list of contributors - GALA

SOUTH AFRICA
Chris Job & Lindsey Kilmartin
Adams & Adams
ckj@adamsadams.co.za
www.adamsadams.co.za
1. Conformity with
legislation
Topic: Clause 4.1 and 4.2 of Appendix A of the Advertising Standards Authority
(“ASA Code”) Code of Advertising Practice (“conformity with legislation”)
Who: ASA Directorate of South Africa
When: April 2005
Where: South Africa
What Happened: Pfizer Laboratories lodged a complaint against a Thebe Pharmaceuticals
information brochure and product packaging for a product called Ceralyte
50.
The complainant was of the view that the medicinal claims were being made
in relation to the product which constituted food. The claimant advised that
products making medicinal claims should be registered with the Medicines
Control Council (MCC) in terms of the Medicines and Related Substances
Control Act 101 of 1965 (“Act 101 of 1965”). Since this product had not been
registered in terms of the Medicines Act, it was regarded as food, and
therefore did not comply with the requirements of the Foodstuffs, Cosmetics
and Disinfectants Act 54 of 1972.
The complainant further submitted that the claim on the packaging: “a unique
rice-based product, CeraLyte was found to best meet all criteria and is the result of
over 40 years of medical research worldwide” was misleading as it could be
interpreted by the consumer to mean that the product complied with the
stringent requirements for medicines.
The respondent advised that CeraLyte contained water, rice syrup and basic
electrolytes needed to protect the body against dehydration.
Furthermore, the electrolyte concentration of the product had been amended
and fell below the registerable limit as set out in Act 101 of 1965.
Ceralyte had also been submitted for registration as a complimentary
medicine in terms of the Act, and the respondent submitted a copy of the
application for registration.
The respondent agreed to remove certain claims complained of.
The Directorate received confirmation from the MCC that the application for
registration had been submitted, as well as confirmation from the
Department of Health that the product was not a foodstuff.
The Directorate came to the conclusion that, in light of the fact that, both the
MCC and Department of Health ex facie agreed that the product was not a
food, but rather a medicine, that it was in fact a medicine, and had applied
for registration as such.