Pesticide Labeling Questions & Answers - Advertising Claims
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(Note: Contact your Pesticide Product Registration Ombudsman for specific label issues about a single product).
These answers are not intended to create significant new guidance or require any changes to previously accepted labeling. The Agency will contact registrants directly about how to correct problematic labels as appropriate. Changes to EPA accepted labeling will only be required in accordance with standard agency procedures. These answers are primarily based on federal law, regulations and policies implemented by EPA. States, tribes, territories, and other federal agencies may have additional requirements relevant to their jurisdictions.
- Advertising Claims
- Antimicrobial Claims
- Contract Manufacture
- Use Sites
- Definitions of Terms
- Distributor Product Labeling
- Exception to Use in a Manner Not Permitted (FIFRA Sec 2ee)
- Existing Stocks
- General Labeling
- Labeling from Web Sites
- Multiple Products Packaged Together
- NAFTA Labeling
- Pesticide Exemption (FIFRA 25B)
- Pictures and Logos
- Repacked Products
- Service Containers
- Subject to FIFRA
- Superlative Terms
- Supplemental Labeling (NOT distributor products)
- If my clear waterbased roof coating contains the EPA recommended maximum dosage of an already EPA registered fungicide/mildewcide, can I claim on my marketing pieces that my coating contains an EPA-registered fungicide/mildewcide as long as I do not specify the kinds of fungus/mildew it prevents growth on the film? Also, would I need to list that EPA registered fungicide/mildecide on my label and literature? LC13-0656; 08/30/13
40 CFR 152.25(a) provides an exemption from the requirements of registration for qualified treated articles or substances. The exemption provision states that “an article or substance treated with, or containing, a pesticide to protect the article or substance itself (for example, paint treated with a pesticide to protect the paint coating, or wood products treated to protect the wood against insect or fungus infestation), [is exempt] if the pesticide is registered for such use.” If your product otherwise qualifies for the treated article exemption, you may make claims about the pesticide in your product so long as each of the requirements cited above continue to be met and none of your claims or statements state or imply in any way that the pesticide provides any benefit beyond mere protection of the treated product itself. If any of the above-cited requirements are not met or if any of the statements or claims state or imply in any way that the pesticide is protecting more than the treated product itself, the treated product would need to be registered.
- May a FIFRA exempt 25(b) label state:“Bedbugs are small parasitic insects that feed on the blood of humans. Use...to eliminate infestation."? LC12-0546; 08/02/12
Pesticides qualify for an exemption from registration requirements as described at 40 CFR 152.25(f) [promulgated under the authority of FIFRA 25(b)] if they: 1) contain only active ingredients listed at 40 CFR 152.25(f)(1); 2) contain only permitted inerts as described in 40 CFR 152.25(f)(2); and 3) meet all of the conditions listed in 40 CFR 152.25(f)(3). One of the conditions in 40 CFR 152.25(f)(3) is that such product "must not bear claims either to control or mitigate microorganisms that pose a threat to human health, including but not limited to disease transmitting bacteria or viruses, or claims to control insects or rodents carrying specific diseases, including, but not limited to ticks that carry Lyme disease.” While the Agency does consider bedbugs to be pests of significant public health importance (see PR Notice 2002-1), the claim “bedbugs are small parasitic insects that feed on the blood of humans. Use ... to eliminate infestation” does not indicate that bedbugs carry specific diseases and therefore does not itself disqualify a pesticide product from the exemption. Another condition in 40 CFR 152.25(f)(3) is that the pesticide labeling not include any false and misleading statements. To meet this condition, all claims, such as a claim that the product will eliminate bedbug infestation, should be substantiated in accordance with the Federal Trade Commission’s guidelines for substantiating advertising, available at http://www.ftc.gov/bcp/guides/ad3subst.htm. For more information on FTC's guidelines, see http://www.ftc.gov/bcp/menus/resources/guidance/adv.shtm.
- Does the Agency distinguish between repellency claims and resistance claims for purposes of determining whether a product is a pesticide? For example, if a mulch product claimed to “resist insects” would that constitute a pesticide claim? If “resists insects” is considered a pesticide claim would the mulch in this example require registration prior to being offered for sale? LC12-0525; 05/24/12
FIFRA section 2(u) defines pesticide, in part, as “any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest.” As explained in 40 CFR 152.15(a), when a person distributes or sells a substance with claims that it can or should be used for a pesticidal purpose (e.g. preventing, destroying, repelling or mitigating pests), the substance must be registered unless it has otherwise been exempted from the requirement for registration in 40 CFR 152 Subpart B. Product claims are considered to be pesticidal if they are synonymous with “preventing, destroying, repelling, or mitigating pest.” Claims are judged on a case-by-case basis considering the context in which they are made, but it is likely that a claim that mulch “resists insects” would be considered a pesticidal claim because "resisting" pests is similar to "preventing, destroying, repelling or mitigating" pests. One exception is products, containing no toxicants, that are intended to exclude pests only by providing a physical barrier against pest access are not considered pesticides because EPA has determined they are not intended for a pesticidal purpose. 40 CFR 152.10(c). Unless the mulch fits this exception or is otherwise exempt, it would need to be registered to be sold or distributed in the United States. For more detail on what pesticide products are exempt from registration requirements see http://www.epa.gov/pesticides/bluebook/chapter1.html#pest.
