Dear Friends,

The following is our summary of FDA’s recently released, August 24, 2010, Draft Guidance for Industry: Questions and Answers Regarding Implementation of the Menu Labeling Provisions of Section 4205 of the Patient Protection and Affordable Care Act of 2010.

Health Care Reform

Section 4205: Nutrition Labeling of Standard Menu Items at Chain Restaurants

1. Amends nutrition labeling laws in which restaurants have previously been exempt from food labeling requirements

2. Overrules all current local and state menu-labeling legislation

3. Timeline:

• March 23, 2010: Health Care Reform signed into law
• August 24, 2010: Draft Guidance for Industry released
• December 2010: Final guidance anticipated

FDA is to establish a time period for implementation in the final guidance which is anticipated this December.

4. Requires all restaurants with 20 or more locations to disclose:

• Calories in each standard menu item that appears on the menu, menu board, online menus and take-out menus (beverages, salad bars and buffets included). Calories must be placed adjacent to menu items under the heading “Calories” or “Cal” and should appear in a type size at least as large as the name or the price of the menu item, whichever is larger, with the same prominence, i.e., same color and contrasting background.
• Calories for self-service items are to be posted on a sign placed adjacent to each food item—serving sizes are to be determined by FDA.
• A succinct statement that puts the calories information in the context of a total daily caloric intake must be included on the menu. FDA will provide specific language for this statement.
• Written nutrition information available to consumers upon request. A statement regarding the availability of this information must be disclosed on the menu and should read, “Additional nutrition information is available upon request.”
• Nutrients to be listed include: total calories, calories from fat, total fat, saturated fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars and protein. Trans fat is also expected.

5. Exemptions:

Items not listed on the menu such as condiments and other items placed on the table for general use

• Daily specials
• Temporary menu items/ specials (less than 60 days/year)
• Custom orders
• Market test items (less than 90 days)
• Pre-packaged food that bears a complete Nutrition Facts label

6. FDA needs to clarify:

• Reasonable variations in serving size and formulation of menu items
• Succinct statement and information on its placement
• Space on menu and menu boards
• Staff training
• Inadvertent human error
• Variation in ingredients
• What constitutes a servings size for self-service items (i.e., soda fountains, and salad bar or buffet line items)
• Nutrient determination method (i.e. calorie range) for variable menu items with more than one flavor listed or displayed (i.e., pizza or ice cream w/toppings), as well as combination meals.

7. Comments on the guidance should be submitted to www.regulations.gov. All comments should be identified with docket number DA-2010-N-0298.