GT Legal Food Talk Episode 27: From Slam Dunks and Big Tech to Launching New Brands: Alan and Maxine Henderson’s Journey into Food & Beverage Entrepreneurship [Podcast]
In this episode of Greenberg Traurig Legal Food Talk, host Justin Prochnow sits down with Alan and Maxine Henderson, a dynamic husband-and-wife duo in the food and beverage industry. Alan, a former college basketball and NBA star and more recent spirits entrepreneur, and Maxine, a former electrical engineer turned beverage innovator, share their unique paths to launching their respective brands, Henderson Spirits Group and Bollygood.
Maxine brings the flavors of India to her beverage with Bollygood, the first Indian-inspired sparkling lemonade, rooted in her family’s recipe for Nimbu Pani. Alan crafts spirits that honor African American history under brands like Tom Bullock’s and Birdie Brown. They discuss the challenges of entrepreneurship, the lessons learned, and how their backgrounds in sports and engineering have shaped their approach to business.
Whether you’re a budding entrepreneur or a fan of innovative products, this episode offers valuable insights and inspiration. Tune in!
California Delays Extended Producer Responsibility Regulations for Plastic and Packaging: Three Takeaways
Earlier this month, California Governor Gavin Newsom directed the state’s recycling agency, CalRecycle, to restart the process of issuing regulations for California’s landmark plastic and packaging extended producer responsibility (EPR) law.
Over the past year, CalRecycle has been working to finalize implementing regulations by March 7. Facing a one-year deadline to finalize the regulations, Governor Newsom asked them to start again.
CalRecycle will now issue a new administrative rulemaking notice and reopen draft regulations for public comment. The agency is expected to revise its proposed rules due to Governor Newsom’s concern over the cost of the initial draft regulations, estimated at $36 billion over 10 years.
As this development with California’s EPR legislation shows, EPR programs for plastic and packaging are still evolving. Even before Governor Newsom’s decision, CalRecycle had revised its draft regulations twice in response to public feedback. We have previously covered trends in plastic regulation at state, national and global levels here and here, as well as California’s first-in-the-nation producer responsibility law for textiles here.
An overview of California’s plastic and packaging EPR law and key takeaways for impacted businesses follow below.
California’s EPR Landscape
In 2022, California enacted the Plastic Pollution Prevention and Packaging Producer Responsibility Act (SB 54), setting ambitious goals for reducing and recycling plastic. By 2032, the law requires:
A 25% reduction in single-use plastic packaging and food ware.
65% of single-use plastic packaging and food ware to be recycled.
100% of single-use packaging and plastic food ware to be recyclable.
The law also sets interim recycling targets, requiring 30% plastic packaging and food ware recycling by 2028, and 40% Fby 2030.
The law requires “producers” of “covered material” to join a producer responsibility organization (PRO), a nonprofit organization formed by producers. The PRO works with CalRecycle and producers to build and operate source reduction and recycling programs.
“Covered material” includes single-use packaging and plastic food service ware, such as plates and utensils. The “producer” is typically a California-located entity that owns or licenses the brand under which the covered product is sold. If there is no California-located entity, the distributor into California is considered the “producer.”
The PRO’s responsibilities include submitting a program plan for CalRecycle’s approval, detailing how it will meet the law’s targets. For example, the plan may involve creating recycling programs, like curbside or drop-off collection, or improving sorting processes. To fund these efforts, the PRO will assess fees on producers. It will also collect funds for California’s Plastic Pollution Mitigation Fund. From 2027-2037, the PRO must deposit $500 million annually into the fund. CalRecycle has named the Circular Action Alliance as the PRO.
Takeaways
There are three key takeaway points from the regulated community:
EPR Programs Are Evolving: Although some EPR laws have existed for decades, producer responsibility for many products is new. Recent years have seen state EPR laws for batteries, pharmaceutical drugs, tires, and household items such as mattresses, textiles, paint, and carpets. We expect more regulatory developments over the next several years, as states refine these laws and their implementing regulations.
Impacted Businesses Have Another Chance to Comment: By restarting the regulatory process, businesses have another opportunity to comment on the proposed regulations. California law requires at least 45 days for public comment on new proposals.
Potential Changes in Regulation: Over the past year, CalRecycle considered whether to include plastic-coated paper items in its source reduction and recycling rate targets. CalRecycle decided to include these items (composed mostly of paper and less than 20% plastic) because it believed that option better served the law’s goals. However, given Governor Newsom’s concern about program cost, CalRecycle may decide to exclude these items from some recycling targets.
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This Week in 340B: March 11 – 17, 2025
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick summary of relevant updates from the prior week in this industry-shaping body of litigation.
Issues at Stake: Rebate Model; Contract Pharmacy; Other
In three appealed cases challenging a proposed Louisiana law governing contract pharmacy arrangements, the appellee filed a motion to consolidate.
In a case challenging the US Department of Health and Human Services (HHS) and the Health Resources and Services Administration (HRSA’s) decision to prevent drug manufacturers from unilaterally implementing rebate models, defendants filed a cross motion for summary judgment and opposition to the plaintiff’s motion for summary judgment.
In a case challenging HRSA’s policy limiting the circumstances in which covered entities can use their group purchasing arrangements to purchase non-340B drugs, the plaintiff filed a motion for summary judgment.
In three cases challenging a proposed state law governing contract pharmacy arrangements in Missouri, defendants and intervenors in each case filed answers to amended complaints.
