Supplementing your supplements

This article was first published in the Business Day, 12 August 2013. Please click on the number links to view notes

The question of what really goes into supplements cannot be answered by looking at the label; this creates serious health risks for users and difficulties for professional athletes, both issues which must be addressed immediately.

Although many consumers do not realise it, over the counter supplements could be lethal. The supplements market in South Africa is worth hundreds of millions of Rands every year (1), an income which is generated through sales to both professional athletes and the average consumer. As a result of the vastly competitive market, and the fact that consumers are looking to be bigger, stronger and faster, faster, there has been much speculation that supplement companies add “a little extra” to their off-the-shelf-supplements in order to give the consumer the results they want (2) but one must ask, at what cost this is happening? Substances such as Methylhexanamine, commonly known as 1,3-dimethyl or DMAA , which has been linked to a number of deaths (3) is still being widely used in over the counter supplements without any warning to consumers. The serious health concerns relating to DMAA are not merely speculative and have been acted on in many foreign jurisdictions including Canada, New Zealand, parts of Sweden, Australia and the United Kingdom (4) all of which have banned DMAA. In the United States the FDA has issued warning letters to manufacturers of DMAA products on the basis that they have failed to submit the necessary documentation relating to the safety of the products (5).

The failure to properly and accurately label supplements introduces the additional problem that professional athletes are often not aware of the true ingredients in the supplements, which can lead to positive tests for banned substances (6). The South African Institute for Drug Free Sport (SAIDS) stated in 2011 that it believed that the increase in positive results which it had experienced during the course of 2011 was as a result of the impunity with which supplement companies acted (7). SAIDS went on to state that they were working together with the South African Sports Medicine Association (SASMA) to develop a framework around the regulation of the industry but to date nothing appears to have come of this.

Despite all of these concerns, supplements containing potentially dangerous substances, DMAA included, are still readily available in the South African market place. This is largely because supplements fall into a legislative lacuna – they are not regulated as medicines or as foodstuffs (8). This has led to a rather obscure state of affairs whereby supplement manufacturers are able to act ‘willy-nilly’ in terms of the contents of their products, the marketing of their products, and the labelling of their products.

What protection do consumers currently have?
Currently the protection offered to South Africans is wholly inadequate (9). Some solace is found in the Advertising Standards Authority (“ASA”) Code and the Consumer Protection Act, but this protection is reactionary and does not protect consumers but rather provides them with a means of recourse.

In many cases, the ASA, prompted by a concerned member of the public, has been the consumer’s ‘guardian’ when it comes to the advertising of complementary health products. However, the ASA can only rule after the fact, and complaints to the ASA will almost always be based on misleading advertising, and not product safety or quality per se.

The Consumer Protection Act on the other hand, protects the consumer’s right to safe, good quality products, but again, this will only be after any potential damage has already been suffered. A significant positive to take from the CPA is that is holds manufacturers liable for harm on a no-fault basis (10). This should, in theory anyway, have the effect of encouraging manufacturers to uphold the highest safety standards in the manufacturing process to avoid any possible harm.

But the fact remains that the CPA and the ASA are reactionary and are therefore not a suitable substitute for a properly functioning regulatory body that scrutinises all aspects (including labelling) of a product before it reaches the shelves.

The Proposed Regulations O
n 22 July 2011 the Minister of Health, Dr. Aaron Motsoaledi, published draft amendments (11) to the General Regulations in terms of the Medicines and Related Substances Act , with the aim of bringing complementary medicines, possibly including sport supplements, into the ambit of the Act (12). Shortly thereafter the Medicines Control Council published draft guidelines “to provide recommendations to applicants wishing to submit applications for the registration of Complementary Medicines.” To date, these proposed Regulations are not yet in force.

The Regulations proposed by Minister Motsoaledi aimed to regulate “complementary medicine”, which was defined by the draft Regulations as “a medicine that is used – (a) or is intended to be used for, or manufactured or sold for use in assisting the innate healing power of a human being or animal; and (b) in accordance with the practice of professions regulated under the Allied Health Professions Act, 1982 (Act No. 63 of 1982).”

Although this definition is somewhat problematic it is clear, at least from the aforementioned guidelines that it was intended to include nutritional supplements, and accordingly we proceed on that basis.

In terms of the proposed Regulations, manufacturers of complementary medicines would be required to submit their products to the Medical Control Council (“MCC”) for registration. Contained in this is that the manufacturer would be required to supply proof commensurate with the level of the claim that they intend making for their product. In addition, they will also be required to provide evidence of product safety and the quality measures implemented at their manufacturing facility, while product labels will also be scrutinised for compliance with the Regulations. These measures should significantly decrease the risk of product contamination and cross-contamination, events often associated with a lack of good manufacturing principles.

One of the major problems, and one which is easily resolved, is that it appears that nothing has come of them in almost two years.

A further problem, it is submitted, is that the MCC is simply not capable of dealing with the additional work which will stem from these Regulations. As it stands, and without this additional burden, the MCC is severely understaffed which has resulted in serious inefficiencies in registrations. Furthermore, its law enforcement division is coming under increasing scrutiny for its failure to deal with unscrupulous practices. (13) It remains to be seen whether the Department of Health and the MCC will effectively deal with these challenges once the Regulations are signed into law.

An obvious and serious shortfall of the Regulations is that they still do not protect the interests of professional athletes, as products which may pass muster with the MCC, may still contain substances which are prohibited by the World Anti-Doping Agency (WADA).

Although the problems with the Regulations are numerous many of them can be overcome through a thought through and proper implementation of the Regulations. The Regulations would establish at least some pre-emptive protection for consumers and professional athletes alike.

Where does the solution lie?
One cannot deny that consumers of nutritional supplements, both professionals and average consumers, do bear some responsibility with regards to what supplements they use. However, the level of understanding of these substances (many of which go by dozens of different names, in part due to a lack in regulation) is limited. Add thereto inaccurate labelling and an already difficult task becomes simply impossible.

Although there are a number of shortfalls in the draft Regulations, and the Regulations do not depict the ideal solution, from a pragmatic point of view there is unlikely to be another solution in the foreseeable future. Accordingly it is imperative that the Department of Health finalise the proposed Regulations as a matter of urgency and take the necessary steps to implement them. This will require a significant financial commitment by the treasury to up-staff the MCC and a commitment by the MCC’s enforcement division to act swiftly and harshly against non-compliers.

Furthermore, in order to protect professional athletes, the Regulations should be amended, as soon as possible, to include the compulsory labelling of products which contain ingredients prohibited by WADA. This will allow professional athletes to easily identify which products are suitable for them to use, and which should be avoided. A system of this nature, together with proper implementation of the Regulations will ultimately avoid a lot of future embarrassment for South Africa in so far as its professional athletes are concerned.

The implementation of these Regulations is not simply a matter of good governance, but could be a matter of life and death. Furthermore, it is imperative that these actions be taken to protect professional athletes from the serious consequences of doping if South Africa is to compete on a world stage.

The ball now rests with the Department of Health who must take appropriate measures to protect consumers, failing which it will be a matter of time before the Department has to explain its lacklustre approach to the distraught family of a deceased.

Date published: 2013/08/14
Author: Dirk Hanekom and Bryce Matthewson

Tags: product regulatory advice news consumer protection