Why Herbal Supplements Are Facing Increased Scrutiny Today
New compliance rules are changing how natural herbal products are made and marketed. Discover how these updates affect the supplement industry.
STORY AT-A-GLANCE
Almost 80% of Americans take supplements — and that number keeps growing. It’s no surprise supplements are everywhere. Herbal products alone bring in more than $12 billion a year
The U.S. supplement industry is raising safety standards without banning trusted herbs. Experts advocate for clearer rules, improved testing, and consumer protection while maintaining access to beneficial natural products
Europe is reversing course, with new European Union (EU) rules possibly requiring reformulations, restricting online sales, and limiting access to ingredients like ashwagandha
Supplements have an exceptional, long-standing safety record, with serious adverse effects being rare compared to many medications
In contrast to pharmaceuticals, which carry FDA-mandated “black box” warnings for known lethal risks, there has never been a confirmed death recorded as the direct result of taking a dietary supplement as intended
Over 70% of Americans take supplements today, and that number continues to rise.1 This modern trend has deep historical roots: For thousands of years, people have relied on plants and herbs for healing, with evidence stretching back at least 5,000 years in Egyptian medical texts and Ayurvedic traditions.2
Ancient remedies are reemerging in new forms as researchers examine their effects, and companies develop convenient products for daily use. The industry’s growth highlights a renewed interest in natural health. Annual sales of herbal supplements climbed past $15 billion in 2024, according to the American Botanical Council’s 2023 Herb Market Report — a $533 million increase from the previous year.3
As more consumers turn to botanicals, regulators are responding. Some countries are tightening controls, while others focus on improving safety without pulling products from shelves.
What’s Changing in the US Supplement Landscape
A panel of industry leaders featured in Nutritional Industry Executive’s (NIE) Winter 2025 Roundtable discussed the current state of the U.S. supplement industry.4 They shared recent wins, emerging risks, and how regulators and companies are shaping the future of natural health.
The FDA reversed its nicotinamide mononucleotide (NMN) ruling after industry pushback — In September 2025, the U.S. Food and Drug Administration (FDA) reversed course on NMN, reclassifying it as a lawful dietary supplement after a two-year ban. This landmark decision followed a joint citizen petition from the Natural Products Association (NPA) and Alliance for Natural Health USA.5
“FDA has moved back to accepting NMN as a dietary supplement ... NMN is now in great shape to be sold and marketed by reputable brands,” said Jim Emme, CEO of NOW Health Group.
Industry leaders support clearer rules and guidelines — Across the board, U.S. experts favor firm but fair standards. Dr. Daniel Fabricant, president & CEO of the NPA, commented:6
“NPA is committed to supporting Secretary Kennedy’s goals while remaining wary of proposals with unintended consequences that would stymie dietary ingredient innovation, impose undue burdens on our members, or restrict access to legitimate dietary supplement products.”
Economic pressure is reshaping ingredient sourcing — Tariffs are driving up costs and complicating long-term supply planning, especially for herbs sourced overseas. Loren Israelsen, president of the United Natural Products Alliance (UNPA), shared her thoughts:7
“It’s not a good situation. The most common concern I hear is the level of uncertainty that the tariff policy has created. We had several problems. Traditionally, the average tariff rate for natural ingredients was between 0 and 6 percent.
Today, we’re now looking at numbers ranging from 35 to 100 percent depending on the country. So, we have a tremendous increase, very suddenly. We also have a policy and procedural question of how the White House is conducting tariff and trade policy. Previously, tariff rates were a long, drawn-out process.”
FSA and HSA reform could be a game-changer — Leaders also discussed IRS proposals that would let consumers use Flexible Spending Accounts (FSA) and Health Savings Accounts (HSA) to buy supplements without needing a doctor’s note. “It would be the single best thing we could do to help reduce the cost of products,” Israelsen said.8
MAHA opens the door for natural health expansion — The Make America Healthy Again (MAHA) initiative, led by Secretary Robert F. Kennedy Jr., is elevating national attention to nutrition, clean ingredients, and preventive wellness. Many believe this could lead to better acceptance of natural products — as long as the reforms stay focused on access, not restriction.
