NOTIFICATION TO FDA
Structure/Function Claims Notification Letter
This is to notify our customers that a Structure/Function Claims Notification Letter, for Body Biotics™ SBO Probiotics Consortia™ formula submitted to the FDA Center for Food Safety and Applied Nutrition in June, has been met with no opposition. After some 30 years in the marketplace, science and research is finally confirming much of what we have believed about superior cultures of Soil Based Organisms as a dietary food source for many years. As the original pioneers of the ‘direct to consumer’ Probiotic supplements industry, we have spurred the competition in pushing more and more at getting to this truth. Now, Life Science Products is pleased to once again lead the way. READ LETTER
In a 700 plus page submission including a Consumer Summary and Executive Summary, backed by published peer reviewed scientific literature gathered from studies conducted around the world, we have in-house a substantial amount of documentation which gives evidence to the many benefits that an effective cultured SBO Probiotics Consortia can have on your wellbeing and longevity. Current research on soil based organisms as Probiotic supplements now overwhelmingly indicates the critical need for a daily dose of these friendly bacteria ─ for all ages. From pre-pregnancy, to newborns, to children, to adults, and to the elderly; the daily use of these superior cultures of Probiotic supplements should be considered your cornerstone to vibrant health.
In preparing these documents our consultants revealed twenty two (22) Explicit and Implicit Claims for Soil Based Organisms in the form of a Probiotics Consortia. Among these claims are: SBOs increase absorption of nutrients, SBOs improve immune function, SBOs are a source of Probiotics for children, SBOs prevent harmful bacteria and fungi from colonizing in the gut, SBOs help to mature the immune system in young children; and SBOs help to promote normal weight in children.*
Information regarding our Structure/Function Claims Notification Letter should be posted on the official government website sometime before the end of this year (December, 2010.) The notification was submitted in mid-June 2010 and, although, we have not received the docket number, to date, we have confirmed with the appropriate department that there are no disputes regarding our notification. PRESS RELEASE - CONSUMER SUMMARY - EXECUTIVE SUMMARY
A List of Explicit and Implicit Claims for Soil-Based Organisms (SBOs)
Provided by Life Science Products, Inc. for
BODY BIOTICS™ Advanced Probiotics Consortia
SBOs improve gastrointestinal health*
SBOs prevent harmful bacteria and fungi from colonizing the gut *
SBOs support gut regeneration and balance gut microbiology *
SBOs balance colonic pH and set the stage for restoring immune health *
SBOs increase resistance to harmful bacteria and fungi *
SBOs increase intestinal absorption of nutrients *
SBOs in the diet replenish friendly colonic microflora *
SBOs improve overall health and well being *
SBOs enhance gut metabolism and promote normal bowel function *
SBOs help overcome bloating and gas *
SBOs improve immune function *
SBOs normalize bowel function *
SBOs improve the barrier function of the gastrointestinal tract *
SBOs ingested daily promote regular, comfortable bowel movements *
SBOs enhance the cleansing function of the gut *
SBOs provide safe alternative microbial stimulation for infants *
SBOs are a source of probiotics for children *
SBOs help to mature the immune system in young children *
SBOs help to promote normal weight in children *
SBOs help to promote normal immune function in children and adults *
SBOs produce Lactoferrin an important line of defense *
SBOs Inhibit Overactive Immune Systems in Adults and Children *
* Note: These customer statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.
**Structure/Function submission documents have been
Researched, Reviewed and Compiled by Technology Consults of
Lee B. Dexter & Associates, Austin, Texas
Lee B. Dexter, is a renown Probiotics expert, former Biology Professor at Bradley University, Peoria, Illinois, 1989 winner of the R & D Top 100’s Award, holder of four Probiotic related Patents for the use of bacteria in foods/animal feed, and the largest contributor of bacteria strain identification submissions (over 600) to the USDA in the last 30 years.
NOTE: The FDA does not approve or disapprove dietary supplements/foods they simply notify a company if they find issue with information provided to them within the notification letter/documentation.
Partial List of Notification References:
Bengmark, S., 1998. Ecological Control of the
gastrointestinal tract. The role of probiotic flora. Gut, 42:2-7. Vol. 2/Tab 2
Heyman, M, Ménard, S., 2002. Probioitc microorganisms: how they affect intestinal pathophysiology, Cellular and Molecular Life Sciences, 59:1151-1165.
Vol. 2/Tab 16
Vogel, RF, Knorr, R, Muller, MR, et al., 1999. Non-dairy lactic fermentations: the cereal world. Antonie Van Leeuwenhoek, Jul-Nov;76(1-4):403-11. Vol.3/Tab 53
Yamamoto N, Maeno M, Takano T., 1999. Purifiction and characterization of an antihypertensive peptide from a yogurt-like product fermented by Lactobacillus helveticus CPN4. J Dairy Sci, Jul;8 (7):1388-93.
Vol. 3/Tab 55
Weerkamp, A. H., I. Bovee-Oudenhoven, and R. van der Meer.1996. Effect of probiotics on infections with pathogenic bacteriain human gut flora-associated rats. Page J36 in Proc. FifthSymp. on Lactic Acid Bacteria—Genetics, Metabolism, and Applications,Cahen, France. Vol. 3/ Tab 58
Salminen, E., et al., 1988. Preservation of intestinal; integrity during radiotherapy using live Lactobacillus acidophilus cultures. Clinical Radiology.
39:435-437. Vol. 3 / Tab 64
Rothschild, PR, Huertas, JG, 2002. Ambulatory treatment of chronic digestive disorder with malabsorption syndrome . Progress in Nutrition, 4: 97-108, Suppl