NGOs’ Suit Against FDA Dismissed; No Standing In Formaldehyde Matter, Court Rules

“Injuries to an organization’s government lobbying and issue advocacy programs cannot be used to manufacture standing,” a D.C. district court judge asserts in his ruling against the Environmental Working Group and Women’s Voices for the Earth.

The Environmental Working Group and Women’s Voices for the Earth are not in a position to sue FDA for lack of regulatory action against hair-straightening products that expose users to formaldehyde, the US District Court for the District of Columbia ruled March 19.

In short, neither the nonprofits nor their members have suffered an actionable injury, according to US District Judge Trevor McFadden.

“Injuries to an organization’s government lobbying and issue advocacy programs cannot be used to manufacture standing, because that would allow lobbyists on either side of virtually any issue to take the Government to court,” he asserts in a same-day opinion.

The decision ends a more than two-year legal battle between the agency and NGOs, which have been warning consumers away from hair smoothers that contain or release formaldehyde since at least 2010.

That was when regulators in Oregon and Canada began taking measures to alert salons and consumers about formaldehyde risks associated with popular salon brand Brazilian Blowout, citing adverse-event reports and product analysis. National media attention ensued.  (Also see "Formaldehyde found in Brazilian Blowout products" - HBW Insight, 11 Oct, 2010.)

FDA quickly got involved, but its warning letter to Brazilian Blowout owner GIB, LLC did not issue for another year, following pressure from Congress and a petition from EWG strongly urging the agency to ban formaldehyde and its liquid form, methylene glycol, in heated hair-straightening products.  (Also see "FDA Warns Brazilian Blowout-Like Brand For Undeclared Formaldehyde Risks" - HBW Insight, 23 Sep, 2015.)

In 2015, FDA warned Van Tibolli Corp. for safety and labeling failures associated with its marketing of GKhair smoothers.  (Also see "FDA Warns Brazilian Blowout-Like Brand For Undeclared Formaldehyde Risks" - HBW Insight, 23 Sep, 2015.)

But otherwise the agency has been fairly quiet on the issue, noting on its website that its warning letters should not be construed as a broad condemnation of hair smoothers, while acknowledging the risks of formaldehyde exposure, including the chemical’s cancer links.

Notably, FDA points out that it “does not have authority over the operation of salons or the practice of cosmetology.” Issues of workplace safety and salon air quality generally fall to the Occupational Safety and Health Administration and state and local authorities, it says.

FDA wraps the webpage discussion by stating that it continues to monitor the safety of formaldehyde-releasing hair-smoothers.

This approach is inadequate, EWG and WVE say. Frustrated by FDA’s lack of response to their 2011 petition, the groups filed suit against the agency in December 2016, citing violations of the Federal Food, Drug and Cosmetic Act and Administrative Procedures Act regarding regulatory foot-dragging.  (Also see "EWG Lawsuit Slams FDA’s Failure To Act On ‘Formaldehyde-Laced’ Hair Smoothers" - HBW Insight, 15 Dec, 2016.)

In the context of court proceedings, FDA answered the NGOs’ petition in March 2017, indicating that it was investigating the safety of hair-straightening products that expose salon workers and their customers to formaldehyde, with associated rulemaking potentially to come.

According to FDA, these ongoing initiatives checked two of the three boxes in the groups’ petition. The agency only denied outright one of their requests – that formaldehyde-releasing hair smoothers be labeled with health warnings – which it deemed inappropriate at the time.  (Also see "EWG Seeks Court-Ordered Deadlines For FDA Action On Hazardous Hair Smoothers" - HBW Insight, 22 May, 2017.)

Dissatisfied, EWG and WVE filed an amended complaint in May 2017, now imploring the court to render an order “directing Defendants to grant the Petition by a date certain.”

According to the groups, “six years after the petition was filed, the FDA should be well past the initial information-gathering stage.”

FDA responded in June with a motion to dismiss for lack of jurisdiction and failure to state a claim.