In four cases against HRSA alleging that HRSA unlawfully refused to approve drug manufacturers’ proposed rebate models:
In three cases, the defendants filed a cross motion for summary judgment and opposition to the plaintiff’s motion for summary judgment.
In one case, the plaintiffs filed a motion to strike portions of an amicus brief, and the amici filed a response.
Nadine Tejadilla contributed to this article.
Joint Effort: Why a New Crop of House Members, a New Speaker, and Continued Bipartisan Support Could Finally Light the Way for Medical Marijuana in N.C.
In November 2023, we pondered whether 2024 might be “the year” for medical marijuana legalization in North Carolina. Well, it wasn’t.
Why, you ask? How can a state whose population has expressed overwhelming bipartisan support for medical marijuana legalization still have nothing to show for it? How can a state whose Senate has shown overwhelming bipartisan support (see Senate Bill 3 and Senate Bill 711) for medical marijuana legalization still have nothing to show for it?
Under former House Speaker Tim Moore (R), whose tenure ended earlier this year when he transitioned to serving as a United States congressman, North Carolina Republicans adhered to an informal yet influential guideline: A bill would not reach the House floor unless a majority of Republican House members supported it. Because the 2023-2024 session contained 72 Republicans (out of 120 total seats), 37 Republican supporters were needed for any bill to secure a House vote. In the current session (2025-2026), one less Republican was elected to the House, meaning there are now 71 Republicans, with 36 Republicans creating a “majority of the majority.” This unwritten rule has been the key obstacle to medical marijuana legislation in North Carolina despite its clear bipartisan support.
For example, in 2023, a bipartisan group of senators passed the North Carolina Compassionate Care Act (SB 3) by a margin of 36-10. The act ultimately stalled, however, because it didn’t have support from the requisite 37 House Republicans. Before that, a previous version of the bill (SB 711) passed the Senate by a similar margin and died in the House for the same reason. After that, HB 563, originally a hemp regulation bill, was amended to include medical marijuana provisions from the North Carolina Compassionate Care Act. The bill shared the same fate.
Could It Be Destin[y]?
Earlier this year, Destin Hall (R) replaced Moore as speaker of the House. Despite Hall’s public opposition to medical marijuana reform, there are two reasons to be optimistic about what his tenure might mean for the future of medical marijuana in North Carolina.
First, Hall may choose to abandon Moore’s “majority of the majority” rule, removing the roadblock that killed the North Carolina Compassionate Care Act in 2022, 2023, and 2024. Without strict enforcement of the vote threshold, medical marijuana legislation would likely pass. To date, we’re not aware of any indication Hall has given with respect to whether he intends to continue the rule’s enforcement.
Second, Hall, in reference to medical marijuana, recently indicated that “House Republicans could be more open to what the Senate sends over to them.” In other words, even if the “majority of the majority” rule remains in place, it’s still possible for medical marijuana legislation to pass. It’s unclear how many House Republicans supported SB 711, SB 3, and HB 563. However, if the margin in the Senate is any indication, the number of Republican supporters could already be approaching the threshold.
With President Trump publicly showing support for marijuana legislation, Republican support for legalizing marijuana increasing significantly over the last decade – especially among the younger members of the party – 12 new younger Republican House members, a new speaker of the House, and the “majority of the majority” threshold itself decreasing by one, there is reason for (very) cautious optimism regarding the potential passage of medical marijuana legislation in North Carolina this session.
Clearing the Haze: A Refresher on the N.C. Compassionate Care Act for Those Who Might Have… Uh, Forgotten
It’s unclear what a new (and improved?) version of the North Carolina Compassionate Care Act might look like, or if the next piece of medical marijuana legislation to reach the House will be a version of that act at all. That said, as a reminder to our readers, here’s what it would have done if it had passed.
On the consumer side, it would have allowed individuals in North Carolina to obtain a prescription to purchase marijuana in connection with a limited list consisting only of severe medical conditions, including:
Cancer
Epilepsy
HIV
ALS
Crohn’s disease
Sickle cell anemia
Parkinson’s disease
PTSD
Multiple sclerosis
Cachexia (wasting syndrome)
“Severe or persistent nausea” related to terminal illness or hospice care
On the business side, up to 10 companies would have been granted licenses to control the supply and sale of marijuana, with each supplier permitted to operate up to eight dispensaries.
On the regulatory side, it would have created the Medical Cannabis Production Commission, tasked with overseeing licensing and supervising the state’s marijuana supply and the program’s revenue generation.
The Higher Perspective: A Broader Update on N.C.’s Cannabis Policies
North Carolina is in a bit of a cannabis pickle. No, not a cannabis-infused pickle. Although – apparently, that’s a real thing. We mean, at the risk of sounding a bit Harry Potter-ish, that its policies are a bit of a cannabis contradiction.
While, as we have discussed, North Carolina has been a bit of a straggler when it comes to marijuana legalization, hemp is minimally regulated.
As we have reported, under North Carolina law, “hemp” means the plant Cannabis sativa and any part or derivatives of that plant, with a delta-9 THC concentration of no more than three-tenths of 1% (0.3%) on a dry weight basis. Marijuana is derived from the same plant and is a label applied to concentrations over that amount.
Recently, the Senate introduced the Protecting Our Communities Act (SB 265), which purports to establish a comprehensive regulatory framework surrounding hemp products. The bill would introduce certain licensing, packaging, manufacturing, distribution, laboratory testing, and advertising regulations, including a myriad of civil and criminal penalties that would result from non-compliance.
