NAFFS Newswire - July 14, 2005
FDA Report on Food Allergens; Soy Supports Weight Loss; National Organic Program Update; Caffeine Can Help Athletes; and more.
FDA ISSUES DRAFT REPORT
ON FOOD ALLERGENS FDA has announced the availability of a draft report entitled, “Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food.” The draft report is available on FDA’s website at www.cfsan.fda.gov/~dms/alrgn.html. FDA will be accepting comments and scientific data until August 16.
The draft report, which was prepared by an interdisciplinary group of scientists from FDA's Center for Food Safety and Applied Nutrition (CFSAN), is intended to facilitate the further development of CFSAN's policy for food allergens, particularly CFSAN’s implementation of the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA).
The draft report of the Threshold Working Group provides a summary of the current state of scientific knowledge on food allergens and celiac disease, as well as concepts and data necessary for the evaluation of various approaches for establishing scientifically sound thresholds. While the amount of protein needed to provoke an allergic response varies, there is a general scientific consensus that exposure to protein below a certain level is unlikely to elicit an allergic response in most food allergic individuals. The idea of an allergenic protein “threshold,” while not clearly defined, is frequently used to describe the lowest level of protein from an allergenic food that will elicit a response in a sensitive individual.
While FALCPA requires that the term “gluten-free” be defined for use on food labels, it neither describes how gluten-free should be defined nor states whether there is a safe level of gluten. The draft report evaluates the available data to support various approaches for establishing a threshold for gluten. Such a threshold, if established, would be the basis for decisions on whether to use the term “gluten-free” on product labels. The draft report discusses several approaches for establishing thresholds, but it does not establish or propose any thresholds for food allergens at this time.
The Threshold Working Group identified four general approaches that could be used to establish thresholds for allergens and glutens:
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Analytical methods-based approach: Determines thresholds by the sensitivity of the analytical method(s) used to verify compliance.
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Safety assessment-based approach: Calculates a “safe” level of allergenic protein using the No Observed Adverse Effect Level (NOAEL) from available human challenge studies and an appropriate Uncertainty Factor applied to account for knowledge gaps.
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Risk assessment-based approach: Examines known or potential adverse heath effects resulting from human exposure to a hazard; quantifies the levels of risk associated with specific exposures and the degree of uncertainty inherent in the risk estimate.
- Statutorily-derived approach: Uses an exemption articulated in an applicable law and extrapolates from that to other potentially similar situations.
General criteria for all four approaches are feasibility, data availability, and data quality; the degree of uncertainty in relevant data is a key consideration in determining which approach to use.
The Threshold Working Group made the following five general findings with respect to major food allergens and the approaches for establishing thresholds: -
The initial approach selected to establish thresholds for major food allergens, the threshold values, and any uncertainty factors used in establishing the threshold values should be reviewed and reconsidered periodically in light of new scientific knowledge and clinical findings.
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The analytical methods-based approach can be used to establish thresholds for those major food allergens for which validated analytical methods are available. However, if this approach is used, the thresholds should be replaced by thresholds established using one of the other approaches as quickly as possible.
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The safety assessment-based approach, based on currently available clinical data, is a viable way to establish thresholds for the major food allergens. If this approach is employed, the Lowest Observed Adverse Effect Level (LOAEL) or No Observed Adverse Effect Level (NOAEL) determinations used should be based on evidence of the "initial objective symptom." Individual thresholds should be established for each of the major food allergens. If it is not feasible to establish individual thresholds, a single threshold based on the most potent food allergens should be established. In those instances where a LOAEL is used rather than a NOAEL to establish a threshold, an appropriate uncertainty factor should be used.
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Of the four approaches described, the quantitative risk assessment-based approach provides the strongest, most transparent scientific analyses to establish thresholds for the major food allergens. However, this approach has only recently been applied to food allergens and the currently available data are not sufficient to meet the requirements of this approach. A research program should be initiated to develop applicable risk assessment tools and to acquire and evaluate the clinical and epidemiological data needed to support the quantitative risk assessment-based approach. Thresholds established using this approach should be reevaluated periodically as new data and tools become available.
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The statutorily-derived approach provides a mechanism for establishing thresholds for allergenic proteins in foods based on a statutory exemption. Potentially, this approach could be used to set a single threshold level for proteins derived from any of the major food allergens. This approach might yield thresholds that are unnecessarily protective of public health as compared with thresholds established using the safety assessment-based approach. However, confirming this would require additional data. If this approach is employed to establish thresholds, it should be used only on an interim basis and should be reevaluated as new knowledge, data, and risk assessment tools become available.