What’s next for the industry? — In the next six months, leaders expect changes to tariffs, clearer guidance from the FDA on Generally Recognized as Safe (GRAS) standards and New Dietary Ingredient (NDI) rules, and updates to ingredient approval pathways.9
Many hope for fewer restrictions to encourage innovation, while others see more scrutiny and a stronger push for clinically proven formulas. Karen Howard, CEO and executive director of the Organic & Natural Health Association (ONHA) said:10
“Realistically, our challenges remain the same, only bolstered with steroids. If the industry wants to affect true change, it needs to listen and learn from what the retailer and the customer want and need, and deliver it in full.”
The U.S. supplement industry is prioritizing quality and self-regulation by investing in testing, sustainability, and third-party verification. Industry leaders are advocating for smarter oversight that protects consumers and preserves access to trusted herbs.
Why Europe Is Taking a Harder Line on Herbal Supplements
Meanwhile, in the European Union (EU), a wave of new regulations is reshaping the supplement market. In her Substack page Einfodemic, Maia Romanowska, an infodemic expert,11 explains how the 2025 changes mark a sharp pivot toward safety-first policies, particularly targeting herbal products and natural health claims.
Stricter labeling and health claims — Only health claims approved by the European Food Safety Authority (EFSA) can appear on packaging, and traditional herbal claims need to include a clear disclaimer: “This claim is based on traditional use and has not been evaluated by EFSA.” Labels are now required to show full ingredient details, standard dosage, usage warnings, and nutrient reference values to improve transparency and consumer trust.12
Ingredient bans and restrictions — Several botanicals are under review for safety concerns. Alpha-lipoic acid (ALA) may face a full ban, monacolins from red yeast rice could be heavily restricted, and high-dose green tea extracts and Garcinia cambogia are flagged for liver risk.13
Tighter oversight of botanicals — National authorities can now demand reformulation or removal of products using high-risk herbs or non-approved claims.14
Focus on sustainability and novel foods — New ingredient applications are required to include safety, bioavailability, and sustainability data. Plant-based formats like vegan softgels, phytosomes, and eco-friendly formulations are being prioritized as the EU pushes for greener innovation in supplements.15
Stricter rules for online and cross-border sales — Supplements sold online to EU consumers, even from outside the EU, need to meet safety and labeling laws. Under the Digital Services Act (DSA), platforms like Amazon and eBay are liable for listing banned or non-compliant products, tightening enforcement.16
Risk of a black market — Critics warn that overly strict rules could push consumers toward unregulated websites and foreign sellers, where products may contain unsafe or mislabeled ingredients. The EU plans to counter this with stronger enforcement, consumer education, and transparency campaigns.17
Penalties for non-compliance — Products that fail to meet 2025 standards can be recalled, seized at customs, or banned from future sales. Companies may face heavy fines, sanctions, and even legal liability for consumer harm, making compliance a top priority for manufacturers.18
Impact on traditional systems — Natural remedies from Ayurveda or Traditional Chinese Medicine (TCM) can still be sold in the EU, but they need to comply with all safety, labeling, and claim requirements. Ingredients not used in the EU before 1997 require Novel Food approval, and all traditional-use claims are required to carry the correct disclaimer.19
The EU is moving toward a safety-first, claim-limited model that may block consumer access to popular supplements. While their intent is protection, the result could be over-regulation of low-risk herbs, such as ashwagandha.
How the EU’s Regulatory Crackdown Is Affecting Popular Herbal Remedies
Following these broader shifts, the RegASK 2023 to 2025 Global Regulatory Overview20 shows that Europe is already targeting herbal supplements like ashwagandha with outright bans. The data paints a picture of rising pressure and fragmented enforcement.
