Complementary Medicine or Food Peter Kissane Chief Operating Officer Sphere Healthcare
Therapeutic Goods Act (1990) defines what are Medicines Rx, OTC & Complementary Medicines Complementary Medicines can be Registered (33) Listed (13,300) Listed Medicines Permitted Ingredients & Levels Claims (Codified claims)
Foods Regulated by State Law Provide sustenance Vitamins, Probiotics, Minerals may be added Claims about Symptoms not permitted Superfoods with claims common Good Source of Vitamins A, C, K & Iron Naturally energises the Body Boosts Libido & Balances Hormones
Food Medicine Interface has many Shades of Grey Brand Owners often want their products Listed (seen as providing endorsement) TGA removing products from Register Some ingredients not permitted to be used Some components not permitted to be named TGA Australian Approved Names List
TGA Food-Medicine Interface Guidance Tool Questions Is the product for oral use for humans? Is there a (post 2010) s.7 declaration, in relation to the product, that it is a therapeutic good? Is there a s.7aa declaration in relation to the product, that it is not a therapeutic good? Is the product 'goods for which there is a standard' under the Food Standards Code? Is the product a good for which, in Australia or New Zealand, there is a tradition of use as foods for humans in the form in which the goods are presented? Is the product represented or likely to be taken to be for therapeutic use? Is the product in a class of goods the sole or principal use of which is, or ordinarily is, a therapeutic use?
Complementary Medicines Regulated under the Therapeutic Goods Act Manufactured under a Code of GMP Manufacturers Licensed & Audited Products on ARTG (Registered or Listed) Raw Materials subject to BP, USP Specifications for Products Testing for Actives claimed on the label Quantified by Input (QBI) permitted Stability Requirements Guidance documents on TGA Website
Microbiological Requirements Therapeutic Goods Order No 77 Mandates Micro Tests Pharmacopoeial Methods Guidance on Therapeutic Goods Order No. 77 - Microbiological Standards for Medicines Interpretation of Passing Results
Therapeutic Goods Order No. 77 - Schedule 1 Microbial attributes for Complementary Medicine oral dosage forms containing raw material of natural (animal, vegetal or mineral) origin Microbiological Quality Total Aerobic Microbial Count Total Yeast and Mould Count Bile-tolerant Gram negative bacteria Salmonella Escherichia coli Staphylococcus aureus Acceptance Criteria Less/equal to 10 4 cfu/g Less/equal to 10 2 cfu/g Less/equal to 10 2 cfu/g Absent in 10 g Absent in 1 g Absent in 1 g
Foods State Regulation FSANZ - Standard 1.6.1 Microbiological Limits in Foods NSW Food Authority Microbiological Quality Guide for ready-to-eat Foods Guidelines in Table 1 No comparable requirements in other states
Table 1: Guideline levels for determining the microbiological quality of ready-to-eat foods Category A Category B Category C Applies to ready-to-eat foods in which all components are fully cooked for immediate sale or consumption Applies to ready-to-eat foods that are fully cooked with further handling or processing before consumption Applies to food that contained uncooked fermented ingredients or fresh fruit and vegetables
Table 1: Guideline levels for determining the microbiological quality of ready-to-eat foods Standard Plate Count (cfu/g) Test Good Acceptable Unsatisfactory Potentially hazardous Category A <10 4 <10 5 >10 5 Category B <10 6 <10 7 >10 7 Category C
Table 1: Guideline levels for determining the microbiological quality of ready-to-eat foods Indicator organisms Test Good Acceptable Unsatisfactory Potentially hazardous Enterobacte riaceae <10 2 10 2 to 10 4 >10 4 E. coli <3 3 to10 2 >10 2
Table 1: Guideline levels for determining the microbiological quality of ready-to-eat foods Pathogens Coagulase +ve Staphylococci Clostridium perfringens Bacillus cereus Vibrio parahaemolyticus Campylobacter spp Salmonella spp Listeria monocytogenes
Conclusion Complementary Medicines have a number of safeguards built in as a result of their regulation as Listed Medicines TGA has produced a Guidance Tool to determine if Food or Complementary Medicine Regulations are clear & TGA has worked with industry to make a number of Guidance Documents available Foods are regulated by State Law Regulatory framework difficult to understand and interpret A lot more latitude is possible in interpreting Microbiological Limits