FDA Amends Saturated Fat and Cholesterol Labeling Regulations for Fruits and Vegetables | Practical Law

FDA Amends Saturated Fat and Cholesterol Labeling Regulations for Fruits and Vegetables | Practical Law

The Food and Drug Administration (FDA) has amended its regulations to permit raw fruits and vegetables to qualify to make a labeling claim linking dietary saturated fat and cholesterol with the risk of coronary heart disease.

FDA Amends Saturated Fat and Cholesterol Labeling Regulations for Fruits and Vegetables

by Practical Law Commercial Transactions
Law stated as of 19 Dec 2016 • USA (National/Federal)
The Food and Drug Administration (FDA) has amended its regulations to permit raw fruits and vegetables to qualify to make a labeling claim linking dietary saturated fat and cholesterol with the risk of coronary heart disease.
On December 19, 2016, the Food and Drug Administration (FDA) issued an interim final rule that amends regulations authorizing a health claim on food labels regarding the relationship between dietary saturated fat and cholesterol and the risk of coronary heart disease. The interim rule, which goes into effect immediately, expands the use of the health claim to fruits and vegetable that were previously ineligible for the claim. Comments on the rule must be submitted by March 6, 2017.
Under the old rule, foods could not make this health claim unless they met the following requirements, among others:
  • The food 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 or Daily Reference Value before any nutrient addition. (21 C.F.R. § 101.14(e)(6).)
  • The food must be "low fat" as defined in the regulations. (21 C.F.R. § 101.62.)
Many fruits and vegetables fail to meet these two requirements and were thus disqualified from making the health claim, a result at odds with dietary recommendations encouraging their consumption. The FDA has therefore amended the regulations to exempt raw fruits and vegetables from the minimum nutrient and low fat requirements.
The exemption does not exempt fruits and vegetables from meeting other regulatory requirements before making this health claim, including the requirement that the level of fat in the food must not exceed the disqualifying nutrient level for total fat. (21 C.F.R. § 101.14(a)(4).)
For more information on FDA food labeling requirements and oversight, see Practice Note, FDA Food Labeling: Overview.