- The Department of Pesticide Regulation's Legal Office is currently reviewing the label of a pool filter product that contains diatomaceous earth. The company is claiming that the product is not a pesticide. However, their packaging states the product "removes dirt, harmful pathogens and microbes down to 2 microns". On one hand, the diatomaceous earth filter could be seen as a physical barrier, which would not require registration. On the other hand, the reference to "harmful pathogens" seems to be getting into the arena of a public health claim. Would U.S. EPA consider this product to be a pesticide requiring registration? LC11-442; 10/6/11
The label statement “removes pathogens and microbes down to 2 microns” is a pesticidal claim. In order for the product to qualify as a barrier product under 40 CFR 152.10(c), the product the following conditions must be met:
- The product is not intended to prevent, destroy, repel, or mitigate a pest, or to defoliate, desiccate or regulate the growth of plants.
- The product or article does not make a pesticidal claim on the labeling or in connection with sale and distribution.
- The product is intended to exclude pests only by providing a physical barrier against pest access, and contains no toxicants.
Based on the criteria listed above, this product does not appear to qualify as a barrier because it makes a pesticidal claim and is intended to mitigate a pest (the pathogens) . The product would also not be classified as a pesticidal device since it contains a substance “diatomaceous earth,” which is contained in a number of EPA registered products. Therefore, this product would be a pesticide and subject to regulation under FIFRA.
Can you put on the label of a registered pesticide a statement that is a "new and improved" or "next generation" version of a previously unregistered pesticide? LC10-0353; 05/07/10
Historically, EPA has allowed the claim "new" to be used on labeling for a period of 6 months following approval of a new registration. "New" has not historically been allowed as part of a product name. Terms or marketing claims such as "improved," "next generation," etc. are reviewed on a case-by-case basis to determine whether they are false or misleading and therefore not allowable. A review of the complete label is needed to determine the acceptability of such terms. See Label Review Manual, Chapter 12, Section VII.
May a label contain advertising for a registrant's other products? For example, may it show pictures of fertilizer and other pesticide products the registrant distributes and say "For More Lawn and Garden Products visit. . .(website)"? LC09-0284; 11/4/09
Yes, this is allowed as you have described so long as the reference to other products is (1) not false or misleading and (2) does not detract from required label information. See FIFRA 2(q)(1)(A); (2)(q)(1)(E. If either condition is not met, the product is misbranded and cannot be sold or distributed. FIFRA 12(a)(1)(E). To avoid a product being misbranded, EPA suggests the following guidance for registrants when adding references (including pictures and/or website addresses) to other products including pesticides on a label:
- It should be very clear that those products are separate and distinct from the subject product, ie. such references to these other products should be clearly distinct from the required labeling of the subject product. It is especially important that reference to other products does not distract users from reading the labeled product's Directions for Use.
- The advertising should not contain mandatory language saying another specified product must be used in order to achieve control/relief. Any requirement that products be used in combination to achieve efficacy for a pesticide product must be part of the Directions for Use and must be evaluated by EPA as part of the granting of a registration.
- The registrant should understand that any reference to a website makes that website labeling and therefore subject to more searching EPA review than if it were not referenced. Future versions of a website referenced on a label will also subject to the same review, though at this time the Agency does not require notification or approval of such changes.
Please note that distributor products are not allowed to add claims to the label that have not been approved on the parent product's label. 40 CFR 152.132(d). Therefore, a distributor may not add advertising for its other products unless such advertising is also on the parent product's label.
A lawn care operator (LCO) has advertising in a local newspaper advertising its service, claiming mosquito and other pest elimination from customer yards. At the bottom of the ad, it states "Safe." Is stating a service using a registered product is “safe” in an advertisement a violation of FIFRA or its associated regulations? (LC08-0177)
Section 12(a)(1)(B) of FIFRA makes unlawful any sale or distribution of “any registered pesticide if any claims made for it as a part of its distribution or sale substantially differ from any claims made for it as a part of the statement required in connection with its registration.” The statement required for registration must include “a statement of all claims to be made for [the pesticide].” FIFRA 3(c)(1)(C). EPA generally has not allowed the use of “safe” in labeling because it has been considered to be false or misleading. 40 CFR § 156.10(a)(5)(ix). False and misleading claims make a product misbranded and sale and distribution of such product unlawful. See FIFRA §§ 2(q)(q)(A); 12(a)(1)(E). If use of the term “safe” has not been allowed in labeling and use of the term hasn’t been otherwise approved, use of “safe” in advertising the sale or distribution of a pesticide product would generally be considered to substantially differ from what was approved in the registration and sale or distribution of the pesticide would be unlawful under section 12(a)(1)(B) of FIFRA.
It is important to point out, however, that Section 12(a) is limited to unlawful sale or distribution, which is defined in FIFRA 2(gg) to exclude "the holding or application of registered pesticides ... by any applicator who provides a service of controlling pests without delivering any unapplied pesticide to any person so served." See also FIFRA 2(e)(1). This limits EPA's authority to regulate advertising claims made by certain home lawn care service companies that do not sell or distribute pesticides but merely apply them. To the extent EPA lacks regulatory authority over advertising of services, however, the Federal Trade Commission's (FTC's) broad authority to regulate advertising provides a means to regulate and enforce against excessive or misleading claims made by lawn care operators. Therefore, lawn care operators that do not sell or distribute pesticides but make false or misleading claims about their services, may be subject to enforcement by the FTC.