Judge: Merely ‘Abstract Injury’ To Groups’ Interests

In his opinion, McFadden notes that issues of standing in federal litigation hinge on the assertion of injuries that can be traced to alleged violations.

Damage to an organization’s “activities” can constitute an injury in fact. In cases where such theories are set forth, the court must consider whether defendant’s action or omission to act injured the group’s interest and whether the organization used its resources to counteract that harm, the judge explains.

McFadden cites various case law in determining that FDA’s action (or lack thereof) has not impaired the NGOs’ ability to provide services – i.e., an “inhibition of [their] daily activities.”

"It is damage to organizational activities that an organization must allege, and the Plaintiffs here only allege that their organizational goals have been impeded." – District Judge Trevor McFadden

Further, while EWG and WVE have committed considerable funds to the issue of hair-straightener safety – the latter quotes around $371,000 over the past six years – and they claim the expense has been necessary due to FDA’s dawdling, McFadden says this piece of their argument also comes up short.

“Much of this money appears to have been spent on lobbying,” he states, again pointing to reasoning established in similar cases that excludes lobbying from the realm of actionable injuries.

“And to the extent that the money was spent on educating the public, the Plaintiffs do not allege that these expenditures have imposed operational costs beyond those normally expended,” the judge says, adding, “This type of [educational] work is exactly what these organizations always do.”

He adds, “It is damage to organizational activities that an organization must allege, and the Plaintiffs here only allege that their organizational goals have been impeded.”

McFadden also rejects the NGOs’ claims of associational standing based on physical injuries sustained by members, including VWE’s Jennifer Arce, a salon worker who allegedly experienced blistery rashes, bloody noses, bronchitis and coughing up “chunks of blood” due to hair-straightening formaldehyde exposure.

The problem, the judge says, is that such episodes occurred in the past, and the plaintiffs did not present evidence to suggest an immediate threat of recurrence, which is vital to motions for prospective injunctive relief.

McFadden expands on this, stating, “Indeed, the WVE report titled ‘Beauty and Its Beast: Unmasking the Impacts of Toxic Chemicals on Salon Workers’ states that formaldehyde – in ‘keratin hair straighteners’ specifically – ‘can be avoided by using currently available salon products containing safer alternatives.’”

In conclusion, the D.C. district court judge states, “Accepting all of the Plaintiffs’ allegations as true, they have ultimately alleged nothing more than an abstract injury to their interests that is insufficient to support standing.”

A ‘Sword’ For Industry?

A WVE spokesperson called the suit’s dismissal disappointing, noting, “This means the FDA’s delayed response to the concerns these products pose to salon workers and their clients will only continue.”

She pointed out that even the industry-funded Cosmetic Ingredient Review determined formaldehyde/methylene glycol unsafe for use in heated hair-straightening products.  (Also see "Final CIR Assessment: Formaldehyde Unsafe In Heated Hair-Smoothers" - HBW Insight, 3 Oct, 2011.)

“Allowing stylists and their customers to continue to be harmed by these products for nearly a decade is unconscionable. Lawsuit or not, we expect the FDA to protect salon workers and the public from these dangerous products. We will continue to fight and stand up for salon workers' health,” the rep said. 

In the meantime, WVE maintains a list that consumers can consult to avoid hair-straightening brands/products that expose users to formaldehyde. 

From the start, EWG suggested that the lawsuit against FDA served a secondary purpose – to “remind Congress and consumers that there are virtually no protections from cancer-causing chemicals like formaldehyde in hair straighteners.”

Such messaging has been emanating regularly from the NGO as it puts its weight behind proposed legislation to update federal cosmetics regulations and beef up FDA’s authority in the space.  (Also see "ICMAD Responds To Senate Proposal: Cosmetics Should Not Be Regulated Like Foods" - HBW Insight, 23 Mar, 2018.)

In a March 29 blog post, Hyman, Phelps & McNamara attorneys suggest the EWG/VWE case could have favorable implications for industry.

“To the extent that a company is being sued by an association for injunctive relief, this case might be used as a sword to dismiss a complaint for lack of standing,” they say.