SEPTEMBER
2003
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...INTOUCH... Volume 4/Number 9 -
September 5, 2003
Monthly Updates on Government Action Affecting Food
Labels
Brought to you by: Food Consulting Company
Your source for food label help at
www.foodlabels.com
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Greetings! This month INTOUCH reports on three
labeling- related
outcomes of the FDA initiative "Consumer Health
Information for
Better Nutrition" that was launched in December, 2002.
The
reported outcomes include guidance for "qualified
health claims",
enforcement against false and misleading claims, and a
new
"dietary guidance statement". As always, Food
Consulting Company
will help you apply FDA-compliant label claims to your
products.
To order label claims services, choose Full Label
Compliance
Package or Label Compliance Review at
http://www.foodlabels.com/https://safeco.net/foodlabels/orders.htm
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FDA Gives Guidance for "Qualified Health Claims" on
Food Labels
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As of September 1, 2003, FDA is implementing "interim"
procedures
that will allow food products to carry FDA- approved
"qualified health
claims", provided FDA determines that the claims are
scientifically-
supportable and that they are presented in a way that
accurately
conveys any scientific uncertainty about the claims.
The process
begins with a company's petition to FDA and involves a
full review of
the available scientific evidence by FDA staff and
independent experts.
FDA believes that helpful, scientifically-accurate,
and expertly-
reviewed "qualified health claims" will influence
shopping choices and
thereby encourage food firms to compete on the health
effects of their
products -- not just on taste, price, and convenience.
The procedures are called "interim" because FDA plans
to conduct
and encourage research to improve the understanding of
the most
effective way to present science-based, truthful, and
non-misleading
information to consumers as the "guidance" is followed
by industry.
FDA then plans to develop regulations based on the
research, public
comment, and the agency's experience with the interim
procedures.
Access multiple documents on the guidance:
http://www.fda.gov/oc/mcclellan/chbn.html
Read FDA's Q&A on implementation of "qualified health
claims":
http://www.cfsan.fda.gov/~dms/labqhcqa.html
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FDA Cracks Down on Misleading Supplement / Food Labels
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
FDA has reconfirmed the agency's intent to increase
enforce- ment
activity against food and dietary supplement labelers
who make
misleading claims about the health benefits of their
products that are
not supported by science. Since enhancing its
enforcement activity
(December, 2002), FDA has:
-- issued 73 warning letters and Cyber letters to
marketers of dietary
supplements
-- seized products worth almost $9 million
-- refused to allow the importation of 368 shipments
of dietary
supplements
-- supervised the voluntary destruction of $515,000
worth of dietary
supplements promoted with unsubstantiated structure/function
claims
Read FDA's July 2003 executive summary enforcement
report:
http://www.fda.gov/oc/whitepapers/chbn_summary.html
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Food Labels May Carry a New "Dietary Guidance
Statement"
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FDA is encouraging the produce industry to use a new
"dietary guid-
ance statement" that says "Diets rich in fruits and
vegetables may
reduce the risk of some types of cancer and other
chronic diseases."
This statement was developed in collaboration with the
National
Cancer Institute (NCI) and to support the "Better
Health Information
for Better Nutrition" initiative. Produce marketers
may use this state-
ment by itself on food labels or along with a new NCI
logo that
promotes five to nine servings of fruits and
vegetables a day. If the
NCI "5-to-9-A-Day" logo is included on the food label,
the labeled food
must comply with NCI criteria for foods eligible to
bear the logo with
the statement.
FDA plans to continue to work with federal agencies
(NCI and others)
to encourage the development and use of additional
dietary guidance
statements.
Read FDA press release:
http://www.cfsan.fda.gov/~dms/lab-dg.html
For a definition of products that can bear the NCI
logo, see:
http://www3.cancer.gov/5aday/promos.html
...INTOUCH... Comments:
Further, but limited, explanation of "dietary guidance
statements" is
available. See questions 7 & 8 at:
http://www.cfsan.fda.gov/~dms/labqhcqa.html
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FYI: The labels on olestra-containing foods are no
longer required to
carry the warning that olestra may cause abdominal
cramping and
loose stools in some individuals and that it inhibits
the body's
absorption of vitamins A, D, E, and K and other
nutrients. Manu-
facturers are still required to add Vitamins A, D, E,
and K to olestra-
containing products; each of these added vitamins must
be included
in the ingredient list and each must be followed by an
asterisk that
is referenced with the words "dietarily
insignificant."
© Food Consulting Company, 2003. |