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Copyright © 2017 | www.khlaw.com Keller and Heckman LLP 1

USDA Food Labeling 101: Labeling, Claims and Substantiation

August 15, 2017Evangelia C. Pelonis, PartnerBrian P. Sylvester, Associate

Keller and Heckman LLPWashington, DC Office

[email protected]@khlaw.com


Presenter

Evangelia C. Pelonis is a Partner in the Food and Drug practice of Keller and Heckman LLP in Washington D.C. Her practice focuses on all regulatory and compliance matters of the U.S. Food and Drug Administration and the U.S. Department of Agriculture relating to human food, animal feed, food additives and ingredients, and dietary supplements.

Ms. Pelonis works with clients to achieve their marketing goals within the applicable legal frameworks. She counsels clients in all aspects of food development and marketing, from product formulation and manufacturing considerations to food labeling and advertising.


Presenter Brian P. Sylvester is an Associate in the Food

and Drug practice of Keller and Heckman LLP in Washington D.C. His practice includes advising clients on product safety compliance, advertising and labeling requirements, new product development, and recall and crisis management matters.

Prior to joining the firm, Brian was a regulatory attorney at USDA's Office of the General Counsel from 2009 to 2014 where he obtained experience across the breadth of USDA regulation.


Today’s Presentation

Mandatory Labeling Elements

Generic v. Sketch Approval

Nutrition Labeling

Definition of “Natural”

Animal Raising Claims

Animal Welfare Claims

Recent Consumer Litigation


FDA v. USDA

USDA covers all products containing meat or poultry, exceptproducts containing:

→ 3 percent or less raw meat or poultry, or

→ 2 percent or less cooked meat or poultry


Food Labeling

FDA• Federal Food Drug and Cosmetic Act• Nutrition Labeling and Education Act of

1990

USDA-FSIS• Federal Meat Inspection Act (FMIA) • Poultry Products Inspection Act (PPIA)

The FMIA and the PPIA authorize FSIS to approve labels for meat and poultry products before they are marketed in interstate commerce


Mandatory Labeling Requirements

Label: A display of written, printed, or graphic matter upon the immediate container of any article (FD&C Act 201(k), FMIA 601(o), PPIA 453(s))

Labeling: All labels and other written, printed or graphic matter upon any article or any of its containers or wrappers or accompanying such article (FD&C Act 201(m), FMIA 601(p), PPIA 453(s)))

Advertising: materials that do not accompany the article are advertising not labeling


Misbranding – FDA Authority

Misbranded food is a prohibited act (FD&C Act 301)

• Labeling that is false or misleading in any particular (FD&C Act 403(a))

• Express statements and failure to reveal material information

Misleading to whom??• “the ignorant, the unthinking, and the

credulous”

• “reasonable consumer”


Misbranding – USDA Authority

Under the FMIA (21 U.S.C. § 601(n)) and the PPIA (21 U.S.C. § 453(h) (PPIA)), a food is misbranded if:• Its labeling is false or misleading in any

particular

• It is offered for sale under the name of another food

• It is an imitation of another food without proper labeling


USDA Penalties for Misbranding

Withholding or rescinding use of labeling

Product retention

Product detention

Request for product recall, press releases, and/or fines;

Criminal prosecution

Inspection suspension or withdrawal


USDA-FSIS Labeling Requirements

Up to 8 required features (9 CFR 317.2 and 381 Subpart N)• Product name• Inspection legend and est. number*• Handling statement*• Net weight statement• Ingredients statement• Address line• Nutrition facts• Safe handling instructions*


Apply to “packaged” food

• Principal Display Panel (PDP)– Portion of label most likely to be

seen by consumer at time of purchase

– If alternate PDPs, required info must appear on each PDP



• Information Panel– The part of the label to the right of the

PDP with some exceptions

– Ingredients, signature line, nutrition labeling - appear in one place without intervening material




– All label information must be conspicuous and prominent


Product Identity Statement - PDP• A name specified and/or required by

federal law or regulation (usually a “standard of identity”); or

• If no such required name exists, the “common or usual name”; or

• In the absence of either “an appropriately descriptive term” or fanciful name (if nature of food is obvious)

• No letter may be less than one-third the size of the largest letter used in any other word of the product name


Product Identity Statement - PDP

• Standard of Identity (SOI) – Numerous product standards have been established by

regulation. 9 C.F.R. § 319 et seq. (meat); 9 C.F.R. §381.155 et seq. (poultry

– Requires use of specified ingredients, sometimes quantities; optional ingredients may be permitted

