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Copyright © 2018 | www.khlaw.com Keller and Heckman LLP 1 Pesticide Advertising What Can We Say? Part One: Labels and Labeling April 4, 2018

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Page 1: PowerPoint Presentation April 4...Title: PowerPoint Presentation Author: Gustafson, John B. Created Date: 4/4/2018 12:24:39 PM

Copyright © 2018 | www.khlaw.com Keller and Heckman LLP 1

Pesticide Advertising

What Can We Say?

Part One: Labels and Labeling

April 4, 2018

Page 2: PowerPoint Presentation April 4...Title: PowerPoint Presentation Author: Gustafson, John B. Created Date: 4/4/2018 12:24:39 PM

Copyright © 2018 | www.khlaw.com Keller and Heckman LLP 2

Michael T. NovakMichael Novak practices environmental and business law

for chemical manufacturers and other clients, including

agricultural, antimicrobial, and biochemical pesticide

producers. His practice focuses on the regulation of

pesticides and other chemicals under the Federal

Insecticide, Fungicide and Rodenticide Act (FIFRA) and

other federal and state regulatory programs.

Mr. Novak has expertise in pesticide regulatory issues

associated with product registration, including the

registration of biochemicals and unique technologies;

petitions to cancel or deny registration; data

compensation matters; adverse effects reporting;

enforcement issues; import and export requirements;

tolerance petitions, including the approval of inert

ingredients; and the treated-article exemption.

[email protected] • 202.434.4485

Page 3: PowerPoint Presentation April 4...Title: PowerPoint Presentation Author: Gustafson, John B. Created Date: 4/4/2018 12:24:39 PM

Copyright © 2018 | www.khlaw.com Keller and Heckman LLP 3

Pesticide Advertising: What Can We Say?

Part One The Label and Labeling

Part Two Other Advertising

(Media Other Than the

Label or Labeling)

Page 4: PowerPoint Presentation April 4...Title: PowerPoint Presentation Author: Gustafson, John B. Created Date: 4/4/2018 12:24:39 PM

Copyright © 2018 | www.khlaw.com Keller and Heckman LLP 4

Today’s Topic

Roles of EPA and FTC in Regulating

Advertising

What Can We Say on the Pesticide

Label?

What Can We Say on Labeling?

Page 5: PowerPoint Presentation April 4...Title: PowerPoint Presentation Author: Gustafson, John B. Created Date: 4/4/2018 12:24:39 PM

Copyright © 2018 | www.khlaw.com Keller and Heckman LLP 5

Roles of EPA and the FTC

• EPA – approves claims on the label

through registration of pesticide product

• Section 3 and 40 C.F.R. Part 156

• EPA also regulates “Advertising”

• Not defined in FIFRA

• “Advertising” Regulation: 40 C.F.R. Part 168,

Subpart B

• Section 12 Unlawful Acts – misbranding,

“substantially differs”

Page 6: PowerPoint Presentation April 4...Title: PowerPoint Presentation Author: Gustafson, John B. Created Date: 4/4/2018 12:24:39 PM

Copyright © 2018 | www.khlaw.com Keller and Heckman LLP 6

The FTC

• Section 5 of FTC Act: No deceptive

advertising (i.e., false or misleading)

• Substantiate claim with competent and

reliable evidence

In re: Farnam 45 Fed. Reg. 64596 (Sept. 30,

1980) (false or misleading statement made in

advertising: “non-toxic and safe” in print and

broadcast advertising)

Page 7: PowerPoint Presentation April 4...Title: PowerPoint Presentation Author: Gustafson, John B. Created Date: 4/4/2018 12:24:39 PM

Copyright © 2018 | www.khlaw.com Keller and Heckman LLP 7

EPA and FTC

• Dual jurisdiction over pesticide product

advertising

• Advertising – claims in any medium

(includes label, labeling, websites,

television, radio, print, etc.)

Page 8: PowerPoint Presentation April 4...Title: PowerPoint Presentation Author: Gustafson, John B. Created Date: 4/4/2018 12:24:39 PM

Copyright © 2018 | www.khlaw.com Keller and Heckman LLP 8

What Can We Say on the Pesticide Label?

• FIFRA § 3(c)(1) applicant files statement of claims

• EPA Approves Master Label• Legal document submitted to EPA in application

• Required statements, approved uses, and claims

• EPA-approved, i.e., “stamped”

• Final Printed Label (“FPL”/“Commercial”)• Regulations dictate text size and placement

• Includes registrant’s “art work”

• In past implemented EPA comments

Page 9: PowerPoint Presentation April 4...Title: PowerPoint Presentation Author: Gustafson, John B. Created Date: 4/4/2018 12:24:39 PM

Copyright © 2018 | www.khlaw.com Keller and Heckman LLP 9

What Can We Say on the Label?

