By Steve Austin, ND
Healthnotes Newswire (February 8, 2001)—In a blow to the Food and Drug Administration (FDA), the U.S. District Court of Washington, D.C., has ruled as unconstitutional the FDA’s attempt to prohibit a health claim proposed by the American Preventive Medical Association, Dr. Julian Whittaker, several supplement companies, and authors Durk Pearson and Sandy Shaw.
The claim states, “.8 mg [per day] of folic acid in a dietary supplement is more effective in reducing the risk of neural tube defects than a lower amount in foods in common form.” The health claim arises from the idea that synthetic folic acid—regardless of whether it is found in supplements or in fortified food—is more effective than natural folate in improving the body’s folate status (e.g., improving the level of folic acid found in red blood cells).
The court ruling does not allow supplement companies to begin using the proposed folic acid claim, either on supplement labels or in product information sheets. Rather, the FDA has been ordered to come up with succinct, easily understood, and scientifically accurate disclaimers to be attached to the folic acid claim. The FDA had previously been ordered to do essentially the same thing, but the plaintiffs and now the District Court consider the previous FDA disclaimers to fall below the mandated criteria. The FDA may be hard-pressed to attach new disclaimers to the health claim, as previous statements from the Agency suggest that it considers virtually all parts of the folic acid claim to be inaccurate.1
The FDA has 60 days to appeal the new ruling, and the Agency has made no public statement about whether it intends to do so. Even if it accepts the court’s decision, sources close to the plaintiffs have told Healthnotes Newswire they fully expect the Agency to delay implementation of the court order for as long as possible.
Folate, a B vitamin, is obtained from three sources: foods that naturally contain the vitamin, grains fortified with synthetic folic acid, and synthetic folic acid supplements. The FDA maintains, “ . . . the evidence does not show that dietary supplements are more effective in reducing the risk of [birth defects] than foods in common form.”2 The plaintiffs’ folic acid health claim, on the other hand, favors supplemental folic acid over “foods in common form”—presumably meaning “in their natural state” (i.e., without fortification). Despite the FDA’s statement to the contrary, many scientists contend that the medical literature supports the superiority of synthetic folic acid over folate from natural sources.3 4
The FDA has countered that some evidence shows dietary folate also correlates with at least some protection against birth defects.5 While this is true, no evidence has yet suggested that, despite its very weak ability to increase folate levels in the body, natural folate from food could be as effective in protecting against birth defects as the better-utilized synthetic form of the vitamin. After considering these arguments, the U.S. District Court agreed with the plaintiffs that the FDA’s ban on the folic acid claim overreaches its authority and violates the First Amendment to the Constitution guaranteeing free speech.
The FDA Versus the Scientific Community
Scientists universally agree that folic acid supplementation in pregnant women helps prevent most neural tube defects—a type of birth deformity. The FDA itself accepts this fact and allows a health claim to that effect. However, the Agency fought for years to prohibit such a claim, against a tide of opposing views from the U.S. Public Health Service,6 the Centers for Disease Control in Atlanta,7 and many leading scientists. To the contrary, the FDA had been proposing that the long-standing, recommended intake for folic acid, 400 mcg per day, be reduced by more than 50%—a position a leading Harvard physician and researcher had called “highly imprudent.”8
In an attempt to prevent birth defects, in 1997, the FDA mandated that wheat and rice be fortified with 140 mcg of synthetic folic acid per 100 grams of grain. However, this level of fortification amounts to an average daily intake of only an additional 100 mcg per day—a level deemed inadequate by most responsible scientists.9 10 11 12 13 14 15 16 Even those hailing the FDA fortification program as likely to significantly reduce the risk of birth defects acknowledge that the level of fortification is less than optimal.17
Prominent researchers have shown that as supplementation with 400 mcg of folic acid per day cuts the risk of neural tube defects over 50% below that experienced by children of women who supplement with only 100 mcg per day, which is the level FDA-mandated fortification is aiming to achieve.18 Recent evidence suggests that the level of fortification is so low that the risk of birth defects has not decreased since the mandated fortification program began.19 Even other agencies of the government have advocated for a much higher level of fortification than currently mandated by the FDA.20
Despite the consistency of the scientific evidence and opinion within the scientific community, the FDA continues to take exception to the idea that greater levels of supplementation will be more protective.
