FDA clarifies position on CBD, cracks down on 15 online stores

The U.S. Food and Drug Administration issued a revised consumer alert on Cannabidiol (CBD), warning that the agency is aware that some companies are marketing CBD products in ways that violate the federal Food, Drug and Cosmetic Act (FD&C Act), and that may put the health and safety of consumers at risk. The FDA also sent a new round of warning letters to 15 companies in an effort to crack down on illegal selling practices.

The CBD industry is one of the fastest growing markets in the US. CBD-infused ointments, gummy bears, beauty creams, baby oil, dog treats—you name it, they have it—have been widely adopted by many mainstream retailers as the stigma surrounding the cannabis industry fades.

CBD, a chemical component of the Cannabis sativa plant, is believed to not cause the intoxication or “high” that comes from tetrahydrocannabinol (THC). Hemp is a strain of the Cannabis sativa plant that is grown specifically for the industrial uses of its derived products and, in contrast to marijuana, is known for its low concentrations of THC.

Congress appeared to give hemp-derived CBD sales a green light for the first time in December 2018, when President Trump signed theAgriculture Improvement Act of 2018, known as the Farm Bill, into law. This legislation granted general retail stores the right to sell hemp-derived CBD products by removing “hemp”—defined as cannabis and cannabis derivatives with very low concentrations of THC (no more than 0.3% on a dry weight basis)—from the definition of marijuana in the Controlled Substances Act.

Marijuana-derived CBD remains classified as a controlled substance.

Are CBD products now legal to sell in the US?

Under current FDA guidance, CBD may only be marketed in FDA-approved drugs.

Despite the Farm Bill, it is illegal under the FD&C Act to market CBD as intended for therapeutic uses (the treatment or prevention of disease) in humans or animals.

CBD products are also excluded from the dietary supplement definition under the FD&C Act because purified CBD is the active ingredient in an FDA-approved prescription drug to treat two rare forms of epilepsy.

Following the passage of the Farm Bill at the end of 2018, then FDA Commissioner Scott Gottlieb stated:

[I]t’s unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived. This is because both CBD and THC are active ingredients in FDA-approved drugs and were the subject of substantial clinical investigations before they were marketed as foods or dietary supplements. Under the FD&C Act, it’s illegal to introduce drug ingredients like these into the food supply, or to market them as dietary supplements….

The companies recently targeted by FDA’s warning letters use online stores and social media to affirmatively market CBD as effective for treating serious diseases such as cancers, or for other therapeutic uses such as pain relief. Others marketed CBD products as dietary supplements and added CBD to human and animal foods. Combined with warning letters FDA has issued periodically throughout 2019, it appears FDA is focusing on CBD products making affirmative efficacy claims. Whether due to limited resources or less concern, FDA has not yet targeted products containing CBD that do not claim to treat maladies or provide pain relief.

It is clear that the FDA’s stance and enforcement efforts have had little effect on the growing popularity of these products. Enthusiasts avow CBD’s effectiveness as a remedy for insomnia, stress, anxiety, aches and pains, and other ailments—all claims that are unquestionably illegal according to the FDA.

The FDA plans to provide an update on its progress regarding the agency’s approach to CBD products in the imminent future. Lowell Schiller, FDA’s Principal Associate Commissioner for Policy, stated that

The CBD working group is evaluating all the data available to us, including data we received through the public hearing and the public docket, and evaluating our policy options. We’re asking not just ‘What should we do?’ but also ‘What can we do within our existing authorities and resources?’ And if we conclude that we need additional authorities or resources, we’ll need to think about going back to Congress.

Lurking danger ahead

Beyond FDA compliance issues, consumer class actions based on the alleged illegality of CBD products are proliferating. A number of cases have been recently been filed, claiming that sellers misled consumers when marketing CBD products as dietary supplements despite FDA’s position. This crop of class actions is still developing, and we will be tracking outcomes and trends.

