Press Releases
SAFETY ASSESSMENT OF MALE SEXUAL HEALTH SUPPLEMENT 112 DEGREES TO BE PRESENTED AT SOCIETY OF TOXICOLOGY MEETING
PUYALLUP, Wash., —March 17, 2008—The results of extensive safety and toxicology testing conducted on 112 Degrees™, an all-natural, male sexual health supplement from LIFE SPAN labs, will be presented by Alexander Schauss, Ph.D., FACN, at the Society of Toxicology Annual Meeting being held March 16-20, 2008, in Seattle, Wash. Testing found no evidence of toxicity associated during a two-year series of toxicology studies. Additionally, 112 Degrees was found to be free of any approved pharmaceutical ingredients (API) used for the treatment of erectile dysfunction (ED).
Extensive pre-clinical toxicology studies, all of which were performed in a Good Laboratory Practices and U.S. FDA compliant laboratory included:
- Acute oral toxicity
- Bacterial reverse mutagenicity assay
- Cytotoxicity study to measure ability to damage or kill cells
- Immortalized human hepatocyte assay to measure the effect on liver detoxification enzymes
- Histopathologies of reproductive-related organs and blood/urine chemistries
- Mouse peripheral blood micronucleus assay to measure any potential clastogenic effect
- Chromosome aberration assay in hamster ovary cells to measure the effect on chromosomes in mammalian cells
- Inducible nitric oxide synthase assay to measure ability to induce iNOS enzyme in cells in vitro
- iNOS vs. endothelial nitric oxide synthase assay (eNOS), to measure in vitro ability to induce eNOS enzyme in cells
- 12-week study of 112 Degrees' sexual effect on rats at 10 times the human dose
LIFE SPAN labs additionally conducted numerous quality assurance assays and tests for ingredient and product purity for pilot batches and commercial lots including:
- Developing fingerprint for key ingredient
- Development of validated analytical methods
- Determining conformity to ingredient specifications and suppliers' certificate of analysis
- Conducting analysis for ED adulterants
- Performing screening for presence of some 168 other APIs
- Testing for heavy metals
- Testing for aflotoxins
- Testing for pesticides using both FDA and California pesticide screening panels
- Microbiology analysis
- Selecting a third-party certified manufacturing facility compliant with the FDA's dietary supplement Good Manufacturing Practices regulations
- Reviewing label to ensure compliance with the FDA’s dietary supplement labeling requirements
- Conducting Rho-kinase assay for lot-to-lot consistency
- Conducting an oxygen radical absorbance capacity assay to measure lot-to-lot consistency
- Analyzing finished product for presence of ED adulterants
Since its inception in 1978, AIBMR Life Sciences, Inc., has worked with more than 600 nutraceutical companies in the United States and throughout the world. It maintains one of the largest nutraceutical research libraries in the world. The firm specializes in nutraceutical research, foreign and domestic regulatory compliance, cGMP compliance, preclinical and clinical trials management, safety testing, product pharmacokinetics and product development. For more information visit www.AIBMR.com.
The Society of Toxicology (SOT) Annual Meeting is the largest toxicology meeting and exhibition in the world, attracting approximately 6,200 scientists from industry, academia and government. The program includes a plenary and other special lectures, symposia, workshops, roundtable discussions, and platform and poster presentations. For more information visit http://www.toxicology.org/AI/MEET/AM2008/am.asp.
For more complete information about 112 Degrees and LIFE SPAN labs, including tips on improving male sexual performance, visit www.112degrees.com and www.lifespanlabs.com.
**Media: PDF of the safety assessment poster.
Press contact:
Alex Schauss
(253) 286-2888
alex@aibmr.com