Perhaps most notably, SB 265 would establish an age requirement for hemp products, prohibiting and penalizing anyone under the age of 21 from possessing or purchasing these products.
We’ve been here before—but this time, the climate might actually be right. Stay tuned to find out whether North Carolina turns over a new leaf this session.
What to Take Away from CMMI’s Early Termination of Four Demonstration Models
On March 12, 2025, in one of the Trump Administration’s first actions with respect to the Center for Medicare and Medicaid Innovation (CMMI), CMMI announced that it would prematurely terminate four alternative payment model (APM) demonstration models by December 31, 2025. CMMI’s decision was not entirely unexpected. In response to a 2021 report from a Congressional advisory committee recommending that CMMI “streamline” its portfolio of demonstrations, the Biden Administration initiated a 10-year “strategic refresh” of CMMI. Similarly, a critical report from the Congressional Budget Office (CBO) about the net cost initiated a wave of criticism from Republicans. Combined with the Trump Administration’s hyperfocus on reducing government spending (based on CMMI’s estimation, terminating the demonstrations early will save the federal government $750 million), it is not particularly surprising that CMMI was targeted for some cuts.
Less clear is why these specific demonstrations were targeted and whether CMMI’s decision to terminate the demonstrations is merely the continuation of a calculated, years-long push to reform the way CMMI operates, or whether it foreshadows the beginning of a significant pullback in the use of alternative payment model (APM) demonstrations to test out the use of value-based care in federal health care programs.
CMMI’s Plan to Terminate Demonstrations
The four demonstrations that CMMI will terminate at the end of the year are below, including their original performance periods:
Maryland Total Cost of Care (TCOC) (2019 – 2026). Building on prior demonstrations in Maryland, the TCOC implemented a “global budget” funding system through which hospitals in the state receive a population-based payment amount to cover all hospital services provided during the year rather than fee-for-service (FFS) payments. The TCOC also allowed hospitals that achieved savings under the TCOC to make incentive payments to nonhospital health care providers (e.g. physician groups) who partnered and collaborated with the hospital and performed care redesign activities aimed at improving care.
Primary Care First (PCF) (2021 – 2026). The PCF is a voluntary demonstration model offered in 26 states and regions to test whether delivery of advanced primary care can reduce the total cost of care. Through this demonstration, participating primary care practices receive a prospective population-based payment (based on the total number of Medicare FFS beneficiaries attributed to each practice, and adjusted for the acuity of the attributed beneficiaries) to provide primary care services, and flat visit fees for face-to-face encounters. Primary care practices are eligible for additional bonus payments based on performance on various quality metrics.
ESRD Treatment Choices (ETC) (2021 – 2027). The ETC is a mandatory demonstration designed to test payment adjustments for certain end-stage renal disease (“ESRD”) facilities and managing clinicians.
Making Care Primary (MCP) (2024 – 2034). The MCP is a demonstration designed to provide a pathway for primary care clinicians with varying levels of experience in value-based care to gradually adopt prospective, population-based payments while building infrastructure to improve behavioral health and specialty integration and increase access to care. While the other three models that CMMI will terminate early were already scheduled to terminate in the next year or two, the MCP model only started in July 2024 and was intended to run through 2034.
CMMI also stated that it intends to reduce, or look for opportunities to change the Integrated Care for Kids (2020 – 2026) demonstration and does not plan to move forward with the Medicare $2 Drug List and Accelerating Clinical Evidence demonstrations, which had been announced but had not yet been implemented.
CBO Report from September 2023 Indicated CMMI Increased Spending
CMMI was created by the Affordable Care Act (ACA) in 2010 to test payment models (i.e. demonstrations) in Medicare, Medicaid, and the Children’s Health Insurance Program (CHIP). That same year, CBO, which is an independent agency that provides Congress with analyses and estimates on federal economic and budgetary decisions, estimated that CMMI would save the federal government $10.3 billion over the following decade, offsetting the estimated $7.5 billion that CMMI was expected spend to operate the models. In September 2023, however, CBO reported that most of the CMMI demonstrations between 2011 and 2020 increased Medicare’s direct spending by $5.4 billion (or 0.1% of net Medicare spending). By April 2024, Republicans on the House Budget Committee were uniformly calling for an investigation into CMMI’s spending and operations.
A closer examination of the September 2023 CBO report creates a more complicated and nuanced picture of CMMI’s operations. For one, the September 2023 report did not include the Medicare Shared Savings Program (MSSP), which was also created by the ACA in its calculation of costs. While the MSSP is a permanent model operated by CMS rather than CMMI, CBO acknowledged the fact that its design has been informed by the CMMI’s ACO demonstrations. CBO estimated that this program generated small net savings for the government. The September 2023 report also only assessed demonstrations where provider participation was voluntary. While this decision was logical – most of the demonstrations that CMMI launched during the period were voluntary – mandatory versions of these models could have resulted in more significant net savings. Finally, CBO acknowledged in the report that six of the 49 demonstrations it analyzed produced net savings, including four of which have been certified by the CMS Office of the Actuary for expansion.
Nonetheless, it is not surprising that the new Administration, particularly given its purported focus on substantially cutting government spending, saw terminating CMMI demonstrations as a way to accomplish these goals. The March 12 announcement estimates that eliminating the demonstrations early will save the federal government $750 million (although no detail is provided on how CMMI calculated these potential savings).
