What is “USDA Serum?”

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Information or Misinformation?

Labels may not always tell the truth. Some labels offer little useful information about the product in the bottle, while some may even seek to mislead a buyer into believing something untrue about that product.

Labels that can mislead a buyer are not limited to one industry or geographic region. This topic generated heated global debate between consumers and food companies over claims such as “fresh” or “organic;” label disputes arise between unions and durable goods manufacturers over claims of “Made in the USA,” when parts may originate in China; and, the most dubious labeling practices in the world of fetal bovine serum relate to misleading references involving the United States Department of Agriculture (USDA) and this agency’s role in serum sourcing and supply safety.

Many Faces of the USDA

Depending upon the vendor, fetal bovine serum is currently sold under a variety of label claims that invoke the USDA acronym. Surely you’ve seen the following:

  • USDA Tested
  • USDA Approved
  • USDA • USDA • USDA • USDA • USDA • USDA • USDA
  • Standard Certified Premium Origin FBS Grade
  • Fetal Bovine Serum & USDA (Mis)labeling

What Do these Tag‐Phrases Really Mean?

USDA Tested, USDA Approved and USDA Certified all seem to imply that the USDA has somehow evaluated the product for suitability in cell culture and found it to be tested, approved and/or certified. Labels such as USDA FBS, USDA Standard or just plain USDA could imply that the serum actually comes from the USDA in some way. Most striking is the label USDA Premium, which seems to suggest that FBS is graded like beef for human consumption. None of these ideas are true.

The USDA has two specific roles related to FBS products in this context:

  1. List of Approved Import Sources: the USDA determines which countries will be placed on a list of approved import sources for materials related to US‐bound fetal bovine serum.
  2. In Vivo Safety Testing: most countries are placed on the Approved import source list with the stipulation that incoming materials undergo legislated safety testing to ensure that the material poses no threat to US agriculture.

The countries of origin that are currently “approved” by the USDA for material to be handled in the United States are listed below. Those origins for which the USDA requires no additional safety testing are indicated with an asterisk (*):

  • Australia
  • Canada*
  • Costa Rica
  • El Salvador
  • Guatemala
  • Honduras
  • Mexico
  • New Zealand*
  • Nicaragua
  • Panama
  • United States*

FBS from Gemini Bio‐Products

Gemini makes it easier than ever to know the origin of your fetal bovine serum. We choose to avoid ambiguous references to the USDA on all labels and documentation, clearly declaring the country of origin on every Certificate of Analysis. Moreover, our serum is traceable to the abattoir(s) where the raw blood was collected for every lot of FBS we manufacture.

Gemini Bio‐Products keeps all FBS lot documentation on file for a minimum of five years. Certificates of Analysis for all of our current FBS lots are available online at www.gembio.com. Supplementary Certificates of Origin are also available upon request.