Our rights to natural health are under threat in this country. This since the Department of Health, during November 2013, passed new regulations to control complementary medicines in the same way as pharmaceutical drugs.
In response the Natural Health Alliance was formed last month, chaired by Dr Bernard Brom (photograph on the right)), an Integrative Doctor, who has used natural medicine safely and efficaciously for more than 30 years.
According to these new regulations your probiotics will need the same rigorous research as something like Prozac. This is clearly inappropriate and irrational. Complementary medicines are not drugs. They are not used in the same way as drugs are, and they do not carry the same risks.
The regulations are being challenged in court by the Health Products Association.
No broad consultations – big surprise
The new regulations for natural medicines, or complementary and alternative medicines (CAMS) could effectively remove 60 to 85% of CAMS from the shelves, depending on whose estimate you go on. There was no broad consultation and the regulations came as a surprise to the industry and the public. Only now are people waking up to their broad implications.
The regulations define a new category of medicines, Category D Complementary Medicines. Category D medicines include herbal medicine, Chinese medicine, other traditional medicines and homeopathy. It remains to be seen how this category is affected – the expense of registration may mean companies simply cannot afford to register.
Anything that doesn’t fit into that definition moves to Category A, general medicines, which are pharmaceutical drugs.
- high dose Vitamin C (which has excellent research behind it)
- doses higher than 500iU of Vitamin D3 (the Vitamin D Council in the United States recommends a dose of 5000iU)
- any combination products
- bio-identical hormones
- any product containing an extract like Silymarin (Milk Thistle)
- high dose vitamins
65% of natural products now become ‘drugs’
Around 65% of products now on the market will fall into the “general drugs” category.
The reasons given for the regulations are that it is in the “interests of public safety.” No one is suggesting that we allow unsafe medicines on the market. But consider: Complementary medicines are not drugs. Drugs are toxic, have patent laws which apply to them and require research required to make sure they are safe.
Natural medicines cannot be patented and are generally safe, with hundreds of years of safety record behind them. There is also extensive research on many of the products on the market.
Few are against regulation. There are some dodgy products on the market – especially in the slimming, body building and sexual enhancement sector. There may even be some CAMS which could need to be used on prescription only. Some may need to carry warnings.
No one is against good manufacturing practices: as a consumer I want to know that what the label says is what I get, that it is not adulterated with anything else, and that it has been manufactured in hygienic conditions.
Spending millions to comply with toxicological studies
It’s the Category A medicines which will be hit hard. Because the new regulations are so stringent, companies will need to spend millions of rand to comply with toxicological and clinical studies required, with no way to recoup costs, as there is no proprietary protection for them.
Already some substances are on the banned list, and as such cannot be sold. Others fall under the May 2014 call-up for registration.
What about our free choice around the management of our health?
Dr Bernard Brom is concerned that innovative natural products used by Integrative Medical doctors around the world will require regulation under the new system, which would make it almost impossible for them to be registered.
“I think we need a significant change in the way natural medicines are regulated that comes with the understanding that the practitioner and public should be able to have free choice around the management of ill health, just as we have in choosing to smoke, drink alcohol and buy junk foods.”
The situation is very serious, and requires prompt action if your natural medicines are to remain on the shelves.
By Jeanne Viall
Join the alliance
Help stop the natural health crackdown
The new regulations put out by the MCC will mean that 85% of all natural medicines will disappear from the market place, thousands of people will be out of work and the economy will lose millions. We will have the most stringent and highly regulated natural health industry in the world.
This move by the Medicines Control Council of South Africa (MCC) will mean that 85% of all natural medicines will disappear from the market place, thousands of people will be out of work and the economy will lose millions.
Sign the petition now and stop the crackdown on natural health products.