The Irony of MAHA
Robert F. Kennedy Jr.’s promises to promote health don’t align with staff cuts & Trump administration actions
By Steven Hoffman
I met Robert F. Kennedy, Jr. once, in 2001, when he was speaking at a sustainability conference. At the time, I was publisher of the LOHAS Journal, covering the Lifestyles of Health and Sustainability market. At the event, I gave Kennedy a copy of our magazine and expressed my admiration for his work as a leading environmentalist with Riverkeeper, a group that helped clean up the Hudson River, and for being an outspoken advocate for removing toxic chemicals from our food.
Today, Kennedy has built a large following based on these views, with the acronym Make America Healthy Again, or MAHA, as the rallying cry for his base, many of whom are leaders in the natural health movement.
Since my interaction with him in 2001, however, Kennedy has also become synonymous with the anti-vaccine movement. This single voter issue, based in large part on misinformation and mistrust, drove a significant number of natural health advocates to back Kennedy when he declared in 2023 as an independent third-party candidate for president. When he ended his candidacy and endorsed Donald Trump in August, many of these natural health voters went with him in hopes that he could change the food and healthcare system for the better as Secretary of Health and Human Services (HHS) under the new administration.
Unfortunately, Kennedy’s rhetoric is often profoundly at odds with his actions, and with the actions of the wider Trump administration. To cite just one example, while Kennedy says he seeks to improve Americans’ health by bettering their diet, the administration he serves is gutting programs that provide local and organic produce to schools and low-income residents. Likewise, promises to make Americans “healthy again” is at odds with the administration’s roll-back of regulations designed to limit pollution.
Then there are Kennedy’s ideas about vaccines.
Vaccines and vitamins
About the time I met Kennedy, it was reported that the U.S. had eliminated measles due to widespread vaccination efforts. Since then, the anti-vax movement has picked up steam, encouraged in part by Kennedy’s anti-vaccine comments over the years. Now, in 2025, under his watch as head of HHS, the disease has reappeared in the U.S., spreading from a community in Texas to more than 700 cases throughout the U.S. and two reported deaths. Moreover, Kennedy was an anti-vax advocate during a deadly measles outbreak in Samoa in 2019, which killed 83 people in a population of 200,000.
Frankly, no amount of vitamin A—a nutrient Kennedy touted in a March 4 interview on Fox News as a treatment for measles—will stop its spread. Yet, a week after the interview, when he touted the “very good” results of treating measles with vitamin A-rich cod liver oil, demand for the product skyrocketed in Texas, Yahoo News reported. Now, a number of measles patients in Texas are showing signs of vitamin A toxicity, according to the New York Times, which noted that children being treated for measles at Covenant Children’s Hospital in Lubbock, Texas, included “a handful of unvaccinated children who were given so much vitamin A that they had signs of liver damage.”
Kennedy’s conflation of anti-vaccine messaging and unsubstantiated claims about using nutritional supplements as a cure for highly infectious diseases does a major disservice to the dietary supplement industry, the health care industry—and to consumers.
In fact, the Council for Responsible Nutrition (CRN) was so concerned about how the credibility of nutritional supplements might be affected that it issued a statement on March 26: “While vitamin A is an essential nutrient that plays a critical role in supporting vision, growth, reproduction and immune function, it is not a substitute for vaccination. While vitamin A plays an important role in supporting overall immune function, research hasn’t established its effectiveness in preventing measles infection.”
Andrea Wong, senior vice president, scientific and regulatory affairs for CRN, said, “Measles is a serious and highly contagious viral disease that can lead to severe health complications. Treatment and care for measles should always be conducted under the guidance of a qualified healthcare practitioner. Consumers must make informed decisions and consult qualified health professionals before giving supplements to children—especially in large doses.”
