PRN 2002-X Draft: False or Misleading Pesticide Product Brand Name

***3/14/2002 DRAFT***

PESTICIDE REGISTRATION (PR) NOTICE 2002-X

Notice To: Manufacturers, Producers, Formulators, and Registrants of Pesticide Products

Attention: Persons Responsible for Registration and Reregistration of Pesticide Products

Subject: False or Misleading Pesticide Product Brand Names

This notice provides guidance to registrants and distributors on pesticide product brand names that may be false or misleading, either by themselves or in association with particular company names or trademarks. Occasionally, some registrants and distributors have considered or adopted product brand names (or placed company names or trademarks within or in close proximity to product brand names) that conflict with current Agency regulations concerning false or misleading claims [40 CFR 156.10(a)(5) and 40 CFR 156.10(b)(2)] and with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) sections 12(a)(1)(e) and 2(q)(1)(A). Under these regulations, products with brand names (or any other statements) that state or imply safety, efficacy, or comparative claims, or are false or misleading in any particular, are considered to be misbranded. To address this problem as it specifically relates to pesticide product brand names, the Agency is clarifying the applicability of its regulations as follows:

• These regulations require that a pesticide product brand name, either by itself or containing or located in close proximity to a company name or trademark, not be false or misleading. Examples of potentially false or misleading product brand names are provided in Table 1. In addition, the guidance provided by Section III.4. of PR Notice 93-6 (pertaining to the use of "Brand" to qualify superlative terms) is superseded by this notice.
• The Agency will be applying these regulations as clarified in this notice when evaluating applications for new products or brand names, or notifications for alternate or changed brand names, for registration or reregistration. Registrants should review their product names in light of this notice, and, if warranted, take corrective action before October 1, 2003. As of that date, EPA will use this guidance when determining whether a product is misbranded under FIFRA section 12.

1. Background
2. Guidance
3. Correction And Prevention Of False Or Misleading Product Brand Names
4. Implementation
5. Scope Of Policy
6. For Further Information

1. Background

   1. Legal

      Section 12(a)(1)(e) of FIFRA states that it shall be unlawful for any person to distribute or sell "any pesticide which is adulterated or misbranded." Section 2(q)(1)(A) of FIFRA provides that a pesticide is misbranded if "its labeling bears any statement, design or graphic representation which is false or misleading in any particular." 40 CFR 156.10(b)(1) requires "the name, brand or trademark under which the product is sold" to appear on the pesticide label. In this document, "product brand name," "brand name," or variants thereof include reference to the entire phrase "name, brand or trademark under which the product is sold."

      EPA's regulation concerning "false or misleading claims" on pesticide labeling is codified in 40 CFR 156.10(a)(5) that states, in part: "a pesticide or a device is misbranded if its labeling is false or misleading in any particular...." This rule also lists ten categories of false or misleading statements or representations that constitute misbranding. The examples provided in the regulations include, but are not limited to, product composition, effectiveness, value for non-pesticidal purposes, comparison to other products, statements regarding endorsement by a Federal agency, multiple active ingredients, true statements used in a misleading manner, negating or detracting disclaimers, safety-related claims, and comparative safety claims. 40 CFR 156.10(b)(2) specifically states, "No name, brand, or trademark may appear on the label which: (I) Is false or misleading, or (ii) Has not been approved by the Administrator through registration or supplemental registration as an additional name...." FIFRA and the regulations just cited also prohibit any false or misleading claims that may appear anywhere on pesticide labeling or on the labeling of certain exempted products [40 CFR 152.25(g) minimum risk pesticides]. In addition, advertising may not contain claims that differ from those that have been accepted as part of the labeling of a registered product [FIFRA section 12(a)(1)(B)].

      The role of trademark status does not alter the applicability of these provisions. When the U.S. Patents and Trademarks Office approves a trademark, it only authenticates the uniqueness of the trademark and that a particular person or corporation is the owner of that trademark. Case law has established that the issuance of a trademark confers no authority for the trademark owner to avoid compliance with other statutes. Thus, a trademark appearing on pesticide product labeling must comply with FIFRA and its regulations; it is not exempt from FIFRA requirements simply because it was accepted as a trademark. Consequently, a trademark that is false or misleading pursuant to FIFRA could render a product misbranded under FIFRA.