MedPAC Report and Biden’s Strategy Refresh
Criticism of and initiatives to reform CMMI precede the September 2023 CBO report, however. In response to a 2021 report by the non-partisan Medicare Payment Advisory Committee (MedPAC), which advises Congress on Medicare payment reforms, CMMI had begun the process of “streamlining” its portfolio of demonstrations. While the 2021 MedPAC report identified a variety of concerns with CMMI, the biggest issue MedPAC focused on was the sheer number of simultaneous demonstrations being tested by CMMI, and the operational complexity they created. As noted, during that first decade, CMMI tested 49 APMs. While acknowledging the “valuable information” generated by the demonstrations, MedPAC ultimately concluded that CMMI’s large portfolio created significant overlap between various simultaneous demonstrations. As a result, many providers and beneficiaries were participating in multiple demonstrations at the same time, which MedPAC argued diluted the incentives imposed by each demonstration and complicated the ability of CMMI to properly analyze the impact of specific demonstrations. MedPAC ultimately recommended that CMMI streamline its portfolio. Among other things, MedPAC also noted that some of the demonstrations needed a longer performance period (which is typically five years) for the benefits to truly materialize, and further stated that CMMI’s heavy reliance on bonus payments to entice provider participation, which is a feature of the voluntary demonstrations, created some selection bias and often reduced the net savings of the demonstrations.
In response to the MedPAC report, the Biden Administration announced a “Strategy Refresh” in 2021 to incorporate lessons from the prior decade. Notably, this Strategy Refresh included a statement that CMMI was “undertaking an internal review of its portfolio of models,” and incorporated MedPAC’s recommendation to streamline its portfolio of demonstrations. As such, it is unclear whether the decision to prematurely terminate the demonstrations above represents a change by the new Administration, or whether they are indicative of pre-existing reforms that CMMI was undertaking.
The Case on Maryland
At first glance, the state most affected by the terminations is clearly Maryland, which has integrated its entire hospital system into the TCOC demonstration. Maryland has a rich history of utilizing APMs, having operated under federal waivers since 1977 that have allowed it to set hospital payments for all Medicare, Medicaid, and commercial payers. Until 2014, the state used prospective diagnosis-based payments for each hospital admission, similar to the Medicare hospital payment system, which successfully reduced the rate of spending per hospital admission. Corresponding increases in the volume of hospital admissions, however, limited the impact of this all-payer rate setting on controlling overall hospital spending. The TCOC model sought to address this issue by changing the payment methodology from prospective diagnosis-based reimbursement to a hospital global budget. By all indications, the TCOC has largely succeeded in generating a reduction in hospital spending.
For Maryland and its hospitals, the ultimate impact of the TCOC demonstration termination will likely not be significant because of forthcoming changes. Even though the TCOC was previously set to end at the end of 2026, the state was reportedly planning on winding the program down at the beginning of 2026 year anyway. Beginning in 2025, Maryland plans to implement a new CMMI demonstration waiver called the Advancing All-Payer Health Equity Approaches and Development (AHEAD) model, which is heavily inspired by the TCOC demonstration. While Maryland will be the only state participating in the AHEAD model in 2026, Connecticut, Hawaii, New York, and Vermont plan to implement the AHEAD model in 2027.
The impact of the early termination of the PCF demonstration on primary care providers in Maryland is more complicated, however. The AHEAD model also includes bonuses for participating primary care providers, although, unlike the TCOC, providers must agree to participate in the state’s Medicaid “transformation efforts.” It is unclear what percentage of Maryland primary care providers already participate in Medicaid, although historically, the share of Maryland physicians that participate in Medicaid has been lower than the percentage that participate in Medicare due to lower payment rates by the former program. As such, terminating the PCF model early may incentivize some Maryland primary care providers to begin participating in the AHEAD model, and thus accepting Medicaid patients, early. While this would benefit Medicaid beneficiaries by increasing their access to providers, the significant cuts to Medicaid that congressional Republicans are currently contemplating complicate the picture.
Looking Forward and AHEAD
For right now, the impact of the demonstration terminations appears to be limited, both for Maryland and more broadly for other stakeholders involved in other demonstrations. Recent Republican complaints notwithstanding, payment and delivery demonstrations have long enjoyed some level of bipartisan support. Notably, CMMI stated in the March 12 announcement that it had “determined its other active models can meet the Center’s statutory mandate—either as is or with future modification—and therefore will continue moving forward.” An unnamed source told the publication Axios that CMMI still planned on going forward with the AHEAD model.
As such, there is currently no indication that CMMI has imminent plans to announce the termination of other demonstrations, or terminate the AHEAD model, both of which would have a larger effect on stakeholders. Nonetheless, the wild card is the current Administration’s propensity for rapidly changing its approach to various issues without notice, and the potential for cuts to CMMI’s budget to pay for other priorities. With this in mind, nothing, including the future of CMMI demonstrations, should be considered certain.
Trending in Telehealth: February 2025
Trending in Telehealth highlights monthly state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate the delivery of virtual care.
Trending in February:
Interstate compacts
Telepharmacy services
Veterinary services
Telehealth practice standards
A CLOSER LOOK
Proposed Legislation & Rulemaking:
North Dakota proposed amendments to the North Dakota Century Code related to optometrist licensure and standards for providing tele-optometry. The amendments delineate the circumstances under which a licensed optometrist may use telemedicine to provide care. Proposed practice standards include requirements to establish a proper provider-patient relationship and requirements related to informed consent.
In Indiana, Senate Bill 473 proposed amendments that would allow providers to prescribe certain agonist opioids through telemedicine technologies for the treatment or management of opioid dependence. Current law only allows partial agonist opioids to be prescribed virtually.
