Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.

Australian Supplements Exports to China Double in Two Years

More than half of all Australia’s supplements exports are now going to China or to Hong Kong, with the overall value of industry exports doubling in the past two years.    Source: Gary Scattergood+, Nutra Ingredients-Asia China trade

 

Quote for the month:   “We haven’t had a recession for 25 years in Australia. It’s partly because of our trade with China”   Many commentators

 

If you are going to be in Sydney on 4th – 5th June, 2017 then you simply must check out this year’s Naturally Good Expo (trade-only) being held at the brand new International Convention Centre in Darling Harbour. This is the biggest trade show in the Southern Hemisphere for Everything Healthy. Previous NGE shows have been held at the old Sydney Show Grounds but due to the great demand, this show has been moved to the much larger and oh-so-modern ICC. This will be a fantastic opportunity to not only check out Sydney’s most cutting-edge new building but more particularly, get a first-hand look at all the latest products and services in the natural goods space.

There will be all manner of vendors of everything to do with the supply of natural products in Australia. In fact, there will be more than 450 companies showcasing thousands of the newest and most innovative products all under one roof.

Even RFA Regulatory Affairs will be there! Come and visit us at booth #B43 for a face-to-face chat about your current and future projects.

This year, there is even a dedicated Complementary Health Pavilion along with a Beauty & Living Pavilion and a Food & Drink Pavilion! So, if you’re in the industry and want to keep in touch with all of the latest trends and connected people, then check out all the details and start making your plans: http://naturallygood.com.au

Free-Range Hens Can Now be Stocked up to 10,000 Birds per Hectare but Choice Cries Foul

The five-year wait for a national standard on free-range eggs stocking density is over with the Federal Government announcing new laws. Any eggs labelled "free range" will require a stocking density outdoors of 10,000 hens or fewer per hectare. But consumer group Choice said it was disappointed with the new standards and vowed to maintain its recommendation to "boycott" densely stocked farmed eggs at the supermarkets.   Source: ABC News Free-range eggs

ACCC Issues Guidelines on Country of Origin Claims

Australian Competition & Consumer Commission notes that under the Australian Consumer Law (ACL), certain food products offered or suitable for retail sale will be required to display country of origin information. The ACL doesn’t require non-food products to carry country of origin labelling, although other laws may do so. 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).    Source: Country of Origin labelling    See also related New Zealand ruling: NZ CoOL

Australia and New Zealand Ministerial Forum on Food Regulation Communiqué

The Australian and New Zealand Ministerial Forum on Food Regulation is responsible for maintaining a strong food regulation system that is based on scientific evidence and expertise and is focused on protecting the health and safety of consumers. Ministers recently discussed a range of food regulation issues, including finalising their investigation into low-tetrahydrocannabinol (THC) hemp seeds as a food. They also discussed the latest updates on food labelling of sugar and fats and oils and released the two year progress review report on the implementation of the Health Star Rating system.    Source: Aust-NZ Communique

Hemp Brings New Hope for NSW

NSW Minister for Primary Industries, Niall Blair has welcomed a decision today to approve low THC hemp for sale as food, by the Australia and New Zealand Ministerial Forum on Food Regulation.    Source: Food hemp.   See also, SMH Hemp for food

Why the Health Star Rating System is Flawed

Three years ago, the federal government launched the Health Star Rating System, which resulted in some supermarket products being rated a certain number of stars based on particular nutritional criteria. Despite some superficial success, there is plenty more criticism to suggest that the system is fundamentally flawed and in urgent need of major review. So what is actually wrong with the Health Star Rating System? It’s not mandatory; it’s based on nutrients, not whole foods; healthy foods can have fewer stars than junk food; the equation does not consider the level of processing or raw ingredients; &, the food industry sits on the advisory panel.    Source: Susie Burrell, News.com.au Food stars

FSANZ Update on Allergy Labelling Requirements

Some foods and food ingredients or their components can cause severe allergic reactions including anaphylaxis. Most food allergies are caused by peanuts, tree nuts, milk, eggs, sesame seeds, fish, shellfish, soy and wheat. The Food Standards Code requires these foods to be declared on labels whenever they are present as ingredients or as components of food additives or processing aids. If the food is not in a package or is not required to have a label (for example, food prepared at and sold from a takeaway shop), this information must either be displayed in connection with the food or provided to the purchaser if requested.    Source: Allergy labelling   See also related reading from Department of Agriculture: Allergy labelling 2

