Make Food “Healthy” Again: FDA’s Resolution for a Healthier 2025
The U.S. Food and Drug Administration (FDA) began 2025 with a resolution to make food “healthy” again by announcing a trio of new final and proposed rules that are intended to make it easier for consumers to identify healthy food choices. These rules – which include a new ban on the use of red dye No. 3, a revised definition of what “healthy” claims can be made about foods, and new proposed requirements for nutritional labeling on the front of food packaging – have implications for many stakeholders in the food industry.
Although these healthy food initiatives were initiated under the Biden Administration, they directly align with the new Trump Administration’s agenda for the U.S. Department of Health and Human Services (HHS). The recently confirmed Secretary of HHS under the second Trump administration, Robert F. Kennedy Jr., has campaigned on limiting the use of food dyes and taking aim at highly processed “junk foods” that contribute to obesity. Therefore, we expect that these new rules will be here to stay, despite the new administration’s recent freeze on new proposed rules and recommended postponement of new final rules (which is currently pending court review). Regulated stakeholders should take steps now to prepare for compliance.
Revocation of Use of Red Dye No. 3 in Food and Ingestible Drugs
On January 16, 2025, FDA announced that it amended its color additive regulations to revoke the authorization for the use of FD&C Red No. 3 (commonly known as “red dye No. 3”) as a color additive in food and drugs (90 Fed. Reg. 4628 (Jan. 16, 2025)). Therefore, effective January 15, 2027, red dye No. 3 will no longer be permitted for use in food products, such as candy, cakes, cupcakes, cookies, frozen desserts, frostings, and icings, and all certificates for the use of red dye No. 3 in such products will cease to be effective. Red dye No. 3 will be banned from use as a color additive in ingestible drugs, effective January 18, 2027. Any food and ingestible drug products (including imports) containing red dye No. 3 without effective certification will be considered adulterated.
Notably, although other countries still permit certain uses of red dye No. 3 (sometimes called “erythrosine” abroad), foreign manufactured food products imported into the U.S. will also need to comply with this new ban. Though FDA has not yet signaled whether the implementation of this new rule will be delayed further, food industry members should take steps now to reformulate any products containing red dye No. 3.
FDA’s action on red dye No. 3 is not surprising to some extent, considering that the agency revoked use of the dye in cosmetics in 1990, and its use is already prohibited in food in other countries. What remains to be seen is whether FDA will continue down the regulatory path it has begun. Petitions are presently before the agency to ban other chemicals in food use, such as PFAS, BPA, TCE, and titanium dioxide—some of which have been pending for years. Further, prior to the change in administrations, FDA announced that it is developing a “systemic process” for conducting post-market assessments of chemicals in food, including GRAS ingredients, color additives, food contact substances, and potential contaminants, and established a docket for public comment. By the time the comment period closed, more than 34,000 comments had been submitted to FDA, signaling significant interest in this issue. Given the new HHS Secretary’s stated priorities, it would not surprise us if FDA continues its rulemaking efforts in this space.
Updated Requirements for “Healthy” Claims
In recent years, FDA has expressed concern over the growing prevalence of preventable chronic diseases and health conditions associated with unhealthy diet choices. Because FDA’s research demonstrates that U.S. consumers choose foods based on information readily (and easily) available to them, FDA has focused its attention on revising its food labeling regulations to provide consumers with additional information about a food’s nutritional benefits (or lack thereof). The result is the revised final rule for “healthy” claims and a proposed rule mandating front-of-pack nutrition disclosures, as discussed below.
The preambles to these rulemaking efforts demonstrate that FDA’s thinking has been heavily influenced by the Dietary Guidelines for Americans, 2020-2025 (the “Dietary Guidelines”). Under the National Nutrition Monitoring and Related Research Act of 1990, the U.S. Department of Agriculture (USDA) and HHS must publish the Dietary Guidelines at least once every five years, based on the current state of scientific and medical knowledge. The current Dietary Guidelines deemphasize the importance of individual nutrients or food groups in isolation in favor of a more holistic approach that focuses on dietary patterns during different life stages. A healthy dietary pattern, according to the Dietary Guidelines, emphasizes nutrient dense foods across all food groups, while staying within calorie limits and limiting sugars, saturated fats, and sodium.
FDA regulations have included parameters on “healthy” claims since 1994, but the requirements have not significantly changed since that time, even though nutrition science has evolved. The parameters established under the original rule were fairly rigid, and included specific limits on total fat, saturated fat, cholesterol, and sodium, as well as minimum amounts of nutrients whose consumption was encouraged (e.g., vitamin A, iron, protein). Under the 1994 rule, a food had to meet all the limits of the “discouraged” nutrients and contain the minimum amount of at least one of the “encouraged” nutrients to bear a “healthy” claim. That had the effect of excluding certain “nutrient dense” foods often viewed by consumers as healthy, such as salmon (due to its fat content).
