Choline Nutrient Content Claims Now Allowed
“B4” you reformulate, consider adding choline (also known as vitamin B4) to your nutrient mix. As one of the many recent changes to U.S. food labeling regulations, a Daily Value has finally been set for choline. This creates the opportunity to fortify products with choline and pursue 'good source' and 'high' nutrient content claims for choline.
Nearly 90% of Americans do not consume enough choline,1 so this offers an exciting chance to educate consumers about this vitamin while meeting a very real need.
What is Choline?
Choline is a molecule that plays many roles in the body, ranging from cell membrane signaling to fat transport to early brain development. Choline is required to form the phospholipids in cell membranes and to produce the neurotransmitter acetylcholine, which affects brain and muscle function.
The body makes some of this essential nutrient, but not enough. The balance must be consumed either through diet or supplementation. Fortunately, choline is found in a wide variety of foods such as beef, soybeans, mushrooms, potatoes, egg yolk, and wheat. However, most Americans are not achieving the adequate intake (AI) for choline.
Studies have shown that a choline deficiency can lead to muscle damage as well as liver disease. Choline intake is also considered to be important for pregnant women due to their higher choline needs and the role of choline in preventing neural tube defects. As methyl donors, choline and folate have a complementary relationship, and folate requirements increase when choline intake is low.
FDA Labeling Requirements
The FDA supports the voluntary declaration of choline content on nutrition labels for foods targeting the following groups: adults and children four years and older, pregnant and lactating women, children ages one to three years old, and infants seven to 12 months old, unless choline is added as a nutrient supplement, or the label makes a choline claim. Then, choline content declaration is mandatory.
For supplement labels, the FDA has specified the location of choline within the nutrient list. Choline must be listed after pantothenic acid (which was previously the last vitamin in the list of nutrients) and before calcium.
The Daily Value (DV) for choline is 550 mg for adults and children four years and older (including pregnant and lactating women), 200 mg for children one through three years old, and 150 mg for infants through 12 months.2
A product containing 10 - 19% of the DV per reference amount can make any of the "good source" claims, while a product with 20% or more of the DV can make any of the "high" claims.3 Therefore, a product targeting adults would require 55 mg of choline to make a “good source” claim and 110 mg to make a “high” claim.
“GOOD SOURCE” CLAIMS
|Good source of choline||High choline|
|Contains choline||Rich in choline|
|Provides choline||Excellent source of choline|
Adding Choline To the Mix
Choline is a vitamin that can easily be added to a custom nutrient premix, typically in the form of choline bitartrate. Different concentrations and coatings are available to best suit a variety of products ranging from nutrition bars to drink mixes. Contact us to discuss which one is right for your product.
1. Wallace, T.C., & Fulgoni, V.L. (2016). Assessment of Total Choline Intakes in the United States. Journal of the American College of Nutrition, 35(2), 108-112. doi:10.1080/07315724.2015.1080127
2. Food and Drug Administration. Food Labeling: Revision of the Nutrition and Supplement Facts Labels. 81 Fed. Reg. § 33741 (final rule May 27, 2016) (to be codified at 21 C.F.R. pt. 101).
3. Food and Drug Administration. Food Labeling: Specific Requirements for Nutrient Content Claims. 21 C.F.R. § 101.54 (2017).