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Volume 8, Number 6 - June 2007


About Food Consulting Company

"The labels have been SENT TO PRINT!! YIPPIE!!  You are very good at what you do and you have taken nearly all the stress off. We thank you for that."

~ Heather Maestas
Nothing Bundt Cakes

Greetings: This month Food Consulting Company welcomes more than 100 new readers to Food Label News. Karen Duester, president and lead technical expert for Food Consulting Company, met many of the new subscribers while presenting workshops during April and May 2007 meetings of the National Restaurant Association nutrition study group and Prime Label's 19th Annual Federal Food Regulatory Conference. Welcome to all clients and guest subscribers.

Q.  I would like to sell my product in grocery stores/gourmet shops. What service do I order to make sure my label meets FDA label regulations?
  P.H., Food Company Start-Up, Georgia


A.  Food Consulting Company's Full Label Compliance service takes the product information you provide and produces all required label components in print-ready form. With Full Label Compliance you will receive: nutrition analysis, a Nutrition Facts panel, an ingredient statement including allergen labeling compliance, and help with product naming and label claims. The package also includes label layout instructions and a final label review. Read more at Reader Q&A Page.


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

Guidance - Foods with Uses Beyond Basic Nutrition

Two recently published FDA guidances provide instruction on how foods with uses beyond basic nutrition fit into FDA's regulatory classification: drug, conventional food, dietary supplement, food for special dietary use, and medical food. Product labeling regulations vary between the classifications.

In May 2007, FDA issued Guidance for Industry - Frequently Asked Questions about Medical Foods. The guidance defines the term medical food in detail and explains that "medical foods" do not pertain to all foods fed to sick patients. The guidance instructs on labeling requirements that are specific for this classification. In part medical foods:

  • are exempt from the labeling requirements for health claims and nutrient content claims

  • must contain a statement of identity, an accurate statement of the net quantity of contents, the name and place of business of the manufacturer, packer, or distributor, and a complete list of ingredients compliant with allergen labeling regulations

  • must be labeled in conformance with the principal display panel requirements, the information panel requirements, and the misbranding of food requirements

In February 2007, FDA issued Draft Guidance for Industry - Complementary and Alternative Medicine (CAM) Products and their Regulation by the Food and Drug Administration. The draft guidance is being distributed for comment purposes only; it explains:

  • CAM encompasses a large range of health care practices, products (including food and food components), and therapies that are distinct from those used in "conventional" medicine

  • CAM therapy or practice may be subject to regulation as a biological product, cosmetic, drug, device, or food (including food additives and dietary supplements)

  • how the products would be regulated

Commentary: Choose Food Consulting Company's Ongoing Regulatory Support for help with determining the proper classification of your products and subsequent FDA rules.

FDA Reports on Food Labels Collection of Information

On May 14, 2007, FDA announced the Agency had submitted a "collection of information" report to the Office of Management and Budget (OMB). The document describes what is required by FDA from industry for reporting and recordkeeping related to food labeling.

Under the Paperwork Reduction Act of 1995, federal agencies must obtain approval from OMB for each "collection of information" they conduct. Since food labeling regulations require reports and recordkeeping, FDA must renew approval for ongoing collection of information every three years.

The May 2007 report does not contain new information. It does, however, provide a thorough outline of the authority behind FDA regulations associated with each of the required label components.

Commentary: See this month's Reader Q&A for required label components.

Proposal Expands Allowed Non-Organic Ingredients

The Agricultural Marketing Service (AMS) of USDA is proposing to amend the National Organic Program (NOP) List of Allowed and Prohibited Substances to allow 38 additional non-organic ingredients that can be used in organic handling when the organic forms are commercially unavailable. The list adds 19 coloring ingredients derived from agricultural products (such as annatto, paprika, turmeric, beta-carotene from carrots, beet juice powder, grape skin extract, etc.) and 19 other ingredients including chipotle chili peppers, celery powder, chia, dillweed oil, Turkish bay leaves, Wakame seaweed, frozen lemongrass, frozen galangal, fish oil, intestinal casings, fructooligosaccharides, oligofructose-enriched inulin, whey protein concentrate, gelatin, unbleached orange shellac, unmodified rice starch, sweet potato starch, hops, konjac flour.

The current National List, before being amended, contains only five non-organically produced agricultural products that are allowed in products labeled as "organic."

See proposal.

Commentary: With industry's knowledge that foods labeled "organic" and "natural" are consumer-valued, food labelers should note that while the proposed NOP rule would allow color additives from agricultural sources in foods labeled "organic," FDA regulations for foods labeled "natural" prohibit added coloring agents from any source. Read Food Label News August 2005 report on FDA's stand for "natural."

Service Tip:  Food Label News features an answer to a reader's question each month; see Q&A archive. Readers can submit puzzling food labeling questions to the newsletter division of Food Consulting Company. The newsletter staff responds to one question per month, with no charge to the person submitting. Submitters of the top three questions during the current calendar year (in terms of value and broad appeal to Food Label News readers) are acknowledged with a $25 thank you check in January of the following year.

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© 2007
Food Consulting Company
13724 Recuerdo Drive
Del Mar, CA 92014 USA