Furniture tip-over remains in flux

A brief internet search shows that unambiguously, industry, regulators, and NGOs all agree that furniture tip-over is a priority in the consumer markets sector. However, there is little agreement on the best approach. Over the last year alone, we have seen the U.S. Consumer Product Commission announce that the Commission deems “clothing storage units” that do not meet ASTM F2057-17 as posing a “substantial product hazard” (presumably requiring a Section 15(b) report and perhaps recall). ASTM F2057-17 requires tip-over testing and permanent warning labels for any clothing storage unit over 30 inches in height. CPSC announced this arguably backdoor rulemaking despite initiating rulemaking at the end of 2017 to address tip-over. The public comment period for the proposed rule closed in mid-2018, but there has been no apparent action.

Shortly after CPSC’s announcement, the House of Representatives passed H.R. 2211, the STURDY Act (Stop Tip-overs of Unstable, Risky Dressers on Youth Act). Putting aside the acrobatics required to make that acronym, the STURDY Act would require the CPSC to promulgate a mandatory consumer product safety standard for “clothing storage units” to include testing to simulate real world use of products of any height by children up to 60 pounds, and establish uniform, permanent warning requirements. That legislation has been idling in the Senate Committee on Commerce, Science, and Transportation since September.

To further complicate matters, ASTM recently revised ASTM F2057 to expand its scope. ASTM F2057-19 now applies to clothing storage units 27 inches in height and higher. The revised standard states that it is “intended to reduce injuries and deaths of children associated with tipover of free-standing clothing storage units, including but not limited to chests, chests of drawers, drawer chests, armoires, wardrobes, bureaus, door chests and dresses, 27 in. (686 mm) and above in height.” ASTM F2057-19 does not cover bookcases or entertainment furniture, office furniture, laundry room storage, under-bed storage, dining room furniture, occasional accent furniture, nightstands, built-in units intended to be permanently attached to the building, or clothing storage chests that are already subject to ASTM F2589. The revised standard also adds new labeling requirements for media chests and for clothing storage units not intended to hold a television.

The impact of the revised standard is murky. Under normal circumstances, we would expect CPSC to consider ASTM F2057-19 as the applicable voluntary standard for any clothing storage unit manufactured more than 180 days after ASTM’s publication of the revised standard. But CPSC’s “substantial product hazard” announcement is tied to ASTM F2057-17, and CPSC has not issued any guidance clarifying this. We also have not seen a recall or enforcement trend that would help clarify the situation (as compared to similar CPSC “substantial product hazard” announcements, such as drawstrings and hoverboards). There have only been a handful of furniture tip-over recalls announced in 2019.

Unless and until somebody, anybody, clarifies the situation, we think it’s a safe bet that CPSC would consider ASTM F2057-17 to be the minimum required standard, but would not be surprised if in a reporting/recall situation, CPSC argued that inventory failing to meeting the revised 2019 standard constituted a substantial product hazard.

The mysterious world of Prop 65 reloaded, part 4: the penalties

Editor’s Note: Not much has changed since our original post regarding civil penalties. Unfortunately, Prop 65 enforcers are still out attempting to collect vast amounts of civil penalties (and attorney’s fees) in private enforcement actions.

The obvious concern for many companies facing potential exposure for a Prop 65 violation is what is this going to cost me? The short answer: a lot. The potential for high civil penalties is daunting to many companies, a fact of which private litigants are well aware and bank on to incentivize quick settlements.

Penalty amount

Prop 65 authorizes monetary penalties of up to $2,500 “per day for each violation …” In determining how much to assess for each violation, a trial court considers:

  • the nature and extent of the violation;
  • the number of, and severity of, the violations;
  • the economic effect of the penalty on the violator;
  • whether the violator took good faith measures to comply with this chapter and the time these measures were taken;
  • the willfulness of the violator’s misconduct;
  • the deterrent effect that the imposition of the penalty would have on both the violator and the regulated community as a whole; and
  • any other factor that justice may require.

