By Dennis Raglin
April 12, 2019
Another Example of the Law’s Regulatory Ridiculousness
Millions of Americans, including many grandmothers, suffer from pain, whether it be from swollen joints, bad backs, headaches or stiffness – and dozens of other reasons. For those who do not or cannot take prescription medication for their ailments there are many over-the-counter drugs to choose from. One of the most popular is acetaminophen (paracetamol) and Tylenol is the brand name almost everyone knows it by, having been on the market for over 30 years and earning Johnson & Johnson over $400 million in sales in 2018 alone. Acetaminophen itself has been around since the 1940s. Odds are you have acetaminophen in the medicine cabinet, in the glovebox or in your purse or gym bag. If the state agency that interprets Proposition 65, California’s toxics right-to-know law, has its way in the near future you will see a warning slapped on the package telling you that using acetaminophen may cause cancer. As if grandma did not have enough to worry about.
1. The Intent and Reality of Prop 65
California’s Proposition 65 was enacted in 1986 by the voters through a ballot initiative written by a public interest lawyer. (Health & Safety Code section 25249.5, et seq.) His admitted goal was to make a company presumed guilty of failing to warn of the presence in its product of a chemical known to cause cancer and/or reproductive harm and force the company to spend the money to defend itself and its product even if the allegation of a violation was frivolous. Sixty-three per cent of the voters supported the initiate and likely were not aware of this or the fact that the law permits actions brought by private enforcer “bounty hunter” plaintiffs who, in addition to a portion of penalties a company must pay, receive attorneys’ fees they incur, an amount that exceeded $20 million dollars last year. Many voters, given the title of the initiative, likely believed it dealt with safe drinking water, and who could really be against that? Over 30 years later, the law has metastasized to go well beyond water and affects thousands of products companies large and small sell in California, from headphones to Halloween costumes, whether sold in brick and mortar stores or over the Internet.
2. Prop 65 and Medication
And now it may expand further and include this popular over-the-counter pain pill. Unlike prescription drugs, which are exempt from Proposition 65’s reach, over-the-counter drugs (and medical devices) are fair game. There are numerous OTC medication and products that carry warnings. Interestingly, acetaminophen is not the only over-the-counter pain medication on the Prop 65 list. So too is good old aspirin. (Look out Advil you might be next!) Aspirin, however, is not required to carry a Proposition 65 warning because the FDA, which regulates drugs, already requires a warning on the use by pregnant women during the last trimester and the industry considers that warning sufficient to warn of “reproductive harm”. Acetaminophen, while carrying an FDA-required warning regarding alcohol use and liver damage while using the drug, would not, absent FDA intervention and a court ruling, be able to escape a Prop 65 warning if it gets listed as a carcinogen. It is unlikely the FDA will ride to the rescue here, however, as federal preemption for Prop 65 warnings, with two significant exceptions involving nicotine cessation patches and breakfast cereal, has rarely been a successful defense to the law and the FDA has largely avoided wading into preemption of Prop 65 warnings, including on OTC medications. In the nicotine cessation case, the California Supreme Court held that even though Prop 65 warnings may be different than a label required by FDA that does not automatically mean preemption exists. It held that the FDA can reject a state’s labeling requirement if it interferes with achieving a legitimate objective of the FDA or is misleading. The FDA argument that the court agreed with in finding preemption was that consumers would be confused by the Prop 65 warning an it might prevent pregnant women from quitting smoking. (Dowhall v. SmithKline Beecham Healthcare (2004) 32 Cal.4th 90.) What all this means for acetaminophen is that if it joins the Prop 65 chemical list it is unlikely preemption will play a role and short circuit warnings.
3. The End Result of Metastasizing Prop 65 Regulations
Prop 65 has become so far reaching because of the interpretations and actions taken by the state agency that was designated to enforce the law and write the regulations interpreting its provisions, including deciding which chemicals will be listed, what the safe harbor levels for them are and the methodology that must be used by the presumed guilty defendant to prove its product does not expose a consumer to enough of the chemical to require warnings. The agency with this significant power is the Office of Environmental Health Hazard Assessment (OEHHA). And over the last 30 years it has created a great deal of regulations governing this law. This is an agency that truly embodies the phrase, “I’m from the government and I’m here to help”. In many ways the agency has allowed the regulations to run amok. It sets levels of chemicals that require warnings, for example. Their strict level of the chemical acrylamide recently resulted in a court decision requiring warnings on coffee sold in California given the companies could not meet the miniscule safe harbor number OEHHA established as the “safe” amount.