• “Label” – Written, printed, or graphic matter

on, or attached to, the pesticide or device, its

containers or wrappers

• Physical Proximity

• Label must be “securely attached” to

the immediate container of the

pesticide product. 40 C.F.R. § 156.10

• Label must be attached to the

pesticide product at a registered

establishment. 40 C.F.R. § 167.20

Page 10: PowerPoint Presentation April 4...Title: PowerPoint Presentation Author: Gustafson, John B. Created Date: 4/4/2018 12:24:39 PM

Copyright © 2018 | www.khlaw.com Keller and Heckman LLP 10

Unlawful Misbranding

• FIFRA § 12 (a)(1)(E)

• (a) (1) It shall be unlawful to distribute or sell

• (E) any pesticide which is … misbranded

• FIFRA §2(q)(1)(A) includes but not limited to:

• The label does not bear the registration number

• Any word, statement or other information required by

EPA to appear on the label or labeling is not prominently

placed thereon

• The labeling accompanying does not bear directions for

use

• The label does not contain a warning or caution

Page 11: PowerPoint Presentation April 4...Title: PowerPoint Presentation Author: Gustafson, John B. Created Date: 4/4/2018 12:24:39 PM

Copyright © 2018 | www.khlaw.com Keller and Heckman LLP 11

What Can We Say On the Label?

FPL Includes only Text Verbatim from Master Label

Can We Paraphrase/Revise?

Brackets – [cleans and] disinfects hard surfaces

PR Notice 98-10 – Non-notifications

State Review of FPLs

Page 12: PowerPoint Presentation April 4...Title: PowerPoint Presentation Author: Gustafson, John B. Created Date: 4/4/2018 12:24:39 PM

Copyright © 2018 | www.khlaw.com Keller and Heckman LLP 12

Advertising Strategy

• All Claims in Advertising Approved on the Master Label

• Tension between safety information and marketing claims (FR Notice on Third-party Cause Marketing – Red Cross)

• PM Reviews and Positions Can Vary

Page 13: PowerPoint Presentation April 4...Title: PowerPoint Presentation Author: Gustafson, John B. Created Date: 4/4/2018 12:24:39 PM

Copyright © 2018 | www.khlaw.com Keller and Heckman LLP 13

What Can We Say on Labeling?

Must Labeling be Submitted to EPA for

Approval?

EPA Label Review Manual

If Reference on Label

Page 14: PowerPoint Presentation April 4...Title: PowerPoint Presentation Author: Gustafson, John B. Created Date: 4/4/2018 12:24:39 PM

Copyright © 2018 | www.khlaw.com Keller and Heckman LLP 14

What Can We Say On Labeling?

• “Labeling” – All labels & all other written,

printed, or graphic matter: (a) accompanying

the pesticide or device at any time; or (b) to

which reference is made on the label or in

literature accompanying the pesticide or

device

• Broader concept

Page 15: PowerPoint Presentation April 4...Title: PowerPoint Presentation Author: Gustafson, John B. Created Date: 4/4/2018 12:24:39 PM

Copyright © 2018 | www.khlaw.com Keller and Heckman LLP 15

FIFRA §2(q)(1)(a)

A pesticide is misbranded if

“its labeling bears any

statement, design or graphic

representation which is false

or misleading in any

particular.”

Page 16: PowerPoint Presentation April 4...Title: PowerPoint Presentation Author: Gustafson, John B. Created Date: 4/4/2018 12:24:39 PM

Copyright © 2018 | www.khlaw.com Keller and Heckman LLP 16

False or misleading statements (40 C.F.R. §

156.10(a)(5)) Examples

• A false or misleading statement about

(1) composition; (2) efficacy; (3) non-pesticidal value or a false/misleading comparison with another pesticide

• Any statement implying Agency endorsement

• A direct or comparative safety claims such as “safe,” “nonpoisonous,” “harmless,” or “nontoxic to humans and pets”

• Non-numerical or comparative statements on safety such as “contains all natural ingredients,” “among the least toxic chemicals known”

Page 17: PowerPoint Presentation April 4...Title: PowerPoint Presentation Author: Gustafson, John B. Created Date: 4/4/2018 12:24:39 PM

Copyright © 2018 | www.khlaw.com Keller and Heckman LLP 17

What Can We Say on Labeling?

• EPA Label Review Manual, Chapter 12,

Labeling Claims

• Examples of Unacceptable Claims

Page 18: PowerPoint Presentation April 4...Title: PowerPoint Presentation Author: Gustafson, John B. Created Date: 4/4/2018 12:24:39 PM

Copyright © 2018 | www.khlaw.com Keller and Heckman LLP 18

What Can We Say on Labeling?

• Lawful Paraphrases that are not False or

Misleading or Otherwise Unlawful

• Anchor Claims Approved on Label

Page 19: PowerPoint Presentation April 4...Title: PowerPoint Presentation Author: Gustafson, John B. Created Date: 4/4/2018 12:24:39 PM

Copyright © 2018 | www.khlaw.com Keller and Heckman LLP 19

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

Keller and Heckman LLP

THANK YOUMichael T. Novak

Keller and Heckman LLPWashington, DC Office

+1 202.434.4485

[email protected]