The sliding scale of the penalty amount generally means that any violators who act quickly to remedy problems and are perceived as cooperating are unlikely to be on the hook for the full $2,500 per violation, which is reserved for actors that willfully disregard warning requirements. However, the multiple factors give courts considerable leeway in determining the amount of penalties.

Violation, defined (or not)

What is a violation? Surprisingly, neither the statute nor the regulations define a violation for the purposes of penalties, leaving the question somewhat ambiguous. Courts generally interpret one “violation” for each product unit that does not contain an adequate warning, although there is no controlling or definitive opinion on the subject. As you can well imagine, the amount of penalties can add up very quickly for even small inventories.

As we will discuss more in a future post about the parties that bring these lawsuits, private litigants can receive 25% of any civil penalties collected (not to mention attorneys’ fees), providing a large incentive for them to maximize the number of violations alleged and the amount of penalties assessed per violation.

Applicable statute of limitations

Penalties for Prop 65 violations are governed by California’s one year statute of limitations for statutory penalty actions, Code of Civil Proc. § 340. Plaintiffs will often argue that violations accrue for any units sold without warnings going back one year prior to the date of the Prop 65 60-day notice or the date of the complaint.

Lack of insurance coverage

One of the nasty little side notes for penalties is that insurance policies will usually not cover them, leaving the company to pay the penalties completely out of pocket.

Coverage claims brought under standard form commercial general liability (CGL) insurance policies, which typically cover claims arising from bodily or personal injury, will usually be denied by insurers who argue there is no coverage because Prop 65 claims almost never allege bodily injury.

Many policies will also not cover civil penalty actions based on the implication that the business has violated the law when civil penalties are sought.

Of course, an analysis should be made of existing insurance policies to determine whether coverage exists because there could be exceptions. For example, directors’ and officers’ (D&O) policies, which frequently provide coverage for a company’s own wrongful acts, could have provisions broad enough to encompass a failure to warn.

The bottom line, however, is that standard insurance policies will typically exclude coverage for civil penalties.

The mysterious world of Prop 65 reloaded, part 3: the warning

Editor’s Note: On August 30, 2018, OEHHA’s amendments to the Proposition 65 clear and reasonable warning regulations became effective. The amendments bring two major changes:

  • the first ever allocation of responsibility for warnings, which places the primary responsibility on upstream entities rather than retailers; and
  • significant changes to the “safe harbor” warning regulation, including warning content and methods of transmission.

This post focuses on the content of the warning itself; a detailed discussion of supplier and retailer responsibility can be found here. For a look at the impact of the new regulations six months after passage, click here.

The statutory warning requirement

Prop 65 requires that any person in the course of doing business (meaning any private company that employs 10 or more persons) must provide a “clear and reasonable warning” before exposing individuals to listed carcinogens and reproductive toxins in significant amounts. When it first adopted regulations implementing the warning requirement in 1989, the Lead Agency (now the Office of Environmental Health Hazard Assessment, or OEHHA) was faced with turning that language into directions for businesses to follow to comply with the requirement.

The meaning of “clear and reasonable”

The Lead Agency first interpreted the statute to mean that the “clear” part of the warning requirement applied to the language of the message, and the “reasonable” part applied to the method. It decreed that any warning must “clearly communicate that the chemical in question is known to the state to cause cancer, or birth defects or other reproductive harm.” And “the method employed to transmit the warning must be reasonably calculated, considering the alternative methods available under the circumstances, to make the warning message available to the individual prior to exposure.”

The safe harbor

Recognizing that these standards were fuzzy, OEHHA adopted a “safe harbor” approach, providing specified warnings that were “deemed” to be clear and reasonable, although they were not the exclusive methods. The agency has, over the years, provided versions of safe harbor warning methods and messages for exposures to listed chemicals. As noted above, OEHHA substantively amended the safe harbor requirements effective August 30, 2018.

Amended safe harbor–warning location

Brick-and-mortar stores

Warnings must be provided on product labels or at the point of display (product-specific posting or shelf signs). Point of sale signs are not approved safe harbor warning methods.