      The Agency recognizes that trademarked company names or brand names are a normal part of commerce and serve a vital function in terms of brand name recognition, product "loyalty," and the like. The Agency is not concerned about trademarks per se, but is concerned when trademarks are used in such a way as to make claims about a pesticide product that are false or misleading. The Agency has developed this notice based on an effort to be sensitive to the important role that company and brand names can play in commercial settings while addressing only the issue of false or misleading claims associated with such names. Overall, the intent of this notice is to bring all product names, which may include trademarked company names or brand names, into compliance with FIFRA and its regulations, and thereby create a "level playing field" for all pesticide registrants and distributors, as well as protect the public from false or misleading claims.

   2. Product Brand Names And/Or Related Company Names Or Trademarks That Involve Safety Claims

      In implementing FIFRA and its regulations, the Agency reviews a pesticide product's labeling and informs applicants or registrants if specific statements, claims, product brand names, logos, pictures or other aspects of the labeling are false or misleading in any particular. However, significant issues continue to arise specifically related to false or misleading product brand names.

      One significant issue has been product brand names that involve safety-related claims. FIFRA and its implementing regulations do not permit the use of brand names containing safety-related terms such as "safe" or "natural." EPA regards such terms as misleading and prohibited under its regulations. On some occasions, even after EPA informed registrants of the unacceptability of such product names, certain companies changed their company names or trademarks to include these same words, and then placed their companies' names or trademarks closely enough to the product brand names so that they appear to be included in the products' names or otherwise to constitute claims for the products. In addition, some companies attempted or appeared to qualify their company name or trademark in the product brand name by inserting the word "Brand" between the company name or trademark and the rest of the product brand name.

   3. Product Brand Names Involving Heightened Efficacy

      Another issue concerns product brand names or claims that imply that a product has a greater degree of effectiveness than it actually does or by comparison with other products of similar composition or that the product works in some way that has not been demonstrated for it and/or is inconsistent with what is known about its toxicity or mode of action. In 1993, the Agency issued PR Notice 93-6, which declared the Agency's position that certain claims of heightened efficacy (e.g., "professional strength," "hospital strength," "industrial strength," etc.) are false or misleading. This notice, however, made an exception for product brand names in which a superlative term is qualified by the term "Brand." For example, product brand names such as "Superior Brand," "Ultra Brand," and "Ultimate Brand," were determined to be acceptable. Our experience subsequent to the PR notice and a careful review of our current regulations have shown that the use of the term "Brand" is not in all circumstances sufficient to remove the false or misleading nature of the claim. Therefore, the guidance provided by this notice supersedes section III.4 of PR Notice 93-6 concerning the use of "Brand" to qualify superlative terms.

   4. Treated Articles

      The Agency has had similar concerns over potentially false or misleading product brand names of articles treated with antimicrobial pesticides. PR Notice 2000-1, section III.B., states, "The Agency regards trademarked product names of treated articles or substances [or references to trademarked names of registered pesticides] as potential sources of public health claims that could render a product ineligible for the 'treated article exemption'...."

   5. Scope of Problem And Need For Guidance

      The Agency continues to receive occasional requests for acceptance of federal and state pesticide product brand names that appear to be false or misleading either by themselves or due to the company names or trademarks involved. Because of the growing potential for product brand names (either by themselves or in association with company names or trademarks) that appear not to comply with FIFRA and the regulations, the Agency believes that additional guidance is needed so that registrants can better understand the circumstances under which product brand names are potentially false or misleading and what kinds of corrective actions are needed for registered products already bearing such brand names.




2. Guidance

   A pesticide product brand name, either by itself or in connection with a company name or trademark must not be false or misleading in any particular. EPA's regulations [40 CFR 156.10(a)(5) and 40 CFR 156.10(b)(2)] and FIFRA give the regulatory foundation for this position, as described above.

