Following the EU directive which restricted and eliminated certain supplements in the European Community, many determined users were intending to tap into the US market to obtain supplements such as St John’s Wort and Milk Thistle when they could no longer buy them in Europe.
The supplements to be removed would be viewed as ‘new dietary ingredients’ and would have to pass through rigorous safety tests- Kathryn Borg
However, there is a move to restrict the availability of nutritional supplements and herbs in the US. The US drugs regulator, the Food and Drug Administration (FDA), which, incidentally, is funded by the drug companies, has put forward a new mandate which will effectively remove from the market all nutritional supplements that have been introduced or modified since 1994.
Admittedly, this may not affect St John’s Wort and Milk Thistle; in fact, it may not affect some of the old favourites and supplements that users have relied upon for years. However, if any supplements have been slightly modified they will be under scrutiny.
The supplements to be removed would be viewed as ‘new dietary ingredients’ (NDI) and would have to pass through rigorous safety tests. As in Europe, the costs of these tests would be beyond the reach of many medium and small manufacturers.
Previously, nutritional supplements have been protected under the Dietary Supplement Health and Education Act of 1994 (DSHEA). This has allowed supplements and vitamins to be freely sold as long as the manufacturer does not make any unproven claims for their efficacy. The NDI mandate mirrors the EU directives which prevent any ‘novel’ supplement from being sold without first passing rigorous and expensive safety trials.
As a result of this move to restrict freedom of choice, the Alliance for Natural Health-USA is coordinating protests against the mandate, which it will pass on to members of Congress (www.anh-usa.org/). Here is a quote from the website:
“On July 1, the US Food and Drug Administration issued draft guidance for complying with the (NDI) notification protocols required by the (DSHEA) – 17 years late. The biggest problem is that this guidance will turn a notification system into an approval system – a terrible precedent that will utterly cut off the supply of nutritional supplements. It will also create such huge barriers for supplement manufacturers that it will be much more difficult and expensive to produce them. But of course, that means consumers would either have to pay much more for nutritional supplements, or else risk not being able to buy them at all if the manufacturer deems them too expensive to produce.”
We can only hope that the campaign is more successful than the groups who tried to block the directive being passed in the EU, otherwise the drugs companies have won again, and once more the public’s freedom of choice will be blocked.
Interestingly, and linked to this news, is new research which has confirmed that vitamin C helps children with asthma. This is not a new fact; it has been known since the 1940s. However, it has just been successfully tested.
By giving only 0.2g of vitamin C every day to an asthmatic child, the lung capacity is increased by 37 per cent. Researchers from Tanta University in Egypt have found that the effect was greater in younger children, between the ages of seven and eight.
In addition, results showed that lung capacity improved by 21 per cent in children aged up to 10. The vitamin also works better on children with mild asthma. Those with severe symptoms saw a smaller effect (Clinical and Translational Allergy, 2011).
Further new research carried out on Omega-3 fish oils have discovered that this supplement is an effective way to combat inflammation, which is now being associated with more and more diseases, including heart problems and cancer.
Supplementing with the oil reduces inflammation and even anxiety. This was discovered when researchers tested a group of otherwise healthy young people. It was thought that the elderly and those who have already been diagnosed with a chronic condition, unlike the control group, would benefit even more.
Researchers from Ohio University recruited 68 young medical students for this trial. Each of them was given either standard omega-3 capsules or a placebo. The standard omega-3 capsules, incidentally, deliver around four times the amount of oil compared to that which would be absorbed from a normal serving of an oily fish such as tuna, salmon, sardines or mackerel.
According to profiling tests, those given omega-3 showed a 20 per cent reduction in stress levels compared with the placebo group and subsequent blood tests showed that inflammation levels had fallen by 14 per cent (Brain Behav. Immun., 2011). These two examples of recent research show that even now we are learning how beneficial supplements can be, so it is a shame that some supplements, where rigorous tests have not been carried out, will be taken from the market, as previously mentioned.
Although, as yet, we are not aware of which supplements this mandate could affect, we could be removing the opportunity to help various conditions in a more natural way than taking drugs, which we all know will almost certainly have some side-effects.
kathryn@maltanet.net