FDA confirms contamination in two lots of herbal inhaler products
FDA confirms contamination in two lots of herbal inhalers, orders recall and manufacturing suspension, citing health risks from excessive microbes and mould.
The Food and Drug Administration (FDA) confirmed on Wednesday that specific manufacturing lots of two herbal inhaler brands were found contaminated with harmful microorganisms and have been ordered off the market.
Two Contaminated Lots Identified
FDA secretary-general Supatra Boonserm said laboratory tests confirmed contamination in:
- Hong Thai herbal inhaler, Lot No. 000332
- Chama Herbs herbal inhaler, Lot No. NF 2522503001
She said both lots were contaminated and posed potential health risks to consumers.
Lab Results and Public Disclosure
Earlier, test results of the Hong Thai product had leaked on social media before being officially verified by the Department of Medical Sciences on Tuesday. The FDA’s announcement on Wednesday also included the confirmed findings for the Chama Herbs brand.
Supatra explained that the FDA began testing herbal inhalers after reports surfaced in May suggesting microbial and mould contamination in several brands that could harm users’ lungs.
Details of Contamination
The Hong Thai Lot No. 000332 was manufactured on December 9, 2024, with an expiry date of December 8, 2027.
Tests found excessive levels of yeast, fungi, and Clostridium spp. exceeding safety standards. The microorganism Clostridium perfringens—a bacteria that can cause serious infections—was detected.
The Chama Herbs lot was found to contain aerobic microbial levels above the safety threshold.
FDA Testing Criteria
Supatra outlined the FDA’s safety standards used for testing herbal inhalers:
- Total microbial growth should not exceed 200 colonies per gram.
- Total yeast and mould count should not exceed 20 colonies per gram.
- Specific microorganisms—Staphylococcus aureus, Pseudomonas aeruginosa, and Clostridium species—must be absent.
She added that such contaminants could be particularly harmful to people with weakened immune systems, especially the elderly.
Recall Orders and Manufacturing Suspension
The FDA has ordered both manufacturers to recall the affected lots from the market and safely dispose of them. They must also suspend production until the source of contamination is identified and corrective measures are implemented.
Before resuming production, the companies must submit samples of newly produced batches for FDA inspection and approval.
Supatra assured the public that only the two specific lots were affected and urged consumers not to panic, as other manufacturing batches remain safe for use.
Manufacturers Respond
On Tuesday, Hong Thai issued a public apology and pledged to withdraw the affected lot from retail shelves nationwide.
