Volume
8, Number 6 - June 2007
IN THIS ISSUE:
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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
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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:
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are exempt from the labeling requirements
for health claims and nutrient content
claims
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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
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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:
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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
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CAM therapy or practice may be subject to
regulation as a biological product,
cosmetic, drug, device, or food (including
food additives and dietary supplements)
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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.
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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.
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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."
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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
www.foodlabels.com
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