The Threshold Working Group made the following five general findings with respect to gluten in foods and the approaches for establishing thresholds: -
The initial approach selected to establish a threshold for gluten, the threshold value selected, and any uncertainty factors used to establish the threshold should be reviewed and reconsidered periodically in light of new scientific knowledge and clinical findings.
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The analytical methods-based approach can be used to establish a threshold for gluten. However, if this approach is used, the threshold should be replaced by a threshold established using one of the other approaches as quickly as possible.
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The safety assessment-based approach is a viable approach to establish a threshold for gluten using currently available LOAEL data for celiac disease. An overall uncertainty factor should be estimated from the data and applied to the LOAEL to establish a threshold for gluten. Any threshold derived from this approach should be reevaluated as new research data become available. Available data are insufficient at the current time to use this approach to establish a threshold for oat gluten for those individuals with celiac disease who are also sensitive to oats. However, it is likely that a threshold based on wheat gluten would be protective for individuals susceptible to oat gluten.
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Use of the quantitative risk assessment-based approach to establish a threshold for gluten does not appear to be feasible at the present time. However, considering the benefits that could be gained from using the risk assessment-based approach, priority should be given to establishing a research program to acquire the knowledge and data needed.
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There appears to be no suitable legal requirements or exemptions that would serve as the rationale for a statutorily-derived approach to establish a threshold for gluten. This approach is not viable.
STUDY SHOWS SOY
SUPPORTS WEIGHT LOSS While most Americans think of soy as a healthy food, a recent study showed soy is also effective in adult weight loss. University of Kentucky physician and researcher Dr. James Anderson tested two commercially available meal replacements – one soy-based and one milk-based – in a group of obese adults for 12 weeks. Although both groups lost weight, the soy-based group lost slightly more weight in any given week and displayed lower serum cholesterol levels. Soy intake also produced small but significant reductions in serum glucose values. This evidence suggests soy may be a valuable tool in maintaining overall health, lowering cholesterol and even slowing the development of diabetes. NATIONAL ORGANIC PROGRAM
UPDATE USDA’s Agricultural Marketing Service published a notice in the Federal Register regarding the consent final judgment and order issued by the U.S. District Court in Maine in the case Harvey v. Johanns. The court issued a declaratory judgment that 7 CFR 205.606 shall be interpreted to permit the use of a non-organically produced agricultural product only when the product has been listed in section 205.606 pursuant to National List procedures and when an accredited certifying agent has determined the organic form of the agricultural product is not commercially available. The court's order limits an accredited certifying agent's commercially available determinations for nonorganic agricultural products used in or on processed organic products to the 5 substances contained in 7 CFR 205.606. The products are native cornstarch, water-extracted gums, kelp when used as a thickener and dietary supplement, unbleached lecithin, and high methoxy pectin.
The judgment states 7 CFR 205.606 shall not be interpreted to grant a blanket exemption for certifying agents and their clients to determine the commercial unavailability of nonorganic agricultural substances. It further stated that 7 CFR 205.606 shall be interpreted to permit the use of a nonorganically produced agricultural product only when the product has been listed in section 205.606 pursuant to the National List procedures and when an accredited certifying agent has determined that the organic form of the agricultural product is not commercially available. RESEARCHERS SAY CAFFEINE
CAN HELP ATHLETES Caffeine can help athletes by boosting the body's absorption of carbohydrates, according to scientists at the University of Birmingham. A study conducted by researchers at the university's School of Sport and Exercise Sciences revealed that introducing caffeine into sports drinks increases the absorption rate of carbohydrates by 26 percent.
In the study, a group of eight cyclists took part in three two-hour exercise sessions. For each of the three trials, the cyclists took one of three different sports drinks - glucose, glucose mixed with caffeine and water. The research showed that caffeine increased the amount of carbohydrates absorbed from the sports drink.
Dr. Asker Jeukendrup, director of the university’s Human Performance Lab, said the results do not prove that caffeine is a performance-enhancing substance, but simply show how caffeine affects the body's carbohydrates. Be sure to register for NAFFS’ 88th Annual Convention October 27-30 in Longboat Key, Fla. Registration materials with complete details have been mailed. You may also register at www.naffs.org.
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