   This notice is intended to aid registrants in bringing their product brand names into compliance with those regulatory requirements. Specifically, this notice provides clarifying guidance to help registrants determine whether their product brand names, alone or through association with their company names or trademarks, comply with the regulations cited above. To ensure that a product's name is consistent with those regulations, a registrant should review the brand names of its products in light of the regulations and guidance in this notice and take corrective action, if warranted. Examples of words, terms, or phrases that might cause product brand names to be false or misleading are listed in Table 1. By examining these examples as well as other terms listed in the regulations cited above, registrants can determine whether they need to take corrective steps.

   False or misleading statements of any type, when made on pesticide labels or labeling, are violations of FIFRA and certain regulations promulgated under FIFRA. Whether they appear within product brand names or elsewhere on labels or labeling, false or misleading statements have the effect of directly or indirectly misinforming those who read them. Depending upon the nature of the false or misleading statement, such misinformation could inappropriately bias a customer's selection of which product to buy and apply. False or misleading statements fall into various categories; some declare or suggest that the product for which such statements are made is safer, more effective, or otherwise superior to alternative products even though the competitive products meet all of the same standards for registration. If users are misled by such claims, they may not obtain optimal pest control results and/or may be placed at greater personal risk than they had expected. In addition, the product selected on the basis of false or misleading statements might not be the best choice for minimizing adverse effects on the environment. In any event, product users could suffer an economic disadvantage as a result of such claims.

   As opposed to statements and claims that are false and misleading, acceptable statements or claims are derived from appropriate scientific research or other documented information. Depending upon the nature of the claim being made, EPA may require submission of relevant information prior to accepting the claim or as a condition of its acceptance. For some use patterns, EPA requires submission of data to support target pest claims or to support specific claims over and above the basic pest control claims. For certain other uses, EPA has waived the requirement to submit efficacy data on a routine basis but (1) expects registrants to obtain and maintain such supporting data and (2) reserves the right to require submission of such data at any time. For all products, certain data requirements pertaining to product chemistry and human and environmental safety must be addressed through data submissions, citations, or waivers supported by rationales accepted by EPA. Even where such safety data indicate a low or very low degree of risk, claims of absolute safety or no risk as well as claims of relative safety are generally misleading.

   Table 1. Examples Of Potentially False Or Misleading Product Brand Names

   Selected Types Of False Or Misleading Statements	Examples of Potentially False or Misleading Words or Phrases in Product Brand Names
   Composition	"100% Pure," "Contains No (chemical name)"
   Effectiveness	"Eradicator," "Germ-Shield," "100% Protection," "All-Kill"
   Safety-related or comparative safety	"Safe," "Safer," "Safest," "Natural," "Healthy," "Non-Toxic," "Environmentally Safe"

3. Correction and Prevention of False Or Misleading Product Brand Names

   If corrective steps are needed, a registrant should follow the guidance described in this section. A federal registrant or distributor of a product bearing a false or misleading product brand name (which may or may not contain a false or misleading company name or trademark) may consider and select from the following options to bring that product label into compliance:

   1. Change Or Delete Words, Phrases, Company Names Or Trademarks In The Product Brand Name

      If a product brand name contains one or more words, phrases, company names, or trademarks that are like those listed in Table 1 as potentially false or misleading, the registrant or distributor may simply change them or remove them from the product brand name. If the registrant or distributor decides to remove a company name or trademark from the product brand name, but not change the company name or trademark, then the registrant or distributor should ensure that the company name or trademark:

      (1) appears in a smaller type size ( such as 1Ú2 the size of the product name or smaller) and different font from that of the product brand name, and

      (2) is not located in close proximity to the product brand name (for example, the company name could appear on the back panel or at the bottom of the front panel if the product brand name is at the center or top of the front panel).

      If the registrant or distributor chooses to change a product brand name, change a company name or trademark, change the placement of the company name or trademark on the labeling, or remove a company name or trademark from the product brand name, it should follow the procedures described in Section IV.

