FDA gets to work banning supplements

From David E. Gumpert on the Complete Patient blog:

Drawing from Newsphiles blog. Click image for source.

“One of the distinguishing features of autocrats is that in their frenzy to eliminate enemies, they never finish their work. There are always more enemies lurking in this corner or that.

Old-fashioned dictators like Josef Stalin or Saddam Hussein used to go after people enemies, always finding new plots and traitors.

Our U.S. Food and Drug Administration goes after food and herbs and minerals and vitamins. One by one, or group by group, it seeks to eradicate those it consider threats, ostensibly because of “safety”  concerns, even when no such real-life problem exists.

When it isn’t conducting undercover investigations of Amish farmers or private food clubs, as part of its effort to stamp out raw dairy products, it is diligently making lists of nutritional supplements to ban from the marketplace.

The FDA had compiled a long initial list of herbs, minerals, and vitamins it began targeting ten years ago-I counted 155. Among them, D-Ribose, SAMe, and a variety of internal cleanses.

Its main problem? They have been introduced since October 16, 1994, when the Dietary Supplement Health and Education Act was passed. That legislation sought to protect nutritional supplements from the Big Pharma hacks at FDA by classifying the items as foods, but in a perverse interpretation of the law, the FDA is now suggesting it only recognizes as legal those supplements in existence when the legislation was passed. Anything introduced since then is “new,” and subject to extensive FDA analysis and assessment–in other words, costly and endless delays beyond the ability of small supplement makers to handle. Essentially, it is proposing banning the listed supplements, plus many others that didn’t make that ten-year-old list.

As I indicated, the list of 155 from 2001 is only an initial list. It says in its new Guidance Documents for dietary supplements posted two months ago that the list isn’t complete, and other supplements introduced since 1994 are targets. This means that nutrients many of us have been safely using over the course of three decades, including higher-potency versions of vitamins available before 1994, will be subject to the FDA’s oppressive policies that may mandate costly animal testing, which translates into forced withdrawal from the market, and higher prices IF the supplement is ever allowed to be sold again. As one example of what may well be prohibited: high-potency Vitamin D3 tablets commonly recommended by physicians to counter  widespread vitamin D deficiencies that are now known to lead to various cancers and other serious health problems. Moreover, even pre-1994 supplements are subject to review, as supplement makers will need to document their production and sale.

This isn’t a new push by the FDA. I first wrote about it six years ago, explaining how it is related to conforming with rules of the United Nation’s Codex Alimentarius rule-making.  Codex is about taking control of nutritional supplements out of the hands of small producers and consumers, and putting control into the hands of Big Pharma and Big Healthcare. Some of the health-giving supplements would continue to be available, but only under prescription from your friendly primary care physician, and available from Big Pharma at exorbitant prices….”

Read the whole thing on the Complete Patient blog.

And in a related story, by Robert Verkerk, in Vitality Magazine:

The Health Battlefields of Europe… and why they may come to Canada

Picture via Vitality Magazine. Click for source.

“Introduction by Helke Ferrie

Robert Verkerk is the executive and scientific director of the Alliance for Natural Health International (ANH-Intl) based in the UK. He is an internationally acclaimed expert in agricultural, health, and environmental sustainability with over 30 years’ experience. He successfully challenged Codex issues in international courts.

Here he provides an overview of the ongoing worldwide battle for health freedom. It is essential to understand this global push to protect Big Pharma’s interests, and whom Health Canada really serves (certainly not the public). Dr. Verkerk shows us which strategies seem to work when defending our human right to use non-toxic therapies.

In January, the Harper government started the process of re-introducing the infamous bill C-51 unchanged, ignoring public opinion, to ensure that the Food and Drugs Act will be as Big Pharma-friendly as ever. In 2008 public protest defeated C-51. Now we have to start all over again. Dr. Verkerk provides the Big Picture, and the March issue of Vitality will have my analysis of the evolving Canadian situation.

Download my book on C-51, now as true as it was three years ago: “What Part of No! Don’t They Understand?”, for free from www.kospublishing.com

In this article, I want to take you on a tour of the battlefields that now hold the balance in our ability to manage our health by natural means. I live and work in these battlefields nearly every day. They are situated mainly in Europe, the region that gave birth to the pharmaceutical industry as we know it today, less than six decades ago.

While our bodies succumb increasingly to chronic diseases that even the medical establishment now agrees are linked primarily to poor diets and lack of physical activity, there has never been a more important time to protect our fundamental rights and freedoms. Right at the heart of this is our ability to choose what we put into our mouths. But governments, especially in Europe, in a frighteningly well-orchestrated display of might, are managing to make headway in their bid to regulate the best natural products right off the market.

THE BACKGROUND

Imagine those pharmaceutical industry board rooms – a group of mostly men sitting around glass offices, working out how they can maintain, and continue to grow, their empire. The fact that many of us choose self-care with natural products doesn’t please them. It’s not just an annoying itch; it’s a serious problem because about half of us in western countries do this regularly. When the pharma company executives review the trend data, both for pharma and for natural products, many break into a sweat.

U.S. data is some of the most comprehensive. It tells us that if current five year trends are to be extrapolated, natural product sales could overtake pharmaceutical sales in seven to 30 years. That’s a big worry. It’s an even bigger worry if you’ve checked the expiry dates of the patents of some of Big Pharma’s biggest earners.

By 2013, around 70% of the annual revenue made by pharma from its ‘blockbuster’ drugs over recent years will be lost. This includes Pfizer’s Lipitor, the world’s number one selling drug (U.S. sales $7.5 billion), the patent of which, following an extension, expires in 2011.

