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CFSAN/Office of Food Additive Safety
April 2006
Comments and suggestionsregarding this document may be submitted at any time. Submit comments toDivision of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with thedocket number listed in the notice of availability that publishes in theFederal Register.
For questions regarding this document contactPaul M. Kuznesof, Ph.D., at the Center for Food Safety and Applied Nutrition(CFSAN) at 301-436-1289 or at .
Additional copies are available from:
Office of Food Additive Safety (HFS-205)
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
Issued April 2006
This guidance represents thecurrent thinking of the Food and Drug Administration on this topic. It doesnot create or confer any rights for or on any person and does not operate tobind FDA or the public. An alternative approach may be used if such approachsatisfies the requirements of the applicable statute and regulations. If youwish to discuss an alternative approach, contact the FDA staff responsible forimplementing this guidance. If you cannot identify the appropriate FDA staff,call the telephone number listed on the title page of this document.
The purpose of this document is toprovide guidance on the labeling, under section 403(w) of the Federal Food,Drug, and Cosmetic Act (the Act), 21 U.S.C. 343(w), of certain uses in food oflecithin derived from soy.(1) In particular, as discussed in more detail below, FDA intends to consider theexercise of enforcement discretion for a food labeled on or after January 1,2006, for which lecithin derived from soy is used solely as a component of arelease agent(2)and the label for such food does not declare the presence of the lecithinconsistent with the requirements of section 403(w). FDA intends to considerexercising such discretion when each of the factors discussed in section IV ispresent.
FDA guidance documents do notestablish legally enforceable responsibilities. Instead, guidance documentsdescribe the agency's current thinking on a topic and should be viewed only asrecommendations, unless specific regulatory or statutory requirements arecited. The use of the word "should" in agency guidance documents means thatsomething is suggested or recommended, but not required.
Section 403(i) of the Act, 21 U.S.C. 343(i), requires that afood label bear the common or usual name of the food and, where fabricated fromtwo or more ingredients, the common or usual name of each ingredient of thefood, except that spices, flavorings, and certain colors are not required to beindividually declared.
The Food Allergen Labeling and Consumer Protection Act of2004 (FALCPA) imposes new labeling requirements on certain foods. If a food isnot a raw agricultural commodity and it is, or it contains an ingredient thatbears or contains a major food allergen, that food must comply both withsection 403(i) and section 403(w) of the Act, 21 U.S.C. 343(i), 343(w). Section 403(w)(1) requires that a food's label reveal the name of the foodsource from which the major food allergen is derived in a manner specified bythat section. This source declaration requirement is extended by section403(w)(4) to any incidental additive that is, or that bears or contains, amajor food allergen, notwithstanding the regulatory exemption for incidentaladditives in 21 CFR 101.100(a)(3).(3) The requirements of section 403(w) apply to foods labeled on or after January1, 2006.
Section 201(qq) of the Act, 21 U.S.C. 321(qq), defines"major food allergen" as any one of eight foods or food groups (milk, eggs,fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans) or aningredient that contains protein derived from one of the eight foods or foodgroups. The definition of "major food allergen" excludes any highly refinedoil derived from one of the eight foods or food groups, and any ingredientderived from such an oil, as well as any ingredient exempt under the petitionprocess specified in section 403(w)(6), 21 U.S.C. 343(w)(6), or thenotification process specified in section 403(w)(7), 21 U.S.C. 343(w)(7).(4)
FALCPA recognizes soy as one of the eight most common foodallergens. Although definitive studies assessing the prevalence of soy allergyare lacking, it is currently estimated that 0.2% of children and adults in the U.S. are allergic to soy.(5) Based on this estimate, soy allergy appears to be less prevalent than allergiesto other major food allergens.
As with most common food allergens, allergic reactions tosoy may result in life-threatening symptoms, such as anaphylaxis. Furthermore,even low levels of soy protein may cause adverse effects in some sensitiveindividuals. FDA considers an "adverse effect" to be any objective sign of anallergic reaction.(6) Currently, due to limited data, there is no consensus on the minimal dose ofsoy protein that will elicit an adverse effect (also referred to as the lowestobserved adverse effect level or LOAEL). At least some researchers havesuggested, however, that the LOAEL for soy protein appears to be higher thanthe LOAELs reported for other major allergens, such as milk, egg, andpeanuts.
Lecithin is a food ingredient that is derived from plantsources, including soy. Lecithin is isolated following hydration ofsolvent-extracted soy, sunflower, or corn oil. Lecithin is affirmed as generallyrecognized as safe (GRAS) with no limitation other than current goodmanufacturing practice. 21 CFR 184.1400.(7) Common food applications of lecithin include use as an emulsifier, astabilizer, a dispersing aid, and an incidental additive, such as a releaseagent for baked goods. Regardless of its food application, lecithin isgenerally used in small amounts, with the result that it is, according to onelecithin manufacturer, present in finished foods at levels rarely exceeding 1%by weight of the final food product.