The new Final Rule (89 Fed. Reg. 106,064 (Dec. 27, 2024)) proposes a more flexible approach consistent with the revised Dietary Guidelines. Current nutrition science emphasizes nutrient-dense foods – such as fruits, vegetables, and whole grains – as part of a healthy dietary pattern. Nutrient-dense foods and beverages are defined as those that provide vitamins, minerals, and other health promoting nutrients but also have little or no added sugars, saturated fats, or sodium. Accordingly, foods that meet the requirements for “healthy”, as defined in the new rule, are foods that, because of their overall nutrition profiles, can be the “foundation” or “building blocks” of an overall healthy dietary pattern recommended by the Dietary Guidelines.
Under the rule, a “healthy” food claim “[s]uggests that a food, because of its nutrient content, may be useful in maintaining healthy dietary practices, where there is also implied or explicit information about the nutrition content of the food (e.g., “healthy”).” See 89 Fed. Reg. 106,064, 106161. In general, to meet the new parameters for “healthy” food claims, including claims that foods are “healthful” or “healthier”, food products (including individual foods, mixed products, main dishes, and meals) must (1) for example, contain a certain amount of food (referred to as a “food group equivalent”) from at least one of the food groups or subgroups recommended by the Dietary Guidelines for Americans (e.g., vegetables, fruits, whole grains, fat-free or low-fat dairy, lean meat, seafood, eggs, beans, peas, lentils, nuts, or seeds) and (2) meet specific limits for added sugars, saturated fats, and sodium (based on a percentage of the Daily Value (DV) for these nutrients). Under the new criteria, some categories of foods – vegetables, fruits, seafood, lentils, nuts and seeds, among others – automatically qualify for the “healthy” claim due to their nutrient density, so long as they do not contain any additional ingredients other than water. And some foods that did not qualify for a “healthy” claim under the old rule due to their fat content now do, including avocados, salmon, and olive oil. Conversely, some food products that qualified as “healthy” under the old rule now do not, including fortified white bread, highly sweetened yogurts, and highly sweetened cereal.
The new rule also contains a substantiation requirement. Manufacturers of foods for which “healthy” claims are made must make and keep written records substantiating the “healthy” claims in accordance with the new requirements, except where nutritional food labeling makes clear that the requirements are met.
The food industry may begin voluntarily complying with the new rule on or after February 25, 2025, and must comply by February 25, 2028. Therefore, the food industry should take steps now to review any “healthy” claims made for their products, assess whether those claims should be changed in light of the new final rule, and document the substantiation for their claims.
We add that health claims on food labeling are heavily policed by consumer class action attorneys under consumer fraud laws (particularly in California and New York), and that compliance with FDA’s requirements for “healthy” claims will not necessarily preempt these lawsuits, if a court determines that other aspects of the label or packaging renders the claim misleading on the whole. Therefore, food manufacturers should work closely with experienced counsel in formulating “healthy” claims and ensuring that these claims are properly substantiated.
Nutrition Labeling
On January 16, 2025, FDA published a proposed rule (90 Fed. Reg. 5426 (Jan. 16, 2025)) (the “Proposed Rule”), which, if finalized, would require a front-of-package nutrition label called a “Nutrition Info box” on most packaged foods to assist consumers in more easily identifying healthy foods. This new label would require manufacturers to address the relative amounts of saturated fat, sodium, and added sugars in a serving of the food, and identify whether those amounts are low, medium, or high. FDA’s proposed format for the new label appears below:
The ranges that FDA proposes for each category are as follows:
Low: 5% daily value (DV) or less
Medium: 6% to 19% DV
High: 20% DV or more
In proposing these DV ranges, FDA considered the regulatory history of the percent DV; the agency’s commitment to helping consumers understand the percent DV concept in the context of a person’s daily diet; and the agency’s existing regulatory definitions for nutrient content claims (including definitions established for “low” and “high” claims), among other factors. FDA believes that the ranges it proposes for the interpretive descriptions – and in particular, its designation of 5% DV or less as “low” and 20% DV or more as “high” – align with its longstanding regulatory approach.[1] However, FDA invites comment on its conclusions and analysis.
Calorie disclosures
In the Preamble to the Proposed Rule, FDA acknowledged that some manufacturers already voluntarily include a calorie statement on the front of the food packaging, in accordance with existing regulations. FDA invites comment from industry stakeholders on the inclusion of a mandatory or voluntary statement of calories in the proposed Nutrition Info box, as well as suggestions as to how FDA could consider including quantitative calorie information (e.g., “low”, “medium”, “high”) in the box (including any new data or other information on which FDA could base this interpretation).
Anticipated costs
One notable aspect of the Proposed Rule is its anticipated cost to industry, which FDA analyzed as part of the rulemaking effort. FDA quantified the estimated costs of relabeling to the packaged food industry as a whole to range between $66 million and $154 million per year over a ten-year time horizon. Further, although product reformulation is not a requirement or a stated goal of the Proposed Rule, FDA recognizes that the rule may result in voluntary reformulation efforts by some food producers. FDA estimates that the annualized costs of reformulation would range from $125 million to $377 million over a ten-year time horizon. FDA recognizes the possibility that some of these relabeling/reformulation costs may be passed along to consumers (at least in part).
