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TGA Laboratories testing report: Microbiological testing of medicines containing Green-lipped Mussel

Version 1.0, June 2020

30 June 2020

Introduction

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[1], 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

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).

Table 1: Tests applied to samples
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

Table 2: Batches failing to meet the TGO 100 acceptance criteria
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
TYMC <10 (est.)
BTGN <100 (est.)
No specified or objectionable organisms isolated

Complies
200811 Nutra-Life Green Lipped Mussel 850mg Vitaco Health Australia Pty Ltd 129437 14/03/2020

TAMC 2.2 x 103
TYMC <10 (est.)
BTGN 1.8 x103
No specified or objectionable organisms isolated

Complies

* 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).

Table 3: Batch failing to meet labelling requirements
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
Table 4: Batches that met the TGO 100 acceptance criteria
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

Outcome

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.


Footnotes


Version history
Version Description of change Author Effective date
V1.0 Original publication TGA Laboratories June 2020