Volume 11, Number 4 - April 2010

Hello from Food Label News. No doubt you have heard news about food labels in the consumer media. From FDA's warning letters to healthcare reform, food labeling is a topic of discussion. In this issue we provide insights about FDA's crackdown on misleading food labels and what you can do to protect your company. As healthcare reform unfolds we will keep abreast of what matters in food labeling.

In this issue you'll find:

• FDA Tightens Control on Food Label Claims

• Health Claims on Food Labels:
  Instructional Series - Part 8 of 10

• Reader Q&A: Inner and Outer Labeling

• Helpful links to keep you current

Karen C. Duester, President

" You have found a niche and fulfill a need in the food industry. We have utmost confidence in your expertise and refer our clients who require nutrition labeling or advice on package labeling regulations that are unclear."

FDA Tightens Control on Food Label Claims

Food labelers beware. Center for Food Safety and Applied Nutrition (CFSAN) sent warning letters in February to 16 different companies for false or misleading food label claims. These warning letters marked FDA's stepped-up activity to police the industry's labeling practices and ensure compliance. Highlights of violations cited in the warning letters are:

• Claims that food products can treat or mitigate disease are not allowed; foods that carry such claims are unapproved new drugs.

• Nutrient content claims are not allowed on foods intended for infants or children less than two years of age.

• When "0g trans fat" is stated outside the Nutrition Facts panel for a product that exceeds  threshold levels of total fat, saturated fat, cholesterol and sodium, then the disclosure statement "See Nutrition Information for [name of nutrient] Content" is required.

• Website statements describing products can be considered labeling and are subject to the same regulations as product labels.

• FDA is scrutinizing the use of specific nutrient content claims to ensure the claims meet regulated definitions and conditions for use. Examples: "high antioxidant" is not allowed without qualification; "high in monounsaturated fats" is not allowed because there is no Daily Value for this nutrient; label claims for "healthy" and "light" were cited because the foods did not meet qualifying criteria for the definitions.

For more details, read FDA open letter to the food industry and access the individual warnings.

  Keeping You Current

Healthcare reform legislation (Section 4205, page 455) signed into law on March 23rd establishes new nationwide requirement for nutrition menu labeling for restaurants with 20 or more locations

National Restaurant Association press release praises unified menu labeling standards

Institute of Medicine to host second meeting for front-of-pack labeling April 8th to 10th; public meeting April 9th

FDA indicated two new guidance documents and one new proposed rule related to claims and label statements are forthcoming during a presentation at first IOM front-of-pack meeting

Newly released FDA survey shows consumers often read a label the first time they buy a product, but are skeptical about front-of-pack claims

FDA seeks comments on its  Transparency Task Force

NIH Office of Dietary Supplements releases
2010-2014 strategic plan

GAO report says FDA needs to improve GRAS oversight, especially for self-affirmed GRAS products

While there is new FDA rulemaking activity underway (specifically related to dietary guidance statements - see inset above, 4th item), the warning letters are simply reinforcement of existing regulations. An understanding of nutrient content claims, health claims, structure/function claims, dietary guidance statements and statements of fact is required to develop labeling that complies with FDA regulations. For guidance, you can search the FDA website at www.fda.gov, get a summary from the Silliker/Food Consulting Company Instructional Series (see below), or contact us for help with a specific project.

Health Claims on Food Labels: Instructional Series Part 8 of 10

Health claims are pre-authorized by FDA and the wording for these types of claims is tightly controlled. If a product contains a disqualifying level of total fat, saturated fat, cholesterol, or sodium, then you will not be allowed to cite a health claim. More details can be found in the Guide.

If you missed earlier parts of the series you can view and download them now. (Get Part 1, Part 2, Part 3, Part 4, Part 5, Part 6, Part 7.) The pages from all parts will add up to the complete booklet.

Reader Q&A

Find answers to our readers' questions or send us your question for an upcoming issue.

At Your Service

Food Consulting Company, founded in 1993, provides nutrition analysis, food labeling and regulatory support to ensure 100% compliance with FDA regulations. With over 1,000 clients worldwide, Food Consulting Company's services are ideal for start-up and established food manufacturers, distributors, food importers, brokers, and restaurateurs. Contact Us for more information about your food labeling needs.

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