During manufacture of lecithin derived from soy, most, butnot all, of the soy protein is removed. Soy allergens, to the extent they arepresent in lecithin, would be found in the protein fraction of the ingredient. Accurately measuring lecithin's protein content presents challenges to currentanalytical methodology due to the ingredient's oily matrix and low levels ofprotein. The GRAS affirmation regulation specifies that the ingredient meetthe specifications of the Food Chemicals Codex (FCC). The FCC monographstipulates that food grade lecithin contain not more than 0.3% hexane-insolublematter. Because the protein fraction of lecithin would reside in suchinsoluble material, this specification would limit the amount of protein in foodgrade lecithin to 0.3% or 300 mg/ 100 g lecithin. At least one major U.S. producer has stated that its manufacturing standard for lecithin derived from soy isset at 0.05% hexane-insoluble material or 50 mg/100g lecithin.
As noted, lecithin derived from soy contains very smallamounts of soy protein and it is generally used in small amounts, whether for afunctional or technical effect in the finished food or as an incidentaladditive. The proteins in soy lecithin have been found, in some cases, to besoy allergens, and there are a few case reports in the medical literature ofallergic reactions to lecithin derived from soy. However, allergy to lecithinderived from soy has been neither definitively established nor definitively negated by oral food challenge studies. Despite its widespread use in the food supply, FDA is aware of only a few allergen-related complaints about FDA-regulated productscontaining lecithin derived from soy.(8) Also, FDA is aware that some clinicians believe that foods containing lecithinderived from soy present little or no allergic risk to soy-sensitive consumers,and these physicians do not advise their soy allergic patients to avoidlecithin derived from soy.
Before the enactment of FALCPA, the declaration of lecithinderived from soy as a food ingredient was governed solely by 21 U.S.C. 343(i)and FDA's labeling regulations. Thus, when used as an ingredient that isintended to have a technical or functional effect in the finished food (forexample, as an emulsifier), the ingredient was required to be declared only byits common or usual name, "lecithin." As noted, under 21 CFR 101.100(a)(3), aningredient used in insignificant amounts with no technical or functional effectin the finished food (such as a release agent) is not required to be declaredon the label. Thus, food manufacturers using lecithin derived from soy as arelease agent may have concluded that they were not required to declarelecithin as an ingredient.
FALCPA has altered the way in which lecithin derived fromsoy must be declared on the food label. Whether intended to have a technicalor functional effect in the finished food or used as an incidental additive(such as a release agent), lecithin derived from soy must be declared as aningredient, using its common or usual name, and with the food source ("soy,""soya", or "soybeans") declared as required by section 403(w) of the Act.
FDA is committed to the full and prompt implementation ofFALCPA and enforcement of the new legal authority that it provides. As noted,FALCPA defines as major food allergens eight foods or food groups oringredients that contain protein derived from one of those eight, and requiresthat major food allergens be declared as set out in section 403(w) of the Act. Given the number of ingredients that meet the definition of a major food allergen,FALCPA will have an impact on an enormous number of food labels. It iswell-recognized that various ingredients that are major food allergens presenta range of risks to sensitive consumers. In light of the breadth of FALCPA'simpact on food labels, the range of risks to sensitive consumers presented byvarious major food allergens, and the resources required to implement certainFALCPA provisions (such as the notification and petition processes for labelingexemptions), FDA intends to establish implementation and enforcementpriorities. A major consideration in setting those priorities will be thepublic health impact of a particular implementation or enforcement effort.
FDA acknowledges the widespread use of soy lecithin as acomponent of release agents prior to FALCPA. Although there are no data thatestablish the exact exposure to soy protein that would result from this use,based on the information available to FDA at this time, it is apparent thatwhen lecithin derived from soy is used as a component of a release agent, thelevel of soy protein in the finished food is likely to be low. Also, theexposure to allergenic soy protein from such use would be expected to beconsiderably lower than exposures from other uses of soy lecithin or fromsoy-containing ingredients commonly used in food. This is due to the relativelylow level of soy protein in lecithin derived from soy and the low level of useof the ingredient (lecithin derived from soy) when used as a component of arelease agent. In addition, when a substance is used as an incidentaladditive, the level of the substance in the food can be expected to be low.(9)
There is currently no consensus on the minimal dose of soyprotein that will elicit an adverse effect in sensitive consumers. At leastsome researchers have suggested, however, that the LOAEL for soy proteinappears to be higher than the LOAELs reported for other major allergens, suchas milk, egg, and peanuts. Absent a consensus on a LOAEL for soy protein andon levels of exposure to soy protein from the use of lecithin derived from soyas a component of a release agent, it is not possible to state unequivocallythe risk, if any, that there may be to soy-allergic persons who consume foodsfor which lecithin derived from soy has been used as a component of a releaseagent. However, based on the foregoing, it appears that this risk is lowcompared to the aggregate risk to soy-sensitive individuals presented by theuse of other ingredients containing soy protein, as well as the aggregate risk to allergic persons with non-soy sensitivities presented by ingredients that are,or contain protein derived from, one of the other major food allergens.