If finalized, businesses with $10 million or more in annual food sales will be expected to comply with these requirements within three years of the final rule’s effective date. Businesses with less than $10 million in annual food sales will be expected to comply with the requirements within four years of the final rule’s effective date. FDA is accepting comments on this new proposed rule by May 16, 2025. Food industry stakeholders should consider submitting comments to this proposed rule. Foley’s Food and Beverage Industry Team members have extensive experience assisting regulated stakeholders in preparing comments on FDA rulemaking. Any of the authors would be happy to provide additional information.
Regulatory Freeze
As is standard practice for an incoming administration, one of President Trump’s first Executive Orders (“EO”) places a freeze on all pending regulations proposed in the last days of the Biden administration. The EO encourages a 60-day review of any such proposed rules or guidance, with further consultation by the Director of the Office of Management and Budget (OMB) as-needed for “for those rules that raise substantial questions of fact, law, or policy.”
Next Steps
Though there is some uncertainty about timing, overall, industry should plan for the possibility that these rules and orders will take effect. Therefore, food industry stakeholders should act now to:
Begin planning on reformulation of products with red dye No. 3;
Review and assess what “healthy” food claims are made about their products, and document their support for those claims in accordance with the new “healthy” framework; and
Consider submitting comments to the new proposed rule requiring front-of-package nutrition information labeling.
[1] FDA does not have a regulation that establishes a “medium” nutrient content claim for any nutrient. In the Preamble to the Proposed Rule, FDA effectively takes a common-sense approach to defining that term. See 90 Fed. Reg. 5426, 5445 (“The adjective ‘medium’ is defined as, for example, ‘being in the middle between an upper and lower amount, size, degree, or value . . . and ‘intermediate in quantity, quality, position, size, or degree’ . . . . The common meaning of the adjective ‘medium’, then, aligns with the meaning of the interpretive . . . we are proposing.”). Which is just to say that the “low” and “high” goalposts are really what matter for purposes of comment on the Proposed Rule.
China on the Move: Lessons from China’s 2024 National Negotiation of Drug Prices
China’s share of the global drug development pipeline grew from 3% in 2013 to 28% in 2023, positioning China as the second-largest region for clinical trials after the United States. Additionally, the proportion of drugs launched first in China increased from 9% in 2017 to 29% in 2023, placing China just behind the United States in terms of first-in-class launches. This trend highlights the contributions of domestic companies, whose pipelines are replenishing the global pharmaceutical landscape. As a result, NextPharma estimates that the combined value of China’s licensing-out deals reached around $46 billion in 2024, up from $38 billion in 2023 and $28 billion in 2022.
On the demand side, from 2019 to the first quarter of 2023, the National Healthcare Security Administration (NHSA) allocated 60% of savings from generic drug procurement to innovative drugs listed on the National Reimbursement Drug List (NRDL). This shift mirrors trends in developed markets where patented drugs dominate sales. By 2023, innovative drugs accounted for 15.1% of hospital drug expenditures in sample hospitals, up from less than 10% in 2018. However, affordability remains a challenge, which is significant as China continues to push for increased access to cutting-edge therapies.
The 2024 NRDL negotiations, which concluded in November 2024, offer insights into how China is addressing these affordability concerns while seeking to ensure access to innovative medicines. This GT Advisory explores five key takeaways from the 2024 NRDL negotiations and their potential implications for the future of innovative drug pricing and reimbursement in China.
A Contradiction Between NRDL Outcomes and the Growing Influence of Chinese Companies in Global Innovation
Support for First-in-Class and Innovative Drugs
BMI Fund Sustainability
A Continuous Dilemma for Multinational Companies (MNCs)
Reimbursement Coverage Expansion: Category C and Commercial Health Insurance
Continue reading the full GT Advisory.
It’s The Hope That Kills You: My Experience with Alabama’s Medical Cannabis Experiment
If you haven’t seen Ted Lasso, you need to do that immediately (after reading this). In the final episode of the first season, Ted Lasso – an American football coach hired, for reasons that don’t matter here, to coach an English football team – who is played exquisitely by an endearing Jason Sudeikis – notes that he has heard the expression “it’s the hope that kills you” when describing the trials and tribulations of English football. I will leave my thoughts on the merits of relegation and promotion in American sports for another forum.
It’s a classically English turn of phrase, but Ted rejects the premise. Ted says “I disagree, you know? I think it’s lack of hope that comes and gets you. See, I believe in hope.” As all Budding Trends readers know (and there are tens of you around the world), I couldn’t help but think Lasso was channeling the line from Shawshank: “Hope is a good thing, maybe the best of things.”
