Volume 6, Number 10 - October 2005

IN THIS ISSUE:

• Trans Fat Nutrition Labels Extension Considered

• FDA Regulations for Sodium and "Healthy"

• FDA Studies Food Labels Qualified Health Claims

• FYI: Gluten-Free Food Labeling

Dear Readers, Food Consulting Company invites you to read the company's summary of FDA food labeling requirements that are effective January 1, 2006, at www.foodlabels.com/2006. Food Consulting Company can help companies produce January 1, 2006, compliant labels in time to meet the effective date; see services and place orders at www.foodlabels.com for the help you need.

Trans Fat Nutrition Labels Extension Considered

FDA announced in the September 1, 2005, Federal Register that the Agency is preparing "Guidance for Requesting an Extension to Use Existing Label Stock After the Trans Fat Labeling Effective Date of January 1, 2006." The guidance, when published, will explain when and how businesses can request FDA approval to use label stock that does not comply with the trans fat final rule after the effective date. FDA is accepting requests now and will consider them on a case-by-case basis. The  Agency said that it expects that most businesses, including small businesses, should not have difficulty meeting the effective date.

An FDA spokesperson confirmed to Food Consulting Company that FDA is only accepting extension requests for trans fat labeling (not allergen labeling), noting that trans fat labeling is an FDA regulation and allergen labeling is a law passed by Congress.

See September 1, 2005, Federal Register announcement:
http://www.fda.gov/ohrms/dockets/98fr/05-17413.htm

Commentary: In the past month, several food companies have contacted Food Consulting Company to ask if FDA's September 1, 2005, Federal Register notice is an "across-the-board" extension that they can count on for using existing label stock; the notice does not say this. Rather, FDA requires that all foods entering interstate commerce on or after January 1, 2006, be labeled in accordance with the trans fat labeling requirement. Therefore, Food Consulting Company believes that companies should not use the forthcoming "Guidance" as a reason to delay preparing January 1, 2006, compliant labels. Food Consulting Company can help you get your labels ready. Go to www.foodlabels.com to get started.

FDA Regulations for Sodium and "Healthy"

On September 29, 2005, a final rule regarding the allowed sodium levels on foods labeled with the nutrient content claim "healthy" was published in the Federal Register; this final rule amends the 1994 final rule for sodium levels on "healthy" food labels. Effective immediately, the sodium requirements for products labeled as "healthy" are 600 mg of sodium for meal and main dish products and 480 mg of sodium for individual food products.

Read September 29, 2005, Federal Register Notice:
http://www.fda.gov/OHRMS/DOCKETS/98fr/05-19511.htm

Commentary: The FDA regulation for sodium levels on foods labeled "healthy" has a long history that Food Consulting Company has followed since 1994. See Food Label News archive (June 2002, March 2003, June 2003) for background on some of the most recent activity regarding the rule: www.foodlabels.com/newsletter.htm     

FDA Studies Food Labels Qualified Health Claims

On September 28, 2005, FDA released a report on the Agency's study of the effectiveness of different ways of communicating the "strength of science" behind qualified health claims on food labels. This study was conducted to fulfill the December 2002 directive, from the Consumer Health Information for Better Nutrition Initiative, to understand the most effective way to present scientifically based, truthful and non-misleading information to consumers. See Food Label News report on the Initiative: www.foodlabels.com/archive/2003_02.htm.

The study showed that none of the ways tested performed satisfactorily, including the Agency's current system in effect since 2003 and defined by "interim procedures for qualified health claims."  See current system at: http://www.cfsan.fda.gov/~dms/nuttf-e.html.  FDA has published a Questions and Answers page to help stakeholders understand the study findings.  See Questions and Answers and access the FDA report: http://www.cfsan.fda.gov/~dms/qhc-qa.html.

Also, in relation to the consumer health initiative, FDA announced on September 15, 2005, that funding has been granted and the Agency will conduct "Experimental Study of Health Claims on Food Packages" to learn whether the wording of a health claim needs to refer to the substance (a component of food, e.g., a nutrient) that is the basis of the claim. The study was described in the April 20, 2005, Federal Register: http://www.fda.gov/OHRMS/DOCKETS/98fr/05-7822.htm.

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