Citing that it was becoming difficult to work with the new HHS secretary, the FDA’s top vaccine official, Dr. Peter Marks, submitted his resignation on March 29, saying he was willing to address Kennedy’s concerns about the safety of vaccines but concluded that it was not possible. “It has become clear that truth and transparency are not desired by the secretary, but rather he wishes subservient confirmation of his misinformation and lies,” Marks wrote in his resignation letter. Marks oversaw the FDA’s rapid review and approval of COVID-19 vaccines during the pandemic and is credited with coining the name and concept for “Operation Warp Speed” under President Trump’s first administration.
Office exodus
The same day, Kennedy announced he was cutting an additional 10,000 jobs from the Department of Health and Human Services, which oversees several agencies, including the National Institutes of Health, the FDA and the Centers for Disease Control and Prevention. The latest cuts come after the departure of roughly 10,000 employees over the past few months as a result of the drive by the so-called Department of Government Efficiency (DOGE) to cut jobs throughout the federal government. In total, the cuts amounted to approximately 25% of HHS’s total workforce being eliminated.
The job cuts, allegedly designed to improve efficiency, may well end up costing the government money. “There’s this narrative being spun that somehow by eliminating jobs and functions that taxpayer dollars are going to be saved or that programs will be more efficient,” a staffer with the Centers for Medicare and Medicaid Services who asked for anonymity told Politico. “The reality is the exact opposite.”
Previous cuts to the FDA by DOGE, led by billionaire Elon Musk, resulted in the resignation in February of James Jones, FDA’s Deputy Commissioner in charge of food safety and nutrition, including dietary supplements, following what he called “indiscriminate” layoffs of dozens of food safety inspectors. Jones said the cuts would make it “fruitless” to continue in his role. “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,” Jones wrote.
Following news of DOGE’s February cuts at the FDA, which included a number of staff firings at the FDA’s office of Dietary Supplement Programs, CRN expressed concern about the federal agency’s ability to effectively oversee dietary supplements and food safety. “As the FDA deputy commissioner steps down, it’s critical that the agency maintains adequate staffing and expertise to uphold consumer confidence in the food supply,” CRN said in a statement.
“While staffing changes can occur during any presidential transition, it is critical that the FDA maintains the resources, expertise and staffing levels necessary to ensure effective dietary supplement oversight that undergirds consumer confidence in the supplement market,” said Jeff Ventura, CRN’s vice president of communications.
Growing problems
Meanwhile, at USDA, pauses and cuts to funding for school lunch programs, supplemental nutrition assistance programs and organic farming initiatives run counter to MAHA’s avowed efforts to improve public health. Pauses in funding for organic transition and soil conservation programs are leaving farmers on the hook for millions of dollars they invested on the promise of reimbursement, while “accidental” firings of bird flu researchers have raised concerns that the beginnings of a new pandemic may go undetected.
According to reporting by E&E News by Politico in February, federal officials have been withholding funding for two major organic agriculture programs that make payments directly to farmers, jeopardizing millions of dollars in funding ahead of the 2025 planting season. “The pause on the $85 million Organic Market Development Grant program and the $100 million Transition to the Organic Partnership Program has jolted farmers, nonprofits and businesses struggling to make planting and hiring decisions. Even if the pause on funding is lifted, it could put farmers out of business,” wrote reporter Marcia Brown, who noted that the USDA has yet to release funding for the programs, even though federal courts ordered an end to the across-the-board freeze.
USDA’s Supplemental Nutrition Assistance Program (SNAP), formerly known as the Food Stamp program, is under DOGE scrutiny, while the House of Representatives budget plan seeks to cut up to $230 billion from SNAP. Such funding cuts would affect sales for natural and organic food producers, including for such healthy staples as organic dairy and plant-based foods that are frequently purchased by SNAP recipients.
On March 10, USDA Secretary Brooke Rollins announced the cancellation of $1 billion in federal funding that gave schools and food banks money to purchase food from local farms and ranchers. According to Kevin Hardy, a reporter with Stateline, the funding boosted business for more than 8,000 farmers, providing local food to food banks and schools. “The Trump administration is killing the programs, despite HHS Secretary Robert F. Kennedy Jr.’s campaign against processed food, which he says is poisoning Americans,” Hardy wrote.
