If you are looking at the vitamin shelves at your favourite health shop or retail pharmacy and are a little confused by what you see, don’t worry. You are not the only one. The supplement industry has been hard hit by the implementation of new regulations. It’s not that the industry is against the regulation of supplements – far from it – but it needs to be done in a practical and achievable manner. Of course, there is no denying that there are some dodgy products on the market (particularly in the slimming, body-building and sexual enhancement sector), but what about the products that are deemed safe, have efficacy and do what they say they do?
The new regulations for natural medicines, otherwise known as complementary and alternative medicines (CAMS), may mean up to 60% to 85% of products will be removed from the shelves – and some already have been. The supplement industry is believed to be worth around R7 billion. As of last year, there were around 30 000 different products on the market. However, the new regulations have created a new category of medicines: Category D complementary medicines. And if your product doesn’t fit into this definition, it means it has automatically shifted to Category A (general medicines), and so is now classified as pharmaceutical drugs. Experts estimate that close to 65% of products may fall under this “general drug” category.
According to the Department of Health’s Medicines Control Council Roadmap for Registration of Complementary Medicines (published at the end of 2013), there were increasing numbers of medicines frequently called CAMs, being sold in South Africa, for which claims of safety, quality and efficacy were being made without the products being registered by the council. In July 2011, the Minister of Health published an amendment to the Regulations to the Medicines and Related Substances Act 1965 (Act 101 of 1965) that calls for the regulatory control of all complementary or alternative medicines. According to the report, the MCC is concerned that a number of medicinal products, such as complementary or alternative medicines (despite their long tradition both locally and abroad), “do not fulfil the requirements of a well-established medicinal use with recognised efficacy and an acceptable level of safety, and are not eligible for registration”. Dr Amanda Claaseen-Smithers, registered dietician and exercise scientist, supports the proposed regulations, as, she says, currently you don’t know if what you are taking is effective or safe, despite what the label says. “Chances are that it is not. Bottom line: very few of the thousands of products on the market have actually been tested for both efficacy and safety. If efficacy and safety had to be established (as is the case with scheduled medicines), very few products would make it to the shelves, she feels. Claaseen-Smithers is concerned about buzzwords such as “clinically tested” or “scientifically proven”. Until the products are tested and regulated, any claims of efficacy or safety of a specific supplement or special mix of ingredients, dosages, etc, can be made. “The burden of proof lies in the hands of the authorities and public to prove that what the label says is misleading or wrong.”
She adds that harmful products often only get pulled once a “noticeable number” of people report serious side-effects, or, in the case of athletes, when they test positive for an illegal substance. She also warns that taking large doses of single nutrients or several supplements together is not advisable. Regulating the supplement industry, while a costly experience, will limit the fly-by-night operators and allow those who are above reproach to market their products. Normal Fels, chairman of the Health Products Association of South Africa (HPA), says his association has been requesting CAMS regulations for the past 25 years. However, the new regulations are not clear. He adds that, currently, this means that vitamins above certain levels will have to be registered as allopathic drugs. “We are not sure how low-level doses are to be treated, as we await guidelines to the amended regulations published in September. This draft provides for ‘health supplements’, which are not defined.” Fels explains that the schedules relate to the level of risk, and are intended to control access to products. “At present, there is concern that products such as milk thistle and melatonin are scheduled, have to be removed from the shelves, and may, in future, need a prescription. Yet these are freely available on the Internet and in most other countries.” And, Fels adds: “Consumers may be deprived of their freedom of choice of health modality/products. Many CAMs companies will not survive, as they will be unable to conform to requirements. Practitioners may not have access to the products they need. The damage to our economy could be about R20 billion, and jobs will be lost.” He adds that if the regulations are too onerous and compliance is too expensive, a whole new generation of “cowboys” may be spawned.