The decision was a disaster and an embarrassment to OEHHA and it is furiously seeking to reverse it by (still more) regulation confirming coffee is actually safe to drink, in essence conceding that in this case good science was replaced by the court having to follow an inflexible cut off for a chemical level requiring warnings that the agency imposed. All this after the coffee industry just spent years and multiple millions defending the case, and after the message that coffee is linked to cancer went worldwide. Governors have tried and failed to reform the regulations and Prop 65. The legislature has tried to pass reforms to the law but succeeded in only minor modifications. It is here to stay and the regulations keep expanding the reach of the law and of the warnings requirements – and the expense to comply and defend the cases increases in the process. The open question, like so many aspects of Prop 65, is does any of this truly make Californians safer, and at what cost? The agency has over 900 chemicals to the “Prop 65 list” over the years. And now OEHHA’s potential decision to list acetaminophen may scare people who need pain medication who see a warning that may not be sufficiently supported by evidence. This surely was not the voters’ intent when enacting the law.
4. Acetaminophen can be Added to the Prop 65 List Without Evidence it Causes Cancer to Humans
The way chemicals are added to the Prop 65 list has been a subject of much debate regarding whether there is sufficient scientific support. One way chemicals are placed on the list is through committees that OEHHA convenes with state-appointed experts in the field. There is one for carcinogens and one for reproductive toxicants. To be listed, the chemical “has (to have) been clearly shown through scientifically valid testing according to generally accepted principles to cause cancer or reproductive toxicity” (Health and Safety Code section 25249.8(b)).
In 2011 acetaminophen was placed on the “high priority” list for consideration as a carcinogen by the cancer committee. But what is the “scientifically valid” basis to put it on the list? A bone of contention by the business community is that the regulations allow OEHHA to list a chemical based on a determination by an authoritative body that it causes cancer, including foreign organizations. In this case, a foreign carcinogen committee in Europe concluded there is “limited evidence” acetaminophen causes cancer based on testing in rats, but found no conclusive evidence of carcinogenicity in humans. (IARC Monographs on the Identification of Carcinogenic Hazards to Humans, Volume 50 (1990)). So, a chemical can be listed based on the conclusion by just one agency even if other agencies have taken no position, or even disagree. Here, the FDA has made no determination that acetaminophen is a carcinogen. OEHHA, however, can rely on the European body’s not-that-strong conclusion, which is in turn based on testing of rats, and then proceed to consider placing it on the list even if there is no state or federal agency making a similar determination. This issue is currently in the spotlight with the chemical glyphosate, the Prop 65 chemical in Round Up weed killer and listed on the Prop 65 list as a carcinogen. OEHHA listed it based on the conclusion of the same foreign agency it is now using to have acetaminophen considered, even though the U.S. EPA has concluded that there is not enough evidence to support such a conclusion. Hence, OEHHA can ignore United States agencies in determining whether to list chemicals and require warnings.
What does this mean for acetaminophen – and perhaps more broadly for OTC drugs in general? It is this authority to list based on authoritative bodies the agency relies on that frustrates businesses and industries far and wide. At issue is whether a chemical listed on this basis is truly harmful to humans exposed to it. Some argue OEHHA is including many chemicals on the list for which there is no or inadequate scientific evidence. Businesses suffer the consequences of any chemical listing in over warnings and the possibility these warnings scare and confuse consumers. They have to incur expense to defend themselves when presumed guilty under the burden shift mechanism of the law. But because defending these cases is usually too expensive, especially for small business, companies end up settling and paying for something that may not expose consumers to chemicals that result in hazardous levels requiring a warning.
5. Next Steps and Take Aways
So, against this background we now contemplate something as ubiquitous as Tylenol coming under the cloud of Prop 65 and sporting warnings. Do we really want people avoiding medication for fear of getting cancer based not on an American agency’s determination, but on a rat study and lukewarm conclusion made by a foreign organization? What about the issue of overwarning? Do we want to risk consumers focusing on the Prop 65 warning to the exclusion of other, arguably, more important warnings on the medication labeling such as liver damage or maximum dosage? And, bottom line, do we really want to scare grandma – and other users? OEHHA is accepting comments from the public through May 29, 2019 in connection with its preparing “cancer hazard identification materials” for the committee’s review on the road to listing. Because this promises to be a big deal, the Consumer Healthcare Products Association trade association secured an extension of the earlier-set deadline and is planning on submitting comments in response to the proposed consideration. Whether these will make a difference we will find out. There will then be further dates set for public input before OEHHA makes a determination. If the chemical is placed on the list the warning requirement is not triggered until one year from the listing.
As this is just developing we will stay tuned and monitor this significant situation.
Dennis Raglin is a shareholder with Buchalter, APC in Los Angeles. He is chair of the Chemical Law Industry Group and counsels clients on compliance with Prop 65 and other state and federal chemical regulations and defends Prop 65 cases in litigation.
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