When it comes to our food system, we are all for getting the chemicals out of food, and the FDA’s announcement in January that it would ban Red Dye No. 3 from food products is to be celebrated. Now, if only Kennedy and the Trump administration could start focusing on the other 9,999 questionable chemicals allowed in commercial food production.
Overall, it is difficult to square Kennedy’s rhetoric with the on-the-ground actions of the administration he serves. And that, to me, is the painful irony of MAHA.
Steven Hoffman is Managing Director of Compass Natural, providing public relations, brand marketing, social media and strategic business development services to natural, organic, regenerative and sustainable products businesses. Contact steve@compassnaturalmarketing.com.
DOGE Days: From Supplements to Organic Farming, Natural Industry Feels Cuts
By Steven Hoffman
As the Department of Government Efficiency, or DOGE, led by billionaire Elon Musk under the administration of President Donald Trump, cuts jobs and funding for programs at U.S. agencies across the board, natural and organic food and dietary supplement producers are feeling the impact of DOGE cuts to FDA, USDA, USAID and others.
Cuts to FDA have resulted in the resignation of James Jones, FDA’s top official in charge of food safety and nutrition, following what he called “indiscriminate” layoffs of dozens of food safety inspectors. Jones, who joined the agency in 2023, said the cuts would make it “fruitless” to continue his role. “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,” Jones wrote. News of the resignation was first reported on Feb. 17 by FoodFix.
The U.S. Department of Health and Human Services announced plans in mid-February to fire 5,200 probationary employees across its agencies, including the National Institutes of Health (NIH), the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). The layoffs appeared to focus on employees in the agency’s departments for food, medical devices and tobacco products. It was not clear whether FDA employees who review drugs were exempted. However, Fierce Healthcare reported on Feb. 22 that hundreds of fired FDA probationary workers have received notices from the agency that their terminations were rescinded.
Following news of the DOGE’s layoffs at the FDA, including a number of staff firings at FDA’s office of Dietary Supplement Programs, the Council for Responsible Nutrition expressed concern about the FDA’s ability to effectively oversee dietary supplements and food safety. “As the FDA deputy commissioner steps down, it’s critical that the agency maintains adequate staffing and expertise to uphold consumer confidence in the food supply,” CRN said in a statement.
“While staffing changes can occur during any presidential transition, it is critical that the FDA maintains the resources, expertise and staffing levels necessary to ensure effective dietary supplement oversight that undergirds consumer confidence in the supplement market,” said Jeff Ventura, CRN’s VP of Communications.
USDA Pauses Two Major Organic Programs
At USDA, pauses and cuts in funding for organic transition and soil conservation programs are leaving farmers on the hook for millions of dollars they invested on the promise of reimbursement, while “accidental” firings of bird flu researchers at the agriculture agency have exacerbated the high price and limited availability of eggs. (According to USDA data, the price of eggs increased 38.2% since the beginning of 2025, with the cost of a dozen conventionally produced eggs exceeding of $8 in February 2025.)
Federal officials also are withholding funding for two major organic agriculture programs that make payments directly to farmers, jeopardizing millions of dollars in funding just ahead of the 2025 planting season, reported E&E News by Politico on February 6. “The pause on the $85 million Organic Market Development Grant program and the $100 million Transition to the Organic Partnership Program has jolted farmers, nonprofits and businesses struggling to make planting and hiring decisions. Even if the pause on funding is lifted, it could put farmers out of business,” wrote E&E News reporter Marcia Brown. According to Brown, USDA has yet to release funding for the programs, even though federal courts ordered an end to the across-the-board freeze.
In addition, USDA’s Supplemental Nutrition Assistance Program (SNAP), formerly known as the Food Stamp program, is under DOGE scrutiny, plus the House of Representatives budget plan seeks to cut up to $230 billion from SNAP. Such funding cuts would affect sales for natural and organic food producers, including for such staple healthy products as organic dairy and plant-based foods that are frequently purchased by SNAP recipients.
