Some Safety Issues

From time to time, we are contacted by friends worried about safety matters. More and more people are taking a greater interest in their health and becoming more knowledgeable about their bodies and the effects of diet and medicine. Unfortunately, sometimes it is a case of a little knowledge being not quite enough.

As a science-based company, we always try to discuss our products based on proven fact. We are always happy to receive your questions and concerns. If you are worried, it is our duty to try and allay those worries.

Humifulvate® is completely sterilised as part of the production process. All other raw materials are purchased to pharmaceutical standard - British Pharmacopoeia (BP) and United States Pharmacopoeia (USP) being preferred. All production, packaging, and quality testing takes place under GMP (Good Manufacturing Practice); a quality standard system accepted world-wide, and compulsory throughout the pharmaceutical industry.

In the U.K, the registration of health supplements is not yet compulsory. In the EC, the requirements differ between the member states although there is supposed to be a commonality. For example, Humet® products are registered in Austria.

In the USA, since October 1994, the Dietary Supplements Health and Education Act (DSHEA) has required that extensive safety files be lodged with the Food and Drug Administration (FDA). The safety data on Humifulvate® was accepted by the FDA on February 19, 2001 and the product may be sold in the US as a new dietary ingredient (NDI). Subsequently, the Hungarian manufacturer Humet PLC submitted even more safety data in 2004, which was again accepted by the FDA.

We have received some comments that the titanium dioxide (TiO2) used to colour the capsule white (in infinitesimal quantities) 'causes cancer.' We are aware of general comment 5 years ago that it was thought possible that TiO2 used in sunscreen creams might be absorbed by the skin. The same paper said that the toxicity of TiO2 'remains unclear.'

Equally, some people have told us that the talc used as a lubricant inside the capsules 'causes cancer.' Again, we are aware of two scientific papers that discuss the possibility that talc used as the lubricant on condoms may be responsible for the increase in ovarian cancer. What is unclear is whether it is the talc itself (its chemical construction) or the fact that it might be an irritant.

Interestingly, both these cases are on the topical use of the products. We do not know if pharmaceutical grades of product were used in either case and we do not know of any papers on the internal consumption of these products.

We are keeping a constant watch on these concerns and as soon as we have some definite news, we will advise you.