I suspect those who have known me for a while wouldn’t consider me to be a natural optimist. And years of litigating cases probably hasn’t done anything to change that tendency. I understand why those applicants and would-be patients in the Alabama medical cannabis program would be bereft of hope these days. After all, it has been nearly four years since the Alabama medical cannabis program was enacted by the legislature and not one patient has received medical cannabis.
But somehow in the face of years of advising clients and potential patients going through the hell that can be waiting on lawmakers, regulators, and courts to get a medical cannabis program off the ground, I became an optimist. At first, I’m sure it was little more than putting on a brave face for disappointed, frustrated, and even angry folks wondering why they couldn’t simply get resolution to their dreams. Perhaps this was the “fake it ‘til you make it” phase of my journey, but over time I actually became optimistic that Alabama would be able to launch a medical cannabis program that could provide relief to Alabamians so desperate for a different kind of therapy for what ails them.
I know, maybe as much as anyone in Alabama, how arduous and costly it has been to stand by while this process has played out. I have friends and clients holding licenses issued by the State of Alabama to cultivate and process marijuana. They are wondering whether the countless hours, dollars, and worry have been worth it, and similarly whether it is worth pouring the same into an unknown future. And I have other friends and clients in the integrated and dispensary arena feeling stuck in a regulatory and judicial morass that feels like wading through quicksand.
And, if we’re being honest with each other as friends should, I have left untold fees on the table choosing not to take a side in the long-running litigation because I choose not to take sides when I have clients with different goals and wishes.
For all of these reasons, I am incredibly empathetic to all involved in the seemingly endless delays in the program. But I absolutely believe that Alabama is poised to launch its medical program. Yeah, this is coming from a guy who relies on pop cultural references and jam band quotes. But that guy has never lied to you and has always done his best to take the broader view and make calculated judgments about the facts as they evolve and the future.
I don’t have a crystal ball, and I don’t have a monopoly on predictions. But as I write this, I remain optimistic that Alabama’s medical cannabis program will launch, and it will do so sooner than many believe.
As Coach Lasso instructed: “Onward. Forward.”
Thanks, as always, for stopping by. Your friends at Budding Trends will be right here.
This Week in 340B: February 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: Contract Pharmacy; Medicare Payment; Rebate Model
In a case challenging a proposed state law governing contract pharmacy arrangements in Missouri, the court granted in part and denied in part defendant’s and intervenor’s separate motions to dismiss.
In a breach of contract claim filed by a 340B covered entity against several related party Medicare Advantage plans, defendants filed a reply in support of their motion to compel plaintiff’s claims spreadsheets.
In five cases against the Health Resources and Services Administration (HRSA) alleging that HRSA unlawfully refused to approve drug manufacturers’ proposed rebate models:
Five amicus briefs were filed in support of the drug manufacturer.
In four such cases, drug manufacturers filed a joint position statement on consolidation.
In one such case, a drug manufacturer filed a notice of opposition to consolidation and memorandum in opposition to intervenors.
In one such case, the government filed a position statement in support of consolidation.
Kelsey Reinhardt and Nadine Tejadilla also contributed to this article.
Personal Jurisdiction Considerations for International Biosimilars Companies
The Federal Circuit recently issued decisions in a pair of appeals that provide guidance about when international filers of abbreviated Biologics License Applications (aBLAs) are subject to jurisdiction in the United States. Specifically, the Federal Circuit held that international biosimilars companies are subject to jurisdiction in the United States when they have submitted an aBLA with the intent to market the finished product in the forum state.
1. Regeneron’s Patent Infringement Lawsuits
The plaintiff in each case is Regeneron Pharmaceuticals, Inc., which holds Biologics License Application (BLA) No. 125387 for EYELEA®, which is approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with angiogenic eye diseases—Wet Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR)—via injection into the body of the eye.
Regeneron sued several companies, including Samsung Bioepis Co., Ltd. (SB) and Formycon AG (Formycon), that had filed aBLAs with the FDA seeking approval under the Biologics Price Competition and Innovation Act (BPCIA) to market EYLEA® biosimilars. The cases were consolidated in the U.S. District for the Northern District of West Virginia and the district issued preliminary injunctions against SB and Formycon, barring them from offering for sale or selling the products described in their aBLAs, which have been approved by the FDA. SB appealed the preliminary injunction on several grounds, including that they were not subject to personal jurisdiction, which is the focus of this article.
2. SB’s Connections to the United States
SB is a biosimilar-products company headquartered in Incheon, South Korea. SB argued it has no facilities or employees in the United States; is not registered to do business and has no registered agent in West Virginia; and does not do business with entities in West Virginia. SB also argued that although it would sell its finished product to Biogen MA Inc. (a U.S. company) in a state other than West Virginia, it would not distribute, market or otherwise sell the product in the United States.