Finalized Legislation & Rulemaking Activity:
Ohio enacted Senate Bill 95, authorizing the operation of remote dispensing pharmacies, defined as pharmacies where the dispensing of drugs, patient counseling, and other pharmacist care is provided and monitored through telepharmacy systems.
The Texas Health and Human Services Commission adopted an amendment to the Texas Government Code, requiring that providers be reimbursed for teledentistry services. The amendment allows flexibility for a dentist to use synchronous audiovisual technologies to conduct an oral evaluation of an established client. This change makes oral evaluations more accessible and prevents unnecessary travel for clients in the Texas Health Steps Program.
The Arkansas governor signed Senate Bill 61 into law, authorizing the practice of veterinary telemedicine in the state. The bill includes practice standards for veterinary telemedicine and provision of emergency veterinary care.
Also in Arkansas, House Bill 1427 enacted the Healthy Moms, Healthy Babies Act. The act amends Arkansas law to improve maternal health and establish reimbursement procedures for remote ultrasounds.
Compact Activity:
Several states have advanced licensure compacts. These compacts enable certain categories of physicians to practice across state lines, whether in person or via telemedicine. The following states have introduced bills to enact these compacts:
Dietitian Licensure Compact: Mississippi, Kansas, and North Dakota.
Social Work Licensure Compact: Mississippi, Maryland, and North Dakota.
Occupational Therapy Licensure Compact: North Dakota and New Mexico.
Audiology and Speech Language Pathology Compact: New Mexico.
Why it matters:
States continue to expand practitioners’ ability to provide telehealth services across state lines. While telemedicine is often seen as an alternative method for care delivery, it can sometimes be the most effective and efficient option. Expanding interstate licensure compacts improves access to qualified practitioners, particularly in underserved and rural areas. These compacts also enhance career opportunities and reduce the burdens associated with obtaining multiple state licenses.
States continue to apply telehealth practice standards to various professions. Legislative and regulatory trends reflect recognition that telehealth can be used in a variety of specialty practices, including veterinary medicine, dentistry, and optometry.
Telehealth is an important development in care delivery, but the regulatory patchwork is complicated.
February 2025 Bounty Hunter Plaintiff Claims
California’s Proposition 65 (“Prop. 65”), the Safe Drinking Water and Toxic Enforcement Act of 1986, requires, among other things, sellers of products to provide a “clear and reasonable warning” if use of the product results in a knowing and intentional exposure to one of more than 900 different chemicals “known to the State of California” to cause cancer or reproductive toxicity, which are included on The Proposition 65 List. For additional background information, see the Special Focus article, California’s Proposition 65: A Regulatory Conundrum.
Because Prop. 65 permits enforcement of the law by private individuals (the so-called bounty hunter provision), this section of the statute has long been a source of significant claims and litigation in California. It has also gone a long way in helping to create a plaintiff’s bar that specializes in such lawsuits. This is because the statute allows recovery of attorney’s fees, in addition to the imposition of civil penalties as high as $2,500 per day per violation. Thus, the costs of litigation and settlement can be substantial.
The purpose of Keller and Heckman’s latest publication, Prop 65 Pulse, is to provide our readers with an idea of the ongoing trends in bounty hunter activity.
In February of 2025, product manufacturers, distributors, and retailers were the targets of 341 new Notices of Violation (“Notices”) and amended Notices, alleging a violation of Prop. 65 for failure to provide a warning for their products. This was based on the alleged presence of the following chemicals in these products. Noteworthy trends and categories from Notices sent in February 2025 are excerpted and discussed below. A complete list of Notices sent in February 2025 can be found on the California Attorney General’s website, located here: 60-Day Notice Search.
Food and Drug
Product Category
Notice(s)
Alleged Chemicals
Prepared Foods: Notices include falafel mix, organic veggie wraps, cassava chips, protein bites, plant-based chili mac, vanilla pudding, soba noodles, plant-based flavored ramen, biryani masala, and tofu veggie burger
46 Notices
Lead and Lead Compounds, and Cadmium
Dietary Supplements: Notices include plant-based fruit shakes, daily greens and multivitamins, superfood smoothie kits, customized protein powder, astragalus, chickpea plant-based protein powder, ashwaganda powder, maca root powder, sparkling probiotic elixir
22 Notices
Lead and Lead Compounds, Cadmium, and Mercury
Fruits, Vegetables, and Mushrooms: Notices include carrot juice, sun-dried tomatoes in olive oil, Greek marinated mixed olives, organic mixed vegetables, chopped kale, fruit and vegetable puree, pickled sliced ginger, mushroom powder extract, cactus nopalitos, and basmati rice
18 Notices
Lead and Lead Compounds, and Cadmium
Seafood: Notices include sun dried sea moss, dried seaweed knots, dried shrimp, sardines, calamari tubes and tentacles, seafood stock, cod liver, fermented fish paste, and mackerel in extra virgin olive oil
17 Notices
Cadmium and Cadmium Compounds, Lead and Lead Compounds
Herbs, Spices, and Seeds: Notices include freeze-dried mint, sunflower seeds, golden chai, and dried ginger
7 Notices
Lead and Lead Compounds, and Cadmium
