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 manufactures have been allowed to go off of initial phytosterol requirements without penalty.
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.
Read more about FDA’s extension of the enforcement period for phytosterol-and-heart-disease claims until publication of a final rule at Nutritional Outlook.com