A retailer may also provide a warning by any electronic device or process that provides the warning prior to or during the purchaser without requiring the consumer to seek out the warning, such as electronic shopping carts, QR Codes, smart phone applications, barcode scanners, and self-checkout registers.

Online and catalog sales

For online transactions, retailers must include either the warning or a clearly-marked hyperlink using the word “WARNING” on the product display page, or by otherwise prominently displaying the warning to the purchaser prior to completing the purchase. Warnings contained within general website content will not meet the safe harbor method.

For catalogs, warnings must be printed such that they are clearly associated with corresponding products.

OEHHA has stated that online and catalog warnings must be provided even if the product is already labeled with a warning. This appears to be overreach, but unless/until there is litigation over this issue, it remains an area of risk.

Amended safe harbor–warning content for consumer products

A safe harbor warning must include a warning symbol and identification of at least one chemical in the product that is associated with the warning’s toxicological endpoint (cancer or reproductive harm). Warnings must be provided in the same language or languages as any other label, labeling or sign accompanying a product. Examples include:

  • Warning for exposures to either a carcinogen or reproductive toxicant

 WARNING This product can expose you to [name of one or more chemicals], a chemical [or chemicals] known to the State of California to cause [cancer] [birth defects or other reproductive harm]. For more information go to www.P65Warnings.ca.gov/product.

  • Warnings for exposure to both cancer and reproductive toxicity

 WARNING This product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause cancer, and [name of one or more chemicals], which is [are] known to the State of California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.

Amended safe harbor–short form warnings

In circumstances where a standard warning might not be practical (think product or package size), short form warnings on products that do not require chemical identification are permissible:

WARNINGCancer–P65Warnings.ca.gov/product.

 WARNING–Reproductive Harm–P65Warnings.ca.gov/product].

Note that as of now, the short form warning is not expressly limited to small products/packaging, but we understand OEHHA may soon amend the regulation to limit short for usage due to concerns over misuse.

Amended safe harbor–warning language for specific products

In addition to the general consumer product warnings above, there are product-specific safe harbors that generally tweak the warning language or add additional requirements, including:

  • Food and dietary supplements
  • Alcoholic beverages
  • Food and non-alcoholic beverages in restaurants
  • Raw wood
  • Furniture
  • Prescription drugs and emergency medical or dental care
  • Diesel engine exhaust
  • Vehicle and RV exhaust
  • Parking garages
  • Amusement parks
  • Petroleum products in industrial settings
  • Service stations and automotive repair
  • Smoking areas.

Product-specific safe harbor warning samples and translations can be found here.

Do you have to use the safe harbor?

Companies that stray from the safe harbor risk litigation, where the sufficiency of warning language or methods is a question of fact (meaning that it is unlikely to be decided by the court before trial). Common pitfalls:

  • A warning that says a product “may contain” a chemical known to the State to cause cancer. Public and private enforcers argue that this is an inadequate warning, because it does not actually provide a warning before exposure to the chemical.
  • Not labeling products shipped to non-California locations. Sometimes, companies label only products shipped to California customers or to California warehouses of distributors and retailers, figuring that they don’t need to provide warnings for products shipped to other parts of the country. But multistate retailers and distributors often transship products or fulfill California orders from other warehouses. And customers located throughout the world can sell to resellers in California or to consumers over the internet. All it takes is one product being purchased by an enforcer in California without a warning to subject a company to costly litigation.
  • Assuming that changing the label by the date a warning is required is all that is necessary. The law allows a 12-month “grace period” after the listing of a chemical to require a warning. Sometimes, businesses do not account for products offered at retail when the grace period expires. The enforcers are often in stores the next day looking for products that contain listed chemicals and hold both the manufacturer and retailer responsible for such products.