FSANZ Notifications –

Application A1127 – Processing Aids for Wine. The purpose of this Application is to seek permission for the use of four processing aids, silver chloride, ammonium bisulphite, chitin-glucan and PVI/PVP as processing aids for wine.    Source: Wine aid

Application A1123 – Isomalto-oligosaccharide as a Novel Food. The purpose of the Application is to permit isomalto-oligosaccharide as a novel food for use as an alternative (lower calorie) sweetener and bulk filler in a ranger of general purpose and special purpose foods.    Source: Novel food

FSANZ Recalls -

Lotus & Ming Baby Whiting. The recall is due to the presence of undeclared allergens (egg and milk).    Source: Whiting recall

Authentic Asia Prawn Wonton. The recall is due to the presence of foreign matter (plastic).    Source: Wanton recall

Report - Omega-3 Long-Chain Polyunsaturated Fatty Acid Content and Oxidation State of Fish Oil Supplements in New Zealand

Forty-seven fish oil products available on the New Zealand market were analysed for eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) content, as well as for oxidative status in a collaborative effort by several analytical laboratories. The results are in stark contrast to the very low percentage of fish oil products reported to be in compliance with primary oxidation limits and EPA/DHA content by a recently published assessment of fish oil supplements in New Zealand. Possible reasons for this discrepancy are evaluated and discussed.    Source: Nature.com NZ fish oils

Three E-Cigarette Companies Cop Fines Over Misleading Health Claims in World-First

Three e-cigarette companies have been ordered to pay a total of $175,000 in penalties for making false and misleading health claims, following legal action launched by the consumer watchdog. In separate proceedings against online retailers Jostick, Social-Lites and Elusion, the Federal Court found all three companies misled consumers by claiming their products did not contain harmful carcinogens and toxins, when this was not the case. The Australian Competition and Consumer Commission says it is the first time any regulator globally has successfully taken action for false and misleading claims about the presence of carcinogens in e-cigarettes.    Source: News.com Vape penalty

TGA Consultation – Proposed Amendments to the Poisons Standard  The TGA is seeking comments from interested parties on proposed amendments to the Poisons Standard concerning Chloroacetamide CAS Number 79-07-2; Docusate sodium CAS Number 577-11-7; Vinyl acetate CAS Number 108-05-4; amongst other substances.    Source: New substances

TGA Presentation - Regulatory Reforms at the Therapeutic Goods Administration (TGA)

Speaking at the recent ARCS webinar, Dr Mark McDonald presented an overview of recommendations from the Review of Medicines and Medical Devices Regulation relating to low risk therapeutic goods. Slides and a complete transcript can be read here: TGA - ARCS webinar;  National Institute of Complementary Medicine (NICM) response: NICM response

TGA Recalls –

Span-K (potassium chloride) 600 mg tablets - bottles supplied without child-resistant caps   Source: Span-K

Hyland's Baby homeopathic teething tablets - Hyland's homeopathic teething tablets are complementary medicines marketed to provide temporary relief of teething symptoms in children. This recall is being undertaken following an investigation by the United States Food and Drug Administration that products supplied in the US contained inconsistent amounts of belladonna alkaloids, a toxic substance, which may differ from the calculated amounts listed on the products' labels.   Source: Teething troubles

TGA Safety Advisories –

Editor's note: This month, a record 19 different products claiming to be “natural” and aimed at erectile dysfunction have been listed on TGA website. There are too many to list individually here, but they mostly contain undeclared sildenafil and/or tadalafil and other prescription-only drugs.   Source: TGA safety alerts

Slim-Vie Slimming Capsules -the capsules contain the undeclared substances sibutramine, sildenafil and phenolphthalein.   Source: Slimming caps

TGA Code of Practice for Tamper-Evident Packaging of Therapeutic Goods

The purpose of tamper-evident packaging is to alert consumers of possible safety concerns before they purchase or use goods. This code of practice provides guidance on tamper-evident packaging for therapeutic goods. Compliance with the code improves the security of therapeutic goods supplied in Australia and increases the likelihood that consumers can identify when a product has been tampered with. These guidelines are not currently mandatory.    Source: Tamper evident