Consistent with the need to establish its enforcementpriorities, FDA intends to consider the exercise of enforcement discretion fora food labeled on or after January 1, 2006, in which lecithin derived from soyis used as a component of a release agent and the label for such food does notdeclare the presence of lecithin consistent with the requirements of section403(w) of the Act. The agency's intent to exercise its enforcement discretionfor a limited period for the foregoing use of lecithin will help FDA to applyits increasingly limited resources to efforts associated with implementationand enforcement of FALCPA that are expected to have a more acute public healthimpact.
The agency intends to reconsider its enforcement prioritieswith regard to the labeling of lecithin derived from soy used as a component ofa release agent approximately 18 months after the issuance of this guidance. The agency expects that, during the period in which FDA intends to consider theexercise of its enforcement discretion as described above, manufacturers offoods that use lecithin derived from soy as a component of a release agent willrevise as necessary the labels of their relevant food products to comply withFALCPA and begin to label their products using the FALCPA-compliant labels bythe end of the enforcement discretion period.
FDA intends to consider exercising such discretion when all of the following factors are present:
The agency emphasizes that this guidance does not apply ifthe lecithin derived from soy used as a component of a release agent does notcomply with the Food Chemicals Codex specifications or if the lecithin derivedfrom soy is used other than as a component of a release agent as described inthis guidance.
(1)FDA has previously advised food manufacturers that the names "soy," "soya," and"soybeans" are all acceptable names for this legume. http://www.cfsan.fda.gov/~dms/alrguid.html. In this guidance document, FDA uses the term "soy."
(2) In this document, the term "release agent" refers to an agent used tofacilitate the release of foods (such as baked goods) from food contactsurfaces, such as conveyor belts, molds, extrusion equipment, and baking pans,where the agent has been applied directly to the food contact surface, ratherthan incorporated into the food for such purpose.
(3)21 CFR 101.100(a)(3) exempts from the ingredient declaration requirement anyincidental additive that is present in a food at insignificant levels and hasno functional or technical effect in the food.
(4)Under the petition process, an ingredient may be exempt if the petitionerdemonstrates that the ingredient does not cause an allergic response that posesa risk to human health. Under the notification process, an ingredient may be exempt if the notification contains scientific evidence that demonstrates that theingredient does not contain allergenic protein, or if FDA previously hasdetermined, under section 409 of the Act, that the food ingredient does notcause an allergic response that poses a risk to human health.
(5)[Draft] Report of the Threshold Working Group, Center for Food Safety andApplied Nutrition: Approaches to Establish Thresholds for Major Food Allergensand for Gluten in Food ([Draft] Threshold Report) at p. 11-12. See 70Fed. Reg. 35258 (June 17, 2005), andhttp://www.cfsan.fda.gov/~dms/alrgn.html.
(6) Draft Threshold Report at p. 51.
(7)The lecithin affirmed as GRAS may be bleached with hydrogen peroxide or benzoylperoxide. Also, enzyme-modified lecithin is affirmed as generally recognizedas safe for use as an emulsifier, 21 CFR 184.1063), and hydroxylated lecithinis an approved food additive for use as an emulsifier, 21 CFR 172.814.
(8) This information on the relatively low number of consumer complaints must, ofcourse, be considered in the current regulatory context in which processing aiduses of lecithin derived from soy are not uniformly declared on food labels. In the absence of such declaration, a food allergic consumer who experiences anadverse reaction to a food product may not associate that reaction with soybecause the label does not declare its presence in the food.
(9)FDA believes that at least some food manufacturers, relying on 21 CFR101.100(a)(3) prior to FALCPA's enactment, did not consistently identifylecithin derived from soy in a food's ingredient statement when the substancewas used as a component of a release agent. Thus, consumers, includingsoy-allergic consumers, were likely consuming these small amounts of lecithinderived from soy (with its low level of soy protein) when they consumed thesefoods.
(10)Foods labeled prior to January 1, 2006, are not required to comply withFALCPA's labeling requirements so FDA need not consider the exercise of suchdiscretion with respect to foods labeled before January 1, 2006.
(11)FDA encourages lecithin producers to reduce, to the extent possible, the levelof protein in their soy lecithin products and also encourages foodmanufacturers using lecithin derived from soy as a component of a release agentto reduce, to the extent possible, the level of soy lecithin in finished foods.
FDA/Center for Food Safety & Applied Nutrition
Hypertext updated bycjm May 4, 2006
