The FDA issued warning letters to 17 food companies for unauthorized health and nutrient content claims on product labels. The FDA commissioner sent a letter encouraging companies to review labels to ensure compliance. Two companies claimed "zero grams trans fat" but had high saturated fat levels, which can be misleading. The FDA will propose front-of-package labeling guidance to improve consumer nutrition information and choices. Critics argue stricter rules are needed to prevent misleading claims, including banning some types of claims.

1. NMR News: Volume 3, Issue 3, March 2010
FDA’S COMMITMENT TO A “SCIENCE-BASED” APPROACH TO FOOD
LABELING/NUTRITION & PERSPECTIVES FROM INDUSTRY
By: Latesha Richards, Marketing Coordinator
On March 3, 2010, FDA
Commissioner Margaret Hamburg,
M.D., issued an open letter to the
food industry encouraging food
companies to review their product
labeling to ensure they are in
compliance with FDA regulations,
and are truthful and not misleading
with their marketing claims. This
came after warning letters received
by seventeen (17) food companies for
making unauthorized health claims and/or structure/function and nutrient content claims.
A Look at a Few Labeling Mishaps
The food companies recently targeted by the FDA allegedly made unauthorized and/or
misleading claims for their products and in varying degrees including some nutrient-content,
structure/function and health claims that would deem the product an unapproved drug.
For example, two companies received warning letters for their food products that allegedly made
claims of “zero grams trans-fat...” prominently displayed on the front of package label. The
Center for Food Safety and Applied Nutrition (CFSAN) categorized these products as
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misbranded and essentially misleading because the nutrition facts panel declares saturated fat
levels that are considered “high” by the FDA. Further, any product with saturated fat levels over
4 g are required to “bear a disclosure statement (immediately adjacent to the claim) referring the
consumer to nutrition information for those nutrients, as required in 21CFR 101.13(h)(1)…”
However, their product labels failed to bear that required disclosure, according to CFSAN.
Dr. Hamburg concluded in her letter to industry that “Claims that a product is free of trans fats,
which imply that the product is a better choice than products without the claim, can be
misleading when a product is high in saturated fat, and especially so when the claim is not
accompanied by the required statement referring consumers to the more complete information on
the Nutrition Facts panel.”
CFSAN also issued warning letters to a manufacturer of a functional beverage and a snack food.
According to the warning letters, these food manufacturers made several implied claims that
their products that they can treat or cure specific diseases. From CFSAN’s view, these products
were violating the Federal Food, Drug and Cosmetic Act because they made claims that reflected
intended use as an unapproved drug. CFSAN also said that the scientific publications listed
serve as evidence of its “intended use for the cure, mitigation, treatment or prevention of
disease.”
Dr. Hamburg concludes “Products that claim to treat or mitigate disease are considered to be
drugs and must meet the regulatory requirements for drugs, including the requirement to prove
that the product is safe and effective for its intended use.”
It is for these reasons, Dr. Hamburg implies, that the FDA has been focusing on “improving the
scientific accuracy and usefulness of food labeling” in efforts to “improve consumers’ ability to
make nutritious choices.” The FDA will move in full steam to propose guidance for “front-of-
package” labeling and nutrient information on the Nutrition Facts Panel. This will involve an
extensive examination of all the different labeling systems to ensure that they provide consumers
with useful and meaningful nutrition information. Coming up with this system would be
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consistent with the promise of a “standardized, science-based approach” to all of FDA’s
regulations and guidances.
Perspectives on Changes on the Use of Nutrient-Content, Structure-Function, and
Qualified Health Claims
These types of claims described above
have long been the subject of some organizational
perspectives on food labeling. Among some
individuals and organizations, the Center for
Science in the Public Interest (CSPI or the
“Center”) has been on the forefront of labeling
issues and has been persistently pushing for food
labeling reform.
In its “Food Labeling Chaos: The Case for
Reform” report, CSPI proposes a full makeover of
the nutrition facts panel. They believe among
other things in removing extraneous information,
stating calories per serving in larger font,
including daily value and % daily value for sugar content per serving, prohibiting claims such as
“fat free” and “low fat” on products that are not low in sugar, and making nutrition labeling
mandatory for single-ingredient meat and poultry products. CSPI’s proposal for label makeover
can be found here: http://cspinet.org/new/pdf/beforeafterlabel.pdf.
Aside from nutrition facts panel reform, CSPI endorse regulatory reform for nutrient-content,
structure/function and health claims for foods.