The FDA’s Strong Suit
The folic acid health claim implies that 800 mcg of folic acid in a dietary supplement is more effective in lowering the risk of birth defects than are lower amounts. But most trials have investigated either the effect of one dosage of folic acid versus the effect of placebo, or the comparative effects of 400 mcg per day versus lesser amounts. Neither approach answers the question: is 800 mcg per day more effective than lower amounts? Therefore, the Agency’s position that 800 mcg per day has not been proven to be more effective than 400 mcg per day21 appears to be valid.
Achieving Adequate Protection
The bulk of evidence suggests that women who could become pregnant should consume a diet containing fresh vegetables and fruit high in natural folate and grains fortified with folic acid, and should supplement with at least 400 mcg per day of synthetic folic acid. To do any less is to unnecessarily put the developing fetus at risk for neural tube birth defects.
References1. U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition. Letter Regarding Dietary Supplement Health Claim for Folic Acid With Respect to Neural Tube Defects (Docket No. 91N-100H) pages 1–30.
2. U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition. Letter Regarding Dietary Supplement Health Claim for Folic Acid With Respect to Neural Tube Defects (Docket No. 91N-100H) page 4.
3. Cuskelly GJ, McNulty H, Scott JM. Effect of increasing dietary folate on red-cell folate: implications for prevention of neural tube defects. Lancet 1996;347:657–9.
4. Elkin AC, Higham J. Folic acid supplements are more effective than increased dietary folate intake in elevating serum folate levels. Br J Obstet Gynecol 2000;107:285–9.
5. U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition. Letter Regarding Dietary Supplement Health Claim for Folic Acid With Respect to Neural Tube Defects (Docket No. 91N-100H) page 6.
6. US Public Health Service. Recommendations for the use of folic acid to reduce the number of cases of spina bifida and other neural tube defects. MMWR Morb Mortal Wkly Rep 1992;41:RR–14.
7. The Centers for Disease Control and Prevention. Recommendations for use of folic acid to reduce number of spina bifida cases and other neural tube defects. JAMA 1993;269:1233, 1236, 1238.
8. Willett WC. Folic acid and neural tube defect: can’t we come to closure? Am J Publ Health 1992;82:666–8.
9. Beresford SAA. Annotation: how do we get enough folic acid to prevent some neural tube defects? Am J Publ Health 1994;84:348–50.
10. Schwarz RH, Johnson RB. Folic acid supplementation––when and how. Obstet Gynecol 1996;88:886–7.
11. American College of Obstetricians and Gynecologists. Educational Bulletin: Nutrition and Women. October 1996;229:6–7.
12. Oakley GP. Prevention of neural-tube defects. N Eng J Med 1999;341:1546.
13. American Academy of Pediatrics Committee on Genetics. Folic acid for the prevention of neural tube defects. Pediatrics 1999;104:325–7.
14. American Medical Association. H-440.898: recommendations on folic acid supplementation. Policies of the House Delegates–A–99. Chicago: American Medical Association, 1999.
15. Hale RW, Zinberg S. Letter for the American College of Obstetricians and Gynecologists to the Acting Commissioner, Food and Drug Administration, April 28, 1998, Washington, D.C. American College of Obstetricians and Gynecologists, 1998.
16. Werler MM, Mitchell AA. Folic acid prevention of neural tube defects (NTDs): dietary contributions of folate. Am J Epidemiol 1994;139:11S.
17. Cuskelly GJ, McNulty H, Scott JM. Fortification with low amounts of folic acid makes a significant difference in folate status in young women: implications for the prevention of neural tube defects. Am J Clin Nutr 1999;70:234–9.
18. Wald NJ, Law M, Jordan R. Folic acid food fortification to prevent neural tube defects. Lancet 1998;351:834.
19. Meyer RE, Oakley GP Jr. Folic acid fortification. JAMA 1999;354:2168.
20. Oakley GYP, Erikson JD. Urgent need to increase folic acid consumption. JAMA 1995;274:1717–8.
21. U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition. Letter Regarding Dietary Supplement Health Claim for Folic Acid With Respect to Neural Tube Defects (Docket No. 91N-100H) page 12. Steve Austin, ND, is the Chief Science Officer for Healthnotes, Inc. He is a former Professor of Nutrition at the National College of Naturopathic Medicine in Portland, Oregon. Dr. Austin has also headed the nutrition department at Bastyr University.