Madison Area Lyme Support Group

THE TOPLINE

• The FDA is moving to approve many new drugs based on just one clinical trial, lowering the evidentiary bar for pharmaceuticals in the name of speeding patient access.
• At the same time, federal regulators are pressuring supplement companies to support health claims with expensive randomized controlled trials—sometimes even two—creating a far higher standard for natural products than for drugs.
• Because nutrients and botanicals generally cannot be patented, requiring pharmaceutical-style trials effectively suppresses communication about natural health options and limits consumers’ access to information about their potential benefits.

In a move announced in the New England Journal of Medicine, the FDA says it will drop its long-standing expectation that new drugs be supported by two clinical trials, shifting instead to a “default” of just one trial for many new medications. FDA leadership says the change will cut red tape and accelerate patient access to new drugs.

For advocates of natural approaches to health and healing, this raises an obvious contradiction: while the FDA relaxes standards for drug—new to nature molecules that come with dangerous side effects—federal agencies are simultaneously tightening the screws on the natural health sector, products with long histories of safe use. It is regulatory capture—and crony capitalism—at its peak.

Drugs Get Flexibility—Supplements Get Censorship

In 2023, the Federal Trade Commission (FTC), working closely with the FDA, sent hundreds of warning letters to supplement and natural product companies explaining that health claims must be backed by randomized controlled trials (RCTs)—the same expensive standard used for pharmaceuticals.

In some cases, regulators have even suggested two RCTs may be required to substantiate health benefits in advertising.

That’s right: Drugs that can cause serious side effects—even death—may soon be approved with a single clinical trial. Natural products with decades or even centuries of safe use are being forced to meet an even higher bar just to discuss their benefits. It is an outrageous double standard.

A “Backdoor Ban” on Natural Health Information

Clinical trials are incredibly expensive, often costing tens or hundreds of millions of dollars.

Drug companies can afford them because their products are patent-protected monopolies that can be sold for enormous profits. Nutrients and botanical products are different. They generally can’t be patented, meaning the costs of large-scale trials cannot be recouped.

Regulators know this, which means demanding pharmaceutical-style trials for supplement claims functions as a de facto ban on most health claims about natural products. And when companies can’t communicate the science behind their products, consumers are left in the dark about options that could support their health.

A Pattern of Suppression

The government’s crackdown on truthful health speech is part of a long-standing campaign to steer consumers away from natural options in favor of pharmaceutical drugs:

• Cherry and walnut growers were threatened by the FDA for linking to peer-reviewed studies on their websites.
• Doctors were silenced during COVID for recommending vitamin D and zinc.
• Xlear, a nasal spray company, was dragged into litigation for sharing results of over a dozen studies on its product’s potential benefits—litigation the DOJ finally dropped with prejudice in March 2025.

And the problem goes beyond our borders. US regulators are pushing to “harmonize” with the European Union’s oppressive model, where nearly all botanical claims have been banned and only a few vitamin/mineral claims are allowed. We cannot let that happen here.

The Fight for Scientific Integrity

That’s why the Alliance for Natural Health USA (ANH-USA) has filed a petition challenging the FTC’s censorship regime and demanding a return to a “totality of the evidence” standard—one that considers the full body of scientific research, not just expensive clinical trials.

Science doesn’t begin and end with randomized trials.

Epidemiological studies, mechanistic research, observational data, and centuries of real-world use all contribute to scientific understanding—especially when it comes to nutrients and foods.

Consumers deserve access to all the evidence, not just the evidence that benefits pharmaceutical companies.

Stand with ANH in the fight for free speech and health autonomy by donating to our legal war chest!

For more:

• https://madisonarealymesupportgroup.com/2024/02/08/action-fda-closing-in-on-your-supplements/
• https://madisonarealymesupportgroup.com/2022/12/02/fda-creates-draft-guidance-threatening-homeopathic-medicines-oppose-mandatory-filing-for-supplements-fda-monopolization-of-medicine/
• https://madisonarealymesupportgroup.com/2025/12/05/action-supplements-threatened-in-new-gras-bill/
• https://madisonarealymesupportgroup.com/2019/02/14/what-the-fdas-actions-mean-for-dietary-supplements/
• https://madisonarealymesupportgroup.com/2026/02/04/take-action-biggest-2026-supplement-threats/
• https://madisonarealymesupportgroup.com/2022/11/16/big-pharma-buying-up-supplement-companies-bad-supplement-policy-still-a-threat/

We’re up to our knees working on which policies will have the biggest impact on your supplement access in 2026. Let’s make sure we get the best possible outcomes to assure your access to the health products you need. Action Alert!