3. Formycon’s Connections to the United States
Formycon is a biopharmaceutical company based in Bavaria, Germany. Formycon argued that it has no “direct” ties to West Virginia; is not registered to do business and has no registered agent there; has no assets or employees there; and that it had contracted with manufacturers and packaging partners who would produce the finished product and related materials in other states. Formycon further argued that having developed the product pursuant to an agreement with another German company, it had no plans or rights to itself commercialize the product in the United States. Instead, the product would be sold to another company for marketing and distribution, and Formycon would have no control over the selection of that company or its decisions regarding commercialization.
4. The Federal Circuit’s Jurisdiction Analysis
When evaluating if a defendant is subject to personal jurisdiction in the forum of a particular state, the court looks to (1) whether the state’s long-arm statute permits service of process and (2) whether the assertion of jurisdiction would be inconsistent with due process under the U.S. Constitution. In many states, including West Virginia, the long-arm statutes are “coextensive with the full reach of due process,” so the questions collapse into one constitutional inquiry.
Under the U.S. Constitution, a court in a state may exercise jurisdiction over a defendant that has sufficient “minimum contacts” with the state that it would not “offend traditional notions of fair play and substantial justice.” This standard requires that the defendant’s suit-related conduct create a “substantial connection” with the forum state. The application of the standard in these cases is not necessarily straightforward because patent infringement cases based on an aBLA filing are not easily analogized to other types of actions or even traditional patent infringement cases.
The Federal Circuit, therefore, relied on its precedent in Acorda Therapeutics Inc. v. Mylan Pharmaceuticals Inc., 817 F.3d 755 (Fed. Cir. 2016), which considered the jurisdictional question in the context of a suit arising out of the filing of an Abbreviated New Drug Application (ANDA). In Acorda, the court had held that “minimum contacts” were satisfied by planned future interactions with the state. The submission of an ANDA with the intent to distribute the generic product in a state was held sufficient to support exercising jurisdiction.
Extending Acorda to aBLA cases, the Federal Circuit found similar evidence of conduct sufficient to exercise jurisdiction. Specifically as to SB, the court observed that SB had filed an aBLA; had served Regeneron with a Notice of Commercial Marketing, which communicates an intent to market upon FDA approval; had engaged various partners within the United States; and had entered into a nationwide distribution agreement with a U.S. company, through which SB retained “significant involvement” in commercialization activities.
Notwithstanding the apparent differences in involvement in commercialization activities, the Federal Circuit also found that Formycon intended to market the finished product in West Virginia and other states. As with SB, the court relied on Formycon’s filing of the aBLA, service of Notice of Commercial Marketing, and partnering with U.S. companies to manufacture, package and label its product. Although it had not yet entered into an agreement with a marketing partner, the court found Formycon intended to ultimately distribute the finished product nationwide.
Thus, filing an aBLA, providing Notice of Commercial Marketing, and having more than speculative plans to market the finished product throughout the United States appears sufficient to subject an international biosimilar company to jurisdiction in any state having a long-arm statute coextensive with the U.S. Constitution. The stronger the relationship to commercialization plans, the stronger the argument will be for jurisdiction, although these factors appear to primarily support a finding of jurisdiction as opposed to playing a significant role in the analysis in the first instance.
5. Guidance for International Biosimilars Companies
International biosimilars companies that file aBLAs in the United States with plans to market the finished product should expect a high likelihood of being subject to jurisdiction for related patent infringement cases. Some steps may mitigate the risk, however, and increase the likelihood of avoiding jurisdiction:
Reduce contact with the United States as much as possible. For example, perform all development, sourcing, manufacturing, packaging and labeling outside the United States.
Introduce layers between the aBLA filer and the ultimate marketer. For example, the aBLA filer may contract with other international companies that, in turn, independently contract with a marketing partner in the United States. If the agreement between the aBLA filer and the second international company is not limited to marketing rights in the United States, that may further help.
Carve out particular states. If there are states in which the international biosimilar company does not want to be subject to jurisdiction, expressly exclude those states from commercialization agreements.
These and other factors can significantly affect whether a company is ultimately subject to jurisdiction in the United States, and similar considerations may affect other partners in the international supply chain.
Health Canada Launches FOP Labeling Awareness Initiative
As we have previously blogged about, Health Canada published front-of-pack (FOP) labeling regulations in 2022, which require warnings for most foods high in saturated fat, sugars, and/or sodium. See also Front-of-package nutrition symbol labelling guide for industry – Canada.ca. The regulations will begin to be enforced on January 1, 2026, although the warnings can be voluntarily implemented earlier and have already begun to appear on Canadian shelves.
Recently, Health Canada’s Food and Nutrition Directorate launched an initiative to bring awareness to the new warnings. The initiative aims to inform consumers of the symbol that will be used (black and white box with a magnifying glass, a “high in [X]” declaration, and the words “Health Canada”), its utility (intended to help consumers make informed health choices), and the reason why some pre-packaged foods don’t have it (e.g., the food is a fruit or vegetable or other food exempted because it offers health protection benefits).
We will continue to monitor developments on FOP labeling rules in Canada, the U.S., and other jurisdictions.
