Folic acid health claim to prevent NTDs shortened in final rule; fortification to be required.

FDA ALLOWING MORE "SUCCINCT" FOLIC ACID HEALTH CLAIM under a final rule that is expected to appear in the March 7 Federal Register. The streamlined claim for folic acid is part of several regulations that will appear in the Federal Register aimed at extending the dietary supplement folic acid claim, allowed since January 1994, to conventional foods and requiring dietary supplement fortification of specified grain products. The rules supercede the January 1994 reg.

The final rule provides two examples of "model" health claims with fewer than 30 words for products containing 100% or less of the daily value of folic acid: "Healthful diets with adequate folate may reduce a woman's risk of having a child with a brain or spinal cord birth defect." "Adequate folate in healthful diets may reduce a woman's risk of having a child with a brain or spinal cord birth defect."

FDA has dropped several of the requirements for folic acid health claims outlined in the agency's Oct. 14, 1993 proposed rule ("The Tan Sheet" Oct. 11, 1993, p. 4) and adopted in the final rule for dietary supplement folic acid claims published in the Jan. 4, 1994 Federal Register ("The Tan Sheet" Jan. 3, 1994, p. 7).

In the upcoming rule on the health claim, FDA acknowledges that "many comments" on the earlier rules "criticized the length" of the claims and "their required components." To address complaints that the current claim is "unwieldy," FDA no longer will require wording that NTDs "have many causes" or a statement indicating the incidence of NTDs in the U.S. The final rule also drops the requirement that sources of folate be identified in the claim.

However, in the rule, FDA indicates that it would not object to seeing such information in folic acid health claims and provides optional wording addressing the "multifactorial nature" of NTDs, the "prevalence" of the disease, and sources of folate.

In addition, the rule will require a cautionary statement on foods that contain more than 100% of the folate daily value of 400 mcg (800 mcg for pregnant or lactating women). Such foods and supplements will be required to identify the "safe upper limit of daily intake" set by FDA at 1,000 mcg (1 mg) of folate.

In response to the criticism, FDA stated that "certain information is needed in the health claim, whether for conventional foods or for dietary supplements, for such claims to be truthful, scientifically valid, and not misleading to segments of the population that are not at high risk" of a pregnancy or birth affected by NTDs.

FDA rejected comments urging a condensed claim for dietary supplements. Pointing to its decision to require a cautionary statement on the safe upper level of folic acid intake on all foods above the daily value and not just dietary supplements and fortified foods, the agency maintained that it has been "even-handed in considering conventional foods and dietary supplements."

Several comments had questioned FDA's intentions in proposing to extend the health claim to folate-containing foods when the most important studies showing a benefit of folic acid in reducing NTDs were conducted using dietary supplements. Comments also questioned FDA's use of the term "dietary folate" and pointed out that the Centers for Disease Control's recommendation was for folic acid intake, not folate intake.

Such comments, the final rule states, "do not provide a basis for the agency to change the relationship statement because they are inconsistent with the scientific data, and they do not provide data that demonstrate that `folic acid' performs nutritional functions different from those performed by naturally occurring food folates." Consequently, FDA stated, "making a distinction between `folate' and `folic acid' when all forms of the vitamin are capable of conversion to active vitamin coenzymes and metabolic function is artificial and inappropriate."

"Since increased folate intake is what is of importance, and since a variety of dietary sources of folate are available," the agency declared, "it would be inconsistent with the available evidence for the agency to set different requirements for claims on dietary supplements than for claims on conventional foods."

FDA rejected recommendations to identify 400 mcg of folate per day as the target intake goal or as a recommended level.

The agency said it has "tentatively concluded that there is uncertainty as to the optimal intake of folate with respect to reduction in risk of neural tube defects" and that to require a statement that women "must consume 400 mcg folate per day" to reduce their risk of NTDs "would be inconsistent with the available scientific data."

The final rule allows foods and dietary supplements with at least 10% of the RDI (recommended daily intake) -- 40 mcg per serving -- to carry the claim. Regarding whether dietary supplements should be required to provide more folate than foods do, FDA concluded "that there is no reason why they should."

Supplements or foods containing more than 100% of the RDI for vitamin A as retinol or preformed vitamin A or vitamin D may not carry the folate health claim. However, citing a lack of data, FDA rejected the idea of requiring a warning statement on supplements with inadequate levels of vitamin B12. Because of concerns about the potential for folic acid to mask pernicious anemia in the elderly, one comment had urged FDA to restrict the claim to supplements containing an unspecified level of B12 to prevent anemia.

As with the earlier rules on folic acid claims, the upcoming final rule will disqualify dietary supplements from carrying the health claim if they do not meet U.S. Pharmacopeia standards for dissolution and disintegration.

In a Feb. 29 press release, FDA announced that it will require specified grain products "to be fortified with folic acid at levels ranging from .43 mg to 1.4 mg per pound of product." The foods required to be fortified include enriched bread, rolls and buns; enriched flour; enriched corn grits and corn meals; enriched farina and rice; and all enriched macaroni and noodle products, including vegetable macaroni, vegetable noodle and non-fat milk macaroni products. Breakfast cereals will be allowed to add up to 400 mcg of folic acid per serving.

FDA said in the release that it will "review any new data concerning optimum fortification levels for folic acid and will consider adjusting the level of fortification if the data substantiate the need." The final rules are expected to become effective Jan. 1, 1998.