According to Georgie Lee Smith, who blogs under the moniker Farmer Georgie, the loss of scientists and researchers at USDA agencies including the Agricultural Research Service (ARS) and the Animal & Plant Health Inspection Service (APHIS) will have a long-term negative effect on the ability of U.S. agriculture to respond to issues and opportunities, and maintain its position as one of the world’s leading food producers.
Beginning in mid-February, “DOGE took aim at the United States Department of Agriculture, aka the USDA, firing ‘probationary’ employees in what has been described as a ‘blood bath’ of terminations. To be clear, probationary periods can run from one year to three, depending upon the job, and apply even to long-time USDA employees who have recently taken a job promotion. Translation — it’s a lot of folks, many with significant dollars invested into their training,” Smith wrote.
“The researchers and scientists at ARS are on the frontline of nutrition, food safety and quality, livestock and crop production, natural resources and sustainable agricultural systems. Along with our land grant university systems, ARS researchers are often the first area of investment into solving critical food and agricultural issues, whether that’s preventing food-borne illness outbreaks to breeding more climate-resilient crops and livestock to new ways to combat pests and diseases impacting food production,” she wrote. Smith also pointed to the risks associated with cutting staff at APHIS, USDA’s agency responsible for combatting the escalating avian flu crisis.
“Many farmers and ranchers are still holding onto hope that the funding freezes that have their grants and cost-share monies tied up are only a bump in the road. Perhaps these USDA terminations will be the same. But I’m afraid that is not the case,” Smith wrote on February 16. “Secretary (of Agriculture) Brooke Rollins issued a press release … that DOGE had terminated 78 USDA contracts totaling more than $132 million, with more than 1,000 contracts still under review. And DOGE tweeted they had eliminated an $8.2 million USDA contract to implement programs administered under Biden’s climate-smart initiative, which had funneled $3 billion in grant funds to agricultural producers, marketing organizations and forest landowners nationwide to support the adoption of climate-smart practices. Again, I can’t help but point out that the large majority of the climate-smart grants specifically supported the same ‘soil health/regenerative ag’ mantra that RFK Jr. is purporting. I feel like we just cut off our noses to spite our faces,” Smith commented.
Dismantling of USAID Impacts U.S. Farmers
For the U.S. agriculture economy, 40% of government food assistance comes from American farms through programs including the U.S. Agency for International Development (USAID), which purchased $2 billion in food from American farmers in 2024. As such, the dismantling of USAID, along with its Food for Peace program, has eliminated a valuable market for farmers. It also has resulted in nearly $500 million worth of donated food sitting unused or rotting on docks and in warehouses, according to a report issued on February 10 by the Inspector General of USAID.
“Should parts of USAID be reformed or revisited? Certainly. But shutting down the entire agency in less than two weeks is not the way to do it,” wrote Erin Sikorsky, Director of the Center for Climate and Security and former aide to Wisconsin Congressman Ron Kind, in the Feb. 17, 2025, edition of the Milwaukee Journal Sentinel.
“I know Wisconsinites are proud of the role our farm industry plays in supporting food security and preventing starvation worldwide. The Wisconsin Congressional delegation has consistently stood up for Wisconsin farmers, and they must do the same today by opposing this reckless destruction of these life-saving and economically important food aid programs. This action is a reversal of decades of bipartisan support for programs that provide global food aid and prevent starvation, precisely because such programs help American farmers, help those most in need, and prevent conflict and instability that threatens our national security,” Sikorsky wrote.
Steven Hoffman is Managing Director of Compass Natural, providing public relations, brand marketing, social media and strategic business development services to natural, organic, sustainable and hemp/CBD products businesses. Contact steve@compassnaturalmarketing.com.
