The FDA’s key committee that controls what can and can’t be made by compounding pharmacies has just moved a step further to banning more life-enhancing peptides. The proposed ban now also widens to encompass a commonly consumed amino acid! We need a STRONG grassroots response to vigorously oppose this arbitrary exercise of power and restriction on medical freedom. Action Alert!

THE TOPLINE

• The FDA’s Pharmacy Compounding Advisory Committee (PCAC) voted this week to ban the compounding of several key peptides, with more decisions coming soon—threatening patient access to these natural health solutions.
• The FDA’s advisory process is deeply biased, with inadequate time for industry, academic, and independent experts to address the FDA’s one-sided presentations, signaling a predetermined stance against compounded peptides.
• By demanding clinical trial-level data, the captured FDA is setting impossible standards, effectively banning peptides and one important amino acid from compounding to favor its paymasters in Big Pharma to preserve its monopoly.

Bureaucratic Executioner

Earlier this week, the FDA’s Pharmacy Compounding Advisory Committee (PCAC) met once again to decide the fate of several important, natural compounds. True to form, PCAC—under heavy-handed influence from the FDA—voted overwhelmingly to ban the compounding of peptides like kisspeptin-10, ipamorelin, ibutamoren, , and the non-essential amino acid, as found in tea, L-theanine. PCAC will meet again early in December to vote on other important peptides, including thymosin alpha-1. It is almost a certainty that the committee will vote to ban these peptides from compounding, although citizen outrage at these actions in the halls of Congress is the one thing we know that could make a difference.

To be clear, PCAC’s vote is a recommendation. The FDA must go through the formal rulemaking process to ban these substances from compounding. But, seeing as the FDA recommended that each of these peptides and now L-theanine as well be banned, it’s clear that the agency will try to ban these compounds. It’s just a matter of when it will try this formally and what kind of opposition it has to deal with. And that’s where we come in.

The Stacked Deck

As we’ve argued many times before, the FDA’s process appears to us to be completely rigged against the very idea of compounded medicines. This is perverse given that medical science has payed ever greater lip service to the need for precision medicine and personalized treatments. At this week’s meeting, PCAC considered four substances; three peptides and one amino acid. For each substance, FDA staff calmly and methodically presented their evaluation and conclusions on whether the substance should be allowed in compounding for about 30 minutes, after which PCAC members could ask clarifying questions. Representatives of the compounding industry were then given a mere 15 minutes to present their case. It was clear from anyone watching this — the author included on behalf of ANH-USA — that there was simply not enough time to address all of the pertinent scientific issues regarding chemical composition, safety, and efficacy.

As we’ve seen in other areas of FDA policy regarding compounded medications, it was very clear to us that the FDA was managing the entire process to bring about a desired outcome—and they were successful, at least up until now. The peptides and amino acid in question were nearly unanimously rejected by the committee, some with only one vote in favor.

Warped Science

The FDA presentations did little more than expand upon the issues raised last year when the FDA flagged a group of 22 peptides for “safety concerns.” Those concerns weren’t supported by any evidence of lack of safety, they were supported by a lack of evidence. These two concepts need to be clearly distinguished both in practice and in law!  The FDA claims a lack of data regarding safety and efficacy of compounded peptides, especially for routes of administration other than oral (such as intramuscular or subcutaneous injection). This was a consistent theme throughout all of the FDA presentations, where FDA staff repeatedly concluded that nonclinical and clinical safety and efficacy data were insufficient.

Time and time again in the agency’s communications on compounding, the FDA bemoans the lack of clinical trials that would attest to the safety and efficacy of compounded medicines—the standard used to approve new drugs. But—here’s the key point: legally compounded drugs are exempted from new drug approval requirements. What the agency is really saying is that it does not want compounded drugs to exist, period, because the agency doesn’t control them and they compete with Big Pharma’s drugs.

We’ve seen this playbook before: the FDA tries to seem like it’s playing fair—what’s wrong with wanting clinical trials to affirm the safety and efficacy of medicines? But what’s really going on is the agency is erecting insurmountable obstacles for compounded medicines to get the green light. These medicines are not patentable, so no one is going to spend the astronomical sums necessary to run clinical trials on them. This is a backhanded way of banning innumerable compounded medicines and thus making it impossible for these pharmacies to stay in business.

Another issue raised by FDA staff was the threat of impurities in the active pharmaceutical ingredients (APIs) for peptide medications that could pose a risk for immunogenicity (the ability of the body to produce an immunological response to a given substance). Compounding industry representatives correctly pointed out that this is not an issue with compounding as such but with bulk drug ingredient suppliers, and that this issue could be adequately addressed if the FDA issued guidance on how compounders could run quality control checks on bulk drug ingredients to ensure purity. The FDA confirmed, however, that it has not issued such guidance, nor does it plan to. This is yet another indication that the FDA isn’t really interested in advancing safe compounded medicines: it just wants to ban them based on theoretical concerns about purity.

Cutting Edge Medicines in Peril

Losing access to life-enhancing peptides and L-theanine for use in compounding would be a huge blow for patients, healthcare providers and medical freedom. Peptides, quite simply, are specific combinations of essential, semi-essential and non-essential amino acids linked by strong peptide bonds. Most hormones are peptides. Most of the amino acids used in the peptides that have now found their way onto the FDA’s Category 2 hit-list list are bioidentical – meaning they are chemically identical to ones found in nature – especially in foods, and in healthy humans and animals.

