A recent wave of enforcement actions by the US EPA targeting the sale of unregistered disinfectant cleaners has highlighted a compliance risk for manufacturers, where products intended for foreign markets can mistakenly land on US shelves with unapproved biocidal claims.
Over the last several months, officials from the EPA’s Region 6 office conducted nearly three-dozen 'for‑cause' inspections at small retail locations in Texas, investigating the suspected sale or distribution of unregistered biocides.
The inspections uncovered Spanish-labelled cleaning products from brands such as Clorox and Fabuloso that allegedly made antimicrobial or disinfectant claims, even though they were unregistered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
While the enforcement efforts have so far focused on small retail outlets, they underscore a broader concern for manufacturers about how products intended for one market can appear in another, and how regulatory consequences may follow even when failures occur further down the distribution chain.
Under FIFRA, products that make pesticidal claims generally must be registered with the EPA before they can be sold or distributed in the US. Manufacturers must submit data demonstrating that the product, when used as directed, will not pose unreasonable risks to human health or the environment, and ensure that labelling accurately reflects approved uses. Products that lack this registration or carry unauthorised pesticidal claims may not be sold.
Since the beginning of the year, the EPA has levied a $40,000 fine on one distributor and issued stop sale, use, or removal orders (SSUROs) requiring several retailers to pull products from shelves.
The agency declined to tell Chemical Watch News & Insight what prompted the inspections or whether additional enforcement actions will follow. However, the agency said unregistered products may enter the US undetected "because they do not get accurately reported to authorities or they are mixed with other products declared under a generic labelling".
Several manufacturers whose products were named in the EPA’s inspection reports and other enforcement documents denied responsibility for the alleged violations, saying that products intended for foreign markets may have entered the US through downstream distribution channels without their knowledge.
The American Cleaning Institute (ACI), a trade group for the US cleaning products industry, said its understanding is that the products "entered the US marketplace illegally without the consent of cleaning product manufacturers".
According to the trade group, "it is important that companies importing, distributing or selling retail cleaning products understand whether the products they are distributing or selling are permitted to be sold in the US".
Ultimately, the enforcement actions highlight the complexities of downstream distribution and the difficulties in keeping specific variants out of unauthorised jurisdictions, experts say.
‘Difficult to control’ distribution
Several manufacturers whose products were named in the EPA’s inspection reports and enforcement documents said unauthorised distribution may explain how unregistered products reached US store shelves.
The Clorox Company said that while it was not aware of the specific enforcement actions in Texas, it has heard of products intended for distribution in Mexico that entered the US without the company’s knowledge.
"Once products are sold into authorised markets, it is difficult for the company to control downstream distribution, and products may occasionally be unlawfully imported into the US, where they are typically sold at small retail outlets," Clorox said.
"When we become aware of such situations, we cooperate fully with the appropriate authorities investigating the unlawful diversion of products," the company added.
Colgate‑Palmolive, which owns the Fabuloso brand, said it manufactures Spanish‑labelled products for sale in Latin America, but "third parties" sometimes import those products into the US without authorisation.
To address the issue, the company said it "contacted retailers and distributors selling Fabuloso in the US that were made for sale in Latin America, requesting that they not import or sell the products in the US".
‘Errors can occur’
These examples reflect a well‑recognised challenge tied to complex distribution networks and cross‑border product movement, industry experts said.
Nicholas Georges, senior vice president of scientific and international affairs for the Household & Commercial Products Association (HCPA), said manufacturers typically communicate with distributors to ensure products remain in their intended markets. But "errors can occur", and products intended for specific markets may occasionally surface elsewhere, he said.
In those cases, Georges recommended that companies "maintain regular communication across the supply chain" to ensure proper market placement.
"Depending on the circumstances, it may also be advisable for companies to obtain written acknowledgement of market restrictions or formal agreements confirming that products will only be distributed in their intended markets," he said.
‘A reputation hit’
Ensuring downstream compliance with jurisdiction‑specific requirements is often more complicated than it appears.
David Rosen, principal at Rosen Strategies, working in ingredient defence and material science communications, said it is "more difficult than people might think" for companies to control distribution channels. Unless a company owns its entire distribution network, it must rely on third parties.
"Sometimes the distribution network has a lot of smaller participants, and some of those smaller participants might not have the resources of a large company to keep up with rules that change," Rosen said. "Unless you own your entire distribution network, it's really hard to get visibility into how many units of a product you have for sale in certain places."
The problem can be exacerbated when small retailers lack regulatory knowledge, forcing them to trust distributors who bring them products, according to Rosen. But those distributors "may not be up to date with the latest regulations that vary from one market to the next, either".
"The more that companies cede control of their distribution network, the less immediate visibility they have into those networks, and so mistakes sometimes happen," he said.
And when mistakes happen, the public scrutiny often lands on the brand name.
"It is the brand name company’s logo on the bottle, and from an optics perspective, it doesn’t matter to an extent whether the manufacturer or the distributor made the mistake," Rosen said. "People are going to associate the issue with you and not the distributor – so it’s a bit of a reputation hit, and depending on who gets fined, it could be a financial hit."
Short of owning their entire distribution network, Rosen said manufacturers need to invest in tools that improve oversight of product placement, such as using artificial intelligence (AI) to track distribution patterns and flag irregular product movements.
Divergent regulatory requirements between neighbouring jurisdictions will continue to expose companies to compliance risks, he said.
"As long as those regulations aren't harmonised, large companies run the risk of accidentally having the wrong variant of a product going into the wrong market," Rosen added. "This really underscores the need for regulators, whenever possible, to harmonise global safety regulations."