   
   
   2. Use Qualifiers Or Disclaimers

      If a product brand name contains a word, phrase, company name or trademark that is like one of those listed in Table 1 as potentially false or misleading, and the registrant or distributor does not wish to change or remove that word, phrase, company name or trademark, the registrant or distributor may, in some instances:

      (1) qualify its product brand name with an asterisk (using the same type size, font and color as for the product brand name), and

      (2) place a corresponding asterisk and explanatory text immediately under or in close proximity to the product brand name clarifying that the word or phrase is not intended to constitute the apparent claim; the asterisk and text should be prominent enough that the average consumer can easily find and read the qualifier/disclaimer statement, such as in the same font/color as the product brand name and at least 1Ú2 the type size of the product brand name.

      When using a qualifier or disclaimer, the registrant or distributor needs to provide a brief, credible explanation as to why the word(s) or phrase(s) is/are not false or misleading. This qualifier could, depending on the circumstances, either clarify what the word or phrase does mean or what it does not mean, or both. For example, if a product brand name is "Herbicide X Plus," the word "Plus" by itself may appear to imply greater efficacy than the product is registered to deliver. However, if this word is qualified to explain that "Plus" means that a fertilizer has been added to the formulation to provide plant nutrients, then such a qualifier could be used to prevent a false or misleading impression about the product brand name.

      The Agency will decide on a case-by-case basis whether a particular disclaimer or qualifier requested by the registrant or distributor would be acceptable as a means of preventing a product brand name from being considered to be false or misleading. The factors that the Agency would consider when making such a decision include, but are not limited to: (a) the category of claim and applicable section of the regulations [40 CFR 156.10(a)(5)] involved (i.e., efficacy, chemistry, safety, etc.); (b) the strength of the false or misleading claims; © the degree to which the proposed qualifier/disclaimer language appears to mitigate the false or misleading words or phrases; (d) the similarity of the product brand name to other known false or misleading words or phrases; and (e) the history of the product brand name, company name or trademark.

      If the registrant or distributor of a registered product chooses to add a qualifier or disclaimer to a product brand name, it should follow the procedures described in Section IV.

   
   
   3. Use Of "Brand" After Words, Phrases, Company Names Or Trademarks In A Product Brand Name

      As described in Section I.B. (Background), some companies have attempted to qualify their name or trademark within a product brand name in order to attempt or appear to minimize the potential for being considered a false or misleading claim (e.g., "100% Natural Brand Insecticide"). As of the effective date of this notice, the Agency generally does not expect to consider the use of "Brand" by itself to be an adequate modifier of any word, phrase, company name or trademark within a potentially false or misleading product brand name. However, the Agency will generally consider allowing the use of "Brand" in conjunction with adequate qualifiers and disclaimers, as described in Section III.B. above. When "Brand" is used to modify a word, phrase, company name or trademark in a product brand name, it should clearly connect to what it is modifying, for example, by appearing on the same line and in the same type size, font and color as the company name or trademark. The Agency expects to consider the same factors as described in Section III.B. above when deciding whether to allow the use of "Brand" alone or in conjunction with a qualifier or disclaimer to modify a potentially false or misleading product name. Accordingly, section III.4. of PR Notice 93-6 (pertaining to the use of "Brand" to qualify superlative terms) is superseded by this notice.




4. Implementation

   In order for registrants and distributors to remain in compliance with FIFRA and its implementing regulations, registrants and distributors need to be sure that their products, labeling, and packaging, any collateral literature, advertisements or statements made or distributed in association with the sale or distribution of the pesticide product comply with FIFRA Sections 12(a)(1)(e) and 2(q)(1)(A), and 40 CFR 156.10(a)(5) and 40 CFR 156.10(b)(2). Registrants are reminded that they are responsible for informing their distributors when they change their labeling, and for monitoring the labeling of their distributors to assure that they make the necessary changes.

   As of the effective date of this notice, EPA will review all applications for new pesticide product registrations, for amendments to registered products, and for reregistration of registered products using this guidance. As of October 1, 2003, the Agency will monitor registered products using this guidance to determine whether their labeling is consistent with 40 CFR 156.10(a)(5), 40 CFR 156.10(b)(2) and FIFRA. Pesticide products that are released for shipment by registrants or distributors on or after that date and that bear product brand names or trademarks that EPA determines are false or misleading would risk being a violation of FIFRA.