FDA Objects to CBD Being Sold as a Dietary Supplement; Industry Leaders Speak Out
By Steven Hoffman
FDA’s recent decision to reject New Dietary Ingredient applications for full-spectrum CBD from Charlotte’s Web and Irwin Naturals casts a cloud of market uncertainty; passage of Congressional legislation is only option, say industry leaders
Despite months of diligent communications with the U.S. Food and Drug Administration (FDA), along with the submission of volumes of data demonstrating the safety and efficacy of full-spectrum, hemp-derived cannabidiol (CBD), FDA in a letter posted on August 10 rejected two New Dietary Ingredient notification (NDI or NDIN) applications for CBD submitted by pioneering CBD brand Charlotte’s Web and leading natural supplement brand Irwin Naturals.
The decision, based on the agency’s 2020 ruling to treat CBD as a drug, casts a continuing cloud of uncertainty over the market for dietary supplements and functional food and beverage products made with hemp-derived CBD. FDA’s objection only adds to consumer confusion and investor hesitancy, resulting in stunted market growth, say industry leaders, despite rising interest from U.S. farmers to grow hemp and from consumers in using CBD as a safe and effective dietary supplement and herbal remedy alternative.
It was a disappointing, if not surprising, decision by an agency that has historically shown an aversion to dietary supplements and cannabis-derived products, and that has been criticized for being under the outsized influence of the pharmaceutical lobby.
However, given the FDA’s continuing objection to allowing CBD to be sold as a dietary supplement, the only option left is for the hemp industry to advocate for Congressional legislative action, such as H.R. 841 in the House of Representatives and S. 1698 in the Senate, to mandate the FDA to regulate CBD as a dietary supplement and allow for the growth of the emerging hemp-derived CBD market. See U.S. Hemp Roundtable’s legislative guide to take action.
Writing in New Hope Network, Rick Polito reported, “The agency had signaled willingness to work with brands via the NDI process, but in the end appeared intent on delivering a predetermined verdict that CBD, whether as an isolate or as a component of a full-spectrum hemp supplement, is legally identical to the CBD compound as used in Epidiolex, a pharmaceutical drug used to treat epilepsy. The Food Drug and Cosmetic Act ‘exclusionary clause’ holds that supplements cannot contain pharmaceutical ingredients.”
“Why did the FDA put them through the months of doing this dance back and forth?” Steve Mister, CEO of the Council for Responsible Nutrition, asked New Hope’s Polito, emphasizing that Irwin Naturals and Charlotte’s Web were diligent in the NDI process.
“The FDA’s absence, in all measurable forms of leadership, has not only left the CBD market unregulated, it has also cost the hemp industry hundreds of millions if not billions of dollars in lost revenue and investments, and created obstructive barriers and bottlenecks throughout the entire hemp supply chain,” said Morris Beegle, President of We Are for Better Alternatives and producer of NoCo Hemp Expo.
Read on to hear what Charlotte’s Web and other hemp industry leaders and advocates had to say in response to FDA’s decision.
Charlotte’s Web Official Statement
“Today the U.S. Food & Drug Administration (FDA) published an “objection” to Charlotte’s Web’s New Dietary Ingredient notification (NDI) submitted for our full spectrum hemp extract (FSHE), due largely to its drug preclusion provision. This response from the FDA indicates to Charlotte’s Web that without legislation by Congress, this market will remain unregulated…
Over the last 18 months, Charlotte’s Web collaborated with the FDA, providing information about the cultivation, extraction, manufacturing, use and safety behind our proprietary FSHE with naturally occurring levels of CBD. We also supplied research evidencing our FSHE to be different from purified CBD in isolate form which is an FDA-approved drug.
The FDA letter asserts that a FSHE cannot be used in dietary supplements because it is precluded and expresses safety concerns. Regarding safety, the conclusions drawn by the FDA do not appear to be based on the data provided in our NDI application … We requested the FDA correct the record to reflect that data…
The FDA objection to the NDIN does not impact the existing business operations of Charlotte’s Web but does provide useful guidance about what’s required to secure a regulatory framework for FSHE as a dietary supplement.
Both the House of Representatives and the Senate introduced bills that would legislate hemp CBD as a dietary supplement. We believe this legislation is a critical step to protect consumers and to establish guidance for manufacturers, and Charlotte’s Web intends to stay at the forefront of these efforts. Our vertically integrated supply chain and category leadership uniquely position us to work effectively with Congress, and the FDA, to ensure this critical path forward for the hemp industry.”
