Top 7 Supplements Frequently Detained by the FDA—And Why

Introduction

The dietary supplement industry is booming in the United States, with millions of Americans taking some form of supplement daily. However, not all supplements make it into consumer hands easily. The FDA plays a crucial role in regulating these products, even though many people mistakenly believe supplements aren’t regulated at all.

While dietary supplements don’t require pre-market approval like drugs, the FDA still monitors them for safety and compliance with labeling laws. When imported supplements raise red flags, they can be detained at ports of entry, preventing them from reaching the market until concerns are addressed.

Let’s explore the seven supplements most frequently detained by the FDA and the specific reasons behind these detentions.

Supplement 1: Kava

Reason for Detention

Kava supplements are regularly detained due to concerns about hepatotoxicity—liver damage. The FDA has issued multiple alerts about kava products after reports of severe liver injury, including cases requiring liver transplants.

Details about Kava Usage and Risks

Originally used in Pacific Island cultures as a ceremonial drink, kava gained popularity in Western markets as a natural remedy for anxiety and insomnia. However, since 2002, the FDA has questioned its safety profile. Some research suggests the traditional water-based extraction might be safer than alcohol-based extractions used in many supplements. Regardless, the FDA frequently detains kava products, especially those making unsubstantiated health claims or lacking proper warnings about potential liver risks.

Supplement 2: Ephedra

Reason for Detention

Ephedra (also known as ma huang) was officially banned by the FDA in 2004, but products containing this ingredient still attempt to enter the U.S. market. These products are detained because ephedra has been linked to serious cardiovascular problems, including heart attacks, strokes, and death.

Historical Use and Safety Concerns

Ephedra was once wildly popular in weight loss and athletic performance supplements due to its stimulant properties. Despite its traditional use in Chinese medicine, the concentrated forms found in modern supplements proved dangerous. The FDA’s ban came after reviewing nearly 17,000 adverse event reports, including 155 deaths. Any supplement containing ephedra or its alkaloids is subject to immediate detention upon import.

Supplement 3: Sibutramine

Reason for Detention

Sibutramine, once a prescription weight-loss medication (sold as Meridia), was pulled from the market in 2010 due to increased risks of heart attack and stroke. Despite this, the FDA regularly finds this substance secretly added to “natural” weight loss supplements.

Original Purpose and Health Risks

Sibutramine works by affecting brain chemicals to increase feelings of fullness. Clinical studies revealed it could raise blood pressure and pulse rate, posing serious risks for people with heart conditions. The FDA frequently detains weight loss supplements that contain undeclared sibutramine, which is especially concerning since consumers believe they’re taking an all-natural product but are actually consuming a powerful pharmaceutical.

Supplement 4: Yohimbine

Reason for Detention

Yohimbine, derived from the bark of the yohimbe tree, faces detention due to its potential to cause significant cardiovascular effects and dangerous interactions with medications. The FDA has particular concerns about its unpredictable potency in supplements.

Common Uses and Possible Interactions

Marketed primarily for sexual enhancement and weight loss, yohimbine can cause rapid heart rate, high blood pressure, anxiety, dizziness, and tremors. It’s especially problematic for people taking antidepressants, particularly MAOIs, with whom it can trigger dangerous blood pressure spikes. The FDA detains yohimbine-containing products that fail to properly disclose risks or that make unapproved medical claims.

Supplement 5: DMAA (1,3-dimethylamylamine)

Reason for Detention

DMAA detention is common because the FDA has determined it’s not a dietary ingredient at all, but rather a potentially dangerous synthetic stimulant. The agency has linked DMAA to elevated blood pressure, cardiovascular problems, nervous system disorders, and even death.

Initial Uses and Health Implications

Originally marketed in pre-workout and weight loss supplements as a “natural” stimulant supposedly derived from geranium plants, research showed DMAA was actually synthetic. After being linked to multiple deaths, including several among military personnel, the FDA began aggressively detaining and removing DMAA products. Despite this, manufacturers sometimes try to sneak it in under different names like “geranium extract” or “methylhexaneamine.”

Supplement 6: 5-Hour Energy

Reason for Detention

Though widely available domestically, imported versions of 5-Hour Energy and similar energy shots face detention due to labeling issues, inconsistent ingredient declarations, and concerns about caffeine content.

Ingredients and Reported Adverse Effects

These energy supplements typically contain caffeine, B vitamins, amino acids, and various “energy blend” ingredients. The FDA has received numerous adverse event reports potentially linked to these products, including heart attacks and even deaths, though causation hasn’t been definitively established. Import detentions usually occur when the labels don’t properly declare all ingredients, when caffeine content is excessive, or when therapeutic claims are made that would classify the product as an unapproved drug.

Supplement 7: Glucosamine/Chondroitin

Reason for Detention

While glucosamine and chondroitin are generally considered safe, products containing these ingredients are frequently detained due to labeling violations and misrepresentation of source materials.

Claims vs. Reality in Uses and Sourcing

These supplements are popular for joint health, particularly among arthritis sufferers. However, the FDA has found that many imported products make illegal disease claims (promising to “cure” arthritis) or misrepresent their ingredient sourcing. Since glucosamine typically comes from shellfish and chondroitin from animal cartilage, proper allergen labeling is critical. Products are often detained when they lack allergen warnings, make unapproved health claims, or when testing reveals potency levels that don’t match label declarations.

Conclusion

The FDA’s approach to supplement detention isn’t arbitrary—it’s based on legitimate safety concerns, labeling requirements, and ingredient regulations. Understanding these common detention reasons helps both consumers and businesses navigate the supplement marketplace more safely.

For consumers, these detentions highlight the importance of purchasing supplements from reputable sources and consulting healthcare providers before use. For businesses, they underscore the need for rigorous compliance with FDA import regulations for dietary products.

The most important lesson? Just because something is labeled “natural” doesn’t automatically mean it’s safe or legal to import. The FDA’s vigilance at the border represents the first line of defense in protecting public health from potentially harmful supplements.

Need help getting your supplements safely into the US market? Global Import Agent specializes in navigating FDA compliance requirements for dietary supplements to prevent costly detentions at the border. Our team of FDA regulatory experts can review your product formulation and labeling before shipment, serve as your required FSVP agent, and provide comprehensive guidance on all aspects of FSVP compliance. We’ve helped hundreds of supplement companies successfully enter the US market while avoiding the pitfalls that lead to detention. Contact us today for a consultation and learn how we can help you bring your products to American consumers legally and efficiently.