Food Labeling Enforcement and Compliance Priorities in the ... · FDA’s Nutrition Innovation Strategy •FDA intends to use tools and authorities to better communicate nutrition

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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

[email protected]

mailto:[email protected]


Agenda

▪ FDA Enforcement of Labeling

Violations

▪ Relationship between FDA Actions (or

Inaction) and Class Action Lawsuits


FDA Enforcement of Labeling Violations

▪ FDA Warning Letters

▪ Compliance Policy Guides

▪ Enforcement Priorities and Discretion


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


▪ 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


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”


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


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


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


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



▪ “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



▪ “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


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)


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.


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)


Inaccurate Information Lawsuits

▪ Lawsuits that target inaccurate nutrition

information such as sugars, vitamins

▪ Lawsuits that target inaccurate amounts of

other constituents such as alcohol


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


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


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


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

[email protected]

mailto:[email protected]

Documents

Food Labeling Enforcement and Compliance Priorities in the ... · FDA’s Nutrition Innovation Strategy •FDA intends to use tools and authorities to better communicate nutrition