Two substances on PCAC’s hit-list this week that really caught our eye were kisspeptin and L-theanine.

Kisspeptin is a hormone peptide comprised of 14 amino acids that plays a key role in the regulation of the reproductive system, including its effect on increasing sex drive. It also plays a key role in neuro-regulation, influencing appetite regulation and energy homeostasis. And the FDA thinks Americans don’t need this hormone?

As for L-theanine, found especially in green tea: like so many natural molecules, it has many beneficial effects on the body. It has profound antioxidant and anti-inflammatory effects,  and among multiple benefits (see Figure to the left), it reduces stress and anxiety, it enhances cognition, it helps lower blood pressure and it improves sleep. That’s before you even consider its cancer protective effects. It’s not hard to see just how many of Big Pharma’s blockbusters it competes with.

Figure. The health benefits of L-theanine. Source: Li M-Y, et al. Front. Nutr., 2022.

We must protect access to these vital compounded peptides.

Action Alert! Write to Congress and the FDA, telling them to retain consumer access to natural peptide medicines! Please send your message immediately.

The post FDA Poses Ban on Sex Drive Hormone and Green Tea Amino Acid first appeared on Alliance for Natural Health USA - Protecting Natural Health.

ANH-USA General Counsel, Jonathan Emord, remembers the man with whom he worked for three decades to stem FDA tyranny against natural medicine, who passed away last Saturday.

By Jonathan Emord, Esq.

I had the great privilege of knowing Durk Pearson and Sandy Shaw, and of representing them, for the better part of thirty years. They were brilliant, passionate, and principled advocates of individual liberty who did more than voice opposition to government violations of rights, they fought the FDA in court and won in an unprecedented string of victories and against all odds. It was my great honor to be the legal tip of their constitutional spear.

Sandy passed away 3 years ago. Durk died this past Saturday. Each loss was profound for the country and yet escaped much public attention. Like giant timbers falling, their demise means the loss of much reasoned argument in defence of our liberties. Sandy was a brilliant nutrition scientist, a person with a powerful command of the English language, a great persuasive writer, and a force to be reckoned with in the face of injustice. She and Durk were honest to the core and held the highest standards for their many products, articles, books, and written opinions.

The two of them ushered in the nutrition revolution with their blockbuster New York Times best seller Life Extension: A Practical Scientific Approach. They appeared over 100 times on the Merv Griffin show, many times on the Johnny Carson Show, and repeatedly on other international, national, regional and local television and radio shows. They designed extraordinary nutritional formulas and broke down government barriers to nutrient disease information.

Durk was a renaissance man. He wrote screen plays for Clint Eastwood, including the script for The Dead Pool. He helped create the life support systems on the Gemini spacecraft. He helped come up with the calculus, vector calculus and differential equations used for the guidance systems in cruise missiles. He had dozens of patents. He bred crawfish to be the size of lobsters and sold them in roadside stands labeled “desert lobster.” He was a rancher. He had a voracious appetite for science and one of the most extensive science libraries in the world. He could build or repair everything from a rocket to a machine to sift gold particles from water exiting a mineral spring. His imagination, creative power and raw genius knew no limits. As an undergrad at MIT, he taught graduate level physics classes. He comprehended the intricacies of Einstein’s theory of relativity and was commissioned by Disney to explain the theory to laymen in a Disney movie. His brain was like an immense global encyclopedia. It was all but impossible to find a single subject on which Durk could not pass as an expert.

May Durk and Sandy rest in peace but may their intellectual legacy continue to make a stir and advance the cause of liberty generation after generation. They will be sorely missed.

Key lawsuits

The Alliance for Natural Health USA, then known as the American Preventive Medical Association, was a co-plaintiff on several precedent-setting lawsuits with Pearson, Shaw, and others. These lawsuits expanded the health claims that could be made about dietary supplements.

Pearson v. Shalala (“Pearson I”)

Pearson v. Shalala II (“Pearson II”)

Pearson v. Thompson (“Pearson III”)

The post Remembering Durk Pearson: Natural Medicine Pioneer and Liberator first appeared on Alliance for Natural Health USA - Protecting Natural Health.

A free speech court case involving journalist Alex Berenson exposes the government’s role in controlling online health debates and why this fight matters so much to the future of free speech and our First Amendment rights.

It will not come as a surprise to many of you to learn that different sectors of American society are deeply involved in a war on free speech with the US government, its agencies, and a selection of corporations that have captured it. The COVID pandemic was without doubt a catalyst, but the seeds of this wave of censorship have been sown for many years. What’s at stake is nothing less than our ability receive and communicate information that is essential to our capacity to take control of our own health. Special interests and health bureaucrats are trying to control the information you’re exposed to and, by extension, the health decisions you make. We must stand for free speech and personal sovereignty.

Alex Berenson’s censorship case, Berenson v. Biden, highlights the growing challenge of free speech suppression. Berenson, a former New York Times journalist, award-winning novelist, and outspoken critic of COVID-19 vaccine mandates, was banned from Twitter (now X) in 2021 for allegedly spreading misinformation by questioning the efficacy and safety of COVID vaccines.

In his case, he alleges that the Biden administration, along with Pfizer officials, conspired to silence him by pressuring Twitter to remove his account. Berenson’s lawsuit argues that this action violated his First Amendment rights, as the government and corporate officials coordinated to suppress his views on a critical public health issue.

