FDA Extends Time Period to Change Phytosterol Products

February 22, 2011

Manufacturers of phytosterol products now have 12 months to reformulate products and labels for heart health claims.

Back on December 8, 2010, FDA said it would give companies just 75 days to meet a lengthy list of new requirements for making heart health claims on products containing phytosterols. Now, FDA is offering breathing room with a 12-month extension of enforcement discretion for phytosterol products ending on February 12, 2012, rather than February 21, 2011.

In FDA’s December proposal, the agency drew out a list of several changes to its 2000 phytosterol heart health claim. The most notable change is an increase of the heath claim’s specified daily intake of phytosterols from 1.3 g of plant sterol esters to 2 g.

Among other edits, FDA also stated that, since people commonly consume three meals and one snack per day, products containing 0.5 g of phytosterol should be allowed to bear the claim based on a recommended, effective intake of four daily servings.

But don’t go ahead making all of these changes to your product formulations and labels just yet, says FDA.

“FDA is developing a final rule on this health claim and intends to publish it as expeditiously as possible,” the agency said in a February 17 statement. “The agency cautions manufacturers that the final rule may differ from the broadened criteria listed [in the interim ruling] and that manufacturers would then be required to change their labels to conform to the final rule.”

Nutritional Outlook will provide relevant information on FDA’s final rule on the phytosterol heart health claim as soon as it is made public.