Is HemoHIM FDA Approved? What Its Regulatory Status Really Means

Short answer: no. HemoHIM is not “FDA approved”, because the US Food and Drug Administration does not approve dietary supplements before they are sold. What exists are statements by its manufacturer, Kolmar BNH, about inspections and certificates for its factory. These concern the manufacturing site, not proof that the product works. Here is what each one actually means.

Transparency note: this site is run by an independent, registered Atomy distributor, and we may earn a commission if you register through our links; your price stays the same.

FDA approval vs facility inspection

• FDA approval applies to medicines: the FDA reviews evidence that a drug is safe and effective before it can be sold.

• Dietary supplements are not approved. Companies are responsible for their safety and labelling, and the FDA can act after a product is on the market.

• Facilities that make supplements for the US must follow current Good Manufacturing Practice (cGMP) rules, and the FDA can inspect them. “No Action Indicated” (NAI) is the inspection outcome meaning no objectionable conditions were found that require action.

What Kolmar BNH has announced

• FDA inspection: according to a Kolmar BNH press release (October 2024), the FDA inspected its Sejong plant in September 2024 and gave it an NAI classification.

• Australian TGA: according to the same release, the Sejong plant obtained a GMP certificate from Australia’s Therapeutic Goods Administration (TGA) in 2021.

Both are company announcements about the factory. They indicate that the plant met manufacturing-quality standards at the time of inspection. They are not an FDA or TGA approval of HemoHIM, and they say nothing about whether it has health effects.

Status in South Korea

In South Korea, HemoHIM is registered with the Ministry of Food and Drug Safety (MFDS) as a health functional food. Its approved claims are that it “may help improve immune function” and “may help reduce fatigue”. The Korean label advises children, pregnant and breastfeeding women not to take it, and people on blood thinners to consult a professional first. See what is HemoHIM.

Safety evidence

• An 8-week randomized, placebo-controlled trial in 96 healthy adults found no clinically significant adverse events. The trial was supported by the manufacturer, Kolmar BNH, and included only adults aged 30–59.

• An animal study (Toxicological Research, 2025) found no treatment-related toxicity in rats at up to 2,000 mg/kg per day over 13 weeks, and no genotoxicity in standard tests.

These are encouraging but limited data. See HemoHIM clinical studies and HemoHIM side effects and safety.

The Hong Kong and Taiwan warnings

In November 2021, health authorities in Hong Kong and Taiwan told consumers to stop using HemoHIM after methoxsalen, an undeclared prescription drug, was found in samples; four liver-injury cases had been reported in Hong Kong. The product was withdrawn there and in Singapore. As of October 2026, HemoHIM is sold again in Atomy’s Singapore mall and, as HemoHIM G (艾多美 煥力飲G), in Atomy’s Taiwan mall; it is still not sold in Hong Kong. Read Is HemoHIM banned? and our HemoHIM liver safety analysis.

Bottom line

HemoHIM is not FDA approved — no dietary supplement is. Its manufacturer reports an NAI result from a 2024 FDA inspection and a 2021 TGA GMP certificate for its plant, and in South Korea it is a registered health functional food with approved immune and fatigue claims. None of this replaces medical advice: if you have a health condition or take medicines, ask your doctor before trying it.