The mysterious world of Prop 65 reloaded, part 2: the list

Editor’s Note: The way that chemicals get added to the list has not changed; however, the list of Prop 65 chemicals has. Here are some recently added chemicals that may be found in consumer products:

With the exception of PCBTF (added on June 28, 2019) and Nickel (added on October 26, 2018), all of the aforementioned chemicals have all been added to the list at least 12 months ago, which means that products containing these chemicals must have required warnings if an exposure will be significant.

To determine whether Prop 65 impacts your company, the starting point is the Prop 65 chemical list. Knowing the listed chemicals and keeping up to date on new additions could mean the difference between facing a lawsuit or avoiding thousands of dollars in legal fees and settlement payments through advanced compliance.

Adding chemicals to the list

Under Prop 65, the Office of Environmental Health Hazard Assessment can add chemicals to the list in four ways. Once OEHHA identifies a chemical for possible listing, it initiates a regulatory process including public notice of intent to list, a public comment period, OEHHA’s review of any comments, and public notice of the final decision.

Listing by the state’s qualified experts mechanism

The Science Advisory Board is a group of expert scientists, appointed by the Governor, who determine whether unlisted chemicals are carcinogens or reproductive toxins.

There are two factions of the board: The Developmental and Reproductive Toxicant (DART) Identification Committee and the Carcinogen Identification Committee.

Although the two committees determine risks for different types of concerns, both follow the same process when making decisions about adding chemicals to the list:

  • OEHHA staff scientists prepare hazard identification reports identifying scientific evidence showing a chemical’s carcinogenity or potential for reproductive harm. Once complete, the report is released for a 45-day comment period and the committee members review it.
  • Committee members hear public testimony on the chemical and deliberate.
  • If a chemical has been “clearly shown through scientifically valid testimony according to generally accepted principles” to either cause cancer or reproductive harm, OEHHA will add it to the list.

Listing by the authoritative bodies mechanism

The Science Advisory Board deems certain organizations “authoritative bodies.” If any authoritative body identifies a chemical as either causing cancer or reproductive harm, OEHHA may add it to the list. The Prop 65 regulations outline the process for adding chemicals through this mechanism and identify the following authoritative bodies:

Listing by the formally required mechanism

If a state or federal government agency requires that a chemical be labeled or identified as causing cancer or reproductive harm, OEHHA can add it to the Prop 65 list. OEHHA typically lists prescription medications requiring FDA warnings this way.

Listing by the Labor Code listing mechanism

If a chemical is identified as causing cancer or reproductive harm via one of the lists identified in California’s Labor Code, and meets listing criteria, OEHHA can add it to the list.

Updating the list

OEHHA must update the list at least once a year, but it is usually more frequent than that. We will post updated lists on a regular basis, including new listed chemicals and chemicals OEHHA intends to list. You can also review OEHHA’s California Regulatory Notice Register Notices, which provide public notice of potential and new listings.

Effect of new additions to the list

Prop 65 requires warnings for significant exposures to listed chemicals starting 12 months after OEHHA adds the chemicals to the list (this 12 month window is designed to allow for impacted companies to determine whether a warning is required). Private Prop 65 enforcers commonly issue a rash of notices of intent to sue (called “60-day notices,” discussed further in an upcoming post) for products shortly after the listing anniversary.

As a result, keeping up-to-date on listed chemicals for products you currently sell in California, or checking the list before entering the California market with a new product, is your first (and, perhaps, most effective) line of defense against Prop 65 enforcement actions.

Adler elected Acting Chair of CPSC in surprise

In what can only be described as a shocking turn of events, CPSC Commissioner Robert Adler (Dem.) has been elected Vice-Chair of the Commission. This means he will become the Acting Chairman of the Commission when current Acting Chairman Ann Marie Buerkle steps down at the end of September. Since Buerkle announced she was withdrawing her nomination to be Chairman and would leave the CPSC at the end of her term this year, many assumed that Commissioner Peter Feldman (Rep.) would assume the Acting Chair role, as Republicans had recently gained a majority for the first time in more than a decade.

The CPSC has gone through the ringer over the past few months, as multiple stories from the Washington Post have called into question whether the Commission, under Buerkle’s leadership, was too “business friendly.”