– If product meets SOI, must bear that name; if product does not meet SOI, may not use that name

– If product is similar to standardized food, may use “substitute” but if similar product is nutritionally inferior must use “imitation”


Product Identity Statement - PDP• Common or Usual Name / Appropriately Descriptive Term

– Name must accurately identify or describe basic nature of the food, including characterizing ingredient or flavor

– FDA and USDA may establish common or usual names by regulation

– May be different names (e.g., lima (butter) beans); Use more widely known name, may add regional name in parentheses

– If food is marketed in various forms (e.g., sliced), form must be part of name unless depicted in vignette or seen through container

– USDA – processing methods must be included (e.g., salted, smoked, dried) unless nature of processing is clear from product name or manner of packaging


Address Line

Identity of Manufacturer, Packer, or Distributor• Must be an actual corporate name

• Need street address unless company address is in local telephone book

• May be either the manufacturing location or principal place of business

• If you are not the manufacturer, must qualify signature line with an appropriate statement (e.g., “distributed by”)


Inspection Legend & Est. Number

Inspection legend and establishment or plant number required on PDP

Proves product inspected and passed

Specific dimensions and placement for the inspection legend • 9 CFR 312 for meat

• 9 CFR 381.96 for poultry


Safe Handling Instructions

Required if the meat or poultry component is raw or partially cooked (not RTE) and the product is for household consumers or institutional use

Should not be used on RTE products

Safe Handling Statement• This product was prepared from inspected and passed

meat and or poultry. Some food products may contain bacteria that could cause illness if the product is mishandled or cooked improperly. For your protection, follow these safe handling instruction.


Handling Statement

If special handling needed to maintain wholesome condition must use handling statement-• “Keep Refrigerated”

• “Keep Frozen”

• “Perishable-Keep Refrigerated or Frozen”

9 CFR 317.2(k) and 381.125(a)


Nutrition Labeling

• Mandatory on virtually all packaged foods– FDA-regulated foods

– USDA-regulated foods


Nutrition Facts Requirements

On January 19, 2017, FSIS published a proposed rule to revise its nutrition labeling requirements for meat and poultry products to reflect current scientific research and dietary recommendations. 82 FR 6732.

The changes seek to parallel the FDA's recently revised nutrition labeling requirements.

FDA announced that the compliance date for FDA products will be extended beyond July 26, 2018.


Nutrition Facts Requirements

FSIS issued Notice on November 16, 2016 indicating that FSIS regulated products could use the new FDA nutrition labeling format.

But as of July 2017, the proposed rule has been listed as “inactive”.

Current status for FSIS products: use old format or new FDA format.


Nutrition Labeling

• Printed on Information Panel unless less than 40 square inches in which case it may be printed on any label panel

OR• It may be printed on any

label panel if there is no room on Information Panel because of other requiredinformation


Nutrition Labeling

• Nutrition information is reported “as packaged,” not as consumed or prepared

• FDA and FSIS Enforcement Policy

– For naturally occurring nutrients, permit 20% over declaration of the “good” nutrients

– e.g. fiber, vitamins, and minerals

– For added nutrients, “good” nutrients must be at least equal to label declaration

– For both, permit 20% under declaration of the “bad” nutrients

– e.g. fat, saturated fat

– Permit reasonable excess/deficiency within cGMP


Nutrition Labeling

• Source for obtaining nutrition information

– Not required by regulations to analyze product as basis for nutrition information

• If it is an FDA approved database and there is a problem—– FDA will not take action against company, but will

work with the database publisher to resolve the problem

• FSIS encourages companies wishing to use a database to consult USDA Handbook 8, where applicable


Nutrition Labeling Elements • Serving Size

– Calculated based on FDA or USDAreference amounts customarily consumed (RACCs)

– Calculated based on the amount that comes closest to the RACC except:

– If package contains up to 200% of the reference amount, then entire package is declared as one serving (exception for products with ref. amount at least 100g)

– If package contains more than 200% of the reference amount, may be declared as single serving if it can be reasonably consumed in 1 eating occasion

– Declare serving size by common household measure and provide metric equivalent

– Servings per container


Changes to Serving Size Under New FDA Regulations

• New rules treat containers the same, regardless of RACC size

• Containers with <200% of RACC are single serving• Example: New Soda RACC = 360 mL, so up to 719

mL are single serving containers• No longer permitted to label as single serving if

>200% (formerly permitted if unit could reasonably be consumed in one eating occasion).

