Healthy foods and supplements manufacturers in Canada are concerned that proposed amendments to the Food and Drugs Act will bring an end to what has been a gradual shift to health products being uniquely classified, and usher in a reversion to what they consider inappropriate and costly food regulations.
The Canadian Health Foods Association regulatory affairs assistant, Penny Wilks, said a private bill challenging the amendments was being prepared that would seek to have natural health products legislated as an entirely separate category, following a government committee recommendation from 1998. This would continue the trend to have natural health products regulated with their own health claims, labelling, good manufacturing practice and adverse-event reporting provisions.
If this could not be achieved, Wilks said, it was best for natural health products to remain under their existing drug subcategory. The bill was due to be debated by a parliamentary committee as FF&N went to press.
Meanwhile, Australia?s Therapeutic Goods Administration (TGA) has declared a tightening of herbal product controls in the wake of the Pan Pharmaceuticals debacle of 2003 when more than 1,600 of the now-defunct company?s products were recalled after the discovery of manufacturing anomalies.
The TGA will demand a ?much more rigorous assessment? of all herbal and homeopathic ingredients used in complementary medicines following the recommendations of a committee that assessed the regulatory, health system and industry structures for complementary medicines in Australia.
In particular, any ingredients suspected of causing foetal abnormalities will be banned from use other than in complementary products subject to the same scrutiny as that given to prescription drugs.
The government has also committed to establish a database to identify researchers and centres of excellence on complementary medicines, and take more action to ensure consumers get reliable product information.
See www.tga.gov.au/cm/cmresponse.pdf for more information.