Volume 7, Number 12 - December 2006

IN THIS ISSUE:

• Reader Q&A Spot: Small Business Exemption

• More Guidance for Allergens on Food Labels

• FDA Guides Consumers on Nutrition Labels Calorie Info

• FDA Regularly Updates Food Labels Claims

• Service Tip: Key to a Happy New Year

Seasons Greetings! We hope this end-of-year month includes a break from work along with joyful time with friends and family. Best wishes for a happy holiday season from Food Consulting Company.

Q.  I'm launching my first food product; I have heard about a small business exemption for nutrition labeling. How can I find out if I qualify?  A.T., Start-up Food Company, Oregon

A.   FDA explains the small business exemptions for nutrition labeling at www.cfsan.fda.gov/~dms/sbel.html. When considering an exemption for nutrition labeling it is very important to understand that product labels must still be in compliance with other FDA labeling regulations such as, but not limited to, ingredient statement and allergen labeling. Read more: Reader Q&A Page

Submit a question for Reader Q&A.  Selected questions will be answered at no charge. For speedy answers to regulatory questions, see Services.

More Guidance for Allergens on Food Labels

In the November 2, 2006, Federal Register, the Center for Food Safety and Applied Nutrition (CFSAN) announced publication of "Edition 4" of the final guidance relating to food allergen labeling. The Guidance is given in a Question/Answer format. Edition 4 includes four questions (Questions 25-28) not previously addressed.

• What nuts are considered tree nuts?

• How should fish and Crustacean shellfish be named?

• What is considered wheat?

• How should single ingredient foods that are allergens be labeled?

See Guidance.

Commentary: This latest edition is extremely helpful due to the extent of detail in the answers.

FDA Guides Consumers on Nutrition Labels Calorie Info

In November 2006, the Department of Health and Human Services (HHS) and FDA's Center for Food Safety and Applied Nutrition (CFSAN) announced that two new learning tools can help consumers use the Nutrition Facts label to control calorie intake while making healthy food choices. The tools are:

• a web-based learning program titled "Make Your Calories Count" that helps consumers explore the relationship between serving sizes and calories, while they learn how to limit certain nutrients and get enough of others. An animated character called "labelman" leads the viewer through a series of exercises on food label use. View learning program.

• a downloadable brochure titled "Nutrition Facts Label" that describes how consumers can use the Nutrition Facts label as they shop and plan meals and includes information to help consumers understand the relationship between calories and serving size. Download brochure.

The learning tools are part of the Agency's response to the recommendations made by FDA's Obesity Working Group, in the 2004 Calories Count report.

Read announcement.

FDA Regularly Updates Food Labels Claims

FDA regulations allow for three categories of food and dietary supplement label claims: health claims, nutrient content claims, structure/function claims. The Agency regularly updates the lists of allowed claims. Most recently, on November 15, 2006, FDA authorized a health claim for "Saturated Fat, Cholesterol, and Trans Fat, and Reduced Risk of Heart Disease."

Read FDA announcement for latest health claim.

Access FDA's most recent overview of allowable label claims.

Service Tip: Regulatory Support - Key to a Happy New Year
Confusion about FDA regulations for food labeling can stall projects and steal time from other important issues. Food Consulting Company provides accurate and ready help that will save your company time and money. Order Annual Regulatory Support or another full-service option that will deliver the efficiency you need in completing food labeling projects. See Services.

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