• Dual column labeling will be mandatory for foods packaged and sold individually and foods sold in discrete units with 200-300% of RACC


FDA Label Formats


Net Quantity of Contents - PDP

• FDA-Regulated Foods– On lower 30% of PDP in lines

generally parallel to the base

– Specific type size requirements depending on size of PDP

– Must provide U.S. and metric measure declaration, e.g., “Net Weight 2.07 ounces (58.7 grams)”


Net Quantity of Contents - PDP

• USDA-Regulated Foods– On lower 30% of PDP, in lines generally parallel to

the base

– Specific type size requirements depending on size of PDP

– Must provide U.S. measure declaration – metric declaration not required

– Exemptions for certain types of products


FSIS Label Approval

FMIA and PPIA require food manufacturers to obtain prior approval for labels of meat and poultry products before products may be marketed.

Prior approval is granted in one of two ways:• “Sketch approval” which is approved by the

Labeling and Program Delivery Staff (LPDS)• “Generic approval” which is approved by

being in compliance with applicable regulations


Sketch Approval

Meat and poultry plants submit labels for sketch approval to FSIS’ Labeling and Program Delivery Staff (LPDS).

LPDS only evaluates four categories of sketch labels (9 CFR 412.1 (c)): • Labels for religious exempt products - 9 CFR 412.1

(c)(1); • Labels for export with deviations from domestic

requirements - 9 CFR 412.1 (c)(2); • Labels for temporary approval - 9 CFR 412.1 (c)(4);

and• Labels with special statements and claims - 9

CFR 412.1 (c)(3).


Special Statements and Claims

Detailed list of special statements and claims requiring LPDS approval and examples of claims eligible for generic approval is available on FSIS website• FSIS Compliance Guidance for Label Approval

(November 2015): http://www.fsis.usda.gov/wps/wcm/connect/bf170761-33e3-4a2d-8f86-940c2698e2c5/Label-Approval-Guide.pdf?MOD=AJPERES


Examples of Special Statements and Claims

3rd party raising claims or programs (i.e. Global Animal partnership, AMS Process verified or certified programs, American Heart Association (AHA) claims)

Claims regarding meat and poultry production practices (i.e. claims regarding the raising of animals such as “no antibiotics administered” or “vegetarian fed”)

Implied Nutrition Claims (i.e., Heart Smart, Baked Not Fried, Made without Butter)



Natural claims, e.g. “All Natural”, “100% Natural”

Negative claims or “free” claims (no MSG, no MSG added, no preservatives)

Claims of the use of non-genetically engineered ingredients



“Whole Grain”, “Made with Whole Grains”, “Made with whole wheat” claims

Claims that are undefined in FSIS regulations or the Food Standards and Labeling Policy Book (Note: Although natural and negative claims are defined in the FSIS Policy Book, the Agency requires such claims to be submitted for approval).


Generic Label Approval

Labels will be generically approved if they meet the criteria listed in 9 CFR 412.2(b)

Generic approval forgoes the need to obtain sketch approval

Generic labeling approval requires that all mandatory labeling features are in conformance with applicable FSIS regulations


Generic Approval Permitted

All, 100%, pure

Allergen or “Contains (name of ingredient)” statements (e.g., contains soy)

AMS Grading (Prime, choice, grade A)

Child Nutrition Boxes

Flavor Profiles (e.g. made with fennel, teriyaki flavored, made with real cheese, only white meat)

Foreign Language on domestic products


Generic Approval Permitted

Geographic claims (refer to 9 CFR 317.8(b)(1))

Green Claims/Environmental Claims

Halal, Kosher (not certified)

Hand pulled style/hand pinched style

Handcrafted, handmade, hand slaughtered, hand crafted style


Timeline for FSIS Label Review

The timeline for the label evaluation process is dependent on a variety of factors:

• The complexity of the label (e.g., claims and special features) and the data accompanying it to support claims;

• The accuracy and completeness of label submissions;

• The number of labels in the queue and staff availability; and prevailing project priorities.


Recordkeeping

FSIS in-plant personnel verify that establishments comply with labeling regulations

Labeling record must include:• Final label applied to product

• Product formulation

• Processing procedures

• Supporting documentation, including prior sketch approval from FSIS (if applicable)


Label Approval Q & A #1

Q: If a label is approved with a negative claim such as “gluten free” can I modify the formula by removing an ingredient or changing the order ofpredominance of the ingredients?