Image left: Alex Berenson; journalist and award-winning author (image source: alexberenson.com)

If this sounds familiar, that’s because it is. The recent Supreme Court decision in Murthy v. Missouri brought to light the same heavy-handed censorship from the Biden Administration. In a 6-3 vote, however, the Court dismissed the case, stating that plaintiffs lacked standing. Despite compelling documentation that federal officials heavily influenced platforms like Facebook, the Court refused to delve into these critical First Amendment questions. Justice Samuel Alito, in dissent, emphasized the gravity of the case, warning that the Court’s decision to sidestep the issue allows continued government-led suppression of free speech, particularly on social media platforms.

The broader significance of Berenson’s case lies in its exploration of the growing influence of government and private corporations in controlling the flow of information, especially during the COVID-19 pandemic. It raises the issue that social media platforms, under government pressure, are acting as state censors when they moderate content. We would argue, alongside Berenson, that this represents an unconstitutional overreach that undermines public debate and endangers public health.

Our Call to Action

This ruling, like Berenson’s case, shows how vital it is to fight against censorship, especially when it impacts open discussions on health topics. Our FreeSpeech4Health campaign advocates for ending censorship of medical information online, especially content that diverges from official narratives. Join the fight by signing our petition to pressure platforms like YouTube to reform their medical misinformation policies and allow for more open, diverse discourse.

The post Alex Berensen: A Journalist’s Fight for Free Speech in Health Continues first appeared on Alliance for Natural Health USA - Protecting Natural Health.

For years, the FDA has been threatening the future of homeopathic medicine; it’s now time for it to stop.

Listen to the audio version of this article:

THE TOPLINE

• This week, the Alliance for Natural Health (ANH-USA), along with homeopathic manufacturer Meditrend, filed a lawsuit challenging the FDA’s new regulatory stance that could eliminate most over-the-counter (OTC) homeopathic products. We’re arguing that the policy violates federal law, threatens the $6 billion industry, and ignores decades of safety data.
• The lawsuit contends that the FDA’s policy shift is not only unlawful in that it violates federal law, it also ignores Congressional decisions that required that homeopathic products be treated differently to conventional drugs.   
• By treating homeopathics as “new drugs,” the FDA’s guidance requires that homeopathic medicines undergo pre-market approval and clinical trials in the same way as conventional drugs. This presents an insurmountable obstacle for the homeopathic industry, as these remedies cannot be patented and manufacturers cannot afford the high costs associated with approval.
• The lawsuit seeks to protect access to homeopathic remedies used by over 6 million Americans and prevent the FDA from enforcing its restrictive new policies.

ANH-USA, in conjunction with Meditrend, Inc. have filed a lawsuit challenging the FDA’s recent regulatory changes that could eliminate most over-the-counter (OTC) homeopathic products in the U.S. market. ANH and Meditrend argue that the FDA’s new stance on homeopathy conflicts with federal law, violates the U.S. Constitution, and threatens an entire industry valued at over $6 billion annually.

>>> Download ANH Media Pack including press release

Homeopathy, a centuries-old system of medicine based on highly diluted substances that stimulate the body’s natural healing process, has been formally recognized and protected by U.S. law for over 80 years. In the Food, Drug, and Cosmetic Act (FDCA), Congress recognized homeopathic medicines as distinct from conventional drugs, allowing them to be regulated differently due to their long-standing safety record and unique manufacturing processes.

However, the FDA’s guidance issued in December 2022 now subjects all homeopathic drugs to the same pre-market approval standards as conventional pharmaceuticals. Make no mistake—this requirement is a threat to the entire modality of homeopathy along with the millions that have  benefited from it—and the many more that might benefit from it in the future. Our lawsuit argues that this change is based on unsubstantiated concerns and ignores decades of data showing the safety and efficacy of homeopathic remedies.

Legal background of the case

ANH and Meditrend filed the lawsuit against Robert M. Califf, the Commissioner of the FDA, and the U.S. government, seeking a court ruling to reverse the FDA’s policy.

We argue that the agency has overstepped its legal authority by ignoring provisions of the Coronavirus Aid, Relief, and Economic Security Act of 2020 (CARES Act), which aimed to reduce regulatory burdens on OTC products.

The CARES Act acknowledges homeopathics as a “unique and separate category of drugs” and intended for them to be subject to different, less restrictive regulations than conventional pharmaceuticals. By requiring FDA drug approval for homeopathics, the FDA has disregarded Congressional intent and placed an unreasonable burden on homeopathic drug makers.

Further, the FDA excluded homeopathic drugs from the new drug approval process for decades because they were viewed, appropriately, as a separate category of medicine. The reason for the FDA’s change of heart, in our view, is the growth of the homeopathic industry—one catalyzed at a time of real need during the coronavirus crisis—growth which no doubt threatens the bottom line of the drug manufacturers that work closely with the FDA.

Constitutional violations

The lawsuit also asserts that the FDA’s new guidance violates the Due Process Clause of the Fifth Amendment. Under the current policy, the FDA has broad, discretionary power to remove homeopathic drugs from the market at will. This lack of regulatory certainty has created an unstable environment for the homeopathic industry and its consumers.

ANH and Meditrend are seeking a court ruling that would exempt homeopathic OTC products from the FDA’s pre-market drug approval requirements and prevent the FDA from enforcing its December 2022 guidance.

This lawsuit is critical not just for the survival of the homeopathic industry, but also for maintaining consumer access to these widely used natural remedies.

