FDA yanks soy lecithin labeling exemption without warning – very poor form

Without warning to industry, the Food and Drug Administration’s (“FDA”) withdrew their May 2, 2006 guidance document entitled “Guidance on the Labeling of Certain Uses of Lecithin Derived From Soy Under Section 403(w) of the Federal Food, Drug, and Cosmetic Act” (the “2006 Guidance”), in essence yanking six years of precedent and labeling practices with respect to labeling soy lecithin as an allergen.

As background, the 2006 Guidance had announced that FDA had chosen to exercise its enforcement discretion with regards to food labeled on or after  January 1, 2006, in which lecithin derived from soy was used solely as a component of a release agent and the label for such food did not declare the presence of soy as required under the Food, Drug and Cosmetic Act (“FDCA”).  On February 25, 2013, at 78 FR 12761, FDA published a notice of withdrawal, entitled “Guidance for Industry: Guidance on the Labeling of Certain Uses of Lecithin Derived From Soy Under Section 403(w) of the Federal Food, Drug, and Cosmetic Act; Withdrawal of Guidance” (the “Withdrawal”) that indicates that FDA is withdrawing its enforcement discretion as outlined in the 2006 Guidance due to its belief that “… there has been sufficient time for all manufacturers of foods that use lecithin derived from soy as a component of a release agent to revise the labels for such foods to be consistent with the requirements of [the regulations].. . .” and that FDA “. . . no longer believe[s] it is appropriate to consider the exercise of . . . enforcement discretion with regard to foods that use lecithin derived from soy as a component of a release agent . . .”

The FDA provided virtually no advanced warning to the withdrawal.  There are questions as to whether FDA complied with its internal policies in issuing this withdrawal.   In addition, the experts we have spoken with believe there is no health concern with this use of soy lecithin.   FDA’s action, if it stands, will require allergen labeling for food products processed using soy lecithin as a release agent.

The agency’s decision to withdraw the guidance may be grounded in some unknown health issue.  However, the fact that we have no clear understanding of the agency’s underlying reasoning and no warning is just bad form on the part of the agency.

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