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TGA Laboratories testing report: Microbiological testing of medicines containing Green-lipped Mussel
Version 1.0, June 2020
Complementary medicine oral dosage forms on the ARTG that contain green-lipped mussel (Perna canaliculus) as the active ingredient are generally indicated to help reduce joint pain.
Green-lipped mussels are marine shellfish that are efficient filter feeders, concentrating microorganisms, algal biotoxins and chemical pollutants from the waters in which they are farmed and harvested. Consumption of contaminated shellfish can cause serious adverse effects in humans. From 2017 to 2019 the TGA Laboratories undertook testing projects to monitor the microbiological quality of medicines containing green-lipped mussel supplied in Australia.
Complementary medicines containing green-lipped mussel that are supplied in Australia must comply with Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018, clause 11(2), Schedule 1, in relation to microbial count and absence of specified microorganisms. TGO 100 also requires medicines to be free from contamination with objectionable organisms. Vibrio parahaemolyticus and Listeria monocytogenes are examples of objectionable organisms that could contaminate medicines derived from shellfish and pose a risk to consumer safety. As such, these medicines are expected to be free from contamination with these objectionable organisms. See Table 1 for the acceptance criteria applied.
Testing was performed on twenty seven medicines. Twenty five complied with the requirements of clause 11(2), Schedule 1, of TGO 100 and two failed to comply with this clause (see Table 2).
No specified or objectionable organisms were isolated from any of the samples tested. For one product, the average Total Aerobic Microbial Count for one of three replicate containers tested exceeded the maximum permitted level. For a second product, one of the three containers tested exceeded the maximum permitted level for Bile-tolerant Gram negative bacteria.
One medicine was found not to comply with the labelling standard TGO 92 Standard for labels of non-prescription medicines (TGO 92).
|Test name||Standard applied||Acceptance criteria|
|Microbial Limits Test||TGO 100, Clause 11(2), Schedule 1||TAMC ≤ 104 CFU/g
TYMC ≤ 102 CFU/g
Bile-tolerant Gram negative bacteria (BTGN) ≤ 102 CFU/g
E. coli: Absent in 1g
S. aureus: Absent in 1g
Salmonellae: Absent in 10g
Absence of objectionable organisms
|Label check||TGO 92||Meets the criteria|
TAMC = Total Aerobic Microbial Count, TYMC = Total Yeast and Mould Count
|ARTG No||Product Name||Sponsor||Batch No||Expiry Date||Average Counts (CFU/g)||Label Result|
|208674||Healthy Care New Zealand Green Lipped Mussel 500mg Capsules||Nature's Care Manufacture Pty Limited||695829||30/06/2020||
*TAMC 1.1 x 104
|200811||Nutra-Life Green Lipped Mussel 850mg||Vitaco Health Australia Pty Ltd||129437||14/03/2020||
TAMC 2.2 x 103
* To take into consideration the precision of the microbial plate count method, TGO 100 allows a maximum factor of 2 to be applied to the TAMC, TYMC, and Bile-tolerant Gram negative (BTGN) bacteria count criteria (when tested by plate count methods). For example, where the specification is not more than 104 CFU per gram, then the maximum permitted count is 2.0 x 104 CFU/g. The TAMC for one of three replicates was 2.7 x 104 CFU/g, which exceeded the maximum level of 2.0 x 104 CFU/g permitted by TGO 100.
(est.) = estimate (when there are less than 25 colonies on a count plate the result is reported as an estimate only).