Threat to the homeopathic industry

The FDA’s shift in policy threatens to destroy the entire homeopathics industry in America. Unlike conventional drugs, homeopathic remedies cannot be patented, which means that manufacturers cannot afford the exorbitant costs of clinical trials and regulatory fees required for FDA approval. The FDA is requiring pre-market approval of homeopathic medicines, knowing full-well this is an insurmountable obstacle. These aren’t the actions of an agency looking to protect public health—they are the actions of monopolists looking to eliminate competition for their benefactors in the pharmaceutical industry.

We’re not going to let the FDA, on the flimsiest of pretexts, eliminate an entire modality of medicine that millions of people rely on for their health. We will keep you updated on the case as it progresses.

Fighting the FDA in court takes resources. Stand with us and support our fight against the FDA by contributing to our legal war-chest.

The post ANH Sues FDA to Stop U.S. Homeopathy Ban first appeared on Alliance for Natural Health USA - Protecting Natural Health.

Find out how Big Pharma’s billions in donations to patient advocacy groups compromise healthcare and sideline natural, preventive health solutions.

Listen to the audio version of this article:

THE TOPLINE

• Big Pharma contributes billions to patient advocacy groups, often lacking full transparency.
• Patient advocacy groups are meant to champion your health. But they’re often secretly funded by Big Pharma. These ‘donations’ influence healthcare policy, treatment guidelines, and drug approvals, and end up making sometimes questionable drug treatments the standard of care over natural or preventive health solutions.
• Patient advocacy groups that receive funding from drug companies are compromised, as seen with the approval of controversial drugs like the Alzheimer’s drug Aduhelm, where financial influence appeared to override scientific scrutiny.

The growing influence of the pharmaceutical industry on healthcare policy, treatment guidelines, and even the very agencies meant to regulate them, has always been a massive concern. While Big Pharma’s financial sway over elected officials and its cozy relationship with the FDA are well-documented, there’s another troubling development many may not be aware of: pharmaceutical companies are pouring billions of dollars into patient advocacy groups—organizations that should be independent voices for patient welfare.

According to a recent analysis, at least 83 percent of the largest patient advocacy groups in the United States receive contributions from drug companies, often without full transparency. From 2010 to 2022, the pharmaceutical industry’s main trade group and its member companies contributed over $6 billion in grants to more than 20,000 organizations.

The implications are clear: these “donations” are more about influence than charity.

Let’s take a closer look at some of the blockbuster drugs and the patient groups supporting them. AbbVie, the maker of Humira (an immunosuppressive for rheumatoid arthritis), gave as much as $1 million to the Arthritis Foundation in 2023. Merck, the manufacturer of Keytruda, a cancer drug, contributed over $1 million to the American Cancer Society in 2023, alongside AstraZeneca, Pfizer, and Regeneron. Novo Nordisk, the company behind the popular weight-loss drug Ozempic, funneled at least $1 million to the American Diabetes Association in 2023, alongside Eli Lilly and Xeris Pharmaceuticals. Biogen, the maker of the controversial Alzheimer’s drug Aduhelm, gifted between $250,000 and $500,000 to the Alzheimer’s Association in 2023.

The case of Novo Nordisk and Ozempic is particularly disturbing. This drugmaker spent at least $25.8 million over the past decade promoting its weight-loss drugs, like Ozempic, through payments to U.S. medical professionals. These payments were targeted at a select group of obesity specialists who have advocated for the use of these drugs for millions of Americans. This kind of financial relationship creates a clear conflict of interest, where medical recommendations may be driven more by profit than by what’s truly best for patients.

Big Pharma spends far more on contributing to patient advocacy groups than lobbying. A 2018 analysis by Kaiser Health News found that drug companies made 12,000 donations to patient advocacy groups in a single year, totaling $116 million—nearly double the amount spent on lobbying in that same year.

Why does this matter? These patient groups wield significant influence. They help guide treatment recommendations, lobby for drug approvals, and even shape public perception of health issues. When their funding comes from the very companies that stand to profit from the treatments for which they advocate, their independence is compromised.

Take the case of Aduhelm, the Alzheimer’s drug that was controversially approved by the FDA despite evidence that it was not effective. Several FDA advisory committees recommended against its approval, but patient advocacy groups, many of which receive significant funding from pharmaceutical companies, supported the drug. Unsurprisingly, it was approved, underscoring how financial influence can override scientific scrutiny and patient well-being.

This all points to a deeper problem: our healthcare system is designed to treat illnesses, not prevent them or build health and resilience. Big Pharma’s financial tentacles reach deep into every corner of our health system, including patient advocacy groups, promoting a drug-based treatment model while ignoring the importance of prevention and natural health solutions.

At ANH USA, we believe that many chronic conditions—like obesity, diabetes, cardiovascular disease, arthritis, some cancers, certain degenerative neurological diseases, including Alzheimer’s—can be prevented, or managed, with dietary or lifestyle interventions, natural medicines, and other non-drug approaches. But these options are often sidelined in favor of pharmaceutical treatments that make billions for drug companies but often come with dangerous side effects and questionable efficacy.

We must remain vigilant and push back against Big Pharma’s pervasive influence, which is not only eroding the integrity of patient advocacy but also restricting access to natural and integrative health options. It’s time to advocate for a healthcare system that prioritizes wellness, prevention, and patient empowerment over profits.

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The post Big Pharma’s Billions Buy Influence, Not Prevention first appeared on Alliance for Natural Health USA - Protecting Natural Health.

