Choline Regulatory Status



Health and Nutrition Claims

An Essential Nutrient with Dietary Reference Intakes

In 1998, the Food and Nutrition Board of the Institute of Medicine developed dietary reference intake (DRI) values for choline for age/life stage groups based on then-current understanding of choline metabolism and available data on intake of the nutrient by the US population.



Nutrient Content Claims (US)

Foods are considered a Good Source of choline if they deliver 55 mg/serving, and an Excellent Source if they deliver 110m mg/serving.

Nutrient Content Claims based on current published authoritative statements from federal scientific bodies are permitted for choline under the provisions of the Food and Drug Administration Modernization Act of 1997 (FDAMA).


Health Claims (US & EU)

Balchem Corporation presented a dossier the following structure-function claims to the United States Food and Drug Administration in 2001:

  • Prenatal use may lead to lifelong improvement of visuospatial memory in children born of the pregnancy
  • Supplementation during infancy and childhood may lead to improved lifelong memory
  • May help memory problems associated with aging
  • May help reduce levels of plasma homocysteine
  • May promote healthy liver function
  • May reduce fatigue and increase vigor during strenuous exercise

In April 2011, European Food Safety Authority (EFSA), through its Panel on Dietetic Products, Nutrition and Allergies, issued a scientific opinion on Balchem’s proposed Article 13 (EC Regulation 1924/2006) general health claims, supporting the benefits of the nutrient choline.   The dossiers submitted by Balchem in support of these claims were deemed sufficient for substantiation by EFSA.   

  • Contributes to normal lipid metabolism
  • Contributes to the maintenance of normal liver function
  • Contributes to normal homocysteine metabolism

This positive recommendation is now subject to formal approval by the European Union expected in the coming months.

Compendial Status

Choline chloride and choline bitartrate are the subjects of current dietary supplement monographs listed in the United States Pharmacopeia 34 and Food Chemicals Codex VII.

Organic Foods

Choline’s biological importance clearly distinguishes it from the class of miscellaneous accessory nutrients currently under discussion in the United States Department of Agriculture’s Sunset review of the National List.

Balchem is working to ensure the continued allowance of choline salts as a source of the essential nutrient choline in foods labeled organic and made with organic, including infant formula.  A petition has been submitted to the Standards Board of the USDA to have choline salts included by name on the National List.

Salt Replacement

Choline chloride is listed as a flavor ingredient (#4500) on the GRAS 24 list of the Flavor and Extracts Manufacturers Association (FEMA).  It has a unique functionality as a partial replacement and flavor enhancer for sodium chloride in sodium-reduced foods and beverages.    

In September 2010, Balchem Corporation submitted a Notification of New Technology to the United States Department of Agriculture describing the use of choline chloride as a direct replacement for sodium chloride and an enhancer of salty flavor in foods under USDA’s jurisdiction.   USDA has expressed ‘no objection’ to the use of choline chloride for this non-nutritive purpose, in processed, ready-to-eat, fresh and frozen meat and poultry products (excluding eggs), with or without standards of identity or composition, at levels not to exceed 1200 parts per million (ppm) in the finished application.