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"When I first heard about this product, well frankly, I thought to myself 'this is probably just snake oil.' I was very suspicious. So I went out to Los Angeles and interviewed people who had used it, and looked at their medical histories, and I became a believer. Without a doubt, people are being helped." **

Dr. Don Boys, PhD., Indiana-Former Member, House of Representatives, Columnist for USA Today- Bio/Tech News 1993

Lee B. Dexter & Assoc.

Technology Consultants

 

15704 Webberville Road                                                             Telephone (512) 300-3584

Austin, Texas 78724 USA                                                                         Fax (512) 451-6985

 

 

June 8, 2010

 

Division of Standards and Labeling Regulations

Office of Nutritional Products, Labeling and Dietary Supplements

HFS-820

Center for Food Safety and Applied Nutrition

US Food and Drug Administration

5100 Paint Branch Parkway

College Park, MD 20740

Phone: (301) 436-2371

 

Dear Sir or Madam:

 

In accordance with 21 CFR §101.93 this letter and its accompanying documents will serve as notification that Life Science Products, Inc., Houston, Texas, a distributor for Sino America Group are marketing a Probiotics Consortia consisting of Soil-Based Organisms™ (SBOs) as dietary supplements. The trade names of the various SBO Probiotics Consortia™ (Referred to hereafter as SBOs) products are: Body Biotics Capsules™, Adult’s Chewable Body Biotics™, Children’s Chewable Body Biotics™, Nature’s Biotics™, and Life’s Green Essentials™.  All correspondence relating to this submission should be directed to the address shown below.

 

Life Science Products, Inc.

6830 North Eldridge Parkway, Suite 106

Houston, Texas 77041 USA

Tel: 713-466-9001

 

The marketing of Body Biotics Capsules™, Adult’s Chewable Body Biotics™, Children’s Chewable Body Biotics™, Nature’s Biotics™, and Life’s Green Essentials™. as dietary supplements will utilize the following statements in their product literature:


 

A Listing of the Explicit and Implicit Claims the Soil-Based Organism 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

 

Daily ingestion of SBOs™ promotes 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

 

 

 

 

 

 

 

These functional claims are supported by published peer reviewed scientific literature as well as company supported studies.  Papers describing the safety and efficacy of Soil-Based Organisms™ have been published by scientists worldwide. 

 

Substantiation for the claims listed above is contained in the document which accompanies this letter.  We are providing the agency with three copies of the supporting document, as well as a Consumer and an Executive Summary as stipulated in 21 CFR 101.93.

 

Thank you in advance for your consideration of this Notification. Any comments on this Notification can be directed to the address listed on the letterhead above.

 

Sincerely,

 

 

 

                                                                                                                                   

Lee B. Dexter                                                            Kelli de Santé

Technical Consultant                                             President/CEO

                                                                                    Life Science Products, Inc.

 

 

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