Under the provisions of the Food and Drug Administration Modernization Act of 1997 (FDAMA), a manufacturer may submit to the Food and Drug Administration (FDA) a notification of a health claim. This health claim notification is based on an authoritative statement from an appropriate scientific body of the United States Government or the National Academy of Sciences (NAS) or any of its subdivisions. If FDA does not act to prohibit or modify such a claim, the claim may be used 120 days after receipt of the notification.
On July 3, 2000, Tropicana Products, Inc. (Tropicana) submitted to the agency a notification containing a proposed claim about the relationship of potassium-containing foods to blood pressure and stroke. Subsequently, FDA received several amendments to the notification from Tropicana that modified, among other things, the proposed health claim and clarified the nature of the foods eligible to bear the claim. The notification cited two statements from the NAS report, Diet and Health: Implications for Reducing Chronic Disease Risk (pages 11 and 15) as authoritative statements for the claim. The first statement is: "Epidemiological and animal studies indicate that the risk of stroke-related deaths is inversely related to potassium intake over the entire range of blood pressures, and the relationship appears to be dose dependent. The combination of a low-sodium, high potassium intake is associated with the lowest blood pressure levels and the lowest frequency of stroke in individuals and populations. Although the effects of reducing sodium intake and increasing potassium intake would vary and may be small in some individuals, the estimated reduction in stroke-related mortality for the population is large." The second statement is: "Vegetables and fruits are also good sources of potassium. A diet containing approximately 75 mEq (i.e., approximately 3.5g of elemental potassium) daily may contribute to reduced risk of stroke, which is especially common among blacks and older people of all races. Potassium supplements are neither necessary nor recommended for the general population."
The notification, as amended, states that foods qualifying for the proposed claim must be a "good source of potassium" (contain 10 percent or more of the Daily Value for potassium) and be "low in sodium." Therefore, qualifying foods must have at least 350 mg of potassium per reference amount customarily consumed (RACC), and 140 mg or less of sodium per RACC. In addition, qualifying foods also must be "low in fat," "low in saturated fat," and "low in cholesterol." Therefore, qualifying foods must contain 3 g or less of total fat per RACC, 1 g or less of saturated fatty acids per RACC, and not more than 15 percent of calories from saturated fatty acids. They also must contain 20 mg or less of cholesterol per RACC.
In May 1997, the National Research Council (NRC) Governing Board of NAS approved a policy statement regarding authoritative statements made by NAS or its subdivisions, the NRC, and the Institute of Medicine (IOM). According to the policy, authoritative statements "are limited to those that represent the consensus of a duly-appointed principal investigator so that they appear explicitly as findings, conclusions, or recommendations in a report that has completed the institutional report review process." As articulated in the policy statement, the Executive Summary of Diet and Health (which integrates all the evidence reviewed in the total report) provides the report’s findings, general conclusions and recommendations based on consensus of the Committee of Diet and Health. Following FDA’s previously established procedures, on August 21, 2000, FDA offered NAS the opportunity to comment on the statements from Diet and Health cited in the notification. FDA received no comment from NAS.
FDA reviewed the authoritative statements from Diet and Health in their context and in light of existing authorized health claims for hypertension and cardiovascular disease. FDA has not acted to prohibit or modify the claim, as amended. Accordingly, after October 31, 2000, manufacturers may use the specified claim on the label and in labeling of any food product that meets the eligibility criteria described in the notification. Under the provisions of FDAMA, when the claim is used, it must appear exactly as stated in the notification. The claim states "Diets containing foods that are good sources of potassium and low in sodium may reduce the risk of high blood pressure and stroke."
The notification and materials regarding the claim are publicly available from the FDA Dockets Management Branch (Docket No. 00Q-1582). Persons interested in these documents may view them at the Dockets Management Branch from 9 am to 4pm, Monday through Friday. The Dockets Management Branch may be contacted at 301-827-6860. Their address is 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FDA intends to make the documents available on the Dockets web site, under Docket No. 00Q-1582.
This document was published on October 31, 2000
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