Demand for serum for cell culture has in recent years almost exploded, and there is a lot of money to be made in the business. However it is a very opaque business, which is subject to little if any control. There are many indications that fraud and falsification are widespread. Just a few instances are given here.
False description and country of origin
The USA has stricter rules than the EU and does not allow importation of foetal calf serum from South and Central America, with the exception of Chile. The EU on the other hand has far more lax rules. Fraud concerning content is believed to be widespread. For example, foetal calf serum is mixed with serum from adult animals, yet is still sold under the label foetal calf serum (FBS). Even though the Danish authorities maintain that there is at present no foetal calf serum production in Denmark, some producers nevertheless name Demark as the country of origin of their FBS-product.
How does it happen?
A company imports serum from a country where it can be obtained cheaply, falsifies the papers the documentation on origin, mix and dilute the serum with other sera and fluids, and sell it at a significantly higher price. It is a profitable business, as the price varies according to where the serum comes from. Serum from New Zealand and Australia is considered to be particularly “safe”, as these countries are free of a number of farm animal diseases. It is worth noting, that foetal calf serum from these countries costs more than € 1000 (approx. 7500 D.Kr. or GBP 1290) per litre and is therefore 5 to 10 times more expensive than FBS from South America. FBS from Europe or North America lies between these two price levels.
Examples of fraud
One of the more recent revelations of fraud caused one supplier of FBS to have to issue a warning that batches of its FBS-product could also contain serum from adult cattle, water and/or growth-promoting additives. Furthermore the company had to state that FBS-products sold to countries outside the USA could erroneously have been labelled as coming from Australia or other EU-approved countries of origin. The warning also contained information that the added serum from adult cattle might have come from Argentina, Brazil, Mexico, Canada or the USA. Buyers of the product were therefore completely unable to trust either the purity of the product or the country of origin.
Another example dates from the beginning of 2000, when a German company purchased cheap, poor quality serum from Canada for ca. $ 20 per litre. The serum was poured away because the company was only interested in the accompanying papers on country of origin, which described the serum as coming from Canada. When a Japanese client ordered serum, specifying that is should be Canadian in origin, the German company imported serum from Brazil, Paraguay and other South American countries, at a price of about $ 40 per litre, and sold it to its French subsidiary with the papers describing the serum as originating in Canada. Thereafter the serum was sold to the Japanese client at a litre price of $ 210 – a profit of $ 150 per litre for more than 1000 litres.