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Copyright © 2018 | www.khlaw.com Keller and Heckman LLP 1
Food Labeling Enforcement and Compliance Priorities in the Current Environment
April 12, 2018
Evangelia C. Pelonis, PartnerKeller and Heckman LLP
Washington, DC Office
+1 202.434.4106
Pelonis@khlaw.com
Copyright © 2018 | www.khlaw.com Keller and Heckman LLP 2
Agenda
▪ FDA Enforcement of Labeling
Violations
▪ Relationship between FDA Actions (or
Inaction) and Class Action Lawsuits
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FDA Enforcement of Labeling Violations
▪ FDA Warning Letters
▪ Compliance Policy Guides
▪ Enforcement Priorities and Discretion
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FDA Enforcement of Labeling
▪ FDA’s Nutrition Innovation Strategy
• FDA intends to use tools and authorities to
better communicate nutrition information
1. Modernizing claims on labels
• Health claims, nutrient content claims, food group claims
2. Information about ingredients in food
• Names (e.g., potassium chloride as salt)
3. Standards of identity
4. Implementing NFP and menu labeling
5. Sodium reduction
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▪ Since 2012. . .
• 500+ US consumer food class actions
• 150+ in California – majority in
USDC Northern District (now known as
Food Court)
• Other cases filed in New York, Florida and Illinois
▪ Most are styled as class actions for a single
state, multistate, or national classes
▪ Most claims are for product misrepresentations
regarding food content or labeling
Class Action Lawsuits: The Food Court
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Targeted Labeling Issues
• “Natural”
• Nutrient Content Claims (e.g.,
“Healthy”, “No Trans Fat”, “No Sugar
Added”
• Health Claims
• Value-added ingredient claims
• Inaccurate Information
• Country of Origin/
”Made in USA”
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Natural Lawsuits
▪ Food contains artificial or synthetic food
additives/ingredients • Examples: citric acid, ascorbic acid, xanthan gum,
maltodextrin, potassium chloride, monocalcium
phosphate, dextrose, lactic acid, malic acid, riboflavin,
niacin, cocoa processed with alkali (potassium
carbonate), soy ingredients processed with hexane,
caramel color, sodium acid pyrophosphate
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Natural Class Action Lawsuits
▪ Food produced from GM crops or contains
GM derived ingredients • Oil from GM corn
• Soy lecithin from GM soybeans
• Cereal that claims to be “Made with all natural corn”
• Chips that claim to be “Made with All Natural
Ingredients” but made with corn and vegetable oil
(corn, soybean, canola) from GM crops
• Food contains milk or meat ingredients that are
produced from animals fed GM feed
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Natural Lawsuits
▪ Products that contain glyphosates
(pesticide)• “made with 100% natural whole grain oats”
• “all natural” oatmeal
▪ Products that contain natural flavors that
use synthetic carriers like propylene glycol
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Nutrient Content Claim Lawsuits
▪ “Healthy” • Products high in saturated fat or without requisite
10% DV per RACC of vitamin A, vitamin C, calcium, iron, protein or fiber
• FDA Warning Letters (WL) to KIND Bar LLC 3/17/15 – McDonald v. KIND LLC (C.D. Ca. 8:15-cv-615)
– Short v. KIND LLC (E.D.N.Y. 1:15-cv-02214)
• FDA WL to Carrington Farms Coconut Oil 1/13/15 (also issues with drug claims, other nutrient content claims and health claims)
– Boulton v. Carrington Tea Co. LLC’s Carrington Farms
• Products with high sugar levels
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Nutrient Content Claim Lawsuits
▪ “No trans fat” / “zero trans fat” • Unauthorized nutrient content claims
• Difference between 0g and “no trans fat” claim where
claim made and product contains <0.5g TF
• Bowling v. Johnson & Johnson et al (S.D.N.Y. 1:17-
cv-03982) – Benecol spread
▪ Possibly more trans fat lawsuits when
FDA’s PHO final determination goes into
effect on June 18, 2018 if food contains
PHOs after that date
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Nutrient Content Claim Lawsuits
▪ “No sugar added” • The food that is making the claim must resemble and
substitute for a food that normally contains sugars
• Disclose if food is not “low calorie” or not “reduced
calorie”
▪ Antioxidant Nutrient Content Claims
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Health Claim Lawsuits
▪ Unauthorized health claims• FDA WL to Post Foods 3/10/15
– “By consuming at least 48 g of whole grains per day you can
support healthy digestion and reduce the risk of several
chronic diseases like heart disease and diabetes. New Great
Grains Digestive Blend cereal has 41 g of whole grain which
is more than 85% of the daily recommended amount!”
• Krommenhock et al v. Post Foods LLC (N.D.CA. 3:16-
cv-04958)
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Ingredient/Composition Lawsuits
▪ Failure to include ingredients represented
on label • Truffle oil with no truffles but artificial truffle flavor
• Ginger ale “made with real ginger” but only with
natural flavor derived from ginger
• No maple syrup/sugar
• Sunny Delight names beverages after fruit that is not
present in the product (e.g., “Cherry Limeade”,
“Strawberry Guava”, “Orange Passionfruit”)
– Hunt v. Sunny Delight Beverages Co.
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Ingredient/Composition Lawsuits
▪ Over representing presence of value-
added ingredient• Plaintiff alleges that V8 Splash are flavored juice
products positioned as “healthy, natural beverages
brimming with healthy fruit and vegetable juices” but
are artificially flavored sugar water labeled as fruit
juice because it contains only 3% reconstituted carrot
juice, 2% reconstitute fruit juice blend and HFCS
– Sims et al v. Campbell Soup Co. (C.D. Ca. 5:18-cv-00688)
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Inaccurate Information Lawsuits
▪ Lawsuits that target inaccurate nutrition
information such as sugars, vitamins
▪ Lawsuits that target inaccurate amounts of
other constituents such as alcohol
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Country of Origin Lawsuits
▪ Complaints that focus on country of origin
of ingredients or overall impression of
product’s country of origin • Olive oil “Imported from Italy”
• Correct origin of goji berries
• Location where beer is brewed
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Made in USA Lawsuits
▪ “Made in USA” claims
• 2015: “Product of USA” but beer allegedly produced
using imported hops
– Nixon v. Anheuser-Busch, LLC, Case No. CGC-15-544985
• 2015: Claim “MFD. In U.S.A.” on Heinz 57 sauce;
product alleged to contain turmeric, tamarind extract
and jalapenos that are not from U.S.
– Alaei v. H.J. Heinz, Case No. 3:15-cv-02961
• 2015: “Made in USA” on Rockstar Sugar Free drink;
product alleged to contain taurine, guarana seed
extract and milk thistle extract that are not from U.S.
– Alaei v. Rockstar, Case No. 3:15-cv-02959
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Potential Trends
▪ Claims analogous to “natural” claims = “no artificial
colors,” “no artificial preservatives,” “no artificial flavors,”
“pure,” “simple,” “wholesome,” etc.
▪ Degree of processing that would not be expected by
consumer (e.g., use of thickeners to produce Greek
yogurt, high pressure processing to make cold-pressed
juices)
▪ Overpromising value-added ingredients or hiding
negative ingredients
▪ Inaccurate declaration of nutrients/food components
Copyright © 2018 | www.khlaw.com Keller and Heckman LLP 20
Washington, DC • Brussels • San Francisco • Shanghai • Paris
Keller and Heckman LLP
THANK YOUEvangelia C. Pelonis, Partner
Keller and Heckman LLPWashington, DC Office
+1 202.434.4106
Pelonis@khlaw.com
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