged from 0.02 to 0.05 and 0.08 to 0.18 microg/g, respectively. The difference between our concentrations and those reported by others in 1995-1998 is attributable to the well-established seasonal variation in soybean isoflavone levels. Although the method was applied exclusively to ready-to-feed formula in the present study, it is equally suitable for powder and concentrated liquid infant formulas.