President Trump Signs Executive Order Establishing the Make America Healthy Again Commission
On February 13, 2025, President Donald J. Trump signed an Executive Order establishing the President’s Make America Healthy Again Commission. This initiative, chaired by the newly-confirmed U.S. Health and Human Services Secretary Robert F. Kennedy Jr., aims to tackle the root causes of chronic diseases that affect millions of Americans.
According to the order, six in ten Americans have at least one chronic disease, and four in ten have two or more. The commission aims to review the American diet, “absorption of toxic material,” and “food production techniques,” as part of its objectives.
The Commission has outlined four main policy directives to achieve its goals: (1) requiring federally funded research to be transparent; (2) prioritizing researching the root causes of illness; (3) working with farmers to ensure our food supply is healthy and abundant; and (4) increasing the flexibility of health insurance coverage to provide better support for disease prevention.
The composition of the Make America Healthy Again Commission will include the Secretary of Health and Human Services as Chair, and the Assistant to the President for Domestic Policy as Executive Director, and top officials across several federal agencies related to health, the environment, food and drugs, and others.
The EO requires that within 100 days of the order, the commission will provide a preliminary assessment identifying the causes of childhood chronic disease in America.
Alabama Plans to Issue Medical Cannabis Testing License This Summer
What if I told you that you could get a license to test medical cannabis in Alabama this July? Now is that something you might be interested in?
Lost amidst the torrent of confusing messages and general circus surrounding Alabama’s medical cannabis rollout is that the Alabama Medical Cannabis Commission has actually issued licenses to a number of would-be cannabis operators. More than a half dozen cultivators are licensed to grow medical cannabis, and four processors are licensed to process medical cannabis. These companies need testing facilities to analyze their products, and there is currently only one testing facility licensed to do so.
One testing facility is simply not enough to push out the amount of cannabis that will be necessary to operate a statewide medical cannabis program. With a single facility, there will be a huge logjam and a substantial delay in getting medicine to qualifying patients. The AMCC acknowledged as much the day it issued that license and has reiterated that point on multiple occasions since – hence the announcement last week that the AMCC will be offering additional testing licenses in the coming weeks.
Is It Advisable to Pursue a Medical Cannabis Testing License?
First, a word of caution. Because of court injunctions and administrative stays in issuing licenses, no one is currently licensed to dispense medical cannabis. Nor are there any patients licensed to obtain medical cannabis. Without patients and dispensaries, there is not a substantial market for testing medical cannabis. Therefore, anyone interested in pursuing a testing license should do so only after determining they are willing to take the calculated risk that dispensaries will eventually be opened and patients qualified to purchase medical cannabis.
Personally, as I wrote recently, I believe that the court system will soon provide a pathway for exactly that. But I don’t have a crystal ball and anyone considering this path has to determine their own risk tolerance.
I’m a lawyer, so I can tell you about regulations and some of the politics. I can’t tell you it’s going to be a big moneymaker. I do think the first/second mover status could be helpful, but there is no cap on the number of medical cannabis testing licenses under Alabama law, and there could be increased competition for what ultimately will be a limited supply of medical cannabis to be tested.
What Does a Testing License Allow You to Do?
A state testing laboratory license authorizes the licensee to possess and test cannabis and medical cannabis products cultivated or processed at licensed facilities.
There is an annual license fee of $30,000 for medical testing facilities.
The AMCC conveniently provided the following timeline on its website:
2025 State Testing Laboratory License Offering Timeline
Health Agencies Face Terminations; Jim Jones Resigns from FDA’s Human Foods Program
Thousands of workers employed across the Department of Health and Human Services received notices that they would be terminated following four weeks of leave, including at least 89 members of FDA’s Human Foods Program staff, as part of the Trump administration’s overhaul of the federal workforce. The layoffs follow the confirmation of Robert F. Kennedy, Jr. as HHS secretary on February 13.
Terminated staff from FDA’s Human Foods Program include those working on nutrition, infant formula, and food safety response, as well as 10 staff members “who were charged with reviewing potentially unsafe chemicals in the nation’s food supply.”
Jim Jones, FDA’s deputy commissioner for human foods, resigned from the Agency on February 17, citing the “indiscriminate firing” of food program staff and Robert F. Kennedy, Jr.’s rhetoric toward staff. In a letter, Jones wrote: “I was looking forward to working to pursue the Department’s agenda of improving the health of Americans by reducing diet-related chronic disease and risks from chemicals in food. It has been increasingly clear that with the Trump Administration’s disdain for the very people necessary to implement your agenda, however, it would have been fruitless for me to continue in this role.”
Jones, who was appointed as deputy commissioner for human foods in 2023, had committed to priority areas of preventing foodborne illness, decreasing diet-related chronic disease, and safeguarding the food supply, as we previously blogged.
