title: Safety evaluation of a milk-based protein powder produced by a novel manufacturing technique.
abstract: TruActive™ NF is a novel, fat-free, milk-based protein powder to be added to food to increase protein content and is manufactured using non-thermal treatment to reduce potential pathogens most relevant to protecting public health. TruActive™ NF was evaluated for potential pathogens of concern to public health regulators; none were detected. The estimated daily intake (EDI) of TruActive™ NF at a 90thpercentile consumption for the powder in nutritional beverages and bars is 14,700 mg/day. In vitro genotoxicity testing revealed that concentrations of TruActive™ NF up to 5000 μg/plate did not induce point mutations in selected strains. Oral administration of TruActive™ NF to male Sprague-Dawley rats in an in vivo mammalian chromosomal aberration assay did not induce chromosomal aberrations or significantly affect mitosis in bone marrow cells at 2000 mg/kg. Male and female Sprague-Dawley rats were administered TruActive™ NF at concentrations of 7.5%, 15%, and 30% of the diet during a 28-day subacute dietary study followed by a 14-day recovery period. Some parameters were altered at the 30% diet concentration. The No Observed Adverse Effect Level (NOAEL) in the 28-day dietary study was at 15% of the diet (11,812 mg/kg bw/day for male rats and 11,521 mg/kg bw/day for female rats).
authors.affiliation: Burdock Group, 859 Outer Road, Orlando, 32814, FL, USA. Electronic address: alebeau@burdockgroup.com.
authors.forename: A
authors.initials: A
authors.lastname: LeBeau
authors.affiliation: Burdock Group, 859 Outer Road, Orlando, 32814, FL, USA.
authors.forename: R
authors.initials: R
authors.lastname: Matulka
authors.affiliation: Tamarak Biotics, 7659 N. Pleasant Ave, Fresno, CA 93711, USA.
authors.forename: B
authors.initials: B
authors.lastname: Comstock
mesh_terms: D000818:Animals; D002869:Chromosome Aberrations; D004032:Diet; D005260:Female; D005511:Food Handling / Q000379:methods*; D008297:Male; D008894:Milk Proteins / Q000032:analysis / Q000737:chemistry / Q000633:toxicity*; D009152:Mutagenicity Tests; D019055:No-Observed-Adverse-Effect Level; D011208:Powders / Q000633:toxicity; D017207:Rats, Sprague-Dawley; D018675:Toxicity Tests / Q000379:methods*
chemical_list: D008894:Milk Proteins; D011208:Powders
keywords: Food ingredient; Raw milk; Safety; TruActive; UV-C radiation