Biestmilch also known by the name colostrum is a food no supplement.
When it comes to safety and efficacy it has to be judged according to criteria applied to food and not to medicine or supplements.
For food clinical studies in the classical sense of the word have never been performed, and are not considered as necessary.
In this article I want to straighten out some of the confusions out there in the marketplace. Biestmilch is a food, it thus has to be processed according to the nutrition guidelines published by the food and health authorities in the respective countries.
Europe has a harmonized codex of rules and regulations. In the industrialized Western world the applied quality criteria don't differ that much. The globe shrunk also concerning quality precautions.
WE HAVE TWO DISCOURSES THAT MINGLE WHEN IT COMES TO THE ASSESSMENT OF THE QUALITY OF BIESTMILCH
The one is a quality discourse that refers to the safety of the product. For foods in general apply certain hygienic regulations.
The first proposition is, if it comes to the assessment of quality, whether Biestmilch meets the required hygienic standards. Hygiene has nothing to do with the second proposition which is the efficacy of the product.
All kind of seals and marks that are issued by institutions and institutes all over the globe refer to the problem of hygiene and contamination, and are meant as a kind of proof that a product is clean and safe.
THE OTHER DISCOURSE THAT IS SWAYING AROUND BIESTMILCH IS ABOUT ITS EFFICACY
That the two discourses are treated as one is often done intentionally. This blurry disguise helps to escape arguing about the often doubtful effects of a product.
Especially in the field of foodstuff efficacy is hard to prove. I think this may not necessarily be a big issue, as it should remain with the individual to find out what works best for her or him.
But what I personally don't approve is to pretend that quality equals efficacy. The discourse of efficacy is currently dominated by immunoglobulins, probably due to the fact that they belong to the most familiar molecules among the many immune molecules we know as per today. But more about this later.
Now in the very beginning I want to describe and outline to you, why Biestmilch is a safe product. In the case of new products it is often difficult to differentiate between quality and efficacy, and it's hard to assess the quality.
The following paragraphs want to help you in the decision-making process.
We have two different products, one is made from Biestmilch (bovine colostrum) of German and Austrian cows.
Due to the fact that the raw colostrum in Europe is very limited and will for the time being not exceed the laboratory scale, we have another source of raw colostrum which is Arizona.
Arizona dairy farmers seem to agree on one point: happy cows give better milk. Therefore, no effort is spared to keep the ladies cool and comfortable. Cows rest in the shade and receive cooling showers twice a day. Misters and state of the art ventilation systems keep air temperatures stable. For nearly two decades, these standard practices have helped dairy farmers - many located in central Arizona - to beat the worst of the summer heat.
The cow is the source - our capital since many thousand years
The cow as the basic source of quality Biestmilch has to be healthy and the environment preserved. Cows are very sensitive animals.
As soon as the pastures lose the richness of the grass and herbs the quality (here related to efficacy and content of nutrients) and quantity of the colostrum and milk given go down and so do the nutrients in there.
The same happens when the weather is too hot or cold, or an animal suffers from an illness. Each cow needs the special attention of the farmer every day that quality colostrum can be guaranteed.
The first milking is always kept for the calf.
But the milk cow produces a surplus of Biestmilch. In order to kick off the calf’s immune system, it is vital the newborn calf consumes this first milking colostrum. Each cow produces about 12 liters of first milking colostrum at the time the calf is born. About 2 liters is fed to the calf within the first half hour after birth. About three hours later, the calf is given a boost of another 2 liters. APS then harvests the remaining 8 liters.
The first sip of Biestmilch connects the offspring with the outside world, nurtures it and switches on all organ systems and endows it with the immunity needed until the offspring built up its own.
Its content of fat and other nutrients is high, it contains cells as well as a microbial flora, hormones and thousands of messenger molecules.
The prime location in the Southwest of the United States enables APS BioGroup to collect fresh colostrum all year. Because of the temperate climate, calving occurs year-round here in the Southwest.
All raw colostrum supplied to APS BioGroup must meet 2003 Pasteurization Milk Ordinance (PMO) requirements. Colostrum is only collected from USDA Grade A dairies that are monitored daily for quality assurance compliance by our field quality control specialist.
Raw colostrum from each dairy undergoes a 42 point in-house and/or independent testing protocol including chemistry, specification of pathogens and general microbiology and other necessary testing to assure colostrum is collected from the first milking and free from adulterants.