Presidential elections and natural disasters aside, let’s not get distracted from the ongoing power-grab by the World Health Organization (WHO). Action Alert!

Listen to the audio version of this article:

THE TOPLINE

• Ongoing negotiations over the WHO’s Pandemic Treaty aim to centralize global pandemic responses under the WHO, enhance the power of Big Pharma, and reduce individual freedoms.
• The treaty has stalled on controversial issues such as bio-surveillance and equitable vaccine distribution, and the WHO is under pressure to finalize the treaty before a November deadline.
• The treaty promotes fast-tracking emergency medical products, raising concerns about potential safety and effectiveness. It aims to impose a one-size-fits-all approach during future pandemics, while silencing dissent and promoting a global pandemic cartel.

While many Americans are understandably focused on other issues, negotiations over the so-called “Pandemic Treaty” are still going on. As we’ve been reporting for some time, this treaty, along with key amendments to the International Health Regulations, aims to centralize decision-making at the WHO, effectively forming a global pandemic cartel that funnels customers, and profits, straight into the hands of Big Pharma—all at the expense of your freedom. We need to remain vigilant in opposing this transfer of power to unelected bureaucrats.

The 11^th round of negotiations on the Pandemic Treaty occurred in September, but not a lot of progress was made, particularly on several controversial issues. The main point of contention is the creation of a coordinated bio-surveillance apparatus under the banner of the One Health approach originally created by the Centers for Disease Prevention and Control (CDC), and the “equitable” distribution of medical countermeasures (i.e. vaccines) that arise from this data sharing.

The problem for the WHO—and the 8 billion of the rest of us on planet Earth—is that time is running out to iron out these differences: the next round of negotiations is set for early November; November 12 is the latest date by which a December special World Health Assembly session can be called so the Pandemic Treaty can be adopted.

In response to this time crunch, a familiar tactic is being employed. Proponents of this treaty are essentially saying: “Just sign on the dotted line and we’ll figure out this difficult stuff later!” The latest draft of the Pandemic Treaty shifts important decisions to a Conference of the Parties, which will be set up after the World Health Assembly has adopted the treaty.

Other problematic provisions we’ve discussed previously remain. The “treaty” aims to ensure that states have the regulatory structures in place to grant fast-track emergency authorizations for investigational medical products.

But that’s not all. It cements a global, coordinated attack on free speech in the name of combatting mis- and dis- information that distracts people from the one-size-fits-all approach they should dutifully be following. Whether there are adequate measures in place to ensure the safety and effectiveness of these fast-tracked medicines, or systems in place to address and monitor the injuries caused by these drugs/vaccines, are issues that are largely ignored.

This is all in service to the creation of a global pandemic cartel. You’ll be told when the next pandemic hits, made fearful of the latest virus, then offered a quick-fix: a rushed, emergency-approved vaccine or gene-based drug. They’ll claim it’s all “following the science” while manipulating data to push their agenda. Critics will be silenced, alternatives discredited, and the complexity of our immune system ignored for their one-size-fits-all solution. If you think they haven’t learned from their COVID mistakes and are not gearing up to enforce their medical mandates more efficiently next time, think again.

Action Alert! Write to Congress and tell them to reject the Pandemic Treaty and the IHR amendments approved at the 77^th WHA meeting. Please send your message immediately.

The post Are You Ready for the WHO/CDC One Health Solution? first appeared on Alliance for Natural Health USA - Protecting Natural Health.

Apeel’s organic produce coatings may seem harmless, but hidden synthetic ingredients and transparency issues raise serious concerns about the erosion of true organic standards.

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THE TOPLINE

• Apeel Sciences, a company partnered with the Gates Foundation, produces coatings like Organipeel for fruits and vegetables to reduce spoilage.
• The lack of clear labeling of products that are covered with these products prevents consumers from knowing exactly what is on their food, particularly for those concerned with potential allergens or synthetic substances.
• The use of substances like glycerides, permitted under loopholes, is part of a broader trend of Big Food weakening organic regulations. This threatens the integrity of the organic label, which was originally meant to ensure transparency and natural, non-chemical farming and food production methods.

When you see the word “organic” on your food, you might expect your food to be grown in harmony with nature, free of synthetic chemicals, additives, and unnecessary processing. Right? Well, no longer. The rise of corporate interests in the organic food industry threatens to dilute the very essence of organic standards. Big Food is increasingly finding ways to capitalize on the organic label without adhering to the principles that make organic agriculture a healthier, more sustainable option. One such example is the use of products like Apeel’s Organipeel, which raises serious questions about transparency and the integrity of organic labeling.

What is Apeel and its Organipeel Product?

Apeel Sciences is a company that’s partnered with the Gates Foundation that produces coatings, like Organipeel and Edipeel, which are applied to fruits and vegetables to slow down spoilage. These coatings are derived primarily from plant oils. While the goal—reducing food waste—may seem commendable, the methods and ingredients used raise significant concerns, particularly when it comes to organic produce. It also begs other questions: how far should we go to extend the lifespan of vegetables and fruits? Should we be trying to cheat Nature’s sell by dates?

Organipeel, intended for use on organic produce, is registered with the EPA under the Federal Insecticide, Fungicide and Rodenticide Act as a pesticide, with citric acid listed as its active ingredient. The so-called “inert” ingredients include sodium bicarbonate (baking soda) and mono- and diglycerides. It’s the latter that should raise red flags for consumers, especially those trying to adhere to a truly organic diet.