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4. NMR News: Volume 3, Issue 3, March 2010
CSPI argues that any misleading structure/function claims should be banned entirely. According
to their report, structure/function claims do not have to satisfy stringent substantiation
requirements that health claims do. They further argue that based on FDA research, consumers
cannot differentiate between structure/function claims and health claims, so the substantiation
standard should be the same for both. Therefore they conclude that same significant scientific
agreement (SSA) standard for health claims should apply to structure/function claims for foods.
The Center also argues that the FDA should prohibit qualified health claims altogether because
the use of uncertain scientific evidence and disclaimers would not be enough to fully protect
consumers. They are pushing for the FDA to refrain from giving companies approval for these
claims unless they meet the rigorous SSA requirement.
The CSPI argues in their case for reform report that a nutrient-content statement like “zero trans-
fat” prominently displayed in “banners, large type, and exclamation points…” is grossly
misleading when the food is not low in saturated fat. They propose that the use of “zero” or “no”
should not be used, unless a serving of the product is low in saturated fat and cholesterol.
Similarly, Nutritionists, Marion Nestle PhD, and David Ludwig, M.D., argues in a Journal of the
American Medical Association commentary piece that current label practices have long been
misleading to consumer and claims, typically nutrient-content claims have skewed the truth.
They endorse revisions and updates to the nutrition facts panel that would help facilitate making
healthier choices easier for consumers. However, unlike CSPI who wants to tighten the
requirements for making claims, Nestle and Ludwig call for an outright ban of front-of-package
label claims.
As the FDA is now proactively following through on front-of-label reform, let’s see if the
FDA follows through on CSPI’s other recommendations. Chances are they probably will. The
implementation of CSPI’s other proposed reforms may not happen immediately and
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spontaneously, but the concern that the food industry will continue in their deceptive practices,
will warrant the reforms inevitable.
Nutraceutical Medical Research, LLC is a full-service clinical research organization
dedicated to substantiating product or ingredient claims with scientific and clinical research
services for nutraceutical, natural products, dietary supplements, ingredient, cosmeceutical,
food and pharmaceutical companies, using evidence-based approaches. We provide
comprehensive scientific/clinical research and medical writing services. We also provide a
wide range of consulting services which includes basic science investigations, clinical trial
development, clinical writing, FDA/FTC questions and compliance, label review, market
research, strategic planning and Statistical analysis.
Disclosure: Nutraceutical Medical Research, LLC and its employees do not subscribe to or
endorse any particular statement, opinion, or perspective made in this article.
To access the Center of Science in the Public Interest’s Food Labeling Chaos Case for Reform
Report, go to: http://cspinet.org/new/pdf/food_labeling_chaos_report.pdf
To access the full list of affected food products, go here:
http://www.fda.gov/Food/LabelingNutrition/ucm202859.htm
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References:
1. Food and Drug Administration. FDA Calls on Food Companies to Correct Labeling Violations; FDA
Commissioner Issues an Open Letter to the Industry Press Release. www.fda.gov..
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm202814.htm. Accessed on March 14,
2010.
2. Brandt MB, Moss J, Ellwood K, et al. Tracking Label Claims. Food Technol. 2010. Accessed on March 15,
2010 at: http://members.ift.org/NR/rdonlyres/365E0772-D840-409A-9626-
9EDC1BA7EAA9/0/0110feat_labeling.pdf
3. Food and Drug Administration. 2010. Open Letter to Industry from Dr. Hamburg. www.fda.gov.
http://www.fda.gov/Food/LabelingNutrition/ucm202733.htm . Accessed on March 14, 2010.
4. Silverglade B, Heller IR; Center for Science in the Public Interest. Food Labeling Chaos: Case For Reform
Report, December 2009. http://cspinet.org/new/pdf/food_labeling_chaos_report.pdf. Accessed on March 14,
2010.
5. Food and Drug Administration. Pom Wonderful warning letter. www.fda.gov.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm202785.htm. Accessed on March 14, 2010.
6. Food and Drug Administration. 2010. Dreyer’s Ice Cream Inc. warning letter. www.fda.gov.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm202826.htm. Accessed on March 14, 2010.
7. Food and Drug Administration. 2010. Gorton’s Inc. warning letter. www.fda.gov.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm202829.htm. Accessed on March 14, 2010.
8. Food and Drug Administration. 2010. Diamond Food Inc. warning letter. www.fda.gov.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm202825.htm . Accessed on March 14, 2010.
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