Food Label News, Government Actions for Food Labels, FDA Regulations, Food Labels, Nutrition Labels
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Volume 7, Number 11 - November 2006


About Food Consulting Company

"Thanks. Everything is top notch. You did a superb job."

~ Mike Carpenter
DM Snacks Corp. N.A.

Greetings! This issue of Food Label News marks the beginning of the seventh 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 72 months straight! The entire collection of past issues is available at As with this newsletter, you can count on Food Consulting Company for accurate, on-time project completion and expert guidance on applying FDA regulations. Visit Food Consulting Company on the Web.

Q.  If MSG is a sub-ingredient of an ingredient I use and is present in a very small amount in my product, do I have to list it on my label?  T. E., Tennessee


A.  Yes, FDA requires that all ingredients, including sub-ingredients that have a functional or technical effect, be included within the ingredient statement. Read more: Reader Q&A Page


Submit a question for Reader Q&A.  Selected questions will be answered at no charge. For speedy answers to regulatory questions, see Services.

FDA Opens Talk on "Functional Food" Labels

FDA has announced a public hearing (December 5, 2006) regarding conventional foods that are marketed as "functional foods." Currently FDA has neither a definition nor a specific regulation concerning these foods. The Agency believes that existing provisions of the Federal Food, Drug, and Cosmetic Act are adequate to ensure that such foods are safe and lawful, but also believes that it is in the best interest of public health to begin a dialog with industry, consumers, and other stakeholders regarding the regulation of these products.

Dietary supplements are not part of the discussion since they are regulated by Dietary Supplement Health and Education Act of 1994 (DSHEA).

See Federal Register announcement.

FDA / FTC Warns About Deceptive Internet Claims

FDA announced that FDA and the Federal Trade Commission (FTC) are working with government agencies in other countries to stop deceptive Internet advertisements and sales of products misrepresented as cures or treatments for diabetes. This joint initiative originated with a Web-surf by an organization of law enforcement authorities with members from United States, Mexico, and Canada.

As of October 19, 2006, approximately 180 warning letters/advisories had been sent to online outlets in the three countries; the majority of the identified abuse was by dietary supplement companies. Each of the warning letters advises a company that FDA reviewed the website and determined that therapeutic claims made establish one or more of the company's products as a drug. FDA warns that failure to promptly correct the violations specified could result in enforcement action without further notice.

See FDA announcement.

Commentary: Labels of conventional foods and dietary supplements cannot make claims that a product will cure, mitigate, treat, or prevent a disease. To assure your product label claims are compliant with FDA regulations, contact Food Consulting Company.

Promoting Whole Grains on Food Labels

Food Consulting Company continues to be queried about labeling foods with whole grain claims. FDA's last published action on whole grain labeling was published in February, 2006 as Draft Guidance open for public comment. FDA has not announced a timeline for further regulatory action.

Meanwhile, non-government organizations are developing programs to promote the health benefits of whole grains. At least two organizations offer whole grain product packagers the right to use proprietary label symbols/stamps that convey information about whole grain content to consumers.

  • American Heart Association (AHA) -- A fee is required to use the "heart-check mark with whole grains" and the product must meet AHA criteria that in part requires a product to be 51% by weight/reference amount. Additional criteria pertain to fiber, fat, cholesterol, sodium and percent daily value for specified nutrients. Read more: AHA website.

  • Whole Grains Council -- Paid membership to the Whole Grains Council is required to use the organization's whole grain stamps that include the "Whole Grain" stamp for products with 8 grams of whole grain or more per serving and "100% Whole Grain" stamp for products with 16 grams of whole grain or more per serving. Read more: Whole Grains Council website.

Service Tip: Leap Ahead with Regulatory Support
There is no need to delay progress on food labeling projects that stall due to confusion about FDA regulations. Food Consulting Company provides accurate and ready help with your purchase of Ongoing Regulatory Support or with another full-service option that meets your needs. See Services.


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