Buerkle, who voted for Adler, said in a statement that she supported the Democrat because he is the most senior and experienced commissioner. Feldman and the other Republican Commissioner, Dana Baiocco, both joined the Commission within the past 12 months.

Once Buerkle’s terms expires, the Commission will return to a 2-2 R/D split–as a result, it is unlikely that much will substantively change at the Commission while Adler is Acting Chairman. However, Adler is very outspoken with his positions, leaving the possibility that he will make the most of this window to reposition the Commission. Presumably, once the Trump Administration nominates a new commissioner to replace Buerkle, Feldman will be nominated to lead the Commission. But his confirmation as Chairman will remain uncertain–Ms. Buerkle was not able to attain confirmation despite being put up by the Trump Administration.

The mysterious world of Prop 65 reloaded, part 1: The law

Editor’s Note: This post has been updated to reflect 2018 revisions to the Prop 65 regulations, which for the first time allocated responsibility for compliance within the supply chain. These revisions place the primary responsibility for compliance on manufacturers, distributors, and importers, while limiting the circumstances in which retail sellers are responsible for providing consumer product warnings.

To the average person in California, if they know anything about Proposition 65 at all, it is usually because they have a seen a warning sign in a bar or at a store. In most instances, after seeing the sign, they likely kept drinking or kept shopping.

Back in 1986, however, Californians’ concern over toxic chemicals in the environment, workplaces, and consumer products was a hot button issue because it was much more difficult to get information about everyday exposure to chemicals. As a result, 63% of California voters approved Proposition 65, and shortly thereafter, the ballot initiative became codified in the California Health & Safety Code as the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code § 25249.5 et seq). The following sections provide an overview of Proposition 65. Detailed discussions will follow in upcoming posts.

Prohibitions

Prop. 65 prohibits a person from knowingly discharging chemicals known to cause cancer (carcinogens) or reproductive harm in a place where those chemicals are likely to end up in drinking water. We will skip the drinking water part, as it is relatively straightforward and not controversial.

The statute also prohibits a person from knowingly and intentionally exposing any person to carcinogens or reproductive toxins without first providing a warning, if the exposure is significant. This is the key provision of Proposition 65 that gives retailers, manufacturers, and vendors of consumer products heartburn, and on which we will focus this series.

Enforcement

Prop 65 authorizes both public and private enforcers to bring enforcement actions against parties alleged to have failed to provide required warnings to the tune of up to $2,500 per day per violation in civil penalties. Under California’s Private Attorney General Statute (Code of Civ. Proc. § 1021.5), private enforcers may also seek attorney fees for “enforcement of an important right affecting the public interest” if the action results in a “significant benefit” to the public.

Procedural requirements

The statute contains a number of procedural requirements that public and private enforcers must follow in bringing an enforcement, including the infamous 60-day Notice requirement and settlement procedures, which we will discuss in upcoming posts.

The list of chemicals

The statute directs the Governor to publish the list of carcinogens and reproductive toxins that require a warning if causing a significant exposure, and to revise it at least once per year. Chemicals can get on the list four ways, including (1) determination by designated scientists and health professionals, (2) identification by specified “authoritative bodies,” such as the US EPA, (3) identification by a federal or state agency as requiring warning labels (e.g., FDA drug labeling requirements); and (4) identification as a hazardous substance under the California Labor Code.

Exemptions

Proposition 65 provides three exemptions for the warning requirements. First, it exempts any exposure that is already governed by a federal warning law that preempts Prop 65. Second, it exempts exposures that take place within 12 months of a chemical being added to the list. Third, it exempts exposures that are not significant (no significant risk assuming lifetime exposure at the level in question for substances known to the state to cause cancer and no observable effect assuming exposure at one thousand (1000) times the level in question for substances known to the state to cause reproductive toxicity).

In addition, Prop 65 excludes “any person employing fewer than 10 employees” from the warning requirement.

