Latest Regulatory Affairs Newsletter
A collection of regulatory news from this month.
Cosmetics (& Household cleaning products):
Aerosol Sunscreens May Leave You Burnt This Summer
After a string of consumer complaints about the mists offering no protection, the Cancer Council has changed its tune and says it will strongly recommend against using aerosol sunscreens this year. The problem is not with the sunscreen's ingredients, which are effective, but with how difficult it is to use them to apply the correct amount of sunscreen. The council has found many people use aerosols to lightly mist sunscreen on, and end up unprotected. About a quarter of an average bottle of aerosol sunscreen needs to be applied every two hours to ensure you are fully protected. Adding to the difficulty of judging how much sunscreen has been applied, consumer watchdog Choice says only 40 to 60 per cent of a typical can is sunscreen. The rest is propellant. Source: Aerosol sunscreen
Chemicals Added to the AICS Following Issue of Assessment Certificate
Ten chemicals have been added to the ‘non-confidential’ AICS database as a result of being issued with an assessment certificate. Source: AICS update 1
Chemicals Added to the AICS 5 Years After Issue of Assessment Certificate
Three chemicals have been added to the Australian Inventory of Chemical Substances (AICS) in accordance with section 14(1) of the Industrial Chemicals (Notification and Assessment) Act 1989. Editor’s Note: (these would have been on the confidential AICS database during this time at the request of the company who made the submission) Source: AICS update 2
NZ Government Bans Production and Sale of all Microbeads
Newly elected New Zealand Prime Minister, Jacinda Ardern, said Cabinet had approved the regulation to ban microbeads. It would come into force in six months, following a transition period. Microbeads are tiny plastic beads – less than 5mm in size – used to give products texture, act as an abrasive, or provide visual interest. About 100 personal care products in New Zealand contain the tiny plastic beads. It is estimated about 10,000 tonnes a year of plastic microbeads are used globally. They are usually used for exfoliation or polishing. Source: Laura Walters, Stuff.co.nz Microbead ban
What Are The Latest Trends In The Personal Care Sector?
Bans, restrictions, ingredient disclosure: these are the key chemical issues the personal care industries in Europe, the US and the rest of the world have grappled with throughout the past year. And they will remain hot topics on the 2018 agenda. Specific topics to keep an eye on for 2018 include: Looking for safer preservatives (Trends to watch are multifunctional additives and formulations based on organic acids.); Mineral oil hydrocarbons and health concerns (eg: consider whether dietary exposure to certain mineral oils in lip care products is a health concern); Microplastics (see story above re. NZ ban); &, Increasing transparency (Under rising demands for transparency, large corporations and retailers are beginning to make information on the chemicals in their products more easily available to consumers). Source: Vanessa Zainzinger, ChemicalWatch Personal care trends
All Oils Ain’t Oils: Moroccanoil Israel Ltd v Aldi Foods Pty Ltd
A recent Federal Court decision has found Aldi made misleading and deceptive representations about the natural content and performance benefits of its “Moroccan Argan Oil” products. Aldi’s products in question were its “Moroccan Argan Oil” oil treatments, shampoos and conditioners which were sold under Aldi’s “PROTANE®NATURALS” brand. The case concerned, among other things, claims that the products contained only or substantially ‘natural ingredients’ and that representation was false; and Aldi represented that the benefits of its “Moroccan Argan Oil” products were due to the presence of Argan Oil (such as strengthening hair etc.) and that these “performance benefits” were misleading given the minute quantities of Argan Oil in the products. This case demonstrates that: trade mark holders need to be aware that their trade-marks can, in certain circumstances, amount to representations about the products to which the marks are applied; and that they also need to be able to back up any claims to the performance of a product with empirical evidence relevant to the content of the product. Source: CowellClarke blog Aldi argan oil
Quotes for the month:
"A quiet and modest life brings more joy than a pursuit of success bound with constant unrest."
This advice, on the secret of happiness, written on a note by Albert Einstein 95 years ago, was given to a hotel porter when Einstein was caught short of cash. It sold for $1.7 million at an auction in Israel in October 2017. Source: The Guardian Wise advice
“Do not save what is left after spending, but spend what is left after saving". Warren Buffet
Training Course Update:
NEW COURSE NOW AVAILABLE
Pharmacovigilance Obligations Training. For details see foot of this newsletter
Training Course Update:
NEW COURSE NOW AVAILABLE!
Pharmacovigilance Obligations Training
In September this year, the TGA released guidance on the pharmacovigilance responsibilities of sponsors. Newly developed, this training course is for sponsors and their nominated pharmacovigilance staff with complementary medicines included on the Australian Register of Therapeutic Goods. We cover TGA pharmacovigilance obligations and mandatory reporting requirements, the what, how and when you MUST report. All required documents including SOPs and reporting templates will be provided for your future use.
This one hour training course is available via Skype or in person in our office in Glebe, Sydney. You will receive full course notes, document templates, SOPs and a certificate of attendance. This is all included in the price.
Nordoff-Robbins Music Therapy Corporate Christmas Cards
As per our usual practice, this year we are donating to Nordoff-Robbins Music Therapy (www.nordoff-robbins.com.au) in lieu of sending Christmas cards to clients. Nordoff-Robbins Music Therapy uses music to transform lives and bring the benefits of music therapy to those in need. You can also donate http://www.noro.org.au/support-us/donate-now. RFA Regulatory Affairs is a long-time supporter of Nordoff-Robbins Music Therapy Australia. You can be too! http://www.noro.org.au/about/our-supporters
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.