The Hidden Ingredients in Apeel’s Coatings

The majority of Organipeel’s ingredients are monoglycerides and diglycerides—fatty acids commonly found in ultra-processed foods like candy, ice cream, and gum. While these substances are not unusual in processed foods, they are certainly not something you expect to find on fresh fruits and vegetables, especially those labeled as organic.

The fatty acids used in these coatings are extracted from grapeseed oil through a process that, according to their own documents, involves catalysts and solvents. Note that the grapeseed oil used by Apeel has already gone through an extraction process, using a procedure involving high temperatures and chemicals. Although the company claims that solvents are no longer used in their current manufacturing process, there is still no requirement for this level of transparency on the label of the food you’re buying.

Organic Loopholes

The glycerides that make up the bulk of Apeel’s product are on a list of synthetic substances allowed in organic production, but only for the purpose of “drum drying of foods”—not as a coating. A simple reading of this regulation suggests that Organipeel should not be allowed for this use on organic produce at all. But nonetheless, this highlights a longstanding trend we’ve been highlighting almost since the inception of the USDA’s organic program: the undermining of real organic standards by Big Food.

Consider the following:

• Hydroponically grown (soil-less) food is now allowed to be labeled organic, even though enhancing soil biological activity is a hallmark of organic agriculture.
• Half of all organic eggs and organic milk come from factory farms that make a mockery of real, regenerative organic practices.
• Organic poultry standards allow factory farms to slap the organic label on their products, deceiving consumers who are trying to make informed decisions.

Transparency: What You Don’t Know Can Hurt You

The lack of labeling for edible coatings is another major concern. Consumers have the right to know exactly what they’re feeding their families, especially when it comes to potential allergens or hidden synthetic ingredients. While Apeel claims that its coatings are free of all major allergens, the proprietary nature of their formulation makes it impossible to verify the safety of these coatings for sensitive individuals.

The presence of hidden ingredients in so-called organic products threatens the integrity of the entire organic movement, which was built on transparency and the rejection of unnecessary chemicals. Consumers deserve better.

The Bigger Picture: The Erosion of Organic Standards

Apeel’s Organipeel is just one example of how Big Food and corporate interests are finding ways to sidestep organic principles while still profiting from the organic label. By allowing non-organic substances like mono- and diglycerides on organic produce, we risk watering down the meaning of organic to the point that it no longer reflects a cleaner, healthier alternative.

We must protect the organic movement from becoming yet another marketing term co-opted by corporate interests. True organic integrity means adhering to farming and food production practices that nourish both people and the planet—not hiding behind coatings and synthetic chemicals.

The time has come for all of us to push back against the industrialization of organic foods and reclaim the purity and transparency that made organic such a desirable option in the first place. Consumers deserve nothing less.

The post Protecting Organic Integrity: A Closer Look at Apeel and Its Coatings first appeared on Alliance for Natural Health USA - Protecting Natural Health.

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The Alliance for Natural Health USA (ANH-USA) is excited to announce the rebranding of its Corporate Advisory Board to the Corporate Leadership Circle (CLC). This change marks an important step forward in ANH-USA’s efforts to protect access to natural health products and information, reflecting a growing movement to safeguard consumer rights and ensure that businesses can continue to offer natural health solutions.

The new CLC will play a critical role in supporting ANH-USA’s mission to defend natural health options through advocacy, litigation, and education. While this launch is focused on increasing collaboration with like-minded companies, it ultimately serves a much larger goal: protecting the rights of consumers to access safe, effective, and affordable natural health products.

Why Is This Important for Consumers?

In a world where regulatory agencies like the FDA and FTC often target natural health products, ANH-USA is stepping up its efforts to challenge these actions in courtrooms and legislative halls across the country. By joining forces with businesses in the natural health sector, ANH-USA can amplify its power and fight these battles on behalf of consumers—so that people can continue to access the products and information they rely on for their health.

Looking Ahead

ANH-USA is more than just an organization—it’s a movement that advocates for the right of everyone to access the natural health products and information they need to lead healthier lives. The CLC will help strengthen this movement by uniting businesses and individuals who share a passion for natural health and the freedom of choice.

For more information about ANH-USA and its revamped CDC, visit our website or contact us at office@anh-usa.org. Together, we can make sure that natural health continues to thrive for generations to come.

The post ANH-USA Rebrands Corporate Advisory Board to Corporate Leadership Circle: A New Era for Natural Health Advocacy first appeared on Alliance for Natural Health USA - Protecting Natural Health.

The FDA’s upcoming meeting could jeopardize access to essential natural ingredients used in compounded medicines, threatening personalized healthcare and patient freedom. Action Alert!

Listen to the audio version of this article:

THE TOPLINE

• The FDA’s Pharmacy Compounding Advisory Committee (PCAC) will meet on October 29th to discuss whether critical natural ingredients like kisspeptin-10 and l-theanine should remain available in compounded medications.
• Kisspeptin-10 is vital for reproductive health and fertility treatments, while l-theanine supports cognitive health, reduces stress, and shows potential in preventing conditions like dementia and Parkinson’s disease. Banning these ingredients would limit access to beneficial treatments for many patients.
• The FDA has a history of restricting natural ingredients used by compounding pharmacies, which offer customized treatments for patients with unique medical needs. This trend benefits Big Pharma by limiting alternatives to mass-produced drugs.

