• FDA Issues Proposed Rule on Phytosterol Health Claims
  • December 13, 2010
  • Law Firm: Covington Burling LLP - Washington Office
  • In the December 8, 2010, Federal Register the Food and Drug Administration (FDA) published a notice of proposed rulemaking to amend the regulation currently authorizing, for specified conventional foods and dietary supplements, a health claim regarding the relationship between plantsterol esters and plant stanol esters and reduction in the risk of coronary heart disease (CHD). The proposal would formally codify the FDA’s Letter of Enforcement Discretion, which established an expanded use of health claims about plant sterol/stanol esters and reduced risk of CHD. The proposal would amend the authorized use of the claim by modifying the nature of the substances that may be the subject of the claim for conventional foods to include nonesterified phytosterols, by expanding the types of foods that may bear the claim to include a broader range of foods, by modifying the daily dietary intake of the substance specified in the claim as necessary for the claimed benefit, by adjusting the minimum amount of the substance required for a food to bear the claim, and by making other minor changes.