Azelaic acid in food: ingestion safety
Low risk(People-specific data is limited; this page draws from human adult context.) Azelaic acid (nonanedioic acid; CAS 123-99-9) is a naturally occurring saturated 9-carbon dicarboxylic acid found in cereals (wheat, rye, barley) and produced endogenously in human skin by Malassezia yeast metabolism of oleic acid. It has a remarkably favorable safety profile, supported by decades of clinical use as a prescription dermatological drug (Azelex 20% cream for acne; Finacea 15% gel for rosacea) and as an OTC cosmetic ingredient. Azelaic acid's multifunctional dermatological mechanism encompasses: (1) direct antimicrobial activity against Cutibacterium acnes (formerly P. acnes) and Staphylococcus epidermidis, through inhibition of mitochondrial oxidoreductases; (2) normalization of keratinization in follicular infundibulum, reducing comedone formation in acne; (3) anti-inflammatory activity through inhibition of neutrophil superoxide generation and reactive oxygen species, relevant for both acne and rosacea; and (4) selective tyrosinase inhibition in hyperactive melanocytes, useful for post-inflammatory hyperpigmentation (PIH), melasma, and the erythematous component of rosacea. These combined activities make azelaic acid one of the most versatile dermatological actives. Its safety in pregnancy is notable — it is classified FDA Pregnancy Category B (animal reproduction studies have not demonstrated risk; no adequate well-controlled studies in humans but potential benefit may warrant use despite potential risks), making it one of the few prescription acne treatments considered relatively safe to continue in pregnancy. No carcinogenic signal has been identified. The most common side effect is transient tingling, burning, or stinging upon application, particularly at treatment initiation, which typically subsides with continued use.
What is azelaic acid?
The IUPAC name is nonanedioic acid.
Also known as: nonanedioic acid, Anchoic acid, Finacea, Lepargylic acid.
- IUPAC name
- nonanedioic acid
- CAS number
- 123-99-9
- Molecular formula
- C9H16O4
- Molecular weight
- 188.22 g/mol
- SMILES
- C(CCCC(=O)O)CCCC(=O)O
- PubChem CID
- 2266
Risk for people
Low riskAzelaic acid (nonanedioic acid; CAS 123-99-9) is a naturally occurring saturated 9-carbon dicarboxylic acid found in cereals (wheat, rye, barley) and produced endogenously in human skin by Malassezia yeast metabolism of oleic acid. It has a remarkably favorable safety profile, supported by decades of clinical use as a prescription dermatological drug (Azelex 20% cream for acne; Finacea 15% gel for rosacea) and as an OTC cosmetic ingredient. Azelaic acid's multifunctional dermatological mechanism encompasses: (1) direct antimicrobial activity against Cutibacterium acnes (formerly P. acnes) and Staphylococcus epidermidis, through inhibition of mitochondrial oxidoreductases; (2) normalization of keratinization in follicular infundibulum, reducing comedone formation in acne; (3) anti-inflammatory activity through inhibition of neutrophil superoxide generation and reactive oxygen species, relevant for both acne and rosacea; and (4) selective tyrosinase inhibition in hyperactive melanocytes, useful for post-inflammatory hyperpigmentation (PIH), melasma, and the erythematous component of rosacea. These combined activities make azelaic acid one of the most versatile dermatological actives. Its safety in pregnancy is notable — it is classified FDA Pregnancy Category B (animal reproduction studies have not demonstrated risk; no adequate well-controlled studies in humans but potential benefit may warrant use despite potential risks), making it one of the few prescription acne treatments considered relatively safe to continue in pregnancy. No carcinogenic signal has been identified. The most common side effect is transient tingling, burning, or stinging upon application, particularly at treatment initiation, which typically subsides with continued use.
Regulatory consensus
4 regulatory and scientific bodies have classified Azelaic acid. The classifications differ — that's the data.
| Agency | Year | Classification | Notes |
|---|---|---|---|
| US EPA | 2000 | not classifiable as to human carcinogenicity (Group D) | |
| EFSA | 2005 | not evaluated for carcinogenicity; azelaic acid is listed as a cosmetic ingredient (CAS 123-99-9) permitted in EU cosmetics without specific concentration restrictions in the general cosmetic regulation; as a naturally occurring dicarboxylic acid with decades of pharmaceutical use history and no carcinogenicity signal, it has not been subject to SCCS restriction; available OTC in some EU countries as a dermatological product for acne and rosacea; excellent tolerability profile even with daily long-term use; minimal systemic absorption from topical application | |
| EPA CTX / Genetox | — | Genotoxicity: negative (Ames: negative, 0 positive / 1 negative reports) | |
| EPA CTX / Genetox | — | Genotoxicity: negative (Ames: negative, 0 positive / 1 negative reports) |
Regulators apply different standards of evidence — animal-data weighting, exposure-pattern assumptions, epidemiological power thresholds — which is why two scientific bodies can review the same data and reach different conclusions. The disagreement is the data.
Where you encounter azelaic acid
- Industrial Facilities — Manufacturing plants, Chemical storage areas, Waste treatment sites
- Occupational Environments — Factories, Warehouses, Transportation vehicles
- Food — processed food, beverages, candy, baked goods
Safer alternatives
Lower-risk approaches that achieve a similar outcome to Azelaic acid:
-
Fragrance-free formulations
Trade-offs: Consumer preference for scented productsRelative cost: Lower (ingredient elimination)
-
Essential oil-based fragrances (with disclosure)
Trade-offs: Natural does not mean safe — many essential oils are skin sensitizersRelative cost: 2-5× conventional
Frequently asked questions
What products contain azelaic acid?
Azelaic acid appears in: Manufacturing plants (Industrial facilities); Chemical storage areas (Industrial facilities); Factories (Occupational environments); Warehouses (Occupational environments); processed food (Food).
Why do regulators disagree about azelaic acid?
Azelaic acid has been classified by 4 agencies including US EPA, EFSA, EPA CTX / Genetox, EPA CTX / Genetox, with differing conclusions. Regulators apply different standards of evidence (animal data weighting, exposure-pattern assumptions, epidemiological power thresholds), which is why two scientific bodies can review the same data and reach different conclusions. See the regulatory consensus table on this page for the full picture.
See Azelaic acid in the food app
Look up products containing azelaic acid, compare to alternatives, and explore the full data record.
Open in food View raw API dataSources (2)
- US EPA Azelaic Acid: Group D Not Classifiable; Natural Dicarboxylic Acid Wheat/Rye/Barley; FDA Pregnancy Category B; Azelex 20% Acne Finacea 15% Rosacea; Antimicrobial Anti-inflammatory Tyrosinase Inhibition; 4–8% Dermal Absorption; Excellent Safety Profile (2000) — regulatory
- EFSA/SCCS Azelaic Acid: EU Cosmetic Ingredient No Concentration Restriction; No Carcinogenicity Signal; Malassezia Skin Microbiome Production from Oleic Acid; Pregnancy Acne/Rosacea First-Line Option; Highly Biodegradable OECD 301D; Log Kow 0.17 No Bioaccumulation (2005) — regulatory
Reference data, not professional advice. Aggregates publicly available regulatory and scientific data; not a substitute for veterinary, medical, legal, or regulatory advice. Why we built ALETHEIA →