Various Foods: Notices include traditional refried beans, hearts of palm, green pigeon peas, coconut milk, and olives with minced anchovies
5 Notices
Bisphenol A (BPA)
Dietary Supplements: Notices include plant-based post-workout protein powder, vegan protein muscle building fuel, and plant-based shakes
3 Notices
Perfluorooctanoic Acid (PFOA)
THC-Containing Products: Notices include cannabis-infused edibles
2 Notices
Delta-9-tetrahydrocannabinol
Cosmetics and Personal Care
Product Category
Notice(s)
Alleged Chemicals
Personal Care Items: Notices include body lotions, burn relief gel, facial scrubs, anti-cellulite hot creams, shave gels, healing gels, barrier repair skin creams, stem cell serums, hair makeup, sunscreen, liquid brow soap, shave gel with aloe
37 Notices
Diethanolamine
Cosmetics: Notices include mascara, UV neon makeup, fluid foundation, theatrical blood, body paint makeup, plumping lip balm, lip oil and glitter makeup
16 Notices
Diethanolamine
Consumer Products
Product Category
Notice(s)
Alleged Chemicals
Miscellaneous Consumer Products: Notices include polaroid card holder, foam puzzle play mat, PVC ice packs, jewelry pliers, brass candle snuffer, cup cleaning brushes, vinyl covers, bracelet holder, vinyl banners, PVC aprons, salt and pepper shakers with PVC components, and glassware with exterior designs
40 Notices
Di(2-ethylhexyl)phthalate (DEHP), Diisononyl phthalate (DINP), and Di-n-butyl phthalate (DBP), Lead
Bags and Cases: Notices include backpacks, shower curtain storage bags, makeup bags, phone bag, toiletry bags, dry bag, rug bag, tote bag with PVC components, and purses
27 Notices
Di(2-ethylhexyl)phthalate (DEHP), Di-isodecyl phthalate (DIDP), and Diisononyl phthalate (DINP)
Hardware and Home Improvement Products: Notices include hammer sets, kitchen accessories with USB cords, tire gauges, brass hose fittings, cables, thermometers, flush cutters, brass garden hose splitters
16 Notices
Lead, Di(2-ethylhexyl)phthalate (DEHP), Di-n-butyl phthalate (DBP), and Di-isodecyl phthalate (DIDP)
Metals and Ceramics: Notices include kettles, canisters, bowls, trays, teacups, mugs, teapots, jars, and candle holders
13 Notices
Lead
Clothing and Shoes: Notices include sweatpants, hi-vision gloves, girls jacket, faux fur jacket, gloves with leather, footwear with leather, and sandals
10 Notices
Di(2-ethylhexyl)phthalate (DEHP), and Chromium (hexavalent compounds)
Hobby Items: Notices include fishing weights, badminton rackets, art panels, artist kits for children, exercise equipment, and an artist brush set
8 Notices
Lead and Di(2-ethylhexyl)phthalate (DEHP)
Miscellaneous Consumer Products: Notices include umbrella, tablecloths, shower curtains, girl’s bag, children’s gloves, hi-viz field jacket, rain jacket, and shorts
8 Notices
Perfluorooctanoic Acid (PFOA)
Florida DABT Issues Declaratory Statement on Taxability of “Heat Stick” Products.
Phillip Morris International (PMI) requested a declaratory statement regarding the taxability of their IQOS “heat stick” tobacco products. During the pendency of the ABT response, the First District Court of Appeal released an opinion expanding the judicial interpretation of the term “loose tobacco suitable for smoking” as used in chapter 210, Florida Statutes, to include hookah products. This change pivoted from the traditional interpretation that “suitable for smoking” required some sort of ignition/combustion of the actual tobacco product, and also clarified that tobacco leaves/trimmings in conjunction with a binding agent can still be considered “loose tobacco.”
The opinion created tension with a prior ABT declaratory statement response in which the Division determined that Logic’s tobacco product, which included capsules of loose tobacco and a liquid mixture, were not taxable tobacco products.
To arrive at an outcome where PMI’s product is not taxable, ABT distinguished the product on factual differences – namely that the product did not produce hookah-like smoke infused with nicotine, the makeup of the tobacco product (ground tobacco reformulated into sheets/layers), and the absence of combustion.
Ultimately, while this declaratory statement may be based on distinctions that may not make a difference under the First DCA’s Global Hookah opinion, because ABT administers the tax on tobacco products itself and does not intend to tax the IQOS, any challenge to the taxability of the product or the declaratory statement itself is unlikely.
Note that there is currently pending legislation seeking to amend the definition of other tobacco products in the taxing contests. If the definition is amended, the language could potentially impact the precedential value of both this declaratory statement’s determination and the Global Hookah case.
A copy of the Declaratory Statement is available here.
The Next Wave of ADA Website Accessibility Lawsuits Against Alcohol Suppliers
The increasing popularity of online shopping has made e-commerce businesses – specifically those in the alcohol beverage industry – a frequent target for costly litigation. In lockstep with the continued prevalence of website accessibility cases, plaintiff firms are sending pre-suit demand letters to alcohol suppliers and, in some cases, filing a state or federal court lawsuit. These lawsuits, which are typically filed in California, Florida, or New York, involve claims that a supplier’s website is not accessible to individuals who are blind in violation of Title III of the Americans with Disabilities Act (ADA) and related state laws. In these cases, plaintiffs seek attorneys’ fees, damages (only under state law), and injunctive relief that would require the website to conform with the Web Content Accessibility Guidelines (WCAG) standards, which have been broadly adopted by courts and regulators.