Denmark lit the fuse in 2023 — In April 2023, Denmark became the first EU country to ban ashwagandha outright, forcing all products off shelves after a risk review flagged hormonal and reproductive concerns.21
Within months, other nations began weighing restrictions. France issued warnings for vulnerable groups, Germany launched ongoing safety evaluations, and Sweden and Finland signaled possible action. The U.K. took a “wait-and-see” approach, demanding more data instead of an immediate ban.22
Poland chose limits, not bans — While Denmark pulled the plug, Poland opted for a science-based compromise: capping ashwagandha at 3 grams (g) per day for root powder and 10 milligrams (mg) per day for standardized extracts.23
Ashwagandha isn’t alone — Regulators are also targeting kratom, Tongkat Ali, and high-dose green tea extracts, citing liver toxicity and hormonal risks. Menopause herbs such as black cohosh, red clover, and dong quai are also under review.24
Why the crackdown? — Ashwagandha’s popularity led to bans due to complex chemistry and reports of adverse events, often from contaminated products. Critics say these bans ignore the root issue: adulteration and poor-quality manufacturing.25
Business impact is brutal — Companies face recalls, reformulation costs, and the nightmare of managing multiple product versions for different countries. One regulatory executive summed it up: “We went from managing one European formula to juggling eight different versions. The complexity alone nearly broke our operations team.”26
How to stay ahead — Experts recommend three strategies: build bulletproof safety documentation, use real-time regulatory intelligence to anticipate changes, and diversify formulations so you’re not dependent on a single “hero” ingredient.27
What You Need to Know About Ashwagandha
Ashwagandha (Withania somnifera) is often talked about as a stress supplement, but that label barely scratches the surface. This herb affects multiple systems in the body, which is why it shows up in research on stress, hormones, brain health, inflammation, and recovery. To understand why ashwagandha has become so popular and remains a focus of scientific research, it’s helpful to consider its actual effects within the body.
Ashwagandha has a 3,000-year medical track record — Ashwagandha translates to “smells like a horse” — a nod to its ability to promote stamina, vigor, and strength. But its other name, somnifera, meaning “sleep-inducing,” hints at its calming, sedative effects.28
In Ayurvedic medicine, ashwagandha is classified as a rasayana, an elixir used to promote health and longevity.29 It’s been used for everything from infertility and arthritis to cognitive decline and adrenal exhaustion.30
This adaptogen helps your body normalize stress — Unlike synthetic stimulants or sedatives, ashwagandha supports the body’s stress response by stabilizing cortisol, balancing hormones, and modulating inflammation.31
Its traditional uses cover a wide range of health concerns — In countries where Ayurveda is widely practiced — such as India, Nepal, and Malaysia — ashwagandha is used to treat inflammation, weakness,32 and sexual health issues in both men and women. Some texts even call it beneficial for “almost all disorders that affect human health.”33 Below are just a few of its most common applications:
Improving stamina and energy levels
Gastric ulcers and digestive issues
Parkinson’s, Huntington’s, and Alzheimer’s disease
Mitochondrial health and cellular repair
Chronic inflammation
Rheumatoid and osteoarthritis
Muscle strength and physical recovery
Lowering blood sugar levels
Additional uses recorded by herbal groups like the American Botanical Council include support for:34
Memory loss and brain fog
Childhood emaciation and fever
Nervous exhaustion
Impotence, seminal debility, and uterine tone
Emphysematous dysphonia
Colds and chills
If you want to know more about Ashwagandha’s great benefits, check out “Ashwagandha for Cognitive Function.”
Nutritional Supplements Have a Remarkable Safety Profile
Although a balanced diet is still the best way to maintain optimal wellness, many people, especially those dealing with stress, chronic conditions, or limited diets, often need help meeting their daily nutrient requirements.35 This is where supplements come in handy.
