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FDA PROPOSAL ON FOLIC ACID HEALTH CLAIM UNDERSCORES LINGERING SUPPLEMENT BIAS, SAYS COUNCIL FOR RESPONSIBLE NUTRITION

 WASHINGTON, Nov. 12 /PRNewswire/ -- The Council for Responsible Nutrition issued the following position statement:
 -- Health Claim Should be Specifically for Supplements
 The U.S. Food and Drug Administration's (FDA) folic acid health claim proposal comes 13 months after a recommendation from the Public Health Service recognizing the effectiveness of folic acid in preventing neural tube birth defects. The reason for this lengthy delay was FDA's insistence on establishing a food fortification policy. Unfortunately, the agency's proposal still fails to provide a health claim specifically tailored to supplements. The rationale behind this FDA action is not justified since the only intervention trials that have been done have used supplements of folic acid, not food folate.
 This is further evidence of the agency's longtime bias against supplements and the role they play in promoting good health. In addition, the proposed claim will be nearly impossible for the industry to implement, will needlessly alarm consumers and will continue to limit their access to nutrient/disease information which could help reduce the incidence of these devastating birth defects. Additional flaws in the FDA proposal are discussed below.
 -- Level of Folic Acid or Folate is Inadequate for Health Claim
 Not only is FDA allowing a food folate-based health claim, but the agency is making an exception to the general health claims requirement that a food must have 20 percent of the Reference Daily Intake (RDI) of a nutrient before a health claim can be made. In this case, FDA is allowing a claim for foods or supplements with only 10 percent of the RDI. This is a mere 40 mcg (0.04 mg), whereas the protective intake is 400 mcg (0.4 mg) per day.
 -- Health Claim Should Appear Only on Products Providing Adequate
 Protection
 There is no justification for a health claim based on only 10 percent of the RDI for fortified foods or dietary supplements. The health claim should be permitted only for foods and fortified foods providing at least 25 percent and supplements providing 100 percent of the RDI for folic acid.
 The primary object of health claims is to enhance the consumer's knowledge of nutrients which protect against disease, and the claim should only appear on products which are truly protective.
 -- Claim Implies Lifetime Intake of Folic Acid Necessary
 One of the model claims in the proposal implies that regular lifetime intake of folic acid is necessary to prevent birth defects. This is inappropriate and inaccurate, where supplements are concerned, since studies have shown that short-term periconceptional use is effective. A properly worded claim should tell women that supplements should be taken one to three months before and after conception. Also, the requirement to list dietary sources of folate in the health claim is irrelevant to the demonstrated effectiveness of supplements alone in reducing the risk of neural tube defects.
 -- Labeling Will Unnecessarily Alarm Consumers
 FDA's proposal to require a caution against exceeding 1,000 mcg (1 mg) of folate per day has no firm scientific basis, as FDA recognizes in the proposal. If this is the case, why is the agency allowing it to stand as a barrier to effective action both in providing health information and in fortifying the food supply? The inclusion of the caution in the health claim will counter the "health benefit" message and raise consumer concerns about using safe dietary supplements or fortified breakfast cereals.
 -- Requirements Obscure the Message about Folic Acid's Protective
 Effects
 FDA's proposal requires food and supplement product labels to list information about numerous aspects of folic acid resulting in a lengthy and cumbersome statement. It will be virtually impossible for manufacturers to list all the caveats on a supplement label, which typically measures 2 inches by 6 inches. Of the FDA's five model health claims for folic acid, the shortest version -- which includes essentially the minimum language necessary to satisfy the regulation -- requires 82 words and nine lines of text. Simplification is urgently needed to get information on folic acid's protective effects to women.
 -- Reformulation of Breakfast Cereals Could Diminish Folic Intake by
 Women
 An integral part of FDA's overall folic acid policy is to require the reformulation of the few breakfast cereals that currently provide 400 mcg of folic acid per serving. Under a revised food additive regulation on folic acid, breakfast cereals could contain no more than 100 mcg of folic acid per serving -- 25 percent of the recommended daily intake. Thus, women who currently use fully fortified cereals will be less likely to obtain recommended intakes under the new policy, unless they decide to use dietary supplements instead or eat four servings a day of the reformulated cereal product.
 Recommendations
 -- FDA should adopt a precise, user-friendly health claim for folic
 acid, including a claim specifically tailored to supplements.
 -- Congress should initiate a thorough review of the procedures FDA
 implemented in evaluating a health claim for folic acid.
 -- Congress must act now to develop a new regulatory framework which
 allows consumer access to supplements and information about their
 benefits.
 -0- 11/12/93
 /CONTACT: Mary Burnette of the Council for Responsible Nutrition, 202-872-1488/


CO: Council for Responsible Nutrition; U.S. Food and Drug
 Administration ST: District of Columbia IN: HEA SU:


IH-MH -- DC021 -- 3711 11/12/93 13:10 EST
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Date:Nov 12, 1993
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