THE TOPLINE

• 2026 is shaping up to be a pivotal year for supplement access, with multiple federal and state policies advancing that could sharply limit consumer choice.
• Major federal threats include FDA moves on GRAS reform, Senator Durbin’s supplement “listing” bill, and stricter New Dietary Ingredient rules, all of which could raise costs, eliminate thousands of products, and give the FDA broad new tools to restrict supplements.
• State-level bills targeting youth access to weight loss and muscle-building supplements could unintentionally restrict common nutrients for everyone, reducing visibility and availability of safe, beneficial products and undermining public health rather than protecting it.

We’re off to a blazing start in 2026, which is looking very likely to be a pivotal year for health freedom. We have lots of irons in the fire—we’ve been telling you about our ongoing legal efforts to open up free speech about the benefits of supplements and to protect natural medicines like homeopathy, CBD, natural desiccated thyroid, and peptides. But bad policies are also moving forward on multiple fronts that require your sustained grassroots opposition.  

Here’s a survey of the top initiatives we have our eyes on in 2026:

The ‘GRAS’ Isn’t Always Greener

An FDA rule is due to be issued any time now that will make big changes to the “Generally Recognized as Safe” (GRAS) pathway by which certain food and many dietary supplement ingredients enter the market. It’s been an oft-stated priority for HHS Secretary RFK Jr. and it has been included (as the first item) on a list of 2026 deliverables at the FDA.

We’ve written many articles about this topic in the last year, including providing a white paper on the subject that explains in details how GRAS reform can be done without massively reducing consumer choice and chilling innovation. The main issue at play is the “loophole” by which companies can self-certify ingredients as GRAS (or, “self-GRAS”) without any transparency or FDA review. As we’ve explained in our own blueprint for GRAS reform, we agree that more transparency is needed, but we can’t “throw the baby out with the bathwater” and eliminate self-GRAS entirely, as we’re afraid the FDA is on the verge of doing. Self-GRAS is in fact how many safe, natural supplement ingredients come to the market, so eliminating it will have major ramifications for supplement access.

We are still working on influencing key people in the administration to guide GRAS reform to ensure continued access to health-promoting products.

Supplement Choices Going…Going…Gone!

Senator Dick Durbin (D-IL) has once again introduced his anti-supplement listing bill. We discussed this in last week’s coverage. In short, what sounds like an innocuous transparency measure could actually have a major impact on your supplement access, threatening high-dose products and innovative formulations, raising prices, and reducing choice. The bill gives the FDA a hit list that it can use to attack supplements that haven’t complied with its overreaching policies. It’s been a bad idea for a long time. We’ve beaten Sen. Durbin before, and we can do it again, but only with your help.

State-based Threats

A number of states are considering bills that would prohibit the sale of weight loss and muscle building supplements to those under the age of 18. These bills use vague definitions that could sweep in a wide range of supplements—including protein powders, hormones, and essential nutrients—risking unnecessary restrictions on products unrelated to weight loss, even during a public health crisis.

Some proponents argue that these measures are needed to protect children from “unhealthy weight control behavior,” which are risk factors for eating disorders. This is a noble goal, but the language in these bills casts a wide net that could limit access to products that have nothing to do with weight loss. Additionally, some of these bills require restricting access to these products by placing them behind a counter or in a locked case, so access for everyone, not just minors, is restricted. Hidden from a customer’s view, some people may never become aware of a product that would perfectly suit their health needs—or be too intimidated to ask for it.

The result is reduced access to beneficial products for all consumers, which undermines—not protects—public health.

We’ve identified several states considering these bills. Click your state’s link to take action.

Alaska

Hawaii

Illinois

Massachusetts

Michigan

New Hampshire

Washington

New Dietary Ingredients

This threat has been simmering for a long time at the FDA. The law calls for all “new” (that is, post-1994) supplements that come to the market to comply with “new dietary ingredient” (NDI) requirements. Yet the FDA has turned what was supposed to be a notification process into a complicated and expensive pre-market approval process for all “new” supplements. And to make it worse, the agency has adopted an exceedingly broad view of what counts as a “new” supplement. When we asked a legal scholar and economist to estimate the market impact of the FDA’s NDI rules, the results were astounding:

• as many as 41,700 products disappearing from store shelves;
• an industry-wide cost of between $2 billion and $165 billion in animal and human product safety studies to comply with the FDA’s NDI notification protocols; and
• the loss of between 55,270 and 104,475 jobs in the supplement industry.

“Regulation of New Dietary Ingredients” was another item on the FDA’s list of 2026 deliverables, so we will be on the lookout for developments and update you accordingly.

This is far from  an exhaustive list, but these are the top threats we’re looking out for in the coming weeks and months. As ever, we will remain vigilant in the defense of every Americans’ health autonomy and alert you when threats arise and how your voice can be heard so we can work together to defend the health freedom of every American.

Go here to oppose ‘mandatory filing’ for supplements