While many e-commerce companies, including alcohol suppliers, have turned to “accessibility widgets” to improve WCAG compliance, these quick-fix solutions are not always what they seem. More than 25% of all website accessibility lawsuits in 2024 (more than 1,000) were brought against businesses that used widgets, with many plaintiffs explicitly citing widget features as alleged obstacles to accessibility. Widget developers have also faced scrutiny. The Federal Trade Commission recently leveled a $1 million fine against one such company for falsely claiming that its widgets “make any website complaint.” Therefore, relying solely on widgets to comply with WCAG standards has proven ineffective and could render e-commerce businesses vulnerable to website accessibility lawsuits.
To prevail on a website accessibility claim, plaintiffs must first show that a defendant is a private entity that owns, leases, or operates a “place of public accommodation.” Courts, however, are split on what it means for a website to be considered a place of public accommodation under Title III of the ADA. While some jurisdictions require a “physical nexus” between the website and a brick-and-mortar store, other jurisdictions have permitted these cases to go forward against a website-only company that does not own or operate any physical retail location. Even so, the “physical nexus” test is applied by a majority of federal courts and was recently adopted by the most active court for ADA website litigation in the country: the US District Court for the Southern District of New York. This development will likely add to an emerging trend of website accessibility plaintiffs resorting to state courts in search of more favorable laws.
In addition to establishing that the supplier’s website is a place of public accommodation, the plaintiff must satisfy certain jurisdictional requirements that will depend on whether products can be purchased directly from the website and whether the supplier ships to the state in which the suit was filed. Leveraging these defenses (among others) will be critical when it comes to either convincing the plaintiff to withdraw the claim, filing a motion to dismiss, or achieving an early resolution on favorable terms.
Due to the rise in these website accessibility lawsuits, we encourage industry members to take a proactive approach by:
Training personnel on accessibility requirements and WCAG standards.
Testing their website against WCAG standards (through independent consultants or user testing) and retaining testing documentation to demonstrate that users with disabilities can fully use the website.
Assessing potential areas of nonconformance with WCAG standards.
Working with internal and external technical teams to implement accessibility features into the website.
Developing an accessibility policy that informs users about the company’s accessibility practices.
Considering including a link to their website accessibility policy on every webpage, including a reporting option that is appropriately routed to address accessibility issues.
Regularly auditing their website to assess its level of accessibility (particularly after website updates).
Prioritizing manual audits over “quick fixes,” like accessibility widgets.
Engaging legal counsel to minimize litigation risk associated with website accessibility issues, including whether the ADA is applicable to the company’s website in light of the current state of the law.
Council of the EU Agrees on Negotiating Mandate on Plants Obtained by New Genomic Techniques
The Council of the European Union (EU) announced on March 14, 2025, that the Committee of the Permanent Representatives of the Governments of the Member States to the EU (Coreper) endorsed the Council’s negotiating mandate on the regulation on plants obtained by new genomic techniques (NGT) and their food and feed. The regulation proposed by the European Commission (EC) would create two ways for NGT plants to be placed on the market:
Category 1 NGT plants: Could occur naturally or through conventional breeding methods; they would be exempted from the rules currently set out in the genetically modified organism (GMO) legislation and would not be labeled; seeds produced through those techniques would have to be labeled, however; or
Category 2 NGT plants: All other NGT plants; rules under GMO legislation would apply (including a risk assessment and authorization before they are placed on the market); they would be labeled as such.
The proposed regulation would exclude the use of NGTs in organic production.
The press release states that the Council suggested the following changes in its negotiating mandate, including:
Cultivation and presence of new genomic techniques plants:
Opt-out from cultivation: Under the Council’s mandate, EU member states can decide to prohibit the cultivation of category 2 NGT plants on their territory;
Optional coexistence measures: EU member states can take measures to avoid the unintended presence of category 2 NGT plants in other products and will need to take measures to prevent cross-border contamination; and
The Council’s position also clarifies that, to avoid the unintended presence of category 1 NGT plants in organic farming on their territories, EU member states can adopt measures, in particular in areas with specific geographical conditions, such as certain Mediterranean island countries and insular regions.
Category 1 new genomic techniques plants and patenting: According to the press release, under the Council’s mandate, when applying to register a category 1 NGT plant or product, companies or breeders must submit information on all existing or pending patents. The patenting information must be included in a publicly available database created by the EC that lists all NGT plants that have obtained a category 1 status. The press release notes that the database would ensure transparency regarding NGT 1 plants and information about patents included in the database would be updated. The press release states that on a voluntary basis, companies or breeders could also report the patent holder’s intention to license the use of a patented NGT 1 plant or product under equitable conditions.
Patenting expert group: The Council’s mandate provides for the creation of an expert group on the effect of patents on NGT plants, with experts from all member states and the European Patent Office.
Study on patenting: The press release states that according to the Council’s mandate, one year after the entry into force of the regulation, the EC would be required to publish a study on the impact of patenting on innovation, on the availability of seeds to farmers, and on the competitiveness of the EU plant breeding sector. The study would also have a special focus on how breeders can have access to patented NGT plants. To produce the study, the EC would take into account the findings of the patenting expert group and input from the plant breeding sector. According to the press release, if appropriate, the EC would indicate what follow-up measures are needed or publish a legislative proposal to address any issues found in the study. The press release notes that if the first study does not foresee any follow-up measures or a new legislative proposal, the EC would be required to issue a second study four to six years after the publication of the first one.
Labeling: Category 2 NGT plants must contain a label indicating them as such, in line with the EC proposal. The press release states that the Council proposes that, in case information on modified traits appears on the label, it must cover all the relevant traits (e.g., if a plant is both gluten-free and drought-tolerant owing to genomic changes, either both of those features or neither of them should be mentioned on the label). The Council intends this proposal to ensure that consumers have access to accurate and comprehensive information.
