FDA Gives 18-Month Reprieve On Allergen Labeling For Soy Lecithin

Date: Jun 01, 2006

Soy is one of eight allergens that must be identified on food labels per the Food Allergen Labeling and Consumer Protection Act (FALCPA).

Many food processors commonly use soy lecithin to facilitate food release from food-contact surfaces. However, the law does not establish any thresholds for labeling and the Food and Drug Administration has not otherwise provided guidance. So food companies have been left in a quandary on how to account for components of packaging and other food-contact materials that are derived from soy lecithin.

For the next 18 months, food processors may get a break from the FDA in this area. In a recent guidance document on the FALCPA, the agency announced that it will exercise enforcement discretion with respect to allergen labeling requirements for soy as they relate to the use of soy lecithin.

For the first time, FDA addresses problems in this guidance document that arise from the intentional, albeit minor, use of materials that require labeling under the Act. (see www.cfsan.fda.gov/~dms/soyguid.html). The agency justifies this stance based on the public health impact of various allergens. It cites the breadth of FALCPA's impact, the range of risks to consumers and the resources required to submit a notification/petition as reasons for the prioritization approach.

FDA will not charge anyone for not labeling for at least the next 18 months, provided certain conditions are met (see below).

Requirements and exemptions

FALCPA, which went into effect on Jan. 1, 2006, requires complete and clear labeling of foods that contain the eight most common food allergens (milk; eggs; fish; crustacean shellfish; tree nuts; wheat; peanuts; and soybeans) or ingredients with intact protein that are derived from them.

The law specifically provides that, among other things, "incidental additives" (that is, additives that have no technical or functional effect in the finished food product) that bear, contain or are derived from a major food allergen also must adhere to the new labeling requirements.

If parties can show that, although the food ingredient contains allergenic protein, it does not cause an allergic response that poses a risk to human health, the law permits them to (1) petition FDA for an exemption to the labeling requirements, or (2) file a notification instead of a petition.

When soy lecithin is applied directly to the food-contact surface and not incorporated into the food for such purpose, FDA's guidance suggests that allergen labeling for the food product is not necessary, provided that several criteria are met. The criteria include the following:

  • The soy lecithin must meet the specifications in the Food Chemicals Codex, 5th Edition.
  • The soy lecithin must be used solely as a component of a release agent.
  • The release agent must be used at the lowest level possible consistent with GMP.

The FDA will reconsider this enforcement discretion in 18 months. After that, the agency will expect food manufacturers that use soy lecithin as a component of a release agent to follow the allergen labeling law...unless FDA decides to grant another reprieve.

Whether the agency will exercise such discretion for the use of other incidental additives, including those commonly found in packaging and food-contact materials, is yet to be seen.

Used with permission. Copyright FOOD & DRUG PACKAGING, June, 2006.

For further information about this article, please contact George G. Misko at 202-434-4170 or by email at misko@khlaw.com.