APS BioGroup uses flash pasteurization and low-heat indirect steam drying to preserve the efficacy and bioactivity of the colostrum. The state-of-the-art colostrum processing facility has a special High Temperature Short Time (HTST) pasteurizer, which meets all USDA Pasteurization Milk Ordinance (PMO) requirements. Using flash pasteurization (minimum 161°F or 72°C for minimum 15 seconds) potentially harmful pathogens are removed, while immunoglobulins, peptides and other biologically important proteins retain their bioactivity.
The colostrum is spray dried using indirect steam and with low pressure and temperatures (less than 145°F or 63°C) to produce a high quality powder while protecting the colostral proteins.
Unopened bags of biestmilch/colostrum powder have a shelf life of three years.
Biestmilch finished products are made of semifinished high protein powder, agglomerated colostrum powder. This applies to BIESTMILCH capsules, chewable tablets and the BIEST BOOSTER.
All of them are manufactured in Germany. Manufacture is done according to good manufacturing practice (GMP)**. As in Arizona, United States, also here in Germany we follow a strict quality assurance system with in-process control and testing.
The aim of the quality assurance system is to guarantee a safe product concerning hygiene, contamination and toxicity.
Furthermore, since 2002 we are working on optimizing the galenics, the texture, the taste and the convenience of our products. It's the manufacturing process of the finished product that matters a great deal too when it comes to hold a high quality standard that in this case refers to safety and efficacy.
The kind of packaging of the finished product is of great importance for the safety of a product. Therefore the capsules are in blister packaging, the chewable tablets and the BIEST BOOSTER are sealed in foil. This packaging makes our products moisture resistant and prevents the penetration of microbes and other toxins.
All stress tests (temperature, humidity etc.) performed in our laboratory confirmed that a shelve life of 3 years is justified.
THE IMMUNOGLOBULIN DISCOURSE AND EFFICACY CONTROVERSY
It became sort of a trend of the Biestmilch sellers to implicit claim the amount of immunoglobulins as criteria of efficacy for Biestmilch. The ranges mentioned reach from 20% to 45%.
Of course, immunoglobulins are important components of Biestmilch, but by far not the only molecules that explain the diverse effects of Biestmilch. To only give the amount of a biological molecule is always critical, because the quantity does not say anything about the activity of the molecule.
Moreover to compare values without being familiar with the test system is impossible. There are methods to measure the quantity and others that detect the bioactivity, both are two completely different things.
To assess the amount given you need to know whether it is measured in liquid or solid phase. In the liquid phase the amount will always be lower compared to solid phase when all the moisture evaporated.
Another issue is the fact that Biestmilch is a living substance.
The amount of immunoglobulins not only depends on the day of the harvest, but also on the cow's health condition and the food she gets. Immunoglobulin content can vary from one lot to the other.
The smaller the lots the more difficult it is to adjust the content and achieve lot consistency. Whether Immunoglobulins as currently measured and implied as efficacy criteria are suited to fulfill this role needs further studies and discussion.
*HACCP (Hazard Analysis Critical Control Point) is the systematic preventative approach to food safety. It addresses physical, chemical, and biological hazards as a means of prevention rather than finished product inspection. This approach has significant benefits to organisations operating within the food supply chain as it enables them to determine key controls over processes and concentrate resources on activities that are critical to ensuring safe food. Retailers, the food industry and Government in particular are concerned about ensuring that food is produced safely and that the consumer has confidence in the product. This has led to an increase in legislation over time that has focussed upon ensuring safe systems of food production. In the UK the 1995 Food Safety Amendment Regulations, for the first time required manufacturers and providers to adopt HACCP to ensure food safety.
**Good manufacturing practices (GMP) refers to guidelines laid down by agencies which control authorization and licensing for manufacture and sale of food and drug product or a medical device, active pharmaceutical products and pharmaceutical excipients. These guidelines are laid down with the intention of providing requirement that a pharmaceutical or a food product manufacturer must meet while manufacturing of drug or a food product or a medical device, which then assures that the product manufactured in compliance with (GMP) practices are of good quality and does not pose any risk or hazard from cross contamination. Good manufacturing practice guidelines provides guidance for manufacturing, testing, and quality assurance in order to ensure that drug product is safe for human consumption.
***ISO International Organization of Standardization A standard is a document that provides requirements, specifications, guidelines or characteristics that can be used consistently to ensure that materials, products, processes and services are fit for their purpose. ISO International Standards ensure that products and services are safe, reliable and of good quality.