See Charlotte’s Web’s full statement here.
Jonathan Miller, General Counsel, U.S. Hemp Roundtable, Member-in-Charge, Frost Brown Todd, Washington, DC
“There has been general support for our legislative efforts at U.S. Hemp Roundtable, but there have been some holdouts saying, ‘Let’s give the FDA time to sort it out.’ But this latest NDIN rejection puts that argument to bed. The FDA is clearly not going to take steps to regulate CBD unless Congress tells it to do so. FDA’s objection makes it clear that our top priority is securing passage of legislation such as H.R. 841 and S. 1698.
The U.S. Hemp Roundtable is deeply disappointed to witness FDA’s rejection of two dietary ingredient notifications (NDINs) recently submitted for full-spectrum hemp extracts. FDA’s actions send a discouraging message to the entire hemp and CBD industry, especially in light of the fact that these firms provided more than ample safety data and cooperated with FDA’s requests throughout the process.
When held to the same regulatory standards as other dietary supplements and food ingredients, hemp-derived CBD products have a strong safety profile; the dangers to consumers are only posed by the unregulated marketplace that FDA continues to propagate. This should be a clarion call to Congress that it is time to step in and pass legislation to ensure that CBD products are held to the same standard as all dietary supplements and food ingredients, and to reject an NDIN-only path.
It’s been more than two and a half years since hemp was legalized by the 2018 Farm Bill, and without congressional intervention, the hemp farming industry will continue to struggle, and consumers stand to lose as well.”
See U.S. Hemp Roundtable’s legislative guide to take action.
Janel Ralph, CEO, RE Botanicals and Founder, Harmony CBD
“It is mind blowing to me that FDA is asking us to prove that something is safe when it’s never been proven to be unsafe. It’s FDA’s job to prove it’s unsafe, and it hasn’t been able to do that. The agency claims it’s a drug. Well, at what dose is it a drug? Epidiolex is like 300 mg a day, while full-spectrum supplements are like 25-50 mg a day. FDA could legally make an exemption, but it is choosing not to.
On a personal note, my child Harmony, who was born with Lissencephaly or smooth brain syndrome, has been taking CBD every day of her life for the past seven years. She gets tested regularly for liver enzymes and it has never once affected her liver, yet it has significantly alleviated her suffering from seizures.
At the end of the day, CBD is improving people’s lives across the country and it should be available to everyone as a supplement. FDA needs to start looking at CBD differently. If FDA is going to block something that benefits people, that’s a problem.”
Rachael Rapinoe, CEO and Co-founder, MENDI Co.
“FDA’s objection results in further disconnection from hemp brands, consumers and the education needed to progress the industry as a whole. It shows many of us that the FDA isn’t prioritizing CBD products and bringing a clear path forward in a timely manner. The implications will result in continued confusion and discontinuity of language between brands in the industry.
The FDA is making it increasingly difficult to properly educate and protect consumers from the various types of products on the market and the benefits associated with them. Education is the key to progress and we need the full support of the FDA and medical community if we want to see this industry and its consumers mature.
We will continue to operate in highly restricted grey zones, which is very frustrating. We have a lot research and education to pull real data to educate and empower consumers in the industry. As a brand, we want to protect the public from harmful or dangerous products and guide them in directions that will be more beneficial to their long term health. Also as a brand, we would like to operate in the same capacity as other CPG companies.”
Michael McGuffin, CEO, American Herbal Products Association
“Last month, the U.S. Food and Drug Administration (FDA) replied to two separate new dietary ingredient notifications (NDINs) submitted for ingredients identified as ‘full-spectrum hemp extracts,’ one filed by Charlotte’s Web, Inc., and the other by Irwin Naturals. In its responses, FDA informed both companies that the subject ingredients ‘cannot be used in dietary supplements pursuant to the dietary supplement exclusion provision in 21 U.S.C. § 321(ff)(3)(B)’ on the basis that each qualifies as a ‘CBD product.’
