FDA Proposes to Update Phytosterols Health Claim and Announces Change in Exercise of Enforcement Discretion

December 13, 2010

By Riëtte van Laack

FDA published a proposed rule that would amend the regulation governing the use of health claims for phytosterols and coronary heart disease.  In 2000, FDA issued an interim final rule ("IFR"), 21 C.F.R. § 101.83, for health claims concerning the relationship between plant sterol/stanol esters and the reduced risk of CHD.  In 2003, the Agency issued a letter announcing that it would exercise enforcement discretion concerning certain claims that went beyond the claims permitted by the IFR ("2003 letter").  Since then, new evidence has become available concerning the effects of stanol and sterols in the esterified and non-esterified form (primarily evidence from numerous intervention studies), and FDA has received several requests for expansion of the health claim.  Because the public has not had a formal opportunity to comment on FDA’s proposed changes (as well as those announced in the 2003 letter), and because it has been ten years since the Agency published its IFR, FDA decided to issue a proposed rule rather than finalize the IFR. 

The proposed rule includes the following significant changes to 21 C.F.R. 101.83:

  • A broadening of the substances eligible for the health claim for conventional foods to include any mixtures of esterified and nonesterified phytosterols (defined as inclusive of both sterols and stanols) derived from vegetable oils and tall oil.
  • Removal of the restrictions on types of conventional foods eligible for the claim.
  • Setting the daily dietary intake of phytosterols necessary to justify the claim for risk reduction at 2 g phytosterols per day.
  • A requirement that food eligible for the claim contains 500 mg phytosterols per serving (provided that the phytosterols are GRAS at this use level).
  • A requirement that the phytosterol-containing product must be consumed with meals or snacks.
  • A limitation of the exception from the disqualifying fat level (13 g of fat per serving size or per 50 g of food) to vegetable oil spreads that resemble margarine, and inclusion of liquid vegetable oil in the short list of exceptions.
  • The addition of liquid vegetable oils to the products exempt from the “minimum nutrient requirement” (i.e., foods eligible for a health claim must contain no less than 10% of the  Reference Daily Intake or Daily Reference Value for vitamin A, C, iron, calcium, protein or fiber per reference amount without nutrient addition).  Vegetable oil spreads resembling margarine may meet the minimum nutrient requirement by addition of vitamin A.

In the absence of valid scientific evidence, claims for dietary supplements remain limited to dietary supplements containing esterified phytosterols.  The requirement that conventional foods must be eligible for the claim “low in saturated fat” and “low in cholesterol” also remains.  

FDA did not propose a limit on trans fat content of food eligible for the health claim.  The Agency, however, requests input on the setting of a limit based on a single study that showed an effect of phytosterols in the presence of 0.8 g/day of trans fat. 

FDA notes that its proposal should not be interpreted as a statement that foods containing certain phytosterols do not violate § 301(ll) of the Federal Food, Drug and Cosmetic Act.  For more on the potential impact of section § 301(ll), click here.

FDA intends to exercise enforcement discretion with respect to claims that comply with the proposed rule.  However, beginning 75 days from December 8, 2010, FDA will no longer exercise enforcement discretion based on the 2003 letter.

Written comments may be submitted through February 22, 2011.

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