U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Nutritional Products, Labeling, and Dietary Supplements
April 3, 2001

Dear Mr. Emord:

This letter is pursuant to the opinion and order issued February 2, 2001, by the U.S. District Court for the District of Columbia in Pearson v. Shalala, No. 00-2724, 2001 WL 111161 (D.D.C. Feb. 2, 2001)).

In its opinion and order, the Court instructed the Food and Drug Administration (FDA) to draft one or more "short, succinct, and accurate" disclaimers for the health claim

"0.8 mg 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."

2001 WL 111161 at *13, *14. The Court suggested that the agency consider three disclaimers mentioned in the opinion. Id. at *13. The Court further suggested that the agency complete the task of drafting the disclaimer(s) for the claim within 60 days. Id. at *14 n.34.

The three disclaimers the Court asked FDA to consider were:

"The evidence in support of this claim is inconclusive."
"The FDA does not approve this claim."
"Foods fortified with similar amounts of folic acid may be as effective as dietary supplements in reducing the risk of neural tube defects."

FDA considered the disclaimers suggested by the Court, as well as a number of others, and has concluded that the following disclaimer best meets the criteria specified in the Court's decision:

"FDA does not endorse this claim. Public health authorities recommend that women consume 0.4 mg folic acid daily from fortified foods or dietary supplements or both to reduce the risk of neural tube defects."

FDA drafted this disclaimer to communicate, in as short and succinct form as possible, the following points:

• Your claim does not have FDA's endorsement.


• Public health authorities recommend a daily intake of 0.4 mg folic acid to reduce the risk of neural tube defects (NTDs), not the amount promoted in your claim as being more effective.


• Folic acid, whether provided in fortified foods or in a dietary supplement, is effective in reducing the risk of neural tube defects (NTDs).

FDA has concluded that these points are necessary to make the disclaimer "accurate," as required by the Court. The agency further believes that the disclaimer is as "short" and "succinct" as the information to be communicated permits. FDA considered the shorter disclaimer "FDA does not endorse this claim" and concluded that it was inadequate for three reasons. First, the agency was concerned that consumers would misinterpret a succinct "does not endorse" disclaimer to mean that FDA does not endorse any claim relating to folic acid and NTDs. In fact, as you know, FDA has authorized such a claim by regulation in 21 C.F.R. § 101.79. The agency believes that it is very important for women of childbearing age to be made aware that folic acid may reduce the risk of NTDs. Therefore, FDA concluded that the disclaimer should specify what the agency does and does not endorse. Second, the disclaimer "FDA does not endorse this claim" would do nothing to counteract the misleading implications of your claim with respect to the amount and source of folic acid that are necessary to reduce the risk of NTDs. Finally, FDA concluded that it was important to give the reason that the agency does not endorse the claim. Without this information, consumers might make incorrect assumptions about FDA's evaluation of the claim; for example, they might assume that FDA simply had not reviewed the claim and therefore had no basis for an opinion about it, or, as noted above, that FDA does not support recommendations for folic acid and NTDs.

The first sentence of the disclaimer is similar to the second disclaimer suggested by the Court. The agency replaced the word "approve" with the word "endorse" because the Nutrition Labeling and Education Act of 1990 provides that FDA shall not require a person who proposes to make a health claim in compliance with applicable regulations to obtain approval before making the claim. Pub. L. 101-535, § 3(b)(1)(A)(vii), 104 Stat. 2353, 2361 (1990). Thus, although FDA issues regulations authorizing health claims for foods (including dietary supplements) and components of foods, FDA does not "approve" such health claims. The agency believes that "does not endorse" conveys the meaning the Court intended by "does not approve" (i.e., that FDA does not stand behind the claim) without implying that FDA approves, rather than authorizes, health claims. A potentially misleading implication of health claims that do not meet the significant scientific agreement standard is that consumers may expect the claim to have been validated by the government body charged with ensuring that label statements on dietary supplements are truthful and not misleading, i.e., FDA. To correct this potentially misleading implication, the disclaimer advises consumers that the health claim is not endorsed by FDA.

