What are Complementary & Alternative Medicines? Complementary and Alternative Medicines (CAMS) are various traditional supplements and treatments that are not considered to be mainstream registered or conventional (allopathic) medicines. Conventional medicines are regulated by the Medicines Control Council (MCC) through Act 101 of 1965. Medicines are regulated under four categories A, B, C and category D. The most crucial requirement of regulating medicines, which now applies to CAMS products (category D) is showing efficacy and safety. Essentially manufacturers must show that the product is safe for consumption and can fulfil its function as claimed, at its intended dosage.
In terms of the guidelines for CAMS, a complementary medicine means “any substance or mixture of substances which a) originates from plants, minerals or animals; b) is used or intended to be used for, or manufactured or sold for use in assisting the innate healing power of a human being or animal to mitigate, modify, alleviate, or prevent illnesses, or the symptoms thereof or abnormal physical or mental state, and c) in accordance with the practice of the professions regulated under the Allied Health Professions Act, 1982 (Act No 63 of 1982).”
What does this mean for manufacturers of food products? The food labelling regulations R. 146 of 2010 (clause 13(g)) prohibit the sale of any foodstuff which bears a medicinal claim, including prophylactic and therapeutic claims. Simply put, a foodstuff bearing any health claim relating to the prevention or treatment of a disease will be regulated as a CAMS product. These include claims relating to diabetes, cancer, blood pressure, osteoporosis, heart disease etc.
What are the requirements for CAMS products? Since 2013, CAMS are now regulated under categories A and D of the Medicines Act (R. 870 of 2013). Category D includes homeopathy, naturopathy, Ayurveda, osteopathy, phytotherapy and aromatherapy. Category A, one of the categories for conventional medicines now includes CAMS medications such as high potency Vitamins.
Labelling for these newly regulated CAMS must comply with the requirements for medicines by February 2014. Registration of various groups of medicines now falling under category D would be called up in batches:
Is your product affected?
March 2014: 20.2.8 Antiviral agents; 21.2 Oral hypoglycaemics (Diabetes); 6 Cardiac medicines; and 26 Cytostatic agents.
November 2015: 32.3 Slimming preparations (weight reduction products); and 7.1, 21.7, 21.8, 21.9 Sexual stimulation products.
May 2016: 32.16 (Other) Immune boosters; 17 Medicines acting on muscular system (body building products); and 22 (Vitamins) Sport supplements containing vitamins and minerals exceeding the upper limit allowed
November 2019: All remaining pharmacological classifications, including products in Category D and other categories.
What is the responsibility of manufacturers of CAMS? All manufacturers and wholesalers of CAMS must now be licenced by the MCC. This registration process is intended to be simplified compared to that of conventional medicines, but must show evidence of safety of the product, as well as appropriate manufacturing standards (Good manufacturing practices) and efficacy. If an applicant cannot provide suitable information to the Council, they must remove the product from the market, until registration with the MCC. Alternatively the product may remain on sale, but no medicinal claim may be made in any published information including advertising, labels and product inserts. By November 2019 the legislation will have come into effect for all complementary medicines affected by R. 870 of 2013.
In addition, the product label, package insert and patient information leaflet of all Category D medications must comply with CAMS labelling requirements. The requirements for CAMS products include that the label must indicate the category and pharmacological classification of the medicine and the discipline (for example homeopathy). In addition if it has not been registered by the MCC it must bear the statement “This medicine has not been evaluated by the Medicines Control Council. This medicine is not intended to diagnose, treat, cure or prevent any disease”.
Then what claims are allowed on “foodstuffs”? Currently only nutrient content claims are permitted on food products. Nutrient content claims are claims regarding the levels of a particular nutrient or energy present in a foodstuff. These include claims relating to fat, carbohydrates, protein, vitamins, minerals etc. These are prescriptive claims and there are strict conditions regarding their use, provided in the regulations.
Phase two of the food labelling regulations which are currently in draft will address nutrient-function claims and disease risk claims, these will be generic statement and include claims such as “Diets low in saturate fat and cholesterol that contain 2 g of plant sterol esters and plant stanol esters daily, may reduce the risk of heart disease by lowering cholesterol” and “vitamin C contributes to normal collagen formation for the normal function of skin”. However, phase two of the regulations has not yet been passed and until such time as they are, such statements will be prohibited on the labelling of foodstuffs.
In summary? Currently any health related claim that is not a nutrient content claim on a food product is prohibited, unless the product complies to the CAMS regulations and is registered with the Medicines control council. CAMS products require that manufacturers produce their product under Good Manufacturing Practice conditions and show safety and efficacy. Additional labelling requirements for CAMS products under Regulation 8 of the Medicines and Related Substances Act, 1965 are also required to be met.
Article by: Gillian de Villiers