CRN Sends FDA More Comments on Revised Phytosterol Rule

October 31, 2011

Moreover, the association argues, FDA’s proposed enforcement deadline of February 21, 2012, is “untenable” for supplement marketers, many of whom CRN contends would find it difficult to replace or reformulate current products in time.

In response to a proposed final rule for phytosterols usage issued by FDA in December 2010, the Council for Responsible Nutrition (CRN; Washington, DC) has submitted more comments to the agency arguing several points.

FDA’s 2010 proposed final rule suggests removing enforcement discretion it had instituted in 2003. With a final phytosterol rule still outstanding, the enforcement discretion established in 2003 in the meantime allowed a broad range of products, including dietary supplements, to use a health claim stating that plant sterol/stanols (at least 0.8 g/day divided over two daily doses and containing a sterol/stanol blend of a certain composition) reduce LDL and total cholesterol. (Prior to the enforcement discretion, FDA’s interim final rule, issued in 2000, only allowed the health claim for a narrow range of products-salad dressing, spreads, snack bars, and soft-gel dietary supplements.)

In its letter, CRN argues that in FDA’s 2010 proposed final rule, FDA’s abrupt proposal to end the enforcement discretion allowing the cholesterol claim for free phytosterol products may be based on insufficient science: “We tentatively conclude that the available evidence is insufficient to establish what factors are key in predicting which nonesterified phytosterol formulations will be effective and which will not be when consumed as ingredients in dietary supplements.”

“In fact, the majority of phytosterol supplements contain phytosterols in free form, due to technical limitations associated with formulation of phytosterol esters into dietary supplements in tablet/capsule form,” CRN’s letter states.

Moreover, the association argues, FDA’s proposed enforcement deadline of February 21, 2012, is “untenable” for supplement marketers, many of whom CRN contends would find it difficult to replace or reformulate current products in time. “Most in the dietary supplement industry will not be able to ship newly reformulated and/or relabeled product in time to coincide with planogram [retail] changes scheduled to occur before the current February 22, 2012, termination of enforcement discretion…,” CRN stated. “This abrupt change will cause many companies to be faced with costly returns from retailers. And all this must occur while industry awaits FDA’s evaluation of comments on the ‘tentative conclusions’ that underpin the newly proposed rule.”

CRN had sent FDA previous comments on the matter. These new comments were sent after FDA extended its comment period.