Latest Regulatory News
7th August 2013
TGA cancels 12 product listings since 1st January 2013
The following twelve previously listed medicines have been cancelled this year due to many separate failings by the relevant sponsors:
Zenacor (Pharmabrand Labs Pty Ltd); COFFEE SHAPE slimming green coffee (ATP Life Pty Ltd); Stophair-Hair Inhibiting Spray (Stop Hair Pty Ltd); Vitamax Calcium 600mg + Vitamin D, and Vitamax Calcium 600mg (Aurora Pharmaceuticals Pty Ltd); WU JI BAI FENG WAN Pill vial (Shen Neng Herbal Medicines Group Pty Ltd); Inner Health Candex (Health World Limited); Myadec Primetime 50+ Formulation (Myadec Pty Ltd); Swisse Ultiboost Appetite Suppressant (Swisse Vitamins Pty Ltd); BLOOMS CURCUMIN 600 PLUS with enhanced BioP absorption (Phytologic Pty Ltd); Fat Eliminator (Thinz Pty Ltd); and, Energy Slim (World Class Physiques Pty Ltd).
Whilst there were several separate reasons given by ARTG for listing cancellations, by far the most common reason was “as there was insufficient evidence to support the indications for the product”.
5th August 2013
Adulteration of Ginkgo biloba is ‘very widespread’, according to industry sources, but as the adulteration becomes more sophisticated new methods are emerging to help industry ensure the quality of this key herbal.
5th August 2013
Decision under regulation 9 of the Therapeutic Goods Regulations 1990 in relation to an advertisement about ‘Instant Virgin Spray’ (Complaint No. 2011-12-020)
Background: On 15 July 2013 Coast PC Pty Ltd (the Advertiser) was ordered to carry out actions in relation to an internet advertisement at www.instantvirgin.com.au. The advertisement promoted the ‘Instant Virgin Spray’ product. The decision to order the Advertiser to carry out specified actions in relation to the website advertisement was taken as the Advertiser had not fully complied with the Panel’s determination issued on 15 June 2012.
The Panel’s findings : The Panel found that the advertisement clearly represented the ‘Instant Virgin Spray’ product to be for therapeutic use, and that in the absence of any submission from the Advertiser, the advertisement contained many representations that had not been verified, were not correct and balanced, were likely to arouse unwarranted expectations and were misleading. The Panel also found that the advertisement exploited the lack of knowledge of consumers, encouraged excessive use, represented the product as being side effect free and used ‘consumer testimonials’ which were misleading insofar as they reported product benefits that were not substantiated.
The decision: The Delegate was satisfied that the way in which the goods were presented were likely to be taken to be for ‘therapeutic use’ because its overall presentation fitted the definition of ‘therapeutic use’ in that it purported to ‘influence, inhibit or modify a physiological process’ by way of providing a benefit in relation to, ‘tightening the vagina’, ‘restoring suppleness to the vagina’, ‘increasing vaginal secretion’, ‘restoring lubrication’, ‘solving the problem of vaginal dryness’ and ‘releasing esterogen’ [sic] to stimulate the libido. The advertisement included the representation that the ‘Instant Virgin Spray’ product could ‘fully rejuvenate your vagina without the need for more application’, included the offer of a ‘100% money back guarantee’ if ‘for any reason you are not happy'
4th August 2013
Food Standards Australia New Zealand is aware of the announcement by Fonterra regarding several batches of its whey protein concentrate possibly contaminated with Clostridium botulinum and subsequent recalls of two Nutricia products as a precautionary measure.
The Australian Government is continuing to verify whether there are, or have been, any products for sale in Australia that contain a potentially contaminated dairy food ingredient from New Zealand.
The ingredient, a whey protein concentrate, was produced by Fonterra in New Zealand, and may be contaminated with Clostridium botulinum, which can cause botulism. No cases of illness associated with the products have been reported.
The Australian Government continues to work closely with New Zealand authorities and Australian export markets to trace-back potentially affected products manufactured in Australia from the imported contaminated ingredient and then sold overseas.
1st August 2013
Three people who have pleaded guilty to selling slimming food products containing undeclared Sibutramine - a drug not permitted in food, have been convicted of various breaches of the Food Act 2003 in the Downing Centre Local Court. The directors of the deregistered company Bruce Imports were each convicted of 32 charges relating to the sale of imported weight loss coffees, dried fruit and jelly. The charges, brought by the NSW Food Authority included the sale of unsuitable food, sale of falsely described food, and the sale of food with non-compliant nutrient and/or health claims. Specific batches of the products, Leptin Green Coffee 800, Leptin Slimming Coffee (Rose Curve), Lose Weight Coffee, Leptin Weight Loss dried plum and My Leptin Weight Loss jelly cups were seized by the NSW Food Authority and subject to product recalls following their investigation. The investigation followed industry complaints that these types of products contained the prescription drug. The Authority tested the foods and found the undeclared drug ingredient, despite claims the foods contained ‘natural’ ingredients.NSW Food Authority CEO Polly Bennett said the outcome was the result of hard work and dedication by officers of the NSW Food Authority. "This result serves as a clear reminder to business that if you do the wrong thing you will face the full weight of the law." The directors were fined a total of $9,840.
1st August 2013
THREE cosmetics - Nude by Nature Liquid Mineral Foundation, Australian Lavender Essentials Eye Cream and its Face Up, the Essential Moisturiser - have been recalled after testing revealed dangerous levels of microbial contamination. The products, which include various skin tones of Nude's foundation, were detected as part of an Australian Competition and Consumer Commission product safety survey.