Allocation of responsibility

Prior to August 2018, any party in the supply chain could be held liable for failing to provide a warning. But revisions to the warning regulations, effective August 2018, allocate responsibility for warnings primarily to manufacturers, distributors, and importers (together, suppliers), with retailers responsible only in specified circumstances.

Suppliers can meet their warning obligation “either by affixing a label to the product bearing a warning…, or by providing a written notice directly to the authorized agent for a retail seller.”  27 Cal. Code Regs. § 25600.2.

Retailers are responsible for providing a warning (i.e., may be liable in an enforcement action) when:

  • The retailer sells the product under its private label or a brand or trademark owned by the retailer.
  • The retailer has knowingly and intentionally introduced a listed chemical into the product, or caused a listed chemical to be created in the product.
  • The retailer has covered, obscured, or altered a warning label.
  • The retailer has received warning information and materials from the supplier and does not post them—note that consent for the warnings from the retailer is not required; the supplier need only send the information to the retailer’s authorized agent.
  • The retailer has actual knowledge of the potential product exposure requiring the warning, and the suppliers are exempt and have no place of business in California or agent for service of process in California.

A retailer can modify this allocation by contract, requiring its suppliers and other vendors to provide a warning, as long as a required warning is ultimately provided.

Regulations

The statute directs the Governor to appoint an agency to implement Proposition 65. The California Office of Environmental Health Hazard Assessment (OEHHA – pronounced “o-wee-ha” or “o-hee-ya”), part of CalEPA, is tasked with implementing Prop 65. To do so, it has promulgated a series of regulations and issued various guidance documents that more fully explain Proposition 65 compliance. OEHHA also publishes the list of chemicals.

The mysterious world of Prop 65–reloaded!

Nearly five years ago, we started publishing our first serial, The mysterious world of Prop 65. Although we knew we struck gold with the brilliant series title, we could not have contemplated that these would become our most visited, read, and referred to posts.

Since 2014, a lot has changed in the Proposition 65 landscape, ranging from the revised safe harbor warning regulations in 2018 to the cast of characters comprising the Prop 65 plaintiff’s bar.  We thought it high time to provide an updated edition. Over the next few weeks, we will be posting The mysterious world of Prop 65—reloaded. We will publish edited versions of the original posts, with an editor’s note at the top to highlight any changes. In some instances, not much has changed, so you can maintain the same level of frustration over doing business in California.  In others, much has changed, so you will get to have a brand new headache. Our revised edition will “reload” a variety of topics, including:

  • The law and its requirements, including the difference between exposure and chemical composition
  • The chemical list
  • Warnings
  • Penalties and other potential exposure
  • The mechanics of a Prop 65 claim
  • Enforcement (public and private plaintiffs)
  • Burdens at trial, including knowledge requirements, exposure, and warning exceptions
  • Settlements
  • Impacts of the revised safe harbor warning regulation

TARIFFS! Exclusion process for Section 301 tariffs is now available for List 3 products

Unsurprisingly, tariff issues are becoming more and more prevalent for consumer products manufacturers, distributors, and retailers. In a positive turn, List 3 products are now eligible for exclusions from the significant Section 301 (China) tariffs. Check out this summary and analysis of the process from our international trade colleagues.

 

What now? California finalizes Prop 65 exemption for coffee

What now? California finalizes Prop 65 exemption for coffee

On June 3, 2019, the California Office of Administrative Law approved a regulation adopted by the California Environmental Office of Health Hazard Assessment (OEHHA) exempting chemicals in coffee from Prop 65’s warning requirement. The regulation, which has an effective date of October 1, 2019, provides:

Exposures to chemicals in coffee, listed on or before March 15, 2019 as known to the state to cause cancer, that are created by and inherent in the processes of roasting coffee beans or brewing coffee do not pose a significant risk of cancer.

While the adoption of the regulation would seem to end the ongoing controversy about whether Prop 65 warnings are required for acrylamide in coffee, and to be very good news for those who make and sell coffee, much dust remains to settle. Continue reading

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