Traits: The Council negotiating mandate states that tolerance to herbicides cannot be one of the traits for category 1 NGT plants. According to the press release, the Council proposes this change to ensure that such plants remain subject to the authorization, traceability, and monitoring requirements for category 2 NGT plants.
The agreement on the Council’s negotiating mandate allows its presidency to begin negotiations with the European Parliament (EP) on the final text of the regulation. The final text must be formally adopted by the Council and the EP before the regulation can enter into force.
HHS Secretary Kennedy Directs FDA to Explore Rulemaking to Eliminate Self-Affirmed GRAS Pathway
On March 10, 2025, the Department of Health & Human Services (HHS) Secretary Robert F. Kennedy Jr. announced that he is directing the U.S. Food & Drug Administration (FDA) “to explore potential rulemaking to revise its Substances Generally Recognized as Safe (GRAS) Final Rule and related guidance to eliminate the self-affirmed GRAS pathway.”
This self-affirmation process is built into the 1958 Food Additive Amendments, which amended the definition of a “food additive” and allows certain substances to be exempt from premarket review if they are GRAS based on scientific procedures or history of use in food as determined by qualified experts. Notably, the announcement also specifically references “substances that come into contact with food.”
The announcement is made to promote oversight and transparency. The announcement expresses a commitment to working with Congress to close the GRAS self-affirmation pathway and acknowledges that legislation will be pursued in tandem with potential future rulemaking.
Importantly, there is no immediate effect on ingredients currently marketed, allowing companies to continue their operations without disruption while FDA explores potential rulemaking. Keller and Heckman will continue to monitor developments related to the GRAS program.
Telehealth Companies and Social Media Influencers May Face New FDA Laws
On February 20, 2025, U.S. Senators Dick Durbin (D-IL) and Roger Marshall, M.D. (R-KS) introduced bipartisan legislation, the Protecting Patients from Deceptive Drug Ads Act (the Act), which closes perceived “legal loopholes” in social media advertisements by telehealth companies. The Act would require the U.S. Food & Drug Administration (FDA) to target false and misleading prescription drug promotions by social media influencers and telehealth companies.
Background
Whether or not telehealth companies are under FDA jurisdiction when marketing and promoting prescription drugs has been under debate since The New York Times published its 2019 article, Drug Sites Upend Doctor-Patient Relations: ‘It’s Restaurant-Menu Medicine’. The report called into question whether telehealth companies are — or ought to be — subject to FDA oversight when advertising drugs and medical devices. Subsequent investigative reporting alleged how some telehealth companies ran ads on social media describing benefits of prescription drugs but failing to describe the risks of these drugs. Reporters claimed telehealth companies promoted drugs for unapproved uses or featured “testimonials” without disclosing whether or not the testimonials came from actual patients or were from paid actors or company employees.
Under the Federal Food, Drug, and Cosmetic Act (FDCA), advertisements for prescription drugs may not be false, lacking in fair balance, or otherwise misleading. Any advertisements for prescription drugs (with the narrow exception of exempt reminder ads), must present a true statement of information in brief summary relating to side effects, contraindications, and effectiveness. The term “side effects, contraindications” means side effects, warnings, precautions, and contraindications, and also includes any such information under such headings as cautions, special considerations, important notes, etc.
Some have claimed these FDCA legal requirements, although clearly applicable to drug manufacturers, packers, and distributors, do not apply to telehealth companies and associated medical providers because the telehealth company and their associated providers are not addressed in the FDCA and not included in the definition of “firm” under applicable FDA Guidance documents. Under this argument, telehealth companies and their associated providers are not subject to these drug advertising laws in their direct-to-consumer marketing campaigns. Former FDA Commissioner Robert Califf observed how a number of online advertisements by telehealth companies fail to give the complete risk-benefit story (something drug manufacturers must do), as he noted how the FDA lacks the legal authority to regulate the advertising activities of such telehealth companies.
What’s Next?
If signed into law, the Protecting Patients from Deceptive Drug Ads Act would extend FDA’s jurisdiction to specifically include market surveillance of social media influencers and health care providers for whom a financial benefit exists when such communications contain false or inaccurate statements, omits labeling or other key facts regarding a medication, or fails to include traditional risk and side effect disclosures. The Act authorizes FDA to issue warning letters and civil penalties for non-compliance.
The Act is a bipartisan effort and the controversy surrounding telehealth advertising of prescription drugs is not new. We do not anticipate this issue will fade away soon, although similar legislation previously proposed did not pass. Whether this bill can garner sufficient support remains to be seen. What is clear is there is a growing concern among federal policymakers about what they consider unsafe and imbalanced advertisements for prescription drugs by telehealth companies. Given this climate, a best practice is to ensure advertisements and marketing campaigns are reviewed by skilled advisors who can maintain the effective impact of direct-to-consumer promotions while reducing the legal risk of non-compliant advertising campaigns. As the Act moves through Congress, we will provide updates.
Want to Learn More?
Regulation of Digital Health Products by FDA
FDA’s Final Rule on Direct-to-Consumer Advertising – Presentation of Risk Information
DTC Promotional Labeling and Advertisements: Quantitative Efficacy Wins Over FDA in Final Guidance on Presenting Risk Information
Scientific Information on Unapproved Uses of Medical Products: FDA’s Final Guidance on Firm Communication to Health Care Providers