Microbiological hazards occur when cosmetic products are contaminated by micro-organisms such as bacteria, mould and yeast. The ACCC surveyed 115 cosmetic products found in shops and online retailers, which were sent for microbiological testing against internationally set recommended limits. The ACCC urged cosmetics makers to be vigilant about hygienic manufacturing practices and the effectiveness of the preservatives they use in their products.
Read more: http://www.dailytelegraph.com.au/national-news/nsw-act/consumers-warned-to-stop-using-recalled-cosmetics-immediately-by-australian-competition-and-consumer-commission/story-fnii5s3x-1226689352398#ixzz2ah2UV0dy
26th July 2013
Food Standards Australia New Zealand today invited submissions on proposed changes to some Maximum Residue Limits (MRLs) for agricultural and veterinary chemicals that may be present in food. FSANZ Chief Executive Officer Steve McCutcheon said the Proposal includes consideration of MRLs gazetted by the Australian Pesticides and Veterinary Medicines Authority (APVMA) in November 2012 for fenthion, as part of its review of the chemical; other deletions and reductions proposed by the APVMA, and MRLs requested by other parties to further align the Code with Codex or trading partner standards. “The Code ensures that residues of agricultural and veterinary chemicals are kept as low as possible and consistent with the approved use of chemical products to control pests and diseases,” Mr McCutcheon said. “Comments are welcome from government agencies, public health professionals, industry and the community.”
The closing date for submissions is 23 August 2013.
26th July 2013
Food Standards Australia New Zealand today invited submissions on an Application to use quillaja extract as a food additive in a range of beverages to emulsify oil soluble substances. FSANZ Chief Executive Officer Steve McCutcheon said FSANZ had assessed the Application from Ingredion ANZ Pty Ltd to use quillaja extract as an emulsifier. “Quillaja extract has a history of safe use in a number of countries where it is used to emulsify oil-soluble substances, which include flavours and colours, in various beverages. “Submissions are invited from government agencies, public health professionals, industry and the community,” Mr McCutcheon said. Quillaja extract is obtained by aqueous extraction of the bark, stems and branches of the Quillaja saponaria tree (soap bark tree) which is native to China and South America.
The closing date for submissions is 6 September 2013.
25th July 2013
From 12 July 2013 an import permit is not required for the importation of Xylitol, and preparations containing xylitol; nor Oil of wormwood, being an essential oil obtained from plants of the genus Artemisia, and preparations containing oil of wormwood. These substances are no longer considered high risk goods. These substances were previously captured under Schedule 8 of the Customs (Prohibited Imports) Regulations 1956.
The Customs Legislation Amendment Regulation 2013 (No. 3) is available on the ComLaw website.
Products containing these ingredients are still subject to the requirements of the Therapeutic Goods Act 1989 and normal Customs procedures.
- 6th August 2013 Eden Smokehouse smoked mussels: recall
Sapphire Coast Smoked Fish Pty Ltd has recalled batches of its mexican chilli smoked mussels product sold in NSW in Thomas Dux supermarkets, Supabarn, independent supermarkets and seafood shops.The recall is due to contamination with Listeria monocytogenes. Listeria infection can cause miscarriages in pregnant women, illness in the elderly and death in people with compromised immune systems. The affected product is Eden Smokehouse Smoked Mussels Mexican Chilli sold in 200g clear, sealed plastic packaging. All ‘best before’ dates up to and including 27 AUG 13.
For more information telephone: Sapphire Coast Smoked Fish on 02 6496 2331.
- 31st July 2013 Glico Collon biscuits: product recall
Accord United Pty Ltd is conducting a consumer level recall. The product contains allergens (milk, egg, wheat and soy) which are not listed on the label.
The recalled product is Glico Collon Strawberry Biscuits 54g in pink cardboard box, with best before date of 17/9/13; and Glico Collon Chocolate Biscuits 54g in brown cardboard box, with best before date of 30/9/13. The recall only applies to the above batches.
People with an allergy or intolerance to milk, egg, wheat or soy should not consume the product.
Consumers can return the product to the place of purchase for a full refund.
For more information telephone Accord United Pty Ltd on 02 9774 1286
- 22nd July 2013 Beng-beng chocolate bars: product recall
Carefour is recalling batches of Beng-beng chocolate bars sold in Asian grocery stores nationally.
The product contains allergens (milk and soy) which are not listed on the label.
The recalled product is Beng-beng chocolate bars in a 500g red and yellow cardboard box containing 25 bars. All ‘best before’ dates up to and including FEB 2014. The recall only applies to these batches.
People with an allergy or intolerance to milk or soy should be careful to not consume the product.
Consumers can return the product to the place of purchase for a full refund.
For more information telephone Carefour on 0430 302 388.
19th July 2013
Food Standards Australia New Zealand (FSANZ) today released a consultation paper about the qualifying criteria for dietary fibre nutrition content claims.
FSANZ Chief Executive Officer Steve McCutcheon said FSANZ agreed before the gazettal of the new Nutrition and Health Claims Standard to consult further on the criteria for dietary fibre claims.
“FSANZ committed to considering this issue further during the three-year transition period for the new Standard,” Mr McCutcheon said. “We are seeking stakeholder views and evidence relating to the qualifying criteria for nutrition content claims about dietary fibre. FSANZ welcomes comments from government agencies, public health professionals, industry and the community.”
The closing date for submissions is 29 August 2013.
18th July 2013
Chinese herbal products have been found to contain arsenic at potentially dangerous levels by Swedish authorities although no adverse events have been reported.