9, Number 3 - March 2008
IN THIS ISSUE:
About Food Consulting Company
" Thanks for making the label
development process so easy. Your input made
us confident in putting our product to
market and gave us a huge credibility boost
with our partners and investors. Your work
is thorough, clear, and efficient!"
~ Brian M. Pitzer
Dear Readers, This month Food Consulting
Company has a question we would like you to
consider: In your situation, what factor is most likely
to slow down label development projects?
Register your anonymous answer
oils from soybeans, peanuts and tree nuts have to be declared as
allergens on food labels? P.S.,
Product Formulator, California
food labeling regulations require that the
source of the oil is identified (soybean
oil, peanut oil, walnut oil, etc.) in the
ingredient statement. Read more:
Reader Q&A page.
Submit a question
for Reader Q&A (no charge).
FDA Acts on Nutrition Labels Health Claim Abuse
On February 22, 2008, FDA announced enforcement
action against particular companies and
executives that have a history of abusing
nutrition labels health claim regulations. The
companies and executives have signed a consent
decree of permanent injunction whereby they
agree to remove drug and unauthorized health
claims from their labels, brochures, and Web
sites, as well as references to other Web sites
that contain abusive claims. They have also
agreed to hire an independent expert to review
the claims they make for their products and to
certify that they have omitted all violative
Per the consent decree, FDA can order the
companies to stop manufacturing and distributing
any product if the companies fail to comply with
any provision of the consent decree, the
Food, Drug and Cosmetic Act or FDA regulations.
The companies can also be fined $1000 per
violation per day.
Also in FDA's announcement of the injunction the
Agency states it will not tolerate
unsubstantiated health claims and will pursue
necessary legal action to make sure companies
manufacture and distribute safe, truthfully
labeled products to consumers.
claims can boost product position, yet abuse of claims can get companies
into big and unintended trouble. See
Service to learn about food label
FDA Regularly Updates Food Labels Claims
FDA regulations allow for three categories of
food and dietary supplement label claims: health
claims, nutrient content claims,
structure/function claims. The Agency regularly
updates the lists of allowed claims. Most
recently, February 25, 2008, FDA amended the
health claim regulation entitled "Soluble fiber
from certain foods and risk of coronary heart
disease (CHD)'' to add barley betafiber as an
additional eligible source of beta-glucan
FDA announcement for
latest health claim.
FDA's most recent overview
of allowable label claims.
Commentary: Label claims can be an
effective way to increase consumer interest and
purchase of a product. However, selecting the
best claim for a product can be tricky due to
the complexity of FDA rules.
Food Consulting Company can help you choose the
best legal claim/s for your product. For more
At Your Service.
More Time to Influence Nutrition
In response to stakeholder request, FDA is
extending the comment period for the November 2,
2007, Advance Notice of Proposed Rule Making (ANPRM)
that requests input regarding what new
information should be used to calculate the
percent daily values (DVs) and determine what
nutrients should be mandatory on Facts panels.
FDA will accept comments until April 30, 2008.
Food Label News for an earlier report.
FDAís interest in this topic will not result in
mandatory label changes any time soon since the
process to set regulations is multi-step and
includes proposed rules, comment periods, final
rules, and announcement of the uniform
Federal Register notice.
At Your Service: Will a label
health claim help position your product in the
marketplace? Food Consulting Company can review
your productís current label and nutrient
profile and advise you on label claims that can
be legally used. See
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