Soy Lecithin Labeling

An estimated 0.2% of children and adults in the United States are allergic to soy. Although it appears to affect fewer consumers than other food allergens, soy is recognized by the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) as one of the eight most common food allergens. As such, under FALCPA, and in compliance with section 403(w) of FD&C Act, 21 U.S.C. 343(i), a food containing soy must be labeled as such.

Prior to FALCPA, soy lecithin often was not declared on labels, as it is an ingredient generally used in insignificant amounts, with no technical or functional effect in the finished food. However, in accordance with FALCPA, and in recognition that "even low levels of soy protein may cause adverse effects in some sensitive individuals," FDA recently issued a guidance for industry on the Labeling of Certain Uses of Lecithin Derived from Soy; namely, the use of soy lecithin as a release agent.

The guidance reads, in part: For a period of 18 months, "FDA intends to consider the exercise of enforcement discretion for a food labeled on or after Jan. 1, 2006, for which lecithin derived from soy is used solely as a component of a release agent and the label for such food does not declare the presence of the lecithin consistent with the requirements of section 403(w)."

To view the complete document, log on to www.cfsam.fda.gov/~dms/soyguid.html