Food Label News, Government Actions for Food Labels, FDA Regulations, Food Labels, Nutrition Labels
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Volume 9, Number 3 - March 2008

IN THIS ISSUE:

About Food Consulting Company
 

" Thanks for making the label development process so easy. Your input made us confident in putting our product to market and gave us a huge credibility boost with our partners and investors. Your work is thorough, clear, and efficient!"

 

~ Brian M. Pitzer
Vitality Distributing

Dear Readers, This month Food Consulting Company has a question we would like you to consider: In your situation, what factor is most likely to slow down label development projects? Register your anonymous answer here. Thank you!

Q.  Do oils from soybeans, peanuts and tree nuts have to be declared as allergens on food labels?   P.S., Product Formulator, California

 

A.  FDA food labeling regulations require that the source of the oil is identified (soybean oil, peanut oil, walnut oil, etc.) in the ingredient statement. Read more: Reader Q&A page.

 

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

FDA Acts on Nutrition Labels Health Claim Abuse

On February 22, 2008, FDA announced enforcement action against particular companies and executives that have a history of abusing nutrition labels health claim regulations. The companies and executives have signed a consent decree of permanent injunction whereby they agree to remove drug and unauthorized health claims from their labels, brochures, and Web sites, as well as references to other Web sites that contain abusive claims. They have also agreed to hire an independent expert to review the claims they make for their products and to certify that they have omitted all violative claims.

Per the consent decree, FDA can order the companies to stop manufacturing and distributing any product if the companies fail to comply with any provision of the consent decree, the Food, Drug and Cosmetic Act or FDA regulations. The companies can also be fined $1000 per violation per day.

Also in FDA's announcement of the injunction the Agency states it will not tolerate unsubstantiated health claims and will pursue necessary legal action to make sure companies manufacture and distribute safe, truthfully labeled products to consumers.

Read FDA announcement.

Commentary: Label claims can boost product position, yet abuse of claims can get companies into big and unintended trouble. See At Your Service to learn about food label claim help.


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, February 25, 2008, FDA amended the health claim regulation entitled "Soluble fiber from certain foods and risk of coronary heart disease (CHD)'' to add barley betafiber as an additional eligible source of beta-glucan soluble fiber.

Read FDA announcement for latest health claim.

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

Commentary: Label claims can be an effective way to increase consumer interest and purchase of a product. However, selecting the best claim for a product can be tricky due to the complexity of FDA rules. Food Consulting Company can help you choose the best legal claim/s for your product. For more information, see At Your Service.


More Time to Influence Nutrition Labels Revision

In response to stakeholder request, FDA is extending the comment period for the November 2, 2007, Advance Notice of Proposed Rule Making (ANPRM) that requests input regarding what new information should be used to calculate the percent daily values (DVs) and determine what nutrients should be mandatory on Facts panels. FDA will accept comments until April 30, 2008. See December 2007 Food Label News for an earlier report.

FDAís interest in this topic will not result in mandatory label changes any time soon since the process to set regulations is multi-step and includes proposed rules, comment periods, final rules, and announcement of the uniform compliance date.

See Federal Register notice.


At Your Service:  Will a label health claim help position your product in the marketplace? Food Consulting Company can review your productís current label and nutrient profile and advise you on label claims that can be legally used. See Services, or Contact Us.

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