Significantly, the Charlotte’s Web, Inc., ingredient has a cannabidiol (CBD) content of 19.5 mg per serving, and the Irwin Naturals ingredient has a proposed serving limit of approximately 65 mg/day of CBD. In addition, the agency identified ‘concerns about the adequacy of safety evidence’ included in these notifications ‘as a basis for concluding that a dietary supplement containing [the NDI] will reasonably be expected to be safe when used under the conditions’ described in the notifications.
We are fast approaching the three-year anniversary of the enactment of the 2018 Farm Bill, which reflected the decision by the U.S. Congress to support farmers and consumers by establishing a lawful process for production of hemp, which was broadly defined to include the cannabinoids in hemp, including CBD. But ever since FDA has relied on the cited exclusion provision to keep dietary supplements that contain any amount of CBD in a regulatory gray zone, even though the agency already has authority to create a lawful framework for marketing such products.
No one who has been paying attention to this matter should be in the least surprised to see FDA restate its position in these letters. At the same time, it is disappointing and represents another missed opportunity for the agency to bring clarity to the marketplace while using its existing resources to protect the health of the many Americans who already use hemp-derived products.
There are several bills now pending in the U.S. Congress that would resolve this matter and that are supported by the American Herbal Products Association and other organizations who are seeking a resolution that will simultaneously protect the public and the trade. FDA’s NDIN responses should sharpen the focus of all who share such a goal.
At the same time, FDA’s pointed attention to the content of these two NDINs should not surprise any experienced reviewer of the over one thousand such notifications submitted over the past 25 years, and the agency’s replies should be familiar in their scope and tone. Even if Congress acts to remove the current legal barriers to CBD-containing hemp products, companies that intend to bring a new CBD ingredient to market will need to meet the very high standard established for NDINs. In establishing this standard, it is not uncommon for FDA to identify its own specific safety concerns in its response to an initial notification, and the agency often lays out a roadmap for following up with more safety information – as it did for these two full-spectrum hemp extract submissions. These two companies and others who plan to follow their leadership would be well served to study these letters in detail.”
Asa Waldstein, Principal, Supplement Advisory Group; Chair, AHPA Cannabis Committee
“Conducting studies to prove safety is an important part of responsible herbal commerce and Charlotte’s Web should be commended for its time and financial investment. Charlotte’s Web makes the case that a naturally occurring CBD is different from the CBD isolate used in Epidiolex. The FDA comments highlight the agency’s position that any CBD-containing product, including a full-spectrum hemp extract, is not a lawful dietary ingredient due to the Epidiolex drug preclusion provision.
FDA states the Charlotte’s Web (products) are ‘carefully designed to ensure consistent levels of CBD, and that it is produced from your proprietary cultivar (CW1AS1) hemp plants that provide robust levels of CBD.’ FDA’s case here is even though CBD isolate is not added to the products, they still are designed with CBD content in mind. This is a conundrum, as process control and label accuracy are part of dietary supplement regulations. This discussion is further complicated by state requirements in West Virginia and Utah which require CBD content to be listed on the label.
My concern is the FDA response may inadvertently send a ‘do not proceed’ message to companies on the fence about conducting safety studies. I implore companies to continue to add proving product safety into their budgets and strategies.
During this regulatory holding pattern, I suggest companies continue to collect product safety data, as future regulation will likely include a safety component. Acting like a reputable dietary supplement company is the best way forward for hemp-CBD companies. This includes investing in safety studies, but also CFR 111 & 117 compliance, food facility registration, lot number traceability, recall procedures, adverse event reporting, and common allergen labeling.”
Sander Zagzebski, Attorney and Co-leader of Clark Hill LLP’s Cannabis Industry Team
• What does FDA’s objection mean?
“As a technical matter, it means that the person filing the notice (Charlotte’s Web, Inc.) does not have FDA approval to use the dietary ingredient listed in their notification (full spectrum hemp extract) in food products”.
