The Council for Responsible Nutrition (CRN), Washington, D.C., has submitted comments to FDA regarding the agency’s proposal to amend the regulation authorizing a health claim on the relationship between phytosterols and reduced risk of coronary heart disease (CHD).

CRN opposes the agency’s discontinuation of its 8-year-old policy of enforcement discretion allowing use of the CHD health claim on the label of dietary supplements containing phytosterols in free form.

“The sudden termination of enforcement discretion based on tentative Agency conclusions disrupts well-founded industry expectations based on the express terms of the original 2003 enforcement discretion letters and fails to take into account the logistical difficulties and associated time involved in launching reformulated and/or relabeled dietary supplements that conform to the Agency’s newly announced proposed criteria.”

“The Agency’s announcement fails to acknowledge, much less justify, the disparate standards applied to dietary supplements and conventional foods. For these reasons, the termination of enforcement discretion is arbitrary and capricious agency action that cannot stand. To address these concerns, CRN requests that FDA continue to exercise enforcement discretion in accordance with the 2003 letters until the effective date of the final rule, or, at a minimum, until the next uniform compliance date for food of January 1, 2014.”

FDA’s decision effectively bans the CHD claim on dietary supplements containing free form phytosterols, and according to CRN, “imposes different standards on the dietary supplement and conventional food industries … FDA has an absolute obligation to apply its regulatory standards even-handedly among all similarly situated firms.”

“Second, courts have long held that agency action based on change in settled policy is arbitrary and capricious unless the agency formally announces the change in policy and supplies a reasoned explanation for the change of course.”

“CRN believes the following actions can help mitigate the infirmities and potentially irreparable damage associated with the current approach and allow for an orderly transition to dietary supplements labeled and formulated in accordance with the criteria that are established for the CHD health claim when 21 C.F.R. § 101.83 is made final. The optimal approach—and the only approach that is consistent with the procedural and due process requirements of the Administrative Procedure Act on the Agency’s exercise of enforcement discretion—is for the Agency to announce an extension of the time during which it will continue to exercise enforcement discretion under the 2003 letters until such time as the CHD final rule becomes effective. Extending enforcement discretion under the 2003 letters in this manner would allow companies to make changes to their products in an orderly fashion in a manner that coincides with retailer planogram changes, minimizing product discontinuations and costly returns. Equally important, companies would be assured that only one reformulation and label change will be required, minimizing costs and marketplace disruptions associated with successive changes.

“We note that the Agency has allowed product labeled before the effective date of a label change to be sold through after that date. CRN requests that the Agency clarify that it intends to continue this practice with respect to the lifting of enforcement discretion. Specifically, if the Agency declines to change the February 21, 2012 date, the Agency should clarify that enforcement discretion will extend to products labeled prior to that date, even if shipped after that date. This clarification is essential to enable affected companies to manage inventory in a reasonable manner that avoids costly returns, destruction of printed labels, and market interruptions associated with the inability to launch reformulated/relabeled product in advance of this date.”