On October 29th, the FDA’s Pharmacy Compounding Advisory Committee (PCAC) will meet to discuss whether several key ingredients, including kisspeptin-10 and l-theanine, should continue to be allowed in traditional compounding. This meeting is pivotal because PCAC’s recommendations often lead to bans on ingredients that have served the health and well-being of millions of Americans. These bans are a serious threat to the practice of compounding pharmacies, which provide customized, natural medicines for patients with specific health needs.

For years, the Alliance for Natural Health has advocated for the preservation of natural health interventions, which play a crucial role in preventing chronic disease and promoting overall wellness. The relentless efforts of the FDA to restrict access to safe, effective natural substances represents yet another attack on patient freedom and access to life-enhancing alternatives to pharmaceuticals.

Kisspeptin-10 and l-theanine

Two of the most concerning ingredients on the chopping block at this meeting are kisspeptin-10 and l-theanine.

• Kisspeptin-10: This peptide is vital for human reproductive health. It has emerged as a promising therapy for infertility, helping to regulate hormone levels necessary for reproductive function. Removing kisspeptin-10 from the compounding landscape could jeopardize the health of countless individuals struggling with fertility issues.
• L-Theanine: Found naturally in tea and some mushrooms, l-theanine has shown incredible promise in supporting cognitive health. Studies have indicated that regular consumption of green tea, which contains l-theanine, is associated with a lower risk of dementia and Parkinson’s disease. In addition, l-theanine has been shown to reduce stress and anxiety, promoting mental well-being.

These are not isolated substances with fringe benefits—both kisspeptin-10 and l-theanine offer a wide range of health-promoting effects with minimal, if any, safety concerns. If compounding pharmacies are barred from using these ingredients, many patients will lose access to treatments that could profoundly impact their quality of life.

A pattern of FDA overreach

Sadly, the October 29th meeting is not an isolated event in the FDA’s history of targeting safe, natural ingredients. PCAC has previously recommended banning numerous vital compounds, including curcumin (a powerful anti-inflammatory), aloe vera (used for digestive and skin health), acetyl-L-carnitine (important for brain function), and many more. These recommendations, made under the guise of “safety concerns,” disproportionately affect patients who rely on compounding for their unique medical needs—patients who often cannot tolerate or benefit from commercially available products.

The only thing that stops the FDA from banning these substances is push back. So please read on and respond to our Call to Action below!

Compounding pharmacies play a crucial role in our healthcare system, providing tailor-made medications for patients who need individualized treatments. These include:

• Those requiring non-standard, individualized doses or different delivery methods (e.g., creams, gels, suppositories or injectables) that are not available in standard pharmaceutical, dietary supplement, or cosmeceutical preparations.
• Children and the elderly who may have difficulty swallowing pills.
• Patients with allergies or sensitivities to fillers, dyes, and preservatives found in mass-produced drugs.

The FDA’s pattern of stripping away access to natural, compounded medicines is yet another reminder of its broader agenda in relation to compounding: the eventual elimination of compounding pharmacies altogether. Because these medicines exist outside the FDA-approval system, the agency has a kneejerk bias against them. By gradually banning the ingredients that can be used, the FDA also seems intent on forcing more Americans into the hands of Big Pharma, which offers costly and, in many cases, dangerous and less effective alternatives.

A health crisis fueled by profit motives

We have long believed that the FDA’s actions are driven by a desire to protect the profits of large pharmaceutical companies at the expense of patient health. By systematically whittling away at the ingredients allowed for compounding, the FDA appears to be orchestrating a “death by a thousand cuts” for the compounding industry—eliminating competition and limiting patient access to natural, individualized care.

The FDA’s additional restrictions on how much compounded medicine can be sent out-of-state is yet another thinly-veiled tactic to weaken this vital sector of healthcare. It’s a clear attempt to reduce the reach of compounding pharmacies, making it even harder for patients to access these personalized treatments.

Our call to action

The October 29th meeting of the PCAC represents a critical moment in the ongoing battle for healthcare freedom. The time to act is now. We must stand up for the right to access natural, safe, and effective compounded medicines—ingredients that Big Pharma cannot patent or profit from but that have been used for centuries to promote health and well-being.

Action Alert: Write to the FDA today and demand that they allow the continued use of kisspeptin-10, l-theanine, and other vital natural ingredients in compounding pharmacies. Please send your message immediately.

The post Peptides on the FDA Hot Seat first appeared on Alliance for Natural Health USA - Protecting Natural Health.

With chronic diseases on the rise, the FDA’s push to limit access to dietary supplements could further undermine Americans’ health, restricting vital tools for wellness and prevention.

Listen to the audio version of this article:

THE TOPLINE

• Alarming health statistics, such as rising rates of autism, obesity, diabetes, and early death, reflect a failing healthcare system focused on treatment rather than prevention.
• The FDA, along with the FTC, is pushing for stricter regulations on dietary supplements, including requiring expensive clinical trials for health claims, a move that could cripple the industry and limit access to natural health solutions.
• By demanding clinical trials for supplements and censoring claims without them, the government is violating First Amendment rights, restricting the flow of truthful information about the health benefits of supplements.

