Why Quality Matters

Important Considerations When Choosing a Source of Choline

Here at Balchem, we’ve been producing choline for decades, so we know choline. We also know that you have other choices on the market. Our goal is to provide you with the safest, highest quality choline possible at the lowest price. As the old adage goes, you get what you pay for, so before you choose a source of choline, be sure to ask these questions as part of your supplier evaluation:

First and foremost, has the choline tested and proven to be safe?

  • The L(+) tartaric acid we use is the only form that occurs in nature
  • A cheaper, lower quality form of choline bitartrate (CBT) that is now infiltrating the market is not GRAS in the U.S.
  • A 2005 study in Comparative Medicine traced lethal kidney stones in rats to DL tartaric acid in choline bitartrate
  • DL choline bitartrate was removed from the FCC and USP in 2005 as a result of the lethal kidney stone findings

Is the choline actually permitted for use?

  • The FDA has confirmed that DL choline bitartrate is not currently approved for use and requires a new dietary
    ingredient (NDI) submission
  • Finished products which contain the DL choline bitartrate will also require an NDI

Is buying choline that isn’t proven safe a smart investment for you and your company?

  • Products that aren’t approved or are unsafe are typically subject to FDA recall. In a 2011 report on a survey conducted by the Grocery Manufacturers of America (GMA), 52% of manufacturers subject to recall estimated the associated costs at $10 million or higher
  • Over 81% of respondents to the survey characterized the financial impact of the recall as ‘catastrophic’ to the company

Choline Bitartrate: Compliance and Safety Analysis

VitaCholine only uses tartaric acid that:

  • Is GRAS approved (generally recognized as safe for use in foods
  • Is USP (United States Pharmacopeia) specified
  • Is compliant with current FCC (Food Chemical Codes)
  • Has undergone thorough safety and toxicological reviews

VitaCholine L + Tartaric Acid DL Tartaric Acid
Natural or Synthetic Natural Chemically synthesized
Source Yeast lees, a natural by-product of wine productions Two-step chemical process:
– Epoxidation of maleic acid
– Hydrolysis of the epoxide
Approved dietary ingredient YES NO, requires NDI
GRAS as food additive? YES NO
Current USP for choline bitartrate? YES (original mongraph) NO
Current FCC for choline bitartrate? YES NO
Toxicology reivew done? YES NO
Crystals show to form in bladders of laboratory rodents, promote tumors NO YES