Effective Dates of DEA Final Rules for Telemedicine Prescribing Delayed
On Friday, February 14, 2025, the Drug Enforcement Administration (“DEA”) and the U.S. Department of Health and Human Services (“HHS”) announced that the effective dates for two recently published final rules involving telemedicine prescribing of controlled substances – the final rule titled “Expansion of Buprenorphine Treatment via Telemedicine Encounter” and the final rule titled “Continuity of Care via Telemedicine for Veterans Affairs Patients” (collectively referred to herein as the “Buprenorphine and VA Telemedicine Prescribing Rules”) – are delayed from February 18, 2025, until at least March 21, 2025 (see our previous post on the Buprenorphine and VA Telemedicine Prescribing Rules).
The final rule delaying the effective dates of these final rules is scheduled for publication to the Federal Register on Wednesday, February 19, 2025.
The delays stem from the Presidential Memorandum titled “Regulatory Freeze Pending Review,” (the “Freeze Memo”) issued on January 20, 2025. The Freeze Memo orders all executive departments and agencies to “consider postponing” the effective dates of all rules published to the Federal Register that have not yet taken effect, such as the Buprenorphine and VA Telemedicine Prescribing Rules, until at least March 21, 2025 (sixty days from the issuance of the Freeze Memo), to allow review of any questions of fact, law, and/or policy raised by the rule, and to “consider opening” a comment period for stakeholders to comment on those questions. Accordingly, the DEA is also soliciting comments on: 1) the extension of the effective dates, 2) whether the effective dates should be further extended, and 3) questions of fact, law, and policy raised by these rules, for consideration by officials of the two agencies. Comments are due by February 28, 2025.
The Friday, February 14, 2025 announcement by HHS and DEA, delaying the effective dates, clarified that: “[t]hese new effective dates will not delay or limit the ability of the practitioners covered by these two rules to prescribe via telemedicine, because the ‘Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications,’ which has been in effect since May 10, 2023, permits practitioners to prescribe via telemedicine through December 31, 2025.”
The DEA issued a Notice of Proposed Rulemaking (“NPRM”) titled “Special Registrations for Telemedicine and Limited State Telemedicine Registrations” on January 17, 2025, the same date that HHS and DEA published the Buprenorphine and VA Telemedicine Prescribing Rules. Because the NPRM is in the early stages of the administrative rulemaking process, the proposed rule appears largely unaffected by the Freeze Memo, and comments remain due March 18, 2025.
Takeaways
Practitioners can continue to prescribe via telemedicine without first having an in-person visit with the patient, subject to compliance with other federal and state prescribing requirements, because the Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications, permits practitioners to prescribe via telemedicine through December 31, 2025. The EBG team continues to monitor any changes to the Buprenorphine and VA Telemedicine Prescribing Rules, which are now scheduled to go into effect on March 21, 2025.
David Shillcutt contributed to this article.
January 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 January of 2025, product manufacturers, distributors, and retailers were the targets of 337 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 January 2025 are excerpted and discussed below. A complete list of Notices sent in January 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
Dietary Supplements: Notices include protein powder, prenatal vitamins, and spirulina
22 Notices
Lead and Lead Compounds
Assorted Prepared Food and Snacks: Notices include chips, soup mix, plant-based patties, and protein bars
21 Notices
Cadmium and Lead and Lead Compounds
Seafood: Notices include sardines, mussels, cod liver, tuna, and clams
19 Notices
Cadmium and Cadmium Compounds and Lead and Lead Compounds
Cannabinoid Products: Notices include tinctures, gummies, CBD oil, and seltzer
14 Notices
Delta-9-tetrahydrocannabinol
Fruits and Vegetables: Notices include olives, chopped spinach, dried tomatoes, and artichoke hearts
13 Notices
Lead and Lead Compounds and Cadmium and Cadmium Compounds
Spices and Sauces: Notices include chat masala, dried ginger, and chili
6 Notices
Lead and Lead Compounds
Noodles, Pasta, and Rice: Notices include vegetable lasagna, cheese tortellini, and angel hair pasta
4 Notices
Lead and Lead Compounds and Cadmium
Mint Products: Notices include mint candy and mint caffeine pouches
2 Notices
Pulegone
Seafood: Notices include whole clams and sardines
2 Notices
Perfluorononanoic acid (PFNA) and its salts, Perfluorooctane Sulfonate (PFOS), and Perfluorooctanoic Acid (PFOA)
Dietary Supplements
1 Notice
Perfluorooctanoic Acid (PFOA)
Fruits and Vegetables: Notices include dried mandarin oranges
1 Notice
Perfluorooctanoic Acid (PFOA)
Cosmetics and Personal Care
Product Category
Notice(s)
Alleged Chemicals
Personal Care Products: Notices include shaving cream, moisturizers, shampoo, sunscreen, and hair dye
52 Notices
Diethanolamine
Personal Care Products: Notices include shaving cream, cleansing foam, and hair mousse
5 Notices
Nitrous oxide
Consumer Products
Product Category
Notice(s)
Alleged Chemicals
