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Volume 7, Number 2 - February 2006


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– Penny Hennessy
Rich-SeaPak Corp.

Welcome to Food Label News - the monthly resource that keeps you informed. Readers tell us Food Label News is an important resource they use to stay informed on regulatory compliance issues. The entire five-year archive can be accessed at

Non-Compliant Food Labels Subject To FDA Action

In FDA's December 30, 2005, addendum to the final guidance regarding use of existing label stock after the trans fat labeling effective date of January 1, 2006, food labelers are advised that the Agency intends to withhold enforcement action if an extension request was postmarked on or before December 31, 2005. The addendum states that enforcement action will be withheld until the Agency responds.

The addendum to the final guidance does not apply to extension requests that are postmarked after December 31, 2005, or to requests that were denied by FDA.

Read Final Guidance and Addendum.

Commentary: Food Consulting Company is aware that many companies do not yet have products properly labeled to comply with 2006 requirements for trans fat. FDA's language in the addendum suggests that the Agency is serious about enforcing the 2006 regulations. Food Consulting Company advises companies to act quickly to get labels into compliance.

FDA Regulations - Color Additives on Food Labels

In the January 30, 2006, Federal Register, FDA proposes to require that the coloring additives, cochineal extract and carmine, be declared by their names within the ingredient statement when the colorings are present in food. The proposed rule responds to reports of severe allergic reactions to these colorings.

The proposed effective date for any final rule that may be issued based on the proposal is two years after its date of publication in the Federal Register. Stakeholders may submit comments by May 1, 2006.

Read Federal Register notice.

Commentary: Until a final rule is published, cochineal extract and carmine can be declared by their names within the ingredient statement, or they can be covered by the words "artificial colors." Presently, the only color additives that must be listed by name are FD&C certified colors such as Red #40 or Yellow #5.

USDA Regulations for Healthy on Food Labels

On January 11, 2006, USDA's Food Safety and Inspection Service (FSIS) announced that individual meat and poultry products bearing the claim "healthy" must contain no more than 480 milligrams (mg) of sodium and that meal-type products bearing this claim must contain no more than 600 mg of sodium. FSIS's intentions to adopt more restrictive levels (of 360 mg of sodium for individual meat and poultry products and 480 mg for meal-type products) are postponed indefinitely. FSIS is taking this action partly to have labeling regulations consistent with FDA; FDA amended its regulations to establish sodium requirements for products labeled as "healthy" in September 2005.

See Federal Register notice.

Commentary: Read the report on FDA's decision in the Food Label News archive (October 2005 issue) at

FYI:  A transcript of FDA's November 17, 2005, public meeting on "Assessing Consumer Perceptions of Health Claims" is posted on the FDA website. Access the transcript here.
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