A: Yes, in this case, the removal of an ingredient or change in its order ofpredominance will not affect the special statement or claim so thechange is generically approved under 9 CFR 412.2.


Label Approval Q & A #2

Q: A label with a negative claim (e.g., “No MSG”) was approved by FSIS and the establishment wants to use a new seasoning mix that includes ingredients that were not included in the product formula for the previously approved label. Are the label changes generically approved?

A: No. In this case the label is required to be resubmitted to LPDS for approval so the Agency can verify that the new ingredients do not contain sources including naturally occurring sources of monosodium glutamate.


Food Standards and Labeling Policy Book

Available online

Provides additional guidance regarding FSIS standards outside of the regulations

Used in conjunction with the Meat and Poultry Inspection Regulations and FSIS Directives and Notices

Claims found in the Policy Book may be approved generically except: naturalclaims and negative claims


Animal Raising Claims

FSIS Labeling Guideline on Documentation Needed to Substantiate Animal Raising Claims for Label Submissions (September 2016).

Examples of animal raising claims include: “Raised Without Antibiotics,” “Grass- Fed,” “Free-Range”, and “Humanely Raised”.


Substantiating Animal Raising Claims Documentation typically needed to support animal raising

claims include:• Detailed written description explaining the controls used to

ensure that the claim is valid from birth to harvest or the period of raising being referenced by the claim;

• Signed and dated document describing how the animals are raised (e.g., vegetarian-fed, grass- fed, etc.), to support that the specific claim made is truthful and not misleading;

• Written description of the product-tracing and segregation mechanism from time of slaughter or further processing through packaging and wholesale or retail distribution;

• Written description for the identification, control, and segregation of non-conforming animals or products; and

• If a third party certifies a claim, a current copy of the certificate.


Animal Welfare Claims

Examples: • “Raised with Care” • “Humanely Raised”• “Sustainably Raised”

FSIS has not defined any animal welfare claims in regulations or policy guidelines.

FSIS must approve all animal welfares claims affixed to USDA regulated food labels.

An approvable claim must show ownership and include an explanation of the meaning of the claim for consumers• e.g., “XYZ Ranch Defines Raised with Care as [explain the meaning

of the claim on the label]" or “XYZ Ranch Defines Sustainably Raised as [explain meaning of the claim on the label].”


Litigation – Animal Welfare Claims

Recent case involving animal raising claims:• People for the Ethical Treatment of Animals Inc.

et al., v. Whole Foods Market California, Inc. et al., No. Case No. 15-cv-04301 NC. (N.D. CA, filed Sep. 21, 2015).

– “raised right tastes right”

– “humane meat”

– “no cages”

– “5-Step Animal Welfare Rating”


“Natural” Claims

Challenges to “natural” claims on food products have proliferated in recent years.

Neither FDA nor USDA formally define “natural”


USDA and FDA Policy on “Natural”

FDA• “Natural” means nothing artificial (including artificial flavors) or

synthetic (including all color additives regardless of source) has been included in or has been added to a food that would not normally be expected to be in the food.

USDA• “Natural” may be used on labeling for meat products

and poultry products, provided the applicant for such labeling demonstrates that:

– (1) the product does not contain any artificial flavor or flavoring, coloring ingredient, or chemical preservative (as defined in 21 CFR 101.22), or any other artificial or synthetic ingredient; and

– (2) the product and its ingredients are not more than minimally processed.


Recent Consumer Litigation

• Animal Legal Defense Fund v. Hormel Foods Corp., No. 2016 CA 004744 (D.C. Supr. Ct. filed June 29, 2016)

• Phelps v. Hormel Foods Corp., No. 16-cv-62411 (S.D. Florida, filed on Oct. 11, 2016)

• Organic Consumers Association et al. v. Sanderson Farms Inc., No. 3:17-cv-03592, (U.S. District Court for the Northern District of California, filed June 22, 2017)


Key Takeaways

USDA requires “prior approval” of labeling claims

USDA has specific substantiation requirements in place for “animal raising” claims (updated as of 2016)

No immediate action by USDA to revise Nutrition Facts Requirements is expected

Potential rollback of federal regulations and/or possible halting of activity under new administration could further foment an uptick in consumer litigation.

KH’s Daily Intake Blog: www.dailyintakeblog.com


Washington, DC • Brussels • San Francisco • Shanghai • Paris

Keller and Heckman LLP

THANK YOUEvangelia C. Pelonis, PartnerBrian P. Sylvester, Associate

Keller and Heckman LLPWashington, DC Office

[email protected]@khlaw.com

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