Our Verdict: USE WITH CAUTION

Salicylic Acid

CAS69-72-7

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

Salicylic Acid — food additive

Salicylic acid (2-hydroxybenzoic acid) is an organic compound with antimicrobial and keratolytic properties that has been investigated as a flavoring agent. It is not currently approved as a food additive by the FDA and has limited use in food applications.

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 Salicylic Acid?

Salicylic acid, with CAS number 69-72-7, is an organic compound belonging to the class of hydroxybenzoic acids. It consists of a benzene ring with a carboxylic acid group and a hydroxyl group in the ortho position. The compound is naturally present in small amounts in various plants, fruits, and vegetables, including berries, apples, citrus fruits, and certain herbs. Chemically, it is 2-hydroxybenzoic acid and should be distinguished from acetylsalicylic acid (aspirin), which is a derivative.

Common Uses

Salicylic acid has historically been used in pharmaceutical and cosmetic applications, particularly for treating acne and other skin conditions due to its keratolytic properties. In food applications, it has been proposed as a flavoring agent or flavoring adjuvant, though such use remains extremely limited in commercial food production. Some traditional and herbal food preparations may contain salicylic acid from natural plant sources. The compound's antimicrobial properties have generated research interest in food preservation contexts, but regulatory approval for direct food additive use has not been granted.

Safety Assessment

Salicylic acid presents a complex safety profile that differs depending on the route and level of exposure. When applied topically or used in pharmaceutical formulations at regulated concentrations, it has an established safety record spanning decades. However, systemic absorption of salicylic acid—particularly in high concentrations or over extended periods—raises toxicological concerns. The compound can be absorbed through the skin and gastrointestinal tract, and excessive exposure has been associated with salicylism, a condition characterized by tinnitus, hearing loss, confusion, and metabolic acidosis.

The FDA has not granted Generally Recognized as Safe (GRAS) status to salicylic acid for food use, which reflects the absence of sufficient evidence establishing its safety as a food additive at intended use levels. No adverse events or recalls related to salicylic acid as a food additive have been reported to the FDA, though this likely reflects its minimal use rather than comprehensive safety data. It is important to note that the absence of reported adverse events does not constitute approval or confirmation of safety.

Individuals with salicylate sensitivity or intolerance may experience adverse reactions to foods containing elevated salicylic acid levels. Such sensitivities are documented in medical literature, though the prevalence and clinical significance remain subjects of ongoing research.

Regulatory Status

Salicylic acid is not approved as a food additive by the FDA. It does not appear on the FDA's list of substances Generally Recognized as Safe (GRAS) for food use. In the European Union, salicylic acid is not authorized as a food additive under Regulation (EC) No. 1333/2008. The compound is approved for pharmaceutical and cosmetic use in regulated concentrations in most jurisdictions.

Because salicylic acid is not FDA-approved for food use, manufacturers cannot legally add it to foods intended for sale in the United States as an intentional additive. Its presence in foods would be limited to naturally occurring amounts from plant-based ingredients.

Key Studies

Research on salicylic acid has primarily focused on its pharmaceutical and dermatological applications rather than food safety. Toxicological studies have established dose-dependent effects and identified potential for systemic absorption. Studies on salicylate sensitivity in certain populations have documented clinical responses to dietary salicylates, though individual salicylic acid's specific contribution remains understudied in the food context. Additional research would be necessary to establish safe levels for intentional food additive use, which may explain the regulatory hesitation regarding approval.

Frequently Asked Questions

What is Salicylic Acid?

Salicylic acid (2-hydroxybenzoic acid) is an organic compound with antimicrobial and keratolytic properties that has been investigated as a flavoring agent. It is not currently approved as a food additive by the FDA and has limited use in food applications.

Is Salicylic Acid safe?

Salicylic Acid 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 Salicylic Acid banned in any country?

Salicylic Acid 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.