Nutritional supplements, which include vitamins, minerals, herbs, enzymes, amino acids, and probiotics, help fill nutritional gaps or support the body during stressful and busy times. They’re available in many forms (capsules, powders, teas, and gummies)36 and, when used thoughtfully, can contribute to healthier habits and better overall well-being.
Supplements are often portrayed as risky or loosely regulated. But when you look at the actual safety data, a very different picture emerges.
They’re linked to far fewer deaths than prescription drugs — Despite frequent warnings about supplement risks, deaths associated with dietary supplements are extraordinarily rare37 38 when compared to pharmaceutical drugs. According to a 2012 analysis by the UK-based Alliance for Natural Health International (ANHI):39
“Nutritional supplements are the safest foodstuffs available; adverse reactions to pharmaceutical drugs are 62,000 times more likely to kill you than nutritional supplements.”
The ANHI calculated that the lifetime risk of dying from an herbal product or dietary supplement is less than 1 in 10 million — roughly the same odds as being struck by lightning. By contrast, prescription medications are consistently listed among the leading causes of death in developed countries.
There is no confirmed record of deaths caused directly by supplements — In contrast to pharmaceuticals, which carry FDA-mandated “black box” warnings40 for known lethal risks, there has never been a confirmed death recorded as the direct result of taking a dietary supplement as intended.
Media scares about supplements have repeatedly fallen apart — One high-profile example occurred in 2015, when CBC News aired a Marketplace report41 claiming that several supplement companies failed to meet label claims. Within two months, CBC was forced to issue a retraction after independent verification showed the testing methods were flawed and unreliable.42
Supplements are regulated like food, not drugs — A common misconception is that dietary supplements are “unregulated.”43 In reality, they are regulated under a different framework. In the U.S., the FDA oversees both supplement ingredients and finished products, while the Federal Trade Commission44 (FTC) governs marketing and advertising claims.
Supplements are classified as foods, which is why they don’t need to undergo drug-style clinical safety trials before entering the market. Supplements don’t bypass regulation; they are regulated appropriately for what they are.
If you want to gain more awareness on how the pharmaceutical industry undermines the small wins of natural supplements, read “Big Pharma Wants to Put an End to Vitamins and Supplements.”
You shouldn’t have to fight for access to something that supports your health and well-being. In a time when helpful herbs are being banned instead of being better understood, there’s real value in keeping an open mind. Exploring natural alternatives gives you more options for feeling better without drugs, harsh side effects, or invasive interventions.
Instead of restrictions, it’s time to focus on smarter regulations, the kind that protect your safety and your choices. You deserve options, clarity, and above all, the chance to care for your health in a way that feels right for you.
Frequently Asked Questions (FAQs) About Supplement Regulations
Q: Why are more people turning to supplements nowadays?
A: Nearly 80% of Americans now take supplements — and it’s not just a trend. People are looking for natural ways to manage stress, improve sleep, and boost energy. With herbal products alone generating over $12 billion a year, it’s clear that more folks are turning to nature for real, lasting support.
Q: What is the U.S. doing to regulate herbs and supplements?
A: U.S. experts prefer improving safety data, labeling, and FDA regulations over banning ingredients. Their goal is to safeguard consumers while maintaining access to trusted herbs such as ashwagandha. The consensus among leaders is that it’s about reform rather than restriction.
Q: Why is Europe trying to restrict herbal supplements?
A: European regulators are tightening rules around health claims and herbal ingredients. Ashwagandha may be limited by a lack of EU-approved data, despite its strong safety record and long history of use.
Q: Can supplements aid in achieving a healthier lifestyle?
A: Even with a balanced diet, some people need extra support — especially during stress, illness, pregnancy, or aging. Supplements offer targeted nutrients to help fill common nutritional gaps and keep you feeling your best.
Q: Do supplements have a strong safety record compared to medications?
A: Yes. Dietary supplements have one of the strongest safety profiles in health care. When used as intended, serious adverse effects are far less common than with prescription drugs, making supplements a low-risk option for long-term wellness support.
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Big Pharma trying to stop natural healing remedies