Volume 6, Number 11 - November 2005

IN THIS ISSUE:

• Food Label Allergen Questions Answered

• Misleading Food Labels / Label Claims Targeted

• Annual Support Plans for Food Labels Regulatory Help

• FYI: FDA Meeting on Health Claims

Greetings! This issue of Food Label News marks the beginning of the sixth year of publication and free distribution to clients and guest subscribers. Food Consulting Company is proud to report that Food Label News has been delivered each month for 60 months straight!  As with this newsletter, you can always count on Food Consulting Company for accurate, on-time project completion, and expert guidance on applying FDA regulations. Visit Food Consulting Company at www.foodlabels.com.

Food Label Allergen Questions Answered

In a Food Label News, October 2005 special edition, Food Consulting Company reported on FDA's October 5, 2005, Final Guidance entitled "Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004." Food Consulting Company was answering many questions about allergen labeling at the time and so promised to answer readers' allergen questions in the November issue of Food Label News. According to FALCPA, all packaged foods regulated under the Federal Food, Drug, and Cosmetic Act that are labeled on or after January 1, 2006, must comply with the new allergen regulations.

Food Consulting Company found readers are interested in the following points:

• Products with labels that do not comply with FALCPA that were labeled prior to January 1, 2006, can remain in the marketplace.

• FALCPA does not require the "contains" statement as long as the ingredient statement uses the common or usual name of the allergens present. When a "contains" statement is used, it must include all of the Big 8 allergens that are present in the product and be equal in print size and prominence to the ingredient statement.

• FALCPA does not require advisory labeling, such as "manfactured in a facility that also processes [name of allergens]," however companies may use it voluntarily as a statement of fact.

• FDA discourages the use of "may contain [name of allergens]" labeling, and says that such labeling should not be used as a substitute for adherence to current Good Manufacturing Practices.

Read FDA Q&A Guidance on Allergen Labeling and access FALCPA: http://www.cfsan.fda.gov/~dms/alrguid.html

Find more information on 2006 compliance requirements for food labels: www.foodlabels.com/2006

Misleading Food Labels / Label Claims Targeted

On October 24, 2005, FDA sent notices to 29 companies warning them to stop making unproven treatment/prevention claims, for cherries and other fruits, on product labels and web sites. FDA warns the companies to take prompt corrective action or face FDA enforcement action that could include seizure of products, injunctions or criminal sanctions.

Read FDA press release and access warning letters: http://www.fda.gov/bbs/topics/news/2005/new01246.html

On October 27, 2005, a consumer watch group, Center for Science in the Public Interest (CSPI) released a press statement that criticizes FDA for failing to stop food labeling that deceives consumers about a product's healthfulness. CSPI says FDA's inaction has been a signal to food manufacturers to use more deceptive claims. The release notes that in the absence of adequate FDA oversight and enforcement, CSPI acts independently, through legal action, to get companies to cease deceptive labeling.

Read CSPI press release: http://www.cspinet.org/new/200510272.html

Commentary: Food Consulting Company believes that the use of misleading claims and product information in labeling and marketing is wrong and a poor business choice. Food Consulting Company guarantees that all label components and regulatory advice provided by Food Consulting Company on clients' behalf are 100% compliant with current FDA regulations.

Annual Support Plans for Food Labels Regulatory Help

Beginning November 1, 2005, Food Consulting Company is offering annual support plans for food labeling and regulatory help. The plans are prepaid arrangements for food labeling advisory help over a 12-month period; a basic and comprehensive plan is offered. The two plans differ by the type and volume of help a company anticipates needing in the upcoming period. The Ongoing Regulatory Support Plans are described on the Services page at www.foodlabels.com. Companies can begin service immediately or at any later date by placing an online order.

Companies subscribing to the support plans before January 1, 2006, can use the service from the date of payment and for the full 12 months beginning January 1, 2006.

As always, companies can submit questions for Regulatory Research on a per incident basis.

Commentary: Both small and large companies, with and without dedicated food labeling staff can benefit by the plans. Because Food Consulting Company is well versed in FDA food label regulations and keenly able to work back-and-forth through the Code of Federal Regulations, final rules and FDA guidance, the Company can save all sizes and types of companies many hours of research time and the related costs.

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