Latest Regulatory Affairs Newsletter
A collection of regulatory news from this month.
Training Course Update:
NEW COURSE NOW AVAILABLE
Pharmacovigilance Obligations Training. For details see foot of this newsletter
Complementary Medicines (“Dietary supplements”):
Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 Update.
This far reaching bill has implications for those involved in the supply of Listed Medicines, or Medical Devices, as it “…amends the Therapeutic Goods Act 1989 to: allow(s) the minister to specify, by legislative instrument, permitted indications for use with listed medicines; establish an additional pathway for intermediate risk medicines through a new application and assessment process for sponsors of listed complementary medicines seeking to use indications that fall outside the permitted indications list; strengthen monitoring powers in relation to biologicals; implement stronger compliance and enforcement powers and graduated penalties for non-compliant behaviours; remove the distinctions between advertisements for therapeutic goods for which an approval is, or is not, required; enable the secretary to utilise the work of comparable overseas regulators in the course of making assessments of medical devices; …”. The Bill has passed its 2nd reading in the House of Representatives and has been referred to the Federation Chamber for consideration. Source: Bill update
TGA Safety Advisories – Source 2017 alerts
Melanotan – (Illegal therapeutic goods). Consumers are advised not to use Melanotan-I, Melanotan-II and similar injectable tanning products. These injectable tanning products are generally obtained through websites, which are often based overseas. They may cause serious side effects and should not be used.
Tamo 20 tablets. Tamo 20 tablets are not related to the approved medicine Tamoxifen Citrate. The tablets contain the substance tamoxifen at a strength lower than that described on the bottle. The supply of Tamo 20 tablets is illegal as they are considered to be counterfeit.
Hard Rod Plus capsules. They contain the undeclared (prescription only) substance aminotadalafil.
Super Soniic capsules. They contain the undeclared (prescription only) substance sildenafil and also contain (poison) strychnine (Yes, ‘strychnine’!)
Lishou Fuling Jiaonang capsules. They contain the undeclared substance sibutramine.
Maximum powerful (Baiwei USA) tablets.The tablets contain the undeclared substance sildenafil.
Red Ant tablets. They contain the undeclared substance sildenafil.
Beautiful Lose Weight Gold 30 Capsules. The capsules contain the undeclared substances sibutramine and phenolphthalein.
Lose Weight 30 capsules: They contain the undeclared substance sibutramine.
Semenax capsules: They contain the undeclared substance Yohimbine.
Cosmetics (& Household cleaning products):
Correction of an Error on AICS
The National Industrial Chemical Notification Scheme (NICNAS) has corrected a listing error on the Australian Inventory ofChemical Substances (AICS), after an entry that was nominated (without assessment) and listed on AICS in error. Source: AICS amendment See also: Recent addition of chemicals to AICS: AICS update
New NZ Government Pulls NHP Bill
Regular readers of this newsletter will have noticed the tortuous path of the Natural Health Products bill as it slowly makes its way through the New Zealand Parliament. With a newly elected government now in place all current bills before the house have to be reconsidered. As can be seen from the following link, the NHP Bill is now in abeyance and we await further notice from the new government Health Minister and Health Select Committee. Source: NZ NHP Bill
Australia and New Zealand Ministerial Forum on Food Regulation Communiqué 24 November 2017
The Forum is chaired by the Australian Government Assistant Minister for Health, Dr David Gillespie and Australian state and territory Ministers, the New Zealand Minister responsible for food safety and the Australian Local Government Association participate. The Forum oversees the collaborative joint Australia and New Zealand food regulation system. The food regulation system is based on scientific evidence and expertise that protects the health and safety of consumers. The rigorous system reflects the many businesses and stakeholders in the food supply chain, providing a firm platform on which our food industries can operate. The Forum reaffirmed its commitment to the three food regulation system priority areas: Reducing foodborne illness; Support public health objectives to reduce overweight and obesity; &, Maintaining a strong, robust and agile food regulation system. Source: Food regs
New Zealand Steps Up Biosecurity with Increased Penalties for Offenders
The NZ Ministry for Primary Industries is taking a hard line on arriving air passengers who fail to declare items that could bring pests or diseases into New Zealand. So far this year, MPI officers have issued more than 9,100 biosecurity infringements and given 1,135 warnings to air passengers for failing to follow New Zealand's strict biosecurity rules. Last year, officers issued 9,704 fines in total, compared with 6,102 in 2015 and 4,851 in 2014. "The stats show biosecurity fines increased by more than 50% between 2014 and 2016. With the busy summer period yet to start, we are expecting to see another increase this year," says Craig Hughes, MPI Passenger Manager. "The rise is partly due to the increased numbers of visitors, but also to the tough stance we're taking on people that put New Zealand at risk. We're now more likely to issue a fine than give a warning. "Travellers should be aware that failing to declare because you forgot, were tired from travelling, or did not know the rules is not enough to avoid a fine. Source: NZ food fines
FSANZ Approves Low THC Hemp Seeds for Foods
Food Standards Australia & New Zealand have approved the use of foods for sale derived from hemp seeds. These newly designated food category may be described as ‘hemp’, but not as ‘marijuana’ or ‘cannabis’. THC (Tetra-hydro cannabidiol) must not be present in any food for sale at a level greater than 75 mg/kg. Source: Low THC foods; & Hemp legislation
ACCC Clarifies Country of Origin Labelling Changes
The Australian Competition & Consumer Commission is responsible for consumer laws in Australia. All businesses, whether they are legally required or choose to display country of origin labelling, are prohibited from making false or misleading representations or engaging in misleading or deceptive conduct about the origin of goods (both food and non-food). The Country of Origin Food Labelling Information Standard 2016 (Standard) must be fully implemented by 1 July 2018. Source: CoOL requirements
Does Mentioning a Healthy Ingredient Constitute a Health Claim or a Nutrition Content Claim?