|ARTG No||Product Name||Sponsor||Batch No||Expiry Date||Label Result|
|252035||Joint Care 5 in 1||Universal Nutrition & Beauty Care Pty Ltd||1053||31/03/2020||Does not comply|
|ARTG No||Product Name||Sponsor||Batch No||Expiry Date||Result - TAMC||Label Result|
|270395||Greenshell Mussell with Glucosamine||Ageless IP Pty Ltd||2467||31/03/2019||107 CFU/g (est.)||Complies|
|284349||Oviit Green Lipped Mussel||Apotex Pty Ltd||170575||29/02/2020||37 CFU/g (est.)||Complies|
|154245||Dr Natural NZ GlycMussel||Astragrace Corp Pty Ltd||16874||30/06/2020||520 CFU/g||Complies|
|164090||Aussia Green Lipped Mussel Plus||Aussia Pharma||12630||31/01/2019||<10 CFU/g (est.)||Complies|
|265472||Good Health Mussel 6000||Australia Cobayer Health Food Co Pty Ltd||Y47C||31/03/2020||73 CFU/g (est.)||Complies|
|224728||Living Pure Four in One Joint Capsules||Ausvigor Global Pty Ltd||27291||30/11/2018||71 CFU/g (est.)||Complies|
|256772||Blackmores Lyprinol||Blackmores Ltd||281554||23/01/2020||<20 CFU/g (est.)||Complies|
|198002||Arthritis Fighter||Caruso's Natural Health Pty Ltd||161843||30/11/2019||24 CFU/g (est.)||Complies|
|273613||Motipid||Eden Natural Health||14419||31/08/2019||120 CFU/g (est.)||Complies|
|251212||Dr.Nature 4 in ONE JOINT||Health Sharing Group Pty Ltd||30571||30/11/2018||67 CFU/g (est.)||Complies|
|148896||Spring Leaf NZ Green Lipped Mussel Essence 2000mg||Homart Pharmaceuticals Pty Ltd||10446||23/02/2020||<20 CFU/g (est.)||Complies|
|289615||Connie Bonnie Greenshell Mussel 7500||J & J Worldwide Pharma Pty Ltd||15728||31/03/2020||85 CFU/g (est.)||Complies|
|193682||Arthro Support Formula||JNC Co Pty Ltd T/a Panax Pharm T/a Dr. Pro||1302||31/07/2020||44 CFU/g (est.)||Complies|
|149888||Seatone||MacLab Australia Pty Ltd||A60552||30/11/2018||<40 CFU/g (est.)||Complies|
|170866||Nature's Family Premium Green Lipped Mussel 750mg||Nature's Family Australia Pty Ltd||17311||31/07/2020||160 CFU/g (est.)||Complies|
|273247||Nubolic 4 in One Joint||Nature's Kingdom Australia Pty Ltd||1081||31/07/2020||62 CFU/g (est.)||Complies|
|212323||Nutrivital Green Lipped Mussel 850mg||Nutrivital Pty Ltd||110849||12/02/2019||71 CFU/g (est.)||Complies|
|172526||Blooms Green Lipped Mussel||Phytologic Holdings Pty Ltd||838044-1||31/01/2020||11 CFU/g (est.)||Complies|
|282865||Greenshell Mussel 7500||RBK Nutraceuticals Pty Ltd||2970||31/03/2020||29 CFU/g (est.)||Complies|
|182781||Mega Green Lipped Mussel 7500||Sini Australia Pty Ltd||03462||30/04/2020||580 CFU/g (est.)||Complies|
|252035||Joint Care 5 in 1||Universal Nutrition & Beauty Care Pty Ltd||1053||31/03/2020||44 CFU/g (est.)||Does not comply|
|130527||Bio-Green Lipped Mussel Complex 2500||Universal Pharmaceuticals Pty Ltd||170611||30/06/2020||1.4 x 103 CFU/g||Complies|
|200811||Nutra-Life Green Lipped Mussel 850mg||Vitaco Health Australia Pty Ltd||136044||07/06/2020||3.2 x 103||Complies|
|267160||Glucosamine 4-in-1||Wellwisse Pharmaceuticals Pty Ltd||30988||30/06/2019||84 CFU/g (est.)||Complies|
|180947||Osteoflam Plus||Zifam Pinnacle Pty Ltd||6870||29/02/2020||< 40 CFU/g (est.)||Complies|
Twenty seven medicines, representing approximately one third of those on the ARTG containing green lipped mussel, were tested for microbiological quality during the 2017 - 2019 period. Twenty five complied with the requirements of clause 11(2), Schedule 1, of TGO 100 and two did not comply.
The two compliance failures were not safety-related and were considered to be minor product quality concerns. Product sponsors were informed of the test results and asked to investigate potential root causes for the elevated counts. Both provided evidence to show that other product batches were unlikely to be affected. Their proposed actions to address the minor quality concerns were considered satisfactory.
A separate medicine was found not to comply with the labelling standard TGO 92 Standard for labels of non-prescription medicines (TGO 92); this matter was referred to the Complementary & OTC Medicines Branch, who undertook a compliance review, following which the matter was resolved.
|||Therapeutic Goods Order No. 77 Microbiological Standards for Medicines (TGO 77) was in force at the time the project commenced in July 2018. It was automatically repealed (sunset) on 1 October 2018 and remade at this time as TGO 98 Microbiological Standards for Medicines (2018,) without regulatory change but with minor editorial changes to improve clarity. TGO 98 was subsequently remade as Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018, which came into effect on 8 December 2018, repealing TGO 98 on this date. The microbiological quality requirements in TGO 77, TGO 98 and TGO 100 are equivalent.|
|Version||Description of change||Author||Effective date|
|V1.0||Original publication||TGA Laboratories||June 2020|