Our Verdict: RATING UNKNOWN

Mullein Flowers (verbascum Spp.)

CAS977048-46-6

Insufficient data to assign a rating

We do not have enough regulatory data to assign a safety rating to this additive at this time.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

Mullein Flowers (verbascum Spp.) — food additive

Mullein flowers (Verbascum spp.) are botanical flavoring agents derived from the mullein plant, traditionally used in herbal preparations. In food applications, they function as natural flavoring agents or flavor adjuvants to impart herbaceous and slightly sweet notes to beverages and food products.

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
Not EvaluatedUK FSA
Canada
Not EvaluatedHealth Canada
Australia
Not EvaluatedFSANZ
Japan
Not EvaluatedMHLW
South Korea
Not EvaluatedMFDS
Brazil
Not EvaluatedANVISA
China
Not EvaluatedNHC / GB 2760
India
Not EvaluatedFSSAI
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 Mullein Flowers?

Mullein flowers are the dried or processed blooms of plants belonging to the Verbascum genus, a group of flowering plants native to Europe and western Asia. The flowers contain various phytochemical compounds including flavonoids, iridoid glycosides, and saponins. In food manufacturing, mullein flower extracts or dried flower material are used as natural flavoring agents to provide distinctive taste profiles. The CAS number 977048-46-6 identifies this botanical ingredient in regulatory and scientific databases.

Common Uses

Mullein flowers are primarily used in the food and beverage industry as flavoring agents or flavor adjuvants. Common applications include herbal tea blends, where the flowers contribute a mild, slightly sweet, and herbaceous flavor characteristic. The ingredient may also appear in botanical beverage formulations, flavored water products, and some specialty food items targeting consumers interested in traditional or natural ingredients. In herbal tea preparations particularly, mullein flowers are often combined with other botanicals to create complex flavor profiles.

The use of mullein flowers in food reflects broader consumer interest in plant-derived flavoring alternatives to synthetic compounds. However, the ingredient remains relatively niche compared to more commonly recognized botanical flavorings.

Safety Assessment

Mullein flowers have not been formally affirmed as Generally Recognized as Safe (GRAS) by the FDA under 21 CFR Part 182 or Part 184. However, this classification does not indicate the ingredient is unsafe; rather, it reflects that formal GRAS affirmation documentation has not been submitted to or approved by the FDA.

The safety profile appears favorable based on available data. The FDA Adverse Event Reporting System (FAERS) contains zero reported adverse events associated with mullein flowers in food products, and no FDA recalls have been initiated involving this ingredient. This suggests safe use history in food applications when used as intended.

Mullein flowers have a long history of traditional use in herbal medicine and food preparations, particularly in European herbal tea traditions. The absence of documented adverse events in regulatory databases, combined with historical use patterns, suggests the ingredient has not generated safety concerns sufficient to trigger regulatory action.

As with all botanical ingredients, individual sensitivity or allergic reactions remain possible but appear to be rare. Consumers with known sensitivities to plants in the Scrophulariaceae family should exercise caution, though cross-reactivity documentation is limited.

Regulatory Status

Mullein flowers are not listed on the FDA's GRAS list (21 CFR Parts 182 and 184) as a flavoring ingredient. This means manufacturers using mullein flowers as food flavorings do not benefit from the presumption of safety that GRAS status provides. However, ingredients may still be legally used in food if they comply with applicable regulations and do not make unsubstantiated health claims.

In the European Union, mullein is not listed in the Union List of flavoring substances (EC Regulation 1334/2008), though some botanical extracts may be permitted under specific conditions. Regulatory status varies by jurisdiction, and manufacturers should verify compliance with local regulations before marketing products containing mullein flowers.

The ingredient is not prohibited in any major regulatory jurisdiction with available information, and its classification as a botanical flavoring places it within the broader category of plant-derived food additives.

Key Studies

Limited peer-reviewed research specifically addresses mullein flowers as a food additive. Most scientific literature focuses on traditional medicinal uses rather than food applications. Phytochemical analyses have identified constituents in Verbascum species, including flavonoids and iridoid glycosides, which contribute to the plant's flavor profile and historical applications.

The absence of formal toxicological studies submitted for regulatory approval reflects the ingredient's historical use and apparent safety rather than documented hazards. Traditional use documentation and chemical composition analyses form the primary evidence base for safety assessment.

Further research specifically addressing mullein flowers' safety profile in food applications would strengthen the evidence base, though current data do not suggest urgent safety concerns.

Frequently Asked Questions

What is Mullein Flowers (verbascum Spp.)?

Mullein flowers (Verbascum spp.) are botanical flavoring agents derived from the mullein plant, traditionally used in herbal preparations. In food applications, they function as natural flavoring agents or flavor adjuvants to impart herbaceous and slightly sweet notes to beverages and food products.

Is Mullein Flowers (verbascum Spp.) safe?

Mullein Flowers (verbascum Spp.) is currently rated "unknown" 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 Mullein Flowers (verbascum Spp.) banned in any country?

Mullein Flowers (verbascum Spp.) 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.