NHMRC Undertakes Homeopathy Review

National Health & Medical Research Council has reviewed the scientific evidence for the effectiveness of homeopathy in treating a variety of clinical conditions with the aim of providing Australians with reliable information about its use.  The evidence identified in this assessment of the evidence has been summarised in a NHMRC Information Paper, which informed the development of NHMRC’s position on homeopathy. A NHMRC Statement has also been developed, based on the assessment of the evidence.    Source: Homeopathy review;   Read also the response from NICM: NICM reviews homeopathy

GOED Study Shows New Zealand Fish Oil Supplements Meet Label Claims

The Global Organization of EPA and DHA Omega-3s (GOED), in conjunction with several of its members, has published a paper in Scientific Reports that shows the results of oxidation and EPA/DHA content testing on 47 fish oil supplements purchased at retail in New Zealand. The paper concluded that nearly all products met the regulatory limits for oxidation and label claims about EPA and DHA content, and compliance with stricter voluntary industry standards was also high. The study was carried out in response to a report published in January 2015 by Albert et al that stated that nearly all fish oil supplements in the New Zealand market did not contain the EPA and DHA stated on the label and were excessively oxidized.    Source: Fish oils

NPNZ Issues Warning for Suppliers of Iron Supplements

Natural Products New Zealand warns that if you have an iron supplement in your range please check it meets regulatory requirements in New Zealand as some companies are being asked to recall stock. The Dietary Supplements Regulations 1985 state that products must not contain more than 24mg daily dose, however the Medicines Regulations 1984 has additional requirements regarding restrictions on the dose units and the pack sizes. Dietary supplements must not contain more than 24mg per recommended daily dose, and as well, the tablets cannot contain more than 5 mg per dose unit, and, as well, the pack size cannot be more than 750mg in total.    Source: NPNZ Iron supplements

Skin-Whitening Uptake Sparks Concern Among Australian Dermatologists

The popularity of skin-whitening is on the rise with the market for skin lighteners projected to reach $US23 billion ($30.5 billion) by 2020, according to market intelligence firm Global Industry Analysts. Across Asia, it is normal to walk into a beauty store and see mostly skin-whitening products adorning the shelves. Whitening is a cultural trend and derives from what's known as "colourism" — a system that privileges lighter skin. It can be pervasive in Asian cultures where darker skin is often associated with manual outdoor work like farming, and therefore a lower status. Dermatologists in Australia said they were concerned about the risks of using the products where some ingredients were not clearly disclosed or were in foreign languages. The Therapeutic Goods Administration (TGA) said the chemical hydroquinone was the most commonly used ingredient in skin-whitening products.    Source: Thuy Ong, ABC News Skin-whitening

Johnson & Johnson to Pay $148 Million in Damages to Woman Who ‘Got Cancer’ from their Baby Powder

Cosmetics company Johnson & Johnson has been ordered to pay US$110 million (AU$148 million) to a woman who says she developed ovarian cancer after 40 years of using of its talc- based products for feminine hygiene. Lois Slemp, who lives in the US state of Virginia, is undergoing chemotherapy after her ovarian cancer, initially diagnosed in 2012, returned and spread to her liver. Ms Slemp said she developed cancer after four decades of daily use of talc-containing products produced by J & J, specifically the well-known Johnson’s Baby Powder and Shower to Shower Powder.    Source: News.com Talc cancer

TGA Issues Guidance on Advertising Cosmetic Services that Include Schedule 4 Substances

This advice is for health professionals and cosmetic/beauty clinics who advertise cosmetic services that involve therapeutic goods containing Schedule 4 (prescription-only) substances. These groups are reminded that advertising of prescription-only products to consumers is illegal. This offence attracts a maximum penalty of $10,800 for an individual and $54,000 for a body corporate. The Act broadly defines an advertisement in relation to therapeutic goods as including any statement, pictorial representation or design, however made, that is intended, whether directly or indirectly, to promote the use or supply of the goods.    Source: TGA cosmetic advertising

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