Atomy HemoHIM GMP and HACCP: What Can Actually Be Verified
What GMP, cGMP and HACCP mean, which HemoHIM certifications can actually be verified — the Korean MFDS registration and Kolmar BNH’s announcements about its Sejong plant — and what these standards do not guarantee.
Short answer: GMP and HACCP are quality and food-safety systems for factories, not proof that a product works. For HemoHIM, what can be verified is its registration in South Korea as a health functional food and Kolmar BNH’s announcements about its Sejong plant: an FDA “No Action Indicated” inspection result (2024) and a TGA GMP certificate (2021). We could not verify a HACCP certificate specific to HemoHIM, so we do not claim one.
What is GMP? (Good Manufacturing Practice)
Good Manufacturing Practice (GMP) is a set of quality rules for how products are made, with versions for medicines, foods and supplements. Typical requirements: clean, controlled production areas, written procedures, checks on raw materials and finished batches, batch records for traceability and trained staff. GMP covers how a product is made, not whether it has any health effect.
What does cGMP mean?
cGMP means “current” Good Manufacturing Practice, the FDA’s term. Makers of dietary supplements for the US market must follow the FDA’s cGMP rules, and the FDA can inspect their facilities. It does not approve supplements before they are sold.
What is HACCP? (Hazard Analysis and Critical Control Points)
HACCP is a preventive food-safety system. It was developed in the 1960s for food in the US space programme and is now used by food producers around the world. It is built on seven principles:
- Analyse the hazards.
- Identify the critical control points.
- Set critical limits for each point.
- Monitor those points.
- Define corrective actions.
- Verify that the system works.
- Keep records.
GMP vs HACCP: the key difference
GMP covers the whole manufacturing setting: premises, equipment, staff, records and quality control. HACCP targets specific biological, chemical and physical hazards at the points where they can be controlled. Together they lower the risk of contamination and inconsistent batches, but neither shows that a product works.
What can be verified for HemoHIM
MFDS registration in South Korea
HemoHIM is registered with Korea’s Ministry of Food and Drug Safety (MFDS) as a health functional food, with the approved claims 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. See HemoHIM ingredients.
Kolmar BNH’s announcements about its Sejong plant
In an October 2024 press release, HemoHIM’s manufacturer Kolmar BNH stated:
- FDA inspection: the FDA inspected its Sejong plant in September 2024 and classified it “No Action Indicated” (NAI) — no objectionable conditions requiring action were found.
- TGA GMP certificate: the same plant obtained a GMP certificate from Australia’s Therapeutic Goods Administration (TGA) in 2021.
Both are company announcements about the factory, not an FDA or TGA approval of HemoHIM. See Is HemoHIM FDA approved?
HACCP: not verified
Some websites call HemoHIM or its production line “HACCP certified”. We could not find a verifiable HACCP certificate specific to HemoHIM, so we do not claim one. If a seller says so, ask who issued the certificate.
What certifications do and do not guarantee
Manufacturing standards are a useful quality signal, within limits: they show a factory met certain rules when inspected, not that a product works or that problems cannot occur.
HemoHIM shows this. In November 2021, Hong Kong and Taiwan told consumers to stop using it after methoxsalen, an undeclared prescription drug, was found in samples; Hong Kong had recorded four liver-injury cases. It was withdrawn in Hong Kong, Taiwan and Singapore. Whether HemoHIM itself caused the cases is debated — a 2023 review disputes causation. 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.
How to make sure your HemoHIM is genuine
A certificate only covers products that really come from that factory. The simplest way to get genuine HemoHIM is to buy it from Atomy’s official mall in your country, where consumer registration is free. Resale on marketplaces is not authorized by Atomy, and you cannot check how such products were stored. See HemoHIM unauthorized sellers.
Bottom line
GMP, cGMP and HACCP describe how products are made, not whether they work. For HemoHIM, the verifiable points are its MFDS registration and Kolmar BNH’s announced 2024 FDA NAI result and 2021 TGA GMP certificate for its plant — not a HemoHIM-specific HACCP certificate. If you have a health condition or take medicines, ask your doctor or pharmacist first. This site is run by an independent Atomy distributor.
❓ What certifications does HemoHIM have?
It is registered in South Korea with the MFDS as a health functional food. Its manufacturer Kolmar BNH has announced an FDA “No Action Indicated” result after a 2024 inspection of its Sejong plant and a 2021 TGA GMP certificate for that plant. These concern the factory, not approval of the product.
❓ Is HemoHIM HACCP certified?
We could not verify a HACCP certificate specifically for HemoHIM, so we do not claim one. HACCP is a food-safety system that identifies and monitors critical control points in production to prevent contamination.
❓ Is Kolmar BNH GMP certified?
According to Kolmar BNH, its Sejong plant obtained a TGA GMP certificate in 2021 and an NAI classification after a 2024 FDA inspection. Both are company announcements about the factory.
❓ Is GMP mandatory for dietary supplements?
In the US, makers of dietary supplements must follow the FDA’s cGMP rules. In the EU, food businesses must have HACCP-based food-safety procedures. Pharmaceutical GMP is stricter and is generally not required for food supplements.
Want to try HemoHIM? Buy it genuine directly from Atomy — registration is free.
References
- Questions and Answers on Dietary Supplements — U.S. Food and Drug Administration
- HemoHim Manufacturer Kolmar BNH Receives NAI Classification from the US FDA — Business Wire (Kolmar BNH press release, 21 October 2024)
- 애터미 헤모힘 — functional claims, intake and cautions — Food Safety Korea (MFDS)
- Suspected poisoning cases related to consumption of oral product “Hemohim” (1 November 2021) — Hong Kong Government (Department of Health)
- Public urged not to buy or consume oral product “Hemohim” (2 November 2021) — Hong Kong Government (Department of Health)
- Yang SJ et al. Does the Health Supplement HemoHIM Cause Liver Injury? — Journal of Industrial Convergence (2023)
This article is for general information and is not medical advice. Talk to a doctor or pharmacist before taking supplements, especially if you are pregnant, breastfeeding, take medicines or have a medical condition.
Where to buy genuine HemoHIM
Check whether HemoHIM is sold in your country and the member price in Atomy’s official mall.
Check availabilityThis site is run by an independent, registered Atomy distributor. If you register through our links, we may earn a commission. Prices are the same.