FDA Extends Enforcement Discretion Period for Phytosterol Claims

March 2, 2012

The agency said current rules for phytosterol-fortified products remain effective until publication of a final rule.

FDA says it will extend the enforcement discretion period for phytosterol-and-heart-disease claims until publication of a final rule.

In September 2000, FDA issued an interim final rule allowing a claim of reduced risk of coronary heart disease (CHD) for eligible products fortified with phytosterols. Since then, parties have petitioned for more eligible products, eligible phytosterols, and eligible phytosterol forms, and the FDA has even increased the required usage levels for phytosterols (0.5 g per RACC) in products bearing the claim. For years, all of this has been subject to an enforcement discretion period during which time manufacturers have been allowed to market a variety of products so long as the products meet basic requirements for the health claim.

Most recently, the enforcement discretion period was set to expire on February 21, 2012. Products marketed after this date would have to meet all new changes to bear the heart health claim.

But FDA still hasn’t established a final rule.

Citing new phytosterol data and “other public health priorities,” FDA stated on February 21, 2012 that it would again extend its enforcement discretion period until the publication of a final rule. The announcement was made official in a publication of the Federal Register (see link above).