The second sentence of the disclaimer addresses two other misleading aspects of your claim. First, it informs consumers that the scientifically recognized effective daily intake is lower than the amount promoted in your claim. In 1992, the Public Health Service (PHS) recommended that women who are capable of becoming pregnant consume 400 mcg (0.4 mg) of folic acid per day to reduce the risk of NTDs.¹ As a Public Health Service agency, FDA participated in the development of this recommendation. In 1998, the National Academy of Sciences (NAS) also recommended that women capable of becoming pregnant consume 0.4 mg of folic acid daily to reduce the risk of NTDs. ² The following other public health agencies and organizations have made the same recommendation: the Division of Birth Defects and Developmental Disabilities³ and its parent Center, the National Center for Environmental Health of the Centers for Disease Control and Prevention (CDC); ⁴ the National Council on Folic Acid;⁵ and the American Academy of Pediatrics.⁶ Moreover, we note that unlike your claim, which is based primarily on your interpretation of the results from a single study (the Czeizel study), the recommendations of these public health authorities were based on evaluations of the broader body of available scientific evidence, including (but not limited to) the study on which you base your claim.

The second sentence of the disclaimer also informs consumers that an effective intake of folic acid need not be obtained from supplements alone, as implied in your claim, but may also be obtained from fortified foods, or from a combination of supplements and fortified foods. This part of the disclaimer derives from the 1998 NAS recommendation that women capable of becoming pregnant consume 0.4 mg of folic acid daily from supplements, fortified foods, or both, in addition to consuming food folate from a varied diet.⁷ It is also based on the fact that the same chemical form of folic acid is added to both fortified foods and dietary supplements.⁸

FDA intends to exercise its enforcement discretion with respect to folic acid supplements that bear your health claim when the above disclaimer is placed immediately adjacent to and directly beneath your claim, with no intervening material, in the same size, typeface, and contrast as the claim itself.

Folic acid supplements bearing the claim and disclaimer must still meet all applicable statutory and regulatory requirements under the Federal Food, Drug, and Cosmetic Act, including the applicable requirements for health claims.

As you know, the government has filed a motion for reconsideration of the February 2, 2001 decision, and that motion is still pending. As explained in our briefs in support of that motion, FDA believes that no disclaimer can remedy the deceptiveness of your claim because the claim is contrary to the weight of the scientific evidence. Nonetheless, in the interest of complying with the Court's request that we specify a disclaimer within 60 days, we are issuing this letter despite the pending motion. Should the district court or a higher court rule in our favor, we would reconsider our exercise of enforcement discretion and would inform you in writing of any change in the status of your claim under the new court ruling.

1. Joint Excerpts of Administrative Record ("J.R.") at 471-77.
2. J.R at 601.
3. J.R. at 878.
4. J.R. at 788-89.
5. United States' Memorandum in Opposition to Plaintiffs' Motion for Summary Judgment, Exhibit A. The National Council on Folic Acid, founded by the CDC, coordinates a national effort to prevent spina bifida and anencephaly. Members of the Steering Committee of this Council include, among others, the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, the American Dietetic Association, the American College of Physicians, the American Pharmaceutical Association, the Association of Maternal and Child Health Programs, the American Nurses Association, the March of Dimes Birth Defects Foundation, the Pan American Health Organization, the National Coalition of Hispanic Health & Human Services Organizations, Shriners Hospitals for Children, the United States Department of Agriculture, and the Spina Bifida Association of America. J.R. at 944.
6. J.R. at 921.
7. J.R. at 601.
8. Institute of Medicine, Food and Nutrition Board, National Academy of Sciences (IOM/NAS). Dietary Reference Intakes: Thiamin, Riboflavin, Niacin, Vitamin B₆, Folate, Vitamin B₁₂, Pantothenic Acid, Biotin, and Choline. Washington, DC: National Academy Press, 1998, at 197. See also Letter from Christine J. Lewis, Ph.D., to Jonathan Emord, Esq., October 10, 2000, at 12-13; 61 Fed. Reg. 8752, 8759 (1996).

Hypertext updated by dav 2001-APR-09