January 2008

Probiotics are living microorganisms that can beneficially affect health. The effectiveness of probiotics is related to many factors. The type of bacteria (species and strain), potency (number of viable bacteria per dose), acid and bile tolerance (ability to survive transit through the stomach and small intestine), purity (absence of contaminating organisms or chemicals), and stability during manufacture and storage are important considerations for probiotic benefit.

A recent ConsumerLab product review highlights the importance of probiotic manufacturing quality standards. Selected commercial probiotics sold in the U.S. and Canada were tested to determine if they possessed the number of viable bacteria claimed on the label and contained at least one billion live organisms per dose (an amount widely accepted as the minimum for providing notable benefit). Of the probiotics tested, 31% were found to provide less than one billion viable organisms per dose. One product, while containing the minimum one billion organisms per dose, did not contain the 30 billion claimed to be in the product when manufactured.

Klaire Labs™ recognizes that probiotics require precise quality standards during strain selection and manufacture to ensure the potency, viability, and purity of the beneficial microorganisms. Our quality criteria have been developed over many years of experience and involve meticulous formulation and manufacturing processes joined with finished product validation. We operate a GMP 9000 registered facility certified by NSF International and employ rigorous testing and certification throughout the manufacturing process.

Verifying genetic identity
Probiotic strains used in Klaire Labs™ products are thoroughly researched, documented, and banked in recognized microbial culture collections. Each strain is identified genetically by RNA ribotyping, a precise genetic fingerprint based on ribosomal RNA patterns. Authenticating the specific genetic pattern assures that each strain is correctly identified, possessing the beneficial qualities for which it was selected.

Guaranteeing potency
Exposure to heat, moisture, and air can reduce probiotic potency during manufacturing, transport, and storage. All incoming probiotic raw materials are tested upon arrival to verify potency and purity. They are stored at controlled temperature and humidity. Finished products are shipped with cold-packs to ensure maximum viability. These steps assure the full probiotic potency, ranging from 5 billion to 100 billion CFUs per dose, stated on our labels through the expiration date when stored as directed.

Protecting viability upon ingestion
As living organisms, most probiotics are degraded by the acid conditions in the stomach. Some probiotic strains have a higher tolerance to digestive acid than others. For maximum protection upon ingestion, Klaire Labs™ Ther-Biotic® formulas utilize InTactic®, a proprietary, acid-stable delivery technology that protects probiotics from stomach acid and delivers more viable organisms to the small intestine than do unprotected products.

Ensuring purity and hypoallergenicity
Almost all commonly available probiotic materials are grown on dairy-containing media. Klaire Labs™ has been producing hypoallergenic products free of dairy, gluten, and other common allergens for 30 years. We use proprietary vegetarian growth media to ensure that our probiotic supplements are free of casein, soy, or gluten proteins. Neogen® Vertox testing, a highly sensitive technique that detects dairy protein levels as low as 0.00025%, is used to test each batch to verify there is no trace of dairy. Both raw materials and finished products are tested to ensure that no yeasts, molds, or pathogenic bacteria are present.

Validating the finished product through independent testing
Once manufacturing is complete, all Klaire Labs™ probiotic products are independently tested prior to distribution. Probiotic enumeration (potency) and coliform testing are done on each batch to ensure finished product quality. These extra verification steps confirm that manufacturing and packaging have not adversely affected the product potency and purity.

In summary, selecting a bacterial strain for use as a probiotic does not by itself ensure effectiveness. Ongoing quality control during manufacture and storage as well as attention to the properties allowing survival once ingested are important to assure the benefits of probiotics.