Our Verdict: USE WITH CAUTION

St. Johnswort Leaves, Flowers And Caulis (hypericum Perforatuml.)

CAS977092-96-8

Some regulatory concerns have been raised

This additive has been flagged by at least one major regulatory agency or peer-reviewed study. Review the evidence below before forming conclusions.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

St. Johnswort Leaves, Flowers And Caulis (hypericum Perforatuml.) — food additive

St. Johnswort (Hypericum perforatum) is a botanical ingredient derived from the leaves, flowers, and stems of the St. Johnswort plant. Its function in food products is not clearly defined, and it is not approved by the FDA as a Generally Recognized as Safe (GRAS) substance for food use.

US Status

Approved

FDA

EU Status

Not_evaluated

EFSA

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

Global Regulatory Status

United States
ApprovedFDA
European Union
Not EvaluatedEFSA
United Kingdom
UnknownUK FSA
Canada
UnknownHealth Canada
Australia
UnknownFSANZ
Japan
UnknownMHLW
South Korea
UnknownMFDS
Brazil
UnknownANVISA
China
UnknownNHC / GB 2760
India
UnknownFSSAI
Country data is sourced from official regulatory databases and enriched via AI analysis. Always verify with the relevant national authority before making dietary decisions.

What is St. Johnswort Leaves, Flowers And Caulis?

St. Johnswort (Hypericum perforatum L.) is a flowering plant native to Europe and Western Asia, now found in many regions worldwide. The additive in question comprises the leaves, flowers, and stem portions of this plant. St. Johnswort has a long history in traditional herbal medicine, where it has been used for centuries, primarily in European folk remedies. The plant contains various phytochemical compounds, including hypericin, hyperforin, and flavonoids, which are believed to be its active constituents.

Common Uses

St. Johnswort's use in food products remains unclear, as its designated function is listed as "unknown" in regulatory databases. Historically, the plant has been primarily utilized in herbal supplements and traditional medicine preparations rather than as a conventional food ingredient. When encountered in food applications, it may appear in herbal infusions, botanical beverages, or supplement-fortified food products. The lack of a clearly defined food function suggests limited use in mainstream food manufacturing, and any presence would likely be in specialty or niche products marketed for wellness purposes.

Safety Assessment

The safety profile of St. Johnswort in food requires careful consideration. While the FDA has not classified this substance as GRAS for food use, the absence of reported adverse events in the FDA database and zero recalls indicates no documented serious food safety incidents. However, the lack of GRAS status signifies that it has not undergone the rigorous safety review required for direct food additive approval.

It is important to note that St. Johnswort is known to interact with numerous medications, including oral contraceptives, anticoagulants, and various psychiatric medications, potentially reducing their efficacy or causing adverse effects. These interactions are well-documented in medical literature and represent a significant concern for consumers, particularly those taking prescription medications. Additionally, the plant can increase photosensitivity in some individuals, leading to increased risk of sunburn and skin reactions upon sun exposure.

The safety of St. Johnswort when used as a food ingredient differs from its use in concentrated herbal supplements. The concentration levels in food products would typically be lower than in therapeutic herbal preparations, potentially reducing risk of interactions. However, cumulative exposure from multiple sources (food, supplements, and beverages) could increase concern.

Regulatory Status

St. Johnswort does not hold GRAS status in the United States, meaning manufacturers cannot legally add it to conventional food products without prior FDA approval through the food additive petition process. The European Food Safety Authority (EFSA) and regulatory bodies in other countries have similarly not approved it as a food additive with a defined function.

In the European Union, St. Johnswort appears in the register of botanicals used in food, but its regulatory status remains variable by member state. Some European countries permit its use in traditional herbal remedies and certain food categories under specific conditions, while others maintain stricter restrictions.

Key Studies

Scientific literature on St. Johnswort has primarily focused on its use as a herbal medicine rather than as a food ingredient. Research has confirmed its bioactive compounds and documented its interactions with cytochrome P450 enzymes, which explains its significant drug interactions. Studies on the plant's toxicity in animal models have not revealed acute toxicity at typical exposure levels, though long-term safety data specific to food consumption remains limited.

The absence of dedicated food safety studies on St. Johnswort reflects its minimal use as a food additive. Any safety assessment would need to account for potential cumulative exposure and individual susceptibility, particularly among populations taking medications known to interact with the plant's constituents.

Frequently Asked Questions

What is St. Johnswort Leaves, Flowers And Caulis (hypericum Perforatuml.)?

St. Johnswort (Hypericum perforatum) is a botanical ingredient derived from the leaves, flowers, and stems of the St. Johnswort plant. Its function in food products is not clearly defined, and it is not approved by the FDA as a Generally Recognized as Safe (GRAS) substance for food use.

Is St. Johnswort Leaves, Flowers And Caulis (hypericum Perforatuml.) safe?

St. Johnswort Leaves, Flowers And Caulis (hypericum Perforatuml.) is currently rated "caution" based on FDA and EFSA data. It is approved in the US and not_evaluated in the EU. There are 0 FDA adverse event reports associated with this additive.

Is St. Johnswort Leaves, Flowers And Caulis (hypericum Perforatuml.) banned in any country?

St. Johnswort Leaves, Flowers And Caulis (hypericum Perforatuml.) is approved in the United States and not_evaluated in the European Union. Review the regulatory status cards above for the most current information.

Data Sources

Data is sourced exclusively from official government databases and updated periodically. This page does not constitute medical advice. Consult a healthcare professional for dietary guidance.