FDA Warnings: Herbal Products That Require Medical Disclosure

Most people think if it’s sold in a store or online as a "natural" remedy, it’s safe. That’s not true. The FDA has issued dozens of warnings in the last five years about herbal products that can cause serious harm-especially when mixed with prescription drugs. And the worst part? Many users never tell their doctors they’re taking them.

Why Your Doctor Needs to Know What You’re Taking

You might think taking turmeric for joint pain or ashwagandha for stress is harmless. But here’s the reality: herbal supplements aren’t tested like prescription drugs. They don’t go through clinical trials. They don’t need FDA approval before hitting the shelves. The FDA only steps in after something goes wrong.

That’s why disclosure matters. If you’re on blood thinners like warfarin and start taking ginkgo biloba, you could bleed internally without warning. If you’re on antidepressants and add St. John’s wort, you risk serotonin syndrome-a potentially fatal condition. These aren’t rare cases. A 2018 study in JAMA Internal Medicine found that nearly 800 supplements contained hidden pharmaceutical ingredients. Some had antidepressants, erectile dysfunction drugs, or steroids-none listed on the label.

Doctors don’t ask because they assume you’ll tell them. But according to a 2022 survey of physicians, 68% say patients never mention supplements during visits. That silence can be deadly.

Herbal Products the FDA Has Warned About

The FDA doesn’t issue warnings lightly. When they do, it’s because something dangerous is happening. Here are the most common herbal products linked to serious health risks:

• Ginkgo biloba: Increases bleeding risk when taken with aspirin, NSAIDs, or warfarin. At least 12 FDA warning letters since 2018 cite ginkgo products with undisclosed blood-thinning agents.
• St. John’s wort: Interacts with over 50 medications, including antidepressants, birth control, HIV drugs, and chemotherapy. It can make your pills stop working.
• Green tea extract: Linked to over 100 cases of acute liver injury since 2015. The FDA issued a warning in 2022 after multiple hospitalizations from high-dose capsules marketed for weight loss.
• Kava: Banned in Canada and Europe for liver damage. The FDA has issued multiple alerts since 2002, yet it’s still sold in U.S. stores.
• Comfrey and coltsfoot: Contain pyrrolizidine alkaloids-poisons that cause irreversible liver damage. The FDA banned these in oral products in 2001, but they’re still found in teas and tinctures.
• Yohimbe: Marketed for sexual performance, but often contains undeclared stimulants. Over 200 adverse event reports since 2019, including heart attacks and strokes.

These aren’t outliers. They’re red flags. And the FDA keeps finding them in products labeled as "pure" or "organic."

How Supplements Slip Through the Cracks

The Dietary Supplement Health and Education Act (DSHEA) of 1994 lets companies sell supplements without proving they’re safe or effective. All they need to do is notify the FDA if they’re using a "new dietary ingredient." That’s it. No safety data. No efficacy proof. No pre-market review.

Compare that to prescription drugs. A new drug takes 8-12 years and over $2 billion to get approved. Supplements? They can be on Amazon tomorrow. The FDA has only banned two ingredients since DSHEA passed: ephedra in 2004 and methylsynephrine in 2022.

The agency has 45 staff members to oversee 30,000 supplement companies. That’s less than one person per 670 businesses. Meanwhile, over 23,000 new supplement products enter the market every year.

Manufacturers exploit this gap. They slap on labels like "clinically proven" or "doctor-recommended"-even when no such studies exist. Some even add real drugs like sildenafil (Viagra) or sibutramine (a banned weight-loss drug) to boost effects. The FDA finds these in 15% of tested supplements, according to a JAMA Internal Medicine study.

What You Can Do to Stay Safe

You don’t have to give up supplements. But you need to be smarter about them. Here’s how:

1. Always tell your doctor. Say it out loud: "I’m taking ashwagandha, turmeric, and a multivitamin." Don’t assume they’ll ask. Bring the bottle to your appointment.
2. Look for third-party verification. Check for the USP Verified Mark, NSF Certified for Sport, or ConsumerLab.com seal. These mean the product was tested for what’s on the label-and what’s not.
3. Check the FDA’s warning list. Go to the FDA’s website and search their warning letters. Type in the product name. If it’s been flagged, walk away.
4. Know the Latin names. Labels must list botanicals by scientific name. If you see "Hypericum perforatum" instead of just "St. John’s wort," that’s a good sign the maker follows labeling rules.
5. Avoid products that promise miracles. If it claims to cure cancer, diabetes, or Alzheimer’s, it’s illegal-and dangerous. The FDA has issued over 1,800 warning letters since 2002 for these kinds of claims.

The National Center for Complementary and Integrative Health offers a free app called "Supplement Your Knowledge" with over 1,200 evidence-based fact sheets. Use it. It’s the closest thing to a reliable guide you’ll find.

The Hidden Danger: Undeclared Ingredients

You might buy a "natural energy booster" labeled with green tea and ginseng. But lab tests show it also contains caffeine anhydrous, DMAA (a banned stimulant), and synephrine. These aren’t listed because they’re illegal to include.

Weight loss, sexual enhancement, and bodybuilding supplements are the worst offenders. In one case, a product marketed as "herbal testosterone booster" was found to contain 10 times the legal dose of a steroid. Another, sold as a "natural libido enhancer," had sildenafil-the active ingredient in Viagra-hidden in the formula.

These aren’t mistakes. They’re deliberate. Manufacturers know people want fast results. They add drugs to make their products "work better." And they count on you not telling your doctor.

What Happens When You Don’t Disclose

A 2021 case report in the Journal of Clinical Pharmacy and Therapeutics tells the story of a 62-year-old man taking warfarin for a blood clot. He started taking ginkgo biloba for memory. He didn’t tell his doctor. Two weeks later, he was rushed to the ER with internal bleeding. His INR-a measure of blood clotting-was off the charts.

He survived. But he spent six days in the hospital. He had to stop ginkgo. He had to restart his blood thinner at a lower dose. His doctor called it "entirely preventable."

That’s the pattern. People take supplements because they want to feel better. They don’t realize they’re putting themselves at risk. And when they don’t tell their doctor, the risk multiplies.

What’s Changing in 2025?

There’s momentum for reform. The Dietary Supplement Listing Act of 2023 (S.1088) would require companies to list every supplement with the FDA before selling it. That’s a big deal. Right now, companies don’t even have to tell the FDA what they’re selling.

The FDA’s 2023-2027 Strategic Plan aims to cut adulterated products in high-risk categories by 25% within five years. They’re also pushing for better reporting tools and more lab testing.

Third-party verification is growing fast. In 2020, only 5% of supplements had USP verification. By 2025, experts predict that number will hit 15%. That’s progress. But it’s still a minority.

Until the system changes, the responsibility falls on you.

Bottom Line: Speak Up, Check Labels, Stay Informed

Herbal supplements aren’t inherently bad. But they’re not harmless either. The FDA’s warnings exist because real people are getting hurt. The system is broken. The rules are outdated. And the burden of safety is on the consumer.

So here’s what you do: Tell your doctor. Check for verified seals. Avoid miracle claims. And if you feel weird after taking something-stop. Report it to the FDA’s Safety Reporting Portal. Even if you think it’s minor, your report could save someone else’s life.

You’re not being paranoid. You’re being smart.