Under the provisions of the Food and Drug Administration Modernization Act of 1997 (FDAMA), a manufacturer may submit to the Food and Drug Administration (FDA) a notification of a nutrient content claim. The nutrient content claim notification is based on an authoritative statement from an appropriate scientific body of the United States Government or the National Academy of Sciences (NAS) or any of its subdivisions that identifies the nutrient level to which the claim refers. If FDA does not act to prohibit or modify such a claim, the claim may be used 120 days after receipt of the notification.
On May 1, 2001, Central Soya Company, Inc. (Central Soya) submitted to the agency a notification containing proposed nutrient content claims for foods containing choline. Subsequently, FDA received several amendments to the notification, and a complete amended notification for the proposed nutrient content claims. The notification cited a statement from Dietary Reference Intakes for Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin, and Choline (Food and Nutrition Board, Institute of Medicine (IOM), NAS, 1998, page 390) as an authoritative statement that identifies the choline level to which the claims refer. The statement is "Choline functions as a precursor for acetylcholine, phospholipids and the methyl donor betaine. The primary criterion used to estimate the Adequate Intake (AI) for choline is the prevention of liver damage as assessed by measuring serum alanine aminotransferase levels. The AI for adults is 550 mg/day of choline for men and 425 mg/day for women. There are no nationally representative estimates of the intake of choline from food or food supplements. Choline in the diet is available as free choline or is bound as esters such as phosphocholine, glycerophosphocholine, sphingomyelin, or phosphatidylcholine. The critical adverse effect from high intake of choline is hypotension, with corroborative evidence on cholinergic side effects (e.g., sweating and diarrhea) and fishy body odor. The Tolerable Upper Intake Level (UL) for adults is 3.5g/day."
The notification, as amended, proposed that food or dietary supplement products may provide on their labels or labeling the following nutrient content claims to characterize the level of choline: "Good source of choline," "Contains choline," "Provides choline," "Excellent source of choline," "Rich in choline," and "High in choline." These claims would include one of the following statements "Contains [Xmg] choline per serving, which is [X%] of the Daily Value for choline (550 mg)," or "Contains [X%] of the Daily Value for choline per serving. The Daily Value for choline is 550 mg." The area within the brackets would be filled in with the specific percentages of the Daily Value (DV) and milligram amounts of choline in the product.
The amended notification also proposed that food or dietary supplement products may provide on their labels or labeling the following relative nutrient content claims: "Added choline," "More choline," "Enriched with choline," "Fortified with choline," "Extra choline," and "Plus choline." The relative claims would also include the statements "[Percentage 10% or greater] more of the Daily Value for choline per serving than [reference food]. This product contains [X mg] choline per serving which is [X%] of the Daily Value for choline (550 mg). [Reference food] contains [X mg] choline per serving." The area within the brackets would be filled in with the specific percentages of the DV and milligram amounts of choline in the product, and a description of the reference food.
In May, 1997, the National Research Council (NRC) Governing Board of NAS approved a policy statement regarding authoritative statements made by NAS or its subdivisions, the NRC, and the IOM. According to the policy, authoritative statements "are limited to those that represent the consensus of a duly-appointed principal investigator so that they appear explicitly as findings, conclusions, or recommendations in a report that has completed the institutional report review process." As articulated in the policy statement, the Summary in the Chapter titled Choline in Dietary Reference Intakes for Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin and Choline published by NAS qualifies as an authoritative statement. Following FDA's previously established procedures, on June 5, 2001, FDA offered NAS the opportunity to comment on the authoritative statement cited in the notification. FDA received no comment from NAS.
FDA reviewed the authoritative statement from Dietary Reference Intakes for Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin and Choline in its context. FDA has not acted to prohibit or modify the claim, as amended. Accordingly, after August 29, 2001, manufacturers may use the specified claims on the label and in labeling of any food or dietary supplement product that qualifies for the claims described in the notification. Under the provisions of FDAMA, when the claims are used, they must appear exactly as stated in the notification. One example of a nutrient content claim characterizing the level of choline is "Good source of choline. Contains 55 mg of choline per serving, which is 10% of the Daily Value for choline (550 mg)."
This notification and materials regarding the claim are publicly available from the FDA Dockets Management Branch (Docket No. 01Q-0352). Persons interested in these documents may view them at the Dockets Management Branch from 9 am to 4 pm, Monday through Friday. The Dockets Management Branch may be contacted at 240-402-7500. Their address is 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FDA intends to make the documents available on the Dockets web site, under Docket No. 01Q-0352.
This document was issued on August 30, 2001
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