• Why Now?
“The hemp/CBD industry has been operating in a gray area under federal law. While the Farm Bill has legalized certain hemp and hemp derived products, including CBD isolates and full spectrum CBD extracts, under certain circumstances, it is an exaggeration to say the Farm Bill “legalized CBD” in a wholesale fashion. One of the big questions relating to hemp-derived CBD products generally is whether and to what extent manufacturers can include hemp-derived CBD products in food and beverage products that are generally regulated by the FDA. I’m guessing Charlotte’s Web was hoping the FDA under the new Administration would provide some clarity on this issue for the hemp/CBD industry in general and for Charlotte’s Web in particular. By way of background, the law provides that active ingredients in approved pharmaceutical products cannot be sold as dietary supplements in other products. One of the policy purposes behind this law is to encourage companies to undertake the considerable time and expense necessary to get FDA approval for a new pharmaceutical product. If competitors were allowed to sell the active ingredient to a new pharmaceutical product as a dietary supplement, it obviously dilutes significantly the economic benefit of winning FDA approval for a new drug and acts as a strong disincentive to go through the FDA’s drug approval process. When the FDA approved the drug Epidiolex, which is a CBD oral solution for the treatment of epilepsy, that action meant that the active ingredients of Epidiolex, including the CBD compound, could not then be classified as an approved dietary supplement under the law. Left unclear, however, was whether the exclusion would apply only to the specific CBD chemical compound in Epidiolex, or whether it would be applied more broadly to other CBD compounds including ‘full spectrum’ CBD.”
• What was Charlotte’s Web’s objective in applying to the FDA?
“It is likely that Charlotte’s Web was hoping to get clarity on the FDA’s position regarding CBD and to get the FDA’s blessing that, at a minimum, a “full spectrum” hemp-derived CBD products (as opposed to the specific CBD isolate in Epidiolex) would qualify as a permitted dietary supplement.”
• What are the implications going forward re: FDA’s policy toward CBD?
“The broader implications are so far unclear. The hemp-derived CBD industry has existed in this regulatory gray area regarding the FDA for some time, so one could argue that nothing really has changed. On the other hand, the FDA had an opportunity to do the industry a favor, and it declined to do so. Although I don’t have a crystal ball, I think it is likely that the FDA will continue to focus most of its enforcement energy on suppliers that make what the FDA considers to be unsubstantiated health claims, since that doesn’t involve any significant change in their policy stance from the prior Administration. Most federal agencies are loathe to make major policy adjustments when they don’t have a Senate-approved leader at the helm. Since the FDA is currently operating under an Acting Commissioner, it seems a safe bet that the FDA won’t make a major policy decision regarding hemp or CBD until it has its Senate-approved leader.”
• How does that impact companies, consumers and the market?
“In the immediate term, the impact is probably insignificant. The industry had hoped for some clarity, which the FDA has declined to give it, but otherwise the status quo will continue. That said, the industry will have to digest the fact that the FDA hasn’t gone away, and that legislative action is probably necessary to clear the air.”
• What will it take for FDA to allow for and regulate CBD as a safe ingredient in supplements and food and beverage products?
“It is possible that a new FDA Commissioner will, once confirmed, decide to take a more permissive approach to the industry. Absent direction from the top, however, it feels like the career bureaucrats in the FDA do not want to be put in the position of having to make these policy decisions. So legislative action is probably inevitable, eventually.”
• What actions can hemp industry leaders and advocates take to support free access to CBD products in the dietary supplements market?
“Given the regulatory ambiguity, industry leaders would be well advised to be cautious in how they market their products and to be rigid in otherwise complying with all applicable rules and regulations.
• What other comments would you add?
“One coda to this response: The maker of Epidiolex, GW Pharmaceuticals, was sold to Jazz Pharmaceuticals for $7.2 Billion. While GW undoubtedly had other products in the pipeline, the press release announcing the deal describes Epidiolex as GW’s ‘lead product.’ So FDA approval is big business.”
# # #