   To give sufficient time for pesticide products in the channels of trade to be distributed or sold to users or otherwise disposed of, the Agency is providing a period of time for companies to comply with those labeling elements that have been clarified by this notice. Therefore, pesticide products released for shipment prior to October 1, 2003 will be considered existing stocks in the channels of trade that may be sold, used or otherwise disposed of until exhausted. Registrants and distributors should take corrective measures as soon as possible to assure that their product brand names are in compliance with FIFRA and its implementing regulations. Registrants who wish to modify their product labels to ensure compliance with FIFRA should submit revised labeling through the applicable steps described below:

   1. To change a false or misleading product brand name that does not involve a company name or trade name, a registrant should submit a notification (according to PR Notice 98-10) for each product. EPA will review the notification and determine whether the new product brand name is acceptable. The registrant should submit one copy of the label (with changes clearly marked in a way that can be photocopied) along with a completed Application for Registration form (EPA Form 8570-1). A photocopy of the EPA application form is acceptable. The application form should bear the following statements, as set forth in PR Notice 98-10:
      
      "Notification of label change relative to PR Notice 2001-X. This notification is consistent with the guidance in PR Notice 2001-X and the requirements of EPA's regulations at 40 CFR 156.10 and 40 CFR 152.46, and no other changes have been made to the labeling or the confidential statement of formula of this product. I understand that it is a violation of 18 U.S.C. Sec. 1001 to willfully make any false statement to EPA. I further understand that if this notification is not consistent with the guidance of PR Notice 2001-X and the requirements of 40 CFR 156.10 and 40 CFR 152.46, this product may be in violation of FIFRA and I may be subject to enforcement action and penalties under sections 12 and 14 of FIFRA."
      
      Distributors who wish to revise their product names should submit an amended Notice of Supplemental Registration signed by the registrant and distributor so that EPA's records can be changed.
   
   
   2. To change a company name or trademark that appears in or is placed in close proximity to a product brand name and thereby may create a false or misleading product brand name, a registrant should inform the Agency by letter of the change using one of the addresses below. If the company name or trademark is part of or in close proximity to a product brand name, the registrant should follow step 1 as well. Distributors who wish to revise their product names should submit an amended Notice of Supplemental Registration signed by the registrant and distributor so that EPA's records can be changed.
   
   
   3. To change a product brand name either by removing a company name or trademark from the product brand name and placing it elsewhere on the same panel of the label, or by qualifying the product brand name, the registrant should submit an amendment consisting of a completed Application for Registration form (EPA Form 8570-1) and three (3) copies of the revised labeling showing the exact location, size and font of the: (1) amended product brand name, (2) the company name or trademark, and (3) any qualifier (asterisk plus qualifying phrase) associated with the company name or trademark on the product labeling. Distributors who wish to revise and/or qualify/disclaim their product names should submit an amended Notice of Supplemental Registration signed by the registrant and distributor so that EPA's records can be changed.
       



5. Scope Of Policy

   This PR Notice describes the requirements set forth in Agency regulations and FIFRA, and provides general guidance to EPA and to affected parties as well. While the requirements in FIFRA and Agency regulations described here are binding on EPA, registrants, and applicants, this PR notice itself is intended to provide guidance to EPA personnel, pesticide registrants and applicants, and the public. As a guidance document, this policy is not binding on either EPA or any outside parties, and the EPA may depart from the guidance where circumstances warrant and without prior notice. In their applications for registration or amendment, registrants and applicants may propose alternatives to the recommendations described in this notice, and the Agency will assess them for appropriateness on a case-by-case basis and will respond in writing, if requested. If EPA determines that a product name is false or misleading pursuant to 40 CFR Part 156, the Agency may find the product to be misbranded under FIFRA section 2(q) and may take appropriate enforcement and/or regulatory action.




6. For Further Information

   If you have questions, contact your product manager.

   Marcia E. Mulkey, Director
   Office of Pesticide Programs