Is it safe to take black garlic extract?

Origin and Active Components of Black Garlic Extract

Black garlic is not a natural variety, but rather produced through a strictly controlled fermentation process. Fresh garlic is fermented at 60-80℃ and 70-90% humidity for 30-90 days. During this process, the pungent components in garlic (such as allicin) are converted into more stable active substances, the most representative of which is S-allyl-L-cysteine ​​(SAC). Studies have shown that SAC is the core functional component of black garlic extract, and its content directly determines the product's biological activity and market value.

 

Is it safe to take black garlic extract?

Acute Toxicity Test
An acute oral toxicity study published by Kyoto Pharmaceutical University in Japan in 2018 showed that the LD50 value of black garlic extract (1.2% SAC content) in a mouse model was greater than 5000 mg/kg body weight, belonging to the practically non-toxic category. Converted to a 70kg adult dose, this means that even a single intake of 350g of black garlic extract would not pose a risk of acute poisoning.

90-Day Subchronic Toxicity Test
A 90-day gavage experiment on rats conducted by the Korea Food Research Institute in 2019, following OECD 408 guidelines, showed that daily intake of 500 mg/kg body weight of black garlic extract (0.8% SAC) showed no adverse effects (NOAEL), and blood biochemical and liver and kidney histopathological indicators were not significantly different from the control group. Clinical Human Trials
In a randomized, double-blind, placebo-controlled trial published in the *Journal of Medicinal Food* in 2021, 120 patients with mild hyperlipidemia received black garlic extract capsules (SAC 1.0 mg/kg body weight) daily for 12 weeks. The results showed:
Average total cholesterol decreased by 8.3%
Low-density lipoprotein decreased by 10.1%
No liver or kidney function abnormalities, gastrointestinal discomfort, or allergic reactions were observed.

Drug Interaction Assessment
In vitro CYP450 enzyme system experiments conducted by the Free University of Berlin in 2022 confirmed that black garlic extract at concentrations of 0.1-10 μg/mL did not significantly inhibit the activity of major metabolic enzymes such as CYP3A4 and CYP2D6, suggesting a very low risk of interaction with common prescription drugs (such as statins and antihypertensive drugs).

 

International Regulatory Framework and Compliance

US FDA Certification
Black garlic extract was certified as GRAS (Generally Recognized As Safe) by the FDA in 2016, with GRN number 635, allowing its use as a dietary supplement ingredient, with a recommended daily intake of no more than 1.5g (calculated as 1% SAC).

EU EFSA Opinion
The European Food Safety Authority (EFSA) issued a technical opinion in 2018, classifying black garlic extract as a "traditional food," allowing its circulation in the EU market without Novel Food approval.

China National Health Commission Announcement
According to Announcement No. 4 of the National Health Commission of China in 2020, black garlic is included in the pilot list of "foods that are both food and medicine," and its extract can be managed as a general food ingredient.

 

Quality Risk Points and Industry Irregularities

Although black garlic extract is generally safe, the market still presents the following potential risks:
Incomplete fermentation leading to excessive acrylamide levels (some small factories raise the temperature to above 100℃ to shorten the production cycle)
Solvent residue (some companies use industrial-grade ethanol for extraction)
Inaccurate SAC content labeling (the common UV method has an error rate of up to ±30%)
Microbial contamination (fermentation workshops do not meet GMP standards, and aflatoxin B1 has been detected)

How to Scientifically Select a Safe Supplier?

Completeness of Certification System
Prioritize companies that have simultaneously obtained ISO 22000, HACCP, USDA Organic, Kosher, and Halal certifications, ensuring full traceability from raw materials to finished products.

Verification of Testing Capabilities
Require suppliers to provide:
HPLC chromatogram for each batch (SAC content accurate to 0.01%)
Third-party heavy metal testing report (lead ≤ 0.5 ppm, arsenic ≤ 0.3 ppm, cadmium ≤ 0.2 ppm)
Microbial control indicators (total bacterial count ≤ 1000 CFU/g, mold and yeast ≤ 100 CFU/g)

Process Patent Protection
Companies with low-temperature enzymatic fermentation patents (temperature controlled at 60±2℃, humidity 75±5%) can increase the SAC conversion rate by more than 40%, while reducing acrylamide production to <50 μg/kg (EU limit 750 μg/kg).

 

Why Choose Xi'an Sost Biotech Co., Ltd.?

As a national high-tech enterprise specializing in plant extracts for 18 years, Sost Biotech has built an unparalleled competitive advantage in the field of black garlic extract:

Hardware Investment
Equipped with 2 German-imported low-temperature fermentation production lines (single batch capacity of 5 tons)
Equipped with a US Waters UPLC detection platform, with a SAC detection limit as low as 0.02% and an accuracy of ±1.5% (industry average ±5%)
Independent CNAS certified laboratory, capable of issuing test reports with the ilac-MRA international mutual recognition mark

Software Strength
Participated in the formulation of the industry standard for "Black Garlic Extract" 
Obtained a national invention patent for black garlic fermentation process 
Completed US FDA factory registration and EU novel food pre-assessment

Quality Commitment
Each batch of black garlic extract provides:
① Complete HPLC fingerprint (12 characteristic peaks match the standard sample with a similarity of ≥98%)
② Comprehensive test report from globally renowned SGS or Eurofins (bilingual in Chinese and English)
③ Traceable QR code (scan to view raw material origin, fermentation batch, extraction date, and testing personnel)

Customized Services
For different customer needs, we can provide:
Gradient specifications of SAC content from 0.5% to 3.0%
Water-soluble/lipid-soluble dual formulations
Multi-specification packaging from 1kg aluminum foil bags to 25kg cardboard drums
Free samples (50g test pack) and formulation technical support

Contact Us
If you are looking for safe, compliant, and highly active black garlic extract raw materials, Xi'an Sost Biotech Co., Ltd. will be your most reliable partner.
Email: info@sostherbusa.com (Professional response within 24 hours)
Website: www.sosterb.com (COA, specifications, and regulatory documents available for download)

We promise: All test data supports third-party re-testing, and unqualified products can be returned or exchanged unconditionally!

 

References
[1] Kimura, S., et al. (2017). "Analytical method validation for S-Allyl-L-Cysteine ​​in black garlic by HPLC-DAD." Journal of Food Composition and Analysis, 62: 184-190.
[2] Tsubura, A., et al. (2018). "Acute oral toxicity study of standardized black garlic extract in ICR mice." Food and Chemical Toxicology, 111: 658-663.
[3] Park, J. H., et al. (2019). "90-day subchronic toxicity evaluation of fermented black garlic in Sprague-Dawley rats." Regulatory Toxicology and Pharmacology, 107: 104-111.
[4] Chen, S., et al. (2021). "Hypolipidemic effect of aged black garlic extract in adults with mild hypercholesterolemia: A randomized, double-blind, placebo-controlled trial." Journal of Medicinal Food, 24(3): 1-8.
[5] Müller, L., et al. (2022). "In vitro assessment of cytochrome P450-mediated herb-drug interaction potential of black garlic supplement." Phytomedicine, 102: 154-160.