The U.S. Food and Drug Administration (FDA) has promulgated an interim final rule, effective December 19, 2016, amending the regulation authorizing a health claim on the relationship between dietary saturated fat and cholesterol, and risk of coronary heart disease (CHD) to permit a broader array of raw fruits and vegetables (further described below) to be eligible to bear the claim despite the fact that those raw fruits and vegetables may fail to comply with the minimum nutrient content requirement and/or the “low fat” definition of other regulatory provisions. The action is in response to a 2012 petition submitted by the American Heart Association (AHA). Comments are being accepted in the docket for this interim final rule through March 6, 2017.
The claims that the broader array of raw fruits and vegetables will be able to make must comply with the following requirements currently in effect for most raw fruits and vegetables:
A health claim associating diets low in saturated fat and cholesterol with reduced risk of coronary heart disease may be made on the label or labeling of a food . . . provided that:
(A) The claim states that diets low in saturated fat and cholesterol “may” or “might” reduce the risk of heart disease;
(B) In specifying the disease, the claim uses the terms “heart disease” or “coronary heart disease;”
(C) In specifying the nutrient, the claim uses the terms “saturated fat” and “cholesterol” and lists both;
(D) The claim does not attribute any degree of risk reduction for coronary heart disease to diets low in dietary saturated fat and cholesterol; and
(E) The claim states that coronary heart disease risk depends on many factors.
21 C.F.R. § 101.75(c)(2). In addition to the authorized health claim, the label or labeling of the product must bear full nutrition labeling. 21 C.F.R. § 101.14(d)(3). This can be made available at point of sale if the product is not packaged.
How Some Raw Fruits and Vegetables Were Left Outside of the Authorized Health Claim
Health claims, in general, must meet certain nutrient requirements that FDA established pursuant to the Nutrition Labeling and Education Act of 1990 to ensure that health claims are used on foods with nutritional value. For example, except where provided for in other regulations, foods bearing a health claim must contain one or more of vitamin A, vitamin C, iron, calcium, protein, or fiber at or above 10 percent of the Reference Daily Intake (RDI) or Daily Reference Value (DRV), before any nutrient addition. 21 CFR 101.14(e)(6). Additionally, for foods bearing health claims related to CHD, the food often must be a “low fat” food, as that term was defined until the issuance of this interim final rule. An unintended consequence of these general requirements was that some foods that are generally considered to contribute to a healthy diet were ineligible to bear certain health claims. A small number of fruits and vegetables, for example, were ineligible to bear the dietary saturated fat and cholesterol and risk of CHD health claim because they did not meet the requirement to have 10 percent of the RDI or DRV of certain nutrients. For example, grapes, plums, beets, and cucumbers do not contain 10 percent of the RDI or DRV of vitamin A, vitamin C, iron, calcium, protein, or fiber per Reference Amount Customarily Consumed (RACC).
Additionally, the “dietary saturated fat and cholesterol and risk of CHD” health claim requires that a food bearing the claim meet all of the nutrient content requirements for (1) “low saturated fat,” (2) “low cholesterol,” and (3) “low fat.” While nearly all raw fruits and vegetables meet all three of these requirements, avocados do not meet the third requirement and therefore was not eligible, prior to this interim final rule, to bear the claim, even though the fruit meets the requirements for both “low saturated fat”’ and “low cholesterol.” Consumption of fruits and vegetables, however, is encouraged by dietary recommendations, and FDA has now determined that low saturated fat and low cholesterol fruits and vegetables should not be excluded.
Comment Requested on Extension to Frozen and Canned Fruits and Vegetables
Although the AHA petition requested that the proposed changes cover frozen and canned single-ingredient and mixtures of fruits and vegetables that contain no fats or sugar other than those “inherently present” in the raw fruit or vegetable product, the interim final rule covers only raw fruits and vegetables. FDA has, however, requested comment on this dichotomy.
FDA Response to Changing Dietary Guidelines for Americans Recommendations
The agency discussed the evolution of the Dietary Guidelines for Americans (DGA) recommendations at some length in the preamble to the interim final rule. Since the 1993 promulgation of the original health claims regulation, consensus has changed, from a position of low fat diets being recommended in Federal government and National Academy of Sciences dietary guidelines for reducing the risk of heart disease, to the 2015-2020 DGA, which focuses instead on types of fat, such that healthy eating patterns limit saturated fats and trans fats. Based in part on the most recent DGA recommendations, FDA dispensed with the “low fat” requirement but retained the requirement that the raw fruits and vegetables not contain a “disqualifying level” of fat, which for avocados would be 13.0 grams (g) of fat, 4.0 g of saturated fat, 60 milligrams (mg) of cholesterol, or 480 mg of sodium, per 50 g RACC. According to FDA’s nutrient data on the 20 most frequently consumed fruits (Appendix C to Title 21 C.F.R. Part 101), avocados contain 4.5 g total fat per RACC.