Plastic Pouches, Bags, and Accessories: Notices include pet carriers, water bottle sleeves, lunch bags, and eyewear cases
60 Notices
Bisphenol A (BPA), Di(2-ethylhexyl)phthalate (DEHP), Diisononyl phthalate (DINP), and Di-n-butyl Phthalate (DBP)
Tools: Notices include screws, solder slugs, lead anchors, and brass hose nozzles
45 Notices
Bisphenol S (BPS), Di(2-ethylhexyl)phthalate (DEHP), Di-n-butyl Phthalate (DBP), and Lead and Lead Compounds
Glassware and Ceramics: Notices include mugs, vases, ramekins, and bowls
38 Notices
Lead
Housewares: Notices include tablecloths, corkscrews, and vinyl seat cushions
11 Notices
Di(2-ethylhexyl)phthalate (DEHP), Diisononyl phthalate (DINP), Di-n-butyl Phthalate (DBP), and Lead
Sports Gear: Notices include roller skates, batting gloves, and dumbbells
8 Notices
Chromium (hexavalent compounds), Di(2-ethylhexyl)phthalate (DEHP), Diisononyl phthalate (DINP), and Lead
Moth Balls
6 Notices
Naphthalene and p-Dichlorobenzene
Clothing, Shoes, and Jewelry: Notices include hats, gloves, rain footwear, and sandals
5 Notices
Di(2-ethylhexyl)phthalate (DEHP) and Chromium (hexavalent compounds)
Cookware: Notices include single-use oval burrito bowls and paper straws
2 Notices
Perfluorooctanoic Acid (PFOA)
There are numerous defenses to Prop. 65 claims, and proactive measures that industry can take prior to receiving a Prop. 65 Notice in the first place. Keller and Heckman attorneys have extensive experience in defense of Prop. 65 claims and in all aspects of Prop. 65 compliance and risk management. We provide tailored Proposition 65 services to a wide range of industries, including food and beverage, personal care, consumer products, chemical products, e-vapor and tobacco products, household products, plastics and rubber, and retail distribution.
DEA Delays Final Buprenorphine Rule
The Department of Health and Human Services (HHS) and the Drug Enforcement Administration (DEA) have delayed the effective date of the final rule regarding telemedicine prescribing of buprenorphine (the final buprenorphine rule) to March 21, 2025, and have requested public comments on the rule. In its final rule delaying the effective date, the DEA reiterates that the delay in effective date will not delay or limit the ability of practitioners covered by the final buprenorphine rule to prescribe via telemedicine due to the current telemedicine prescribing flexibilities in place through December 31, 2025.
A Brief History
On January 17, 2025, in anticipation of the change of administration, the DEA and HHS finalized and published the final buprenorphine rule, which establishes a permanent pathway for the telemedicine prescribing of buprenorphine for opioid use disorder (OUD). The final buprenorphine rule was set to take effect February 18, 2025. (See our discussion on the requirements of the final buprenorphine rule here.) On January 20, 2025, the Trump administration issued the Regulatory Freeze Pending Review Presidential Memorandum authorizing HHS and the DEA to delay until March 21, 2025, the effective date of the final buprenorphine rule for the purpose of reviewing any questions of fact, law, and policy the rule may raise and to open a comment period to gather input from interested parties.
Make Your Voice Heard
Stakeholders are encouraged to participate in the comment process and share their insights on the final buprenorphine rule. The DEA is soliciting comments on the extension of the effective date of the final buprenorphine rule and whether the effective date should be further extended to address issues of fact, law, and policy raised by the rule. Comments may be submitted until 11:59 p.m. ET February 28, 2025. Stakeholders may submit comments electronically here or via regular or express mail to the following address:
Drug Enforcement AdministrationAttn: DEA Federal Register Representative/DPW8701 Morrissette Drive, Springfield, VA 22152
All correspondence, including attachments, must include a reference to “Docket No. DEA-948”.
Additionally, those with concerns about the final buprenorphine rule can share their feedback by contacting their local Congressperson or the White House.
Opportunity for Clarity
Because so much time had passed since the proposed buprenorphine rule was introduced in March 2023, its finalization in January caught many stakeholders by surprise. This additional comment period is a welcome opportunity for the telemedicine industry to seek clarity on several key issues regarding the final buprenorphine rule.
One concern is whether practitioners may continue to rely on the existing telemedicine flexibilities through the end of year if the final buprenorphine rule takes effect before the flexibilities expire, or if they will need to comply with the additional requirements of the rule once it takes effect. Additionally, stakeholders have raised concerns about the DEA’s shift from the originally proposed 30-day supply to a six-month initial supply. Although a step in the right direction to increase the supply, six months seems like an arbitrary choice to OUD telehealth providers who foresee a potential disruption in patient care depending on the available pathways for telemedicine prescribing after the initial supply.
To help initiate discussions, ATA Action has submitted a letter to the DEA seeking further clarification on several aspects of the final buprenorphine rule. We will continue to monitor developments regarding the final buprenorphine rule, including any further extensions of its effective date.