Citizen Petition Filed Under FDC Act § 301(ll) Takes Aim at Stevia Sweeteners

A citizen petition has been submitted to FDA asking the agency to take regulatory action under § 301(ll) against any foods to which sweetening compounds present in the botanical Stevia rebaudiana have been added, on the ground that those compounds (known as steviol glycosides) are drugs.  The petition asks FDA to seize foods to which steviol glycosides have been added, enjoin the distribution of such foods, and refuse importation of such foods.  The petition further asks FDA to “abstain from issuing a letter of no objection to any pending GRAS notification that addresses any use of a steviol glycoside in food.”  A GRAS notification is a voluntary submission that informs FDA of the notifier’s conclusion that the proposed use of a substance in food is generally recognized as safe (GRAS).  If the use of a substance is GRAS, then it is not subject to premarket approval as a food additive.

Two GRAS notifications for steviol glycosides currently are pending at FDA, and there was some expectation within the food industry that the agency might respond to those notifications as early as November.  Issuance of a letter of no objection by FDA is not required prior to marketing a substance for a GRAS use, but FDA had previously raised a number of questions about the safety of the use of steviol glycosides as sweeteners.  In light of those safety concerns, major food companies have deferred market entry until such time as FDA issues letters of no objection to the pending GRAS notifications.  The petition asserts that issuance of those letters “would effectively sanction a violation of law.”

As we have discussed in a number of previous blog posts, § 301(ll) prohibits the marketing of any food to which has been added an approved drug, a licensed biologic, or a drug or biologic for which substantial clinical investigations have been instituted and their existence made public.  The petition contends that the § 301(ll) prohibition applies to steviol glycosides because they are drugs for which substantial clinical investigations have been instituted and made public: clinical investigations focusing on the effect of steviol glycosides on hypertension have been published in peer-reviewed journals.  Although § 301(ll) provides a number of exceptions, most notably a first-to-market exception for drugs that are first marketed in food, the petition argues that none of those exceptions apply to steviol glycosides.

By Diane B. McColl & Ricardo Carvajal