Volume 9, Number 2 - February 2008

IN THIS ISSUE:

• Reader Q&A: Is a Release Agent an Ingredient? 

• Food Labels Qualified Health Claims in Question

• "Natural" on Your Food Labels? Consider This

• Help With FDA Regulations for Produce/Fish Labeling

• At Your Service: Label Statements and Claims

Welcome to Food Label News - Readers tell us Food Label News is an important resource they use to stay informed on regulatory issues. If you know someone who should know what you know about labeling regulations, pass Food Label News on! New readers can subscribe at www.foodlabels.com/subscribe.

Q.  If a company is using a safe lubricant like beef tallow or lard to lubricate pans for baking, or is using those animal products in the packaging of the product, does FDA require that these additives be listed in the ingredient list?   T.P., Baking Company, Colorado

A.  Pan release agents are generally considered to be processing aids and therefore are typically exempt from ingredient statement labeling for FDA-regulated foods. However when release agents... Read more: Reader Q&A page.

Submit a question for Reader Q&A (no charge).

Food Labels Qualified Health Claims in Question

In September and October 2007, Food Label News reported on a measure in the U.S. House of Representatives 2008 Appropriations Act (H.R.3161) that would prevent FDA from authorizing qualified health claims for conventional foods. The restriction on FDA from allowing the claims depended on language in the final appropriations bill that President Bush would eventually sign.

On December 26, 2007, the President did sign the Appropriations Act of 2008 (Consolidated Appropriations Act of 2008 H.R.2764) into law. The "Explanatory Statement" regarding the Appropriations in H.R.2764 includes language relating to qualified health claims, including:

• Congress believes "FDA may have exceeded its statutory authority when the agency decided to begin allowing the use of qualified health claims for conventional foods in 2003. Such claims are not based on the standard of "significant scientific agreement'' set forth in the Nutrition Labeling and Education Act."

• Congress requests "a report from the Government Accountability Office (GAO) on qualified health claims and ask that GAO work with the Committees on Appropriations of the House and Senate on the parameters of the report."

• Congress urges FDA "not to use funds provided in this bill to review requests for qualified health claims for conventional foods or to issue letters permitting such claims through exercises of enforcement discretion until the independent analysis is completed."

• Congress directs FDA to provide all requested reports and studies within 60 days after enactment of this Act.

Also, in the Federal Register of December 21, 2007, FDA announced that the Agency intended to
re-evaluate the scientific evidence for two previously authorized health claims and two qualified health claims that were the subject of letters of enforcement discretion.

Access H.R.3161 and H.R.2764 at www.thomas.gov (use "Search Bill Text").

Access "Explanatory Statement" at www.thomas.gov. Choose "Congressional Record," then "Browse Daily Issues," then "House" on December 17, 2007, then item 92, then page H15765.

Commentary:  FDA was contacted about the language in the explanatory statement but did not respond prior to publication of Food Label News.

"Natural" on Your Food Labels? Consider This

Despite petitions from stakeholders to do so, FDA has never established a regulatory definition for the term "natural" on food labels. However FDA maintains its policy that was published on page 2407 of the January 6, 1993, Federal Register. FDA's policy:

• not to restrict the use of the term "natural" except for added color, synthetic substances, and flavors as provided in the Code of Federal Regulations

• the use of "natural" means that nothing artificial or synthetic (including all color additives regardless of source) has been added

An Internet newsletter reported that in late December 2007, FDA said the Agency has no plans to define the term "natural" in the near future due to limited resources, and the only way to push the issue onto its radar screen is if the Agency was provided with "consumer research that shows overwhelmingly that people are being misled."

Commentary:  Discerning if FDA regulated products can be labeled "natural" is often tricky. Furthermore some retailers are more restrictive than FDA on this issue. Choose regulatory help to keep your "natural" product in regulatory compliance. See Food Label News August 2005 and June 2006 for earlier reports on "natural."

Help With FDA Regulations for Produce/Fish Labeling

In December 2007, FDA made downloadable posters showing nutrition information for the 20 most frequently consumed raw fruits, vegetables, and fish in the United States available on the FDA website.  FDA did this to encourage retail stores that sell raw fruits, vegetables, and fish to participate in the voluntary point-of-purchase nutrition information program.

Commentary: For an earlier report on the voluntary nutrition information program, see Food Label News September 2006.

At Your Service:  Food Consulting Company offers help with label statements and claims, including use of MyPyramid on food labels. Ongoing Regulatory Support provides periodic help (multiple times) throughout the year for one or more labels; One-time Regulatory Support provides one-time help for one label.

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