Claims such as “rich in Vitamin C”, “low in fat”, “contains antioxidants” and “reduces the risk of heart disease” may be made in relation to certain food products. Are these health claims or nutrition content claims? It is important to comply with the prescribed rules in the Food Standards Code before making such claims to avoid breaching the Australian Consumer Law. Source: Charles Fisher & Jenny Awad, Food Legal Food claims
Targeted Action Dishes Up Food Safety Results
Three Sydney noodle manufacturing businesses have been collectively fined more than $150,000 in relation to various food safety and hygiene failures under the Food Act 2003 and the Food Standards Code following a targeted project by the NSW Food Authority designed to address a high-risk food sector where compliance was less than satisfactory. The "Fresh Noodle Manufacturers Project" was designed to improve standards in the fresh noodle industry after the Food Authority became aware of compliance issues within the sector. Source: Off noodles
Want to Know Who’s Serving Up Bad Food in Your Suburb?
The NSW Food Authority maintains a very useful ‘Name & Shame’ registry. See if any of your local food outlets have been busted for selling sub-standard foods. You can search by trading name, by suburb, or by date. Source: Name & shame
NSW Food Authority Recalls—
Vodka Cruiser Sunny Orange Passionfruit Asahi Premium Beverages Pty Ltd has recalled Vodka Cruiser Sunny Orange Passionfruit due to non-compliant labelling (undeclared tartrazine colour 102). Source: Vodka cruiser sunk
Nudie Brekkie with real berries Monde Nissin Australia has recalled Nudie Brekkie with real berries, real coconut milk & real oats due to the presence of an undeclared allergen (cow’s milk). Source: Nudie embarrassed
Chai Supreme Dark Chocolate Riebeck Pty Ltd trading as Little Zebra Chocolates has recalled Chai Supreme Dark Chocolate due to the presence of an undeclared allergen (dairy). Source: Dark on chocolate
Application A1147 – Food derived from Herbicide-tolerant Cotton Line GHB811. The purpose of the Application is to seek approval for food derived from cotton line GHB811, genetically modified to provide resistance to isoxaflutole and glyphosate. Source: GM cotton1
Application A1153 – Endo xylanase from T. reesei as a Processing Aid. The purpose of the AApplication is to include a genetically modified strain of Trichoderma reesei as a permitted source for Endo-1,4 (3) - ß -xylanase (E.C.220.127.116.11) Source: GM trichoderma
Application A1154 – Food derived from insect-protected cotton line MON88702. The purpose of the Application is to seek approval for food derived from a genetically-modified insect-protected cotton line, MON88702 Source: GM cotton 2
Proposal P1030 – Composition and labelling of electrolyte drinks. The purpose of this Proposal is to undertake an assessment of the compositional and labelling requirements for electrolyte drinks. to undertake an assessment of the compositional and labelling requirements for electrolyte drinks. Source: Electrolytes
The Seismic Shifts in Marketing’s Role in Direct Selling
“Marketing doesn’t matter for a direct selling company.” Have you ever heard this one before? If you’ve been working in direct selling for more than ten years, there’s a good chance you’ve heard someone say this outright, or at least imply it. In fact, that person may have even been you. For example, it was a popular rebuttal to any marketer with a consumer packaged goods background prior to coming on board, as they began their journey in the mysterious waters of direct selling. You’d hear this sentiment when a creative director was asking for packaging that would take away a few extra pennies from the bottom line. You’d even hear it when it felt like corporate was over-stepping their bounds, relying on the field to come up with their own tools, their own campaigns and their own messaging on how to share the products. I always loved the simplicity of that statement, and the loaded implications behind it. Unfortunately, I think there’s a little more to it than that now, though”. Source: Brett Duncan, World of Direct Selling Direct selling & marketing
Quote for the month:
“You don’t have to be great to start, but you have to start to be great”. Zig Ziglar