Regulatory Issues: Obesity Report In, Allergens Out
The Obesity Working Group Report confirms calories are what count when it comes to healthy eating.
By By Leslie Krasny, Contributing Editor | 03/01/2005
The FDA, concerned its policies on obesity had not been effective, created an Obesity Working Group (OWG) in 2003 to develop an action plan for consumers to lead healthier lives through better nutrition.
The final OWG report, released last spring, focused on a "calories count" approach, stating, “Although there is much discussion about 1) the appropriate makeup of the diet in terms of relative proportions of macronutrients (fats [lipids], carbohydrates, and protein) that provide calories and 2) the foods that provide these macronutrients, for maintenance of a healthy body weight it is the consumption and expenditure of calories that is most important."
In other words, "calories count." The FDA plans to issue an advance notice of proposed rulemaking seeking public comment on ways to give more prominence to calories on the food label, such as increasing the font size for calories, including a percent Daily Value (“%DV”) column for total calories, and eliminating the listing for calories from fat.
All federal dietary guidance for the general public must be consistent with The Dietary Guidelines for Americans, science-based advice to promote health and to reduce the risks of major chronic diseases through diet and physical activity. (See "Building a New Pyramid," October 2004.)
The guidelines, published jointly by the Dept. of Health and Human Services (HHS) and the Dept. of Agriculture (USDA), establish the foundation for government nutrition programs, including research, education, and labeling, and for government positions on international food standards and reports. The 2005 edition was just issued in January.
With respect to the obesity epidemic, the new guidelines state, "When it comes to body weight control, it is calories that count — not the proportions of fat, carbohydrates and protein in the diet" and recommend "the healthiest way to reduce calorie intake is to reduce one's intake of added sugars, fats, and alcohol, which all provide calories, but few or no essential nutrients."
However, the relationship among calories, nutrients and weight is complex and not well understood. In late December 2004, a review of the country's most popular diet programs, published in the Annals of Internal Medicine, concluded there is insufficient evidence to support many of the claims regarding weight loss and maintenance.
Recent scientific studies on hunger and satiety indicate creating simple dietary guidelines to assist the public in the area of weight control may present a challenge at this time. In addition to controversies about optimal proportions of macronutrients in the diet, and whether there is scientific justification for "net carb" claims, studies demonstrate the form of food may have an impact on hunger and thus affect weight gain independently of the number and source of calories.
For example, Richard Mattes, Ph.D., of Purdue University found the viscosity of energy-yielding beverages is inversely related to hunger in humans. Other data show test subjects may have difficulty adjusting for calories consumed in liquid form as compared with solid form, possibly leading to greater energy intake from beverages than from an equal caloric intake of solid food.
Clearly, increasing evidence points to dietary cues and product characteristics as playing key roles in regulating hunger and thereby helping to control weight. And studies in the promising field of nutrigenomics indicate nutrients can alter gene expression at the cellular level, potentially affecting metabolism in different ways depending on individual genotypes. For now, placing greater emphasis on the importance of calories, in dietary guidance and labeling should be an effective way to help combat obesity and promote sound dietary practices.
|Food Allergen Labeling|
The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) will become effective Jan. 1, 2006. FALCPA covers "major food allergens," which are defined as milk, eggs, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans or any ingredient that contains protein derived from any of those foods.
This does not include "highly refined oil" derived from a major allergen, an ingredient derived from highly refined oil, or an ingredient exempt from allergen labeling under the petition and notification procedures of FALCPA. However, questions remain regarding the status of certain ingredients under the new law.
One concern is that FALCPA does not define "highly refined oil." Allergenic proteins are generally not detected in common hot solvent-extracted oils, but have been found in cold-pressed and deodorized oils.
Another issue is that FALCPA does not define "tree nuts," merely stating that the category include almonds, pecans, and walnuts, and there is conflicting information regarding whether coconuts are considered to be tree nuts for allergen labeling purposes.
Moreover, some commonly used ingredients derived from major allergens may contain trace quantities of allergenic proteins, although it is accepted that these ingredients do not pose a risk to health. Unless the FDA sets thresholds for substances not considered to be a health risk despite trace levels of protein, it appears allergen labeling or specific exemptions may be required under FALCPA.
A petition may be filed showing an ingredient "does not cause an allergic response that poses a risk to human health." If the FDA does not make a decision within 180 days, the petition is deemed to be denied, unless an extension of time is granted. A notification can be filed if an ingredient is derived from an allergenic source but demonstrably does not contain allergenic protein, or if the FDA has determined the ingredient does not present a risk to health in the context of reviewing a pre-market submission. If the FDA has no objection to the notification within 90 days, the ingredient may be marketed. With the FALCPA implementation date approaching, resolution of these issues in a timely manner is important for the food industry.