DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
College Park, MD 20740
Director, Regulatory Affairs
4300 Duncan Avenue
St. Louis, MO 63110
Re: Food Allergen Labeling Petition 003 – Solae’s Soy Lecithin
Dear Mr. Holt:
This letter is in response to a petition from Solae LLC (Solae), received on June 14, 2007, and designated FALP 003. Solae provided an amended petition on April 14, 2008, and additional information supporting its petition on February 17, 2011. The petition was filed pursuant to section 403(w)(6) of the Federal Food, Drug and Cosmetics Act (the FD&C Act) (21 U.S.C. 343(w)(6)). Section 403(w)(6) of the FD&C Act states that “Any person may petition the Secretary to exempt a food ingredient described in section 201(qq)(2) [of the FD&C Act] from the allergen labeling requirements of this subsection.” This section also states that the “burden shall be on the petitioner to provide scientific evidence (including the analytical method used to produce the evidence) that demonstrates that such food ingredient, as derived by the method specified in the petition, does not cause an allergic response that poses a risk to human health.”
The petition informs the Food and Drug Administration (FDA) of Solae’s view that specific uses of certain soy lecithin products should be exempt from the food allergen labeling requirements under section 403(w) of the FD&C Act. The products identified in FALP 003, as amended, are SOLEC™ E, SOLEC™ F, SOLEC™ NVS, SOLEC™ 152, SOLEC™ K-EML, SOLEC™ HR, and SOLEC™ M. The petitioned uses of Solae’s soy lecithin products include use as release agents when applied to food contact surfaces, use as release agents when incorporated into product formulations, and use as dust control agents when incorporated in powdered product formulations.
The petition describes the manufacturing process for the soy lecithin products that are the subject of the petition. Additionally, the petition provides an estimate of the protein content of the petitioner’s soy lecithin products as hexane insoluble matter (HI), and provides data and statistical analysis regarding the HI content of multiple batches of each of the soy lecithin products obtained over an extended period.
The petition also discusses the scientific literature on the incidence of soy allergy in the population. Further, the petition discusses the scientific literature on the relative sensitivity and clinical reactivity of soy allergic individuals compared to other food allergic individuals, stating that the scientific literature indicates that the dose of soy protein required to elicit an allergic response appears to be greater than for other known food allergens.
Finally, the petition provides exposure estimates based on example food uses of its soy lecithin products, estimated usage rates for those foods, and estimated consumption of those food examples.
At this time, no public health agency has completed a risk assessment to identify food allergen regulatory thresholds that could be compared to exposure estimates for the specified applications of the soy lecithin products that are the subject of the petition. Therefore, FDA evaluated the data in the petition using a safety assessment-based approach as described in the report “Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food” (FDA, 2006). As described in that document, the safety assessment-based approach uses data from the scientific literature to determine Lowest Observed Adverse Effect Levels (LOAEL) and No Observed Adverse Effect Levels (NOAEL) for allergic consumers, additional data to estimate consumer exposure, and then applies appropriate uncertainty factors to determine whether the estimated exposures could cause an allergic response that poses a risk to human health.
FDA evaluated the literature cited in the petition on the distribution of clinical sensitivity in the soy allergic population. FDA also conducted an independent literature review to ensure that there are no additional published studies that should be considered. FDA determined the NOAEL and LOAEL for soy protein consumption that was indicated by the data contained in the cited studies, as well as appropriate uncertainty factors to be used with the NOAEL and LOAEL, to calculate an assessment dose level for evaluating whether a particular exposure the petitioner’s soy lecithin products would cause an allergic response that poses a risk to human health. FDA then evaluated the estimated levels of exposure to soy protein that would result from consumption of the food products that typically use the petitioner’s soy lecithin products. These exposure estimates used the information provided in the petition on the estimated levels of usage of the soy lecithin products for the specified applications, as well as information on consumption levels for the food products described in the petition. Finally, FDA compared the estimated exposure to soy protein from the petitioner’s soy lecithin products to the assessment dose level that FDA calculated to evaluate whether a particular exposure to the petitioner’s soy lecithin would cause an allergic response that poses a risk to human health. FDA did not consider an exposure below the assessment dose level to cause an allergic response that poses a risk to human health.
Based on this review, FDA concludes that the scientific evidence available at this time demonstrates that each of the Solae soy lecithin products (SOLEC™ E, SOLEC™ F, SOLEC™ NVS, SOLEC™ 152, SOLEC™ K-EML, SOLEC™ HR, and SOLEC™ M), as derived by the method specified in the petition, will not cause an allergic response that poses a risk to human health within the meaning of section 403(w)(6) of the FD&C Act when used as a release agent applied to food contact surfaces. Additionally, based on the scientific evidence available at this time, FDA cannot conclude at this time that the Solae soy lecithin products (SOLEC™ E, SOLEC™ F, SOLEC™ NVS, SOLEC™ 152, SOLEC™ K-EML, SOLEC™ HR, and SOLEC™ M), as derived by the method specified in the petition, will not cause an allergic response that poses a risk to human health within the meaning of section 403(w)(6) of the FD&C Act when incorporated into product formulations for use as release agents or dust control agents.
FDA has carefully considered the potential environmental effects of this action. FDA has concluded that the action will not have a significant impact on the human environment, and that an environmental impact statement is not required.
Dennis M. Keefe, Ph.D.
Office of Food Additive Safety
Center for Food Safety
and Applied Nutrition