Consider the following facts:

• Autism rates in kids are 1 in 36 nationally, compared to 1 in 1500 in the early 1990s.
• 74 percent of American adults are currently overweight or obese.
• 1 in 5 children and adolescents have obesity.
• 50 percent of American adults have prediabetes or diabetes.
• 30 percent of teens now have prediabetes.
• Sperm counts are decreasing by 1 percent per year.
• 40 percent of 18–29-year-olds meet criteria for psychiatric disorder.
• Cancers in people under 50 are up 79 percent.
• Americans are dying earlier, driving life expectancy to its lowest point in decades.

These staggering figures tell us a simple truth: we are a profoundly sick country, and it’s only getting worse.

The causes of this decline in our health are many. There’s the standard American diet pushed by Big Food, full of processed carbs, sugar, and ultra-processed foods; there’s our toxic environment, where we’re exposed to pollution and a cocktail of dangerous chemicals and pesticides. But these are also the results of a healthcare system that prioritizes treating sick people rather than preventing chronic diseases that are killing us in record numbers.

Dietary supplements have been shown to have a dramatic impact in keeping us healthy and staving off chronic diseases. They aren’t a silver bullet, but can be instrumental in maintaining wellness. But, as we’ve argued so many times, the federal government has, in large part, mobilized against the wider use of supplements. The FDA, and its allies like Sen. Dick Durbin (D-IL) want to treat them like drugs and require pre-approval—which we’ve argued would be the death knell of the supplement industry as we know it.

Equally as important, the government has been determined to censor truthful speech about the benefits of supplements. The latest attack was launched by the FTC when it sent letters to 670 companies, including those selling dietary supplements, homeopathic products, and functional foods, warning them that if they make claims without proper scientific substantiation, they will face large civil penalties. What is “proper scientific substantiation”? In the government’s view, it means one thing: clinical trials.

We asked our Executive and Scientific Director, Rob Verkerk, Ph.D., what he thought:

Randomized Controlled Trials or RCTs are often inappropriate for studying food and nutrients. A new-to-nature drug molecule can be better isolated in its effects, because you can omit it completely in your placebo group, standardize your variables across both treatment and placebo groups, and get very high statistical validation. That doesn’t mean you necessarily learn about drug interactions, which is why polypharmacy (the regular use of 5 or more medications at the same time, something that’s common in many elderly people) can reveal such shocking and unexpected results.

When it comes to nutrients, you just can’t remove them from your placebo without disastrous consequences. Foods and supplements often also depend on co-factors. For example, if you’re looking at studies on bone health and look only at studies with supplemental calcium, you’ll see mixed evidence, including evidence of harm. That’s because many people already have adequate calcium in their diet and you only start to see consistent benefits when a range of other cofactors are consumed, notably supplemental K2, vitamin D, magnesium, and trace elements like boron.

RCTs are also prohibitively expensive for most companies. High quality RCTs of the type regulators take note of because they follow standards set for pharmaceuticals cost an average of $600 million, and sometimes much more. Clinical trials of integrative medicine can be even more expensive because effect sizes for each intervention are often small, these need to be studied separately so interactions can be quantified and treatment durations may be long and benefits delayed, necessitating long periods of follow-up.

Given that RCTs are the only methodology viewed by regulators as being adequate to determine conclusive proof, you’ll find nearly all nutritional interventions remain tarred with the brush of “inconclusive evidence.”

Then there’s the financial constraints. As nutrients and other integrative therapies generally cannot be patented, there isn’t a way for a commercial interest to recoup the astronomical costs of conducting RCTs. Only pharmaceutical companies making drugs, which can be robustly patented, can afford theses costs. 

There are also problems with the FTC’s actions on legal grounds. Jonathan Emord, Esq., ANH’s General Counsel, explained:

The supreme law is the First Amendment.  Consequently, any agency act or regulation that deprives the public of speech protected by the First Amendment is unlawful.  The blanket RCT requirement effectively imposed by FTC in the health product context is by its very nature unconstitutional.

FTC fails to comprehend a fundamental First Amendment lesson: that speech can be true even if inconclusive. That was the lesson the United States Court of Appeals for the DC Circuit accepted in the case I litigated, Pearson v. Shalala.  

In a world where almost all accepted scientific relationships are more probable than not, but rarely—if ever—deemed conclusively proven, when government erects a barrier to speech that is a rigid, costly one, like the demand for RCTs, government necessarily censors truthful speech, violating the First Amendment.

Emord continued to describe how the FTC, by requiring clinical trials, is engaging in prior restraint and thus violating the First Amendment:

The First Amendment places a burden of proof and production on the government to prove in every instance not that speech is potentially false but that it in context is provably false. The FTC cannot shift those burdens to speakers by demanding that they be prohibited from speaking unless and until they have an RCT or two before uttering a peep. That is a classic prior restraint. There is no more central purpose of the First Amendment than to disarm the federal government of any prior restraint over speech and press.

These are the reasons that the FTC’s Health Products Compliance guidance violates the First Amendment.   

It’s a shame that it has to come to legal actions and a need for new legislation to get federal agencies to allow the American public to learn about products that can improve their health. We’re fighting for changes that allow the free flow of information about supplements. With our newly-appointed General Counsel, Jonathan Emord, we’re also going to be leveraging the recent Supreme Court decisions to use litigation to open up the marketplace to truthful statements about the benefits of supplements.

We’ve got exciting news we’re going to be able report regarding court filings later this month — make sure you keep abreast of our free weekly newsletter and you’ll find updates on this in a forthcoming issue!

The post The FDA and FTC War on Wellness: Why & How Supplements Are Under Attack! first appeared on Alliance for Natural Health USA - Protecting Natural Health.