Source: http://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm073181.htm
Timestamp: 2013-12-04 22:26:54
Document Index: 398004485

Matched Legal Cases: ['§ 101', '§ 101', '§ 101', '§ 101', '§ 101', '§ 101']

Letter Regarding Dietary Supplement Health Claim for Fiber With Respect to Colorectal Cancer (Docket No. 91N-0098) Quick Links: Skip to main page content
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Letter Regarding Dietary Supplement Health Claim for Fiber With Respect to Colorectal Cancer (Docket No. 91N-0098)
(Letter | References | Summary Tables - Dietary Fiber/Colorectal Cancer Studies )
This letter is in reference to the court decision directing the Food and Drug Administration (FDA) to reconsider the health claim "Consumption of fiber may reduce the risk of colorectal cancer" in dietary supplement labeling (Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999)). The other three health claims that FDA was directed to reconsider will be addressed in separate letters.
I. Procedure and Standard for Evaluating the Claim
In reconsidering this claim and the three other health claims that were the subject of Pearson, FDA proceeded as described in the October 6, 2000, Federal Register notice entitled "Food Labeling; Health Claims and Label Statements for Dietary Supplements; Update to Strategy for Implementation of Pearson Court Decision." 65 Fed. Reg. 59,855 (2000). As noted below in section III, FDA first gathered new scientific evidence on the claims by contracting for a literature search and publishing two notices in the Federal Register soliciting comments and data. After reviewing the updated body of evidence on the claims, FDA applied the "significant scientific agreement" standard by which the health claim regulations require the agency to evaluate the scientific validity of claims. Under this standard, FDA may issue a regulation authorizing a health claim only "when it determines, based on the totality of publicly available scientific evidence (including evidence from well-designed studies conducted in a manner which is consistent with generally recognized scientific procedures and principles), that there is significant scientific agreement, among experts qualified by scientific training and experience to evaluate such claims, that the claim is supported by such evidence." 21 C.F.R. § 101.14.
For claims that did not meet the significant scientific agreement standard, FDA next considered whether to exercise enforcement discretion for qualified claims about the substance-disease relationship. Consistent with the Pearson decision, the agency considered whether consumer health and safety would be threatened by the claim, and, if not, whether the evidence in support of the claim was outweighed by evidence against the claim, either quantitatively or qualitatively. See 164 F.3d at 650, 659 & n.10. If the evidence for the claim outweighed the evidence against the claim and there was no health or safety threat, the agency went on to consider whether a qualified claim could meet the general health claim requirements of 21 C.F.R. § 101.14, other than the requirement to meet the significant scientific agreement standard and the requirement that the claim be made in accordance with an authorizing regulation. These requirements were not challenged in Pearson and therefore still apply.
In the October 6 notice, FDA explained that it would consider exercising enforcement discretion for a dietary supplement health claim that did not meet the significant scientific agreement standard if the scientific evidence for the claim outweighed the scientific evidence against the claim, if the claim included appropriate qualifying language, and if the other criteria listed in the notice were met. In that event, the agency explained, FDA would send a letter to the petitioner outlining the agency's rationale for its determination that the evidence did not meet the significant scientific agreement standard and stating the conditions under which the agency would ordinarily expect to exercise enforcement discretion for the claim. See 65 Fed. Reg. at 59,856. The agency also stated that, conversely, if the scientific evidence for the claim did not outweigh the scientific evidence against the claim, or the substance posed a threat to health, or the other criteria for the exercise of enforcement discretion were not met, FDA would issue a letter denying the claim and explaining its reasons for doing so. See 65 Fed. Reg. at 59,856.
Although the deadlines for FDA action in 21 C.F.R. § 101.70(j) apply to health claims that are submitted by petition, they do not apply to the four claims that were the subject of Pearson. FDA is reconsidering those claims under a court order that sets no specific deadlines but clearly contemplates prompt action because of First Amendment concerns and the agency's obligation to comply with court orders as soon as possible. Accordingly, even though the deadlines in § 101.70(j) do not apply, FDA is using them as a guideline. Section 101.70(j)(2) requires the agency to issue a denial or a proposed regulation to authorize the health claim within 190 days of submission of the petition summarizing the scientific evidence relevant to the claim. FDA is issuing this decision letter on October 10, 2000, 190 days after the close of the second comment period for the submission of scientific evidence relevant to the claim.
II. Summary of Review
In 1993, FDA authorized a health claim for fiber-containing grain products, fruits, and vegetables and reduced risk of cancer. 58 Fed. Reg. 2537 (1993) (codified at 21 C.F.R. § 101.76). FDA had concluded that the evidence available at the time did not support an association of reduced risk of cancer and dietary fiber per se, but did support an association of reduced risk of cancer and diets high in fiber-containing grain products, fruits, and vegetables and low in total fat. The available evidence did not resolve whether this association is due to the dietary fiber component of the foods in question, to other components in these foods, to displacement of other foods in the diet (e.g., fats and meats), or to other combinations of factors. Thus, while the available evidence established that dietary fiber is a marker of the types of foods associated with reduced cancer risk, the evidence was not sufficient to support a finding of significant scientific agreement that dietary fiber itself helps to protect against the development of cancer. Because of this limitation in the evidence, the authorized health claim for fiber-containing grain products, fruits, and vegetables and cancer in § 101.76 characterizes the association between reduced risk of cancer and consumption of certain types of foods, not fiber or any other individual component of those foods.
The agency's decision was also based in part on other limitations in the scientific evidence. See 56 Fed. Reg. 60566, 60575-60576 (1991); 58 Fed. Reg. at 2541, 2543-44. Fiber-rich foods differ significantly in the amounts and types of fiber they contain, and different types of fiber vary considerably in chemical composition, physical characteristics, and biological effects. The commonly used analytical methodologies often do not detect many of the characteristics that vary among fibers and that may be related to biological function (e.g., particle size, chemical composition, or water holding capacity). In the animal studies the agency reviewed, different types of fiber produced widely varying results; in fact, some types of fiber appeared to promote the development of cancer. Fiber in general showed no consistent protective effect, and even results for a single type of fiber were not consistent. Human studies were limited by problems in identifying and measuring the type and amount of fiber consumed. Thus, the agency concluded that the evidence for a health claim about dietary fiber and reduced risk of colorectal cancer was inconclusive and did not meet the significant scientific agreement standard.
In response to Pearson, FDA has reconsidered the scientific evidence on the putative relationship between dietary fiber and the risk of developing colorectal cancer, focusing on human study evidence that has become available since the original fiber - cancer health claim rulemaking that concluded in 1993. Both the agency's original 1991-93 scientific evaluation and its evaluation of the evidence that has become available since that time were conducted consistent with the principles and procedures articulated in FDA's Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements (December 1999).
Based on its review of the scientific evidence, FDA finds that (1) the most directly relevant, scientifically probative, and therefore most persuasive evidence (i.e., randomized, controlled clinical trials with fiber as a test substance) consistently finds that dietary fiber has no effect on incidence of adenomatous polyps, a precursor of and surrogate marker for colorectal cancer; and (2) other available human evidence does not adequately differentiate dietary fibe