By Riëtte van Laack –
On April 10, 2017, the American Bakers Association (ABA) submitted a Citizen Petition and a Petition for Stay of Action on FDA’s new definition of dietary fiber in 21 C.F.R. § 101.9(c)(6)(i), and the accompanying recordkeeping requirement in 21 C.F.R. § 101.9(g)(10) and (11).
By way of background, FDA’s final rule issued in May 2016 defined dietary fiber as:
non-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units), and lignin that are intrinsic and intact in plants; isolated or synthetic nondigestible carbohydrates (with 3 or more monomeric units) determined by FDA to have physiological effects that are beneficial to human health.
FDA identified “[beta]-glucan soluble fiber (as described in § 101.81(c)(2)(ii)(A)), psyllium husk (as described in § 101.81(c)(2)(ii)(A)(6))[sic], cellulose, guar gum, pectin, locust bean gum, and hydroxypropylmethylcellulose” as isolated or synthetic non-digestible carbohydrate(s) that have physiological effects that are beneficial to human health. Therefore, these non-digestible carbohydrates qualified as dietary fiber. The Agency indicated that it did not have sufficient evidence for a beneficial physiological effect for a number of other non-digestible carbohydrates. The Agency set a compliance date of July 26, 2018 for companies with more than $10 million in annual sales.
In the months following the issuance of the final regulation, a number of companies submitted Citizen Petitions to amend the dietary fiber definition to include additional non-digestible carbohydrates. See, e.g., Docket No. FDA-2016-P-3620; Docket No. FDA-2016-P-1674; and Docket No. FDA-2016-P-2736. In addition, General Mills submitted a Citizen Petition requesting that FDA extend the compliance date to allow for the required rule making and label revisions (or reformulation of products) for products containing dietary fiber.
It was not until November 2016 that FDA issued a Draft Guidance on the type and amount of scientific evidence fiber petitions would need to include before FDA would review whether an “isolated or synthetic” fiber met the definition of dietary fiber. The Agency also published a summary of the scientific and clinical data for non-digestible carbohydrates for which FDA had not been able to reach a conclusion in the final regulation. After an extension, the comment period for these two documents closed on February 13, 2017.
Since then, FDA has issued several interim responses to the Citizen Petitions advising Petitioners that it has “not been able to reach a decision on [the] petition[s] because of other agency priorities and the limited availability of resources.” These responses have raised serious concerns and uncertainty about the path forward given the imminent compliance date and the time needed to finalize the guidance, review the Citizen Petitions, and complete the notice and comment rulemaking required to amend the definition of dietary fiber. It thus comes as no surprise that the agency has been formally asked to hit the brakes.
The ABA Citizen Petition asks that FDA revoke the new definition of dietary fiber and reinstate the previous “chemical definition.” In the alternative, if FDA does not revoke the definition, ABA asks that FDA revise (and correct) the definition. In any case, while considering such revisions, ABA asks that FDA immediately stay the new definition.
The 29-page Petition posits a number of grounds as to why FDA should take the requested action including 1) FDA’s lack of authority to establish a physiological-based definition for dietary fiber (or any other nutrient); 2) the unjustified application of a different standard for intrinsic and intact fiber (which is presumed to have a beneficial physiological effect) vs isolated or synthetic fiber; 3) FDA’s failure to clearly define dietary fiber which violates the Administrative Procedure Act; and 4) the various errors in the definition of new dietary fiber (e.g., psyllium husk is not an isolated or synthetic fiber). In addition, in a 17-page Appendix to the Petition, Petitioners provide a detailed analysis of FDA’s limited authority to access and inspect records of food manufacturers, and argue that FDA does not have legal authority to establish the records access requirement for dietary fiber.
The Petition is limited to dietary fiber definition but some of the arguments, such as the issue of FDA’s (lack of) authority to access records, would appear to apply also to other aspects of the amended regulation (e.g., labeling of added sugars).
Meanwhile, some in the industry have sought to delay the compliance date of the rule to coincide with the compliance date of the yet to be developed regulations for GMO labeling. Also, FDA’s draft guidance “Questions and Answers on the Nutrition and Supplement Facts Labels Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals” appears to have raised additional questions concerning other aspects of the new regulation (see here).
All in all, it appears that there is great uncertainty within the industry as to how to comply with the new regulations and a need for more time. Additional actions seem likely.