Industry Asks FDA to Extend the Compliance Period for Change in Enforcement Discretion Policy with Regard to Phytosterol Health Claim

January 13, 2011

By Riëtte van Laack

As previously reported here, on Dec. 8, 2010, FDA issued a proposed rule to amend the interim final rule (“IFR”) for the phytosterol health claim.  In the preamble to that proposal, the agency stated its intent to discontinue its policy of enforcement discretion that has been in effect since 2003, by February 22, 2011, and instead exercise enforcement discretion with respect to claims that comply with the proposed rule.  This change in exercise of enforcement discretion would cause dietary supplements containing unesterified phytosterols to no longer be eligible for the health claim.  Moreover, as a result of the stated change, many conventional foods would no longer be eligible for the health claim because the level of phytosterols in many of those foods is below 500 mg per serving, or because the phytosterol used has not been the subject of a GRAS notification to FDA. 

Not surprisingly, this announcement of a dramatic shift in enforcement discretion policy, which has been in effect for seven years, has created a stir in the industry.  On December 22, 2010, the Council for Responsible Nutrition (“CRN”) requested an extension of 18 months to allow dietary supplement companies to reformulate products or modify their labeling.  According to CRN, 18 months will be sufficient to complete reformulation and exhaust current inventory of dietary supplements containing free phytosterols.  An 18-month extension also would be consistent with FDA precedent providing food and dietary supplement companies with at least two years to come into compliance with labeling changes. 

More recently, Cargill, Inc. (“Cargill”) submitted a petition requesting a stay of the change in enforcement discretion until a final rule is issued.  According to Cargill, the sudden change in enforcement discretion would cause many phytosterol products (conventional foods as well as dietary supplements) to no longer be eligible for the phytosterol health claim.  Relabeling or reformulating these products by February 22, 2011, is not feasible.  Thus, a large number of conventional foods and the majority of phytosterol-containing dietary supplements would need to be pulled from the market.  Cargill estimates that relabeling or reformulating these products will take 16 to 34 months. 

As pointed out by Cargill, the change in enforcement discretion policy appears premature.  After all, the proposed rule is just that, a proposal.  It is likely that FDA will revise the proposed rule based on comments and information submitted in response to the notice of proposed rulemaking.  As a result, a company may find itself in the position of having to reformulate and relabel its products twice; first to come into compliance with the proposed rule, and then to come into compliance with the final rule.  Thus, rather than requesting an extension of time to bring its products into compliance with the proposed rule, Cargill requests a stay until the rule is final.