After this, it means, metaphorically, climbing down from the glass towers and fighting hand-to-hand combat in the valleys. There will be deals with generics manufacturers and there will be full on competition from Indian, Chinese and Brazilian generics manufacturers. None of this would be quite so painful if the new drug pipeline was looking promising. But right now it’s sucking on air.

EUROPE: THE CENTRAL BATTLEGROUND

Europe has set up the necessary political, economic and legislative framework to allow Big Pharma’s gameplan to be put to the ultimate test. From the European Economic Community that kicked off the single market concept of the current European Union, we now see a system of 27 Member States and 500 million people, all subservient to an unelected central government in Brussels. It’s  headed up by faceless bureaucrats such as José Manuel Barosso, President of the European Commission, and Herman Van Rompuy, President of the European Council. They are both considerably less well-known to the public than the likes of Obama and Cameron. Van Rompuy was a past Prime Minister of Belgium and is an active member of the Bilderberg group – a group comprised of some 130 people regarded as the highest echelon of the financial and political elite. All Bilderberg meetings are closed to the public, yet decisions taken at its annual, invitation-only, meetings are seminal to all of our futures.

Loosely, the European Council (not to be confused with the Council of Ministers) invisibly develops the overall strategic and constitutional direction of the EU. The European Commission then makes sure the plans are executed. The Council of Ministers and the European Parliament, seen only slightly cynically, then do the rubber-stamping of the laws. While the European Parliament, with its some 750 current members, has more power than it did five or 10 years ago, it ultimately has very little control over the overall policy direction of the EU. We, the people, have even less, as shown by three out of four referendums that rejected the Lisbon Treaty, which was still ushered into force in December 2009. Who said democracy lives on in Europe?

WHAT ARE THEY PLAYING AT?

Having set the scene, let’s now take a closer look at how this corporate and largely undemocratic system goes about regulating natural health products. In their attempt to tie up the small players in the natural health world, and reduce our ability as consumers to obtain the most effective products, four different areas are being targeted:

1) Ingredients in products – many are being banned through the imposition of ‘positive lists’. To get on one of these allowed lists, you must generally be able to prove that an ingredient is safe and (in the case of vitamins and minerals) bioavailable. This all costs money, and in fact, the costs are generally prohibitive for any but the largest, generally pharmaceutical, companies. Even they squeal over the cost of proving safety when they are applying to get drug licenses! Botanical ingredients in food supplements are going to continue to be regulated at a Member State level (subsidiary), rather than being subjected to EU-wide, harmonized laws. But guidance on how Member States should undertake risk assessments has been formulated by the highest European authority on food safety, the European Food Safety Authority (EFSA). It is one of seven formal ‘European institutions’ and is based in Parma, Italy.

2) Dosages – European authorities (principally the European Commission and EFSA) are currently developing EU-wide laws to limit the maximum dosages of vitamins and minerals in food supplements and fortified (and functional) foods. They are apparently worried that we might poison ourselves, having read the small clutch of deliberately orchestrated, misconstrued, research papers that generated global headlines about the dangers of vitamins a few years back. European regulators are trying to agree on ‘maximum permitted levels’ (MPLs) using scientific risk analysis. But unfortunately the approach is quasi-scientific at best, and is actually nothing more than a sleight of hand approach that aims to knee-cap any product that is currently available at a beneficial or therapeutic dose. I have published two papers on this in a leading scientific journal (Toxicology, the official journal of the British and German Toxicology Societies) in 2009 and 2010 respectively. These papers reveal the massively distorted methods of risk analysis being contemplated not only by European authorities, but also by global ones, such as the World Health Organization and the Codex Alimentarius (the United Nations’ coordinated inter-governmental organization responsible for global standards, guidelines and recommendations for food).

3) Health claims – Controlling what you can and can’t say about the benefits of a particular supplement or food has a large bearing on whether someone will try it or use it. At a European level, as per the mirrored version in Codex, health claims are being managed in a way that will create probably the greatest infringement of freedom of speech yet experienced in the western world. The EU’s instrument for this law is called the Nutrition and Health Claims Regulation. It came into force in July 2007 but has yet to be fully implemented. This will only happen when EFSA agrees which claims it will, and more importantly, won’t allow. EU lawmakers are implementing their favourite Napoleonic system of law, which dictates that you are guilty unless proven innocent. Applied to health claims, it means you cannot make any kind of claim – in any medium, whether written, verbal or pictorial – unless it is specifically approved. EFSA has imposed scientific requirements that are so ridiculously high that hardly any claims can be shown by ‘generally accepted scientific data’ to establish a ‘causal relationship’ between a benefit and the consumption of that food or food constituent. Making matters worse, the studies used to support any claim application must have involved healthy people, rather than those with any disease or disorder. This means that all those wonderful studies that show natural products helping people with arthritis, diabetes, hypertension, headache, premenstrual tension, anxiety, depression, as well as hosts of other conditions, are ignored in EFSA’s evaluations. Glucosamine and probiotics are just two groups of products for which EFSA has rejected all claims so that they will have to be sold in the EU with no claims allowed.

Few Canadians realize that their own government, along with that of the USA, have approved a global guideline in Codex which is a more or less identical system. Pressure by none other than the journal Scientific American to adopt this approach in the USA has already begun. Pressure can also be brought under the Sanitary and Phytosanitary (SPS) agreement of the World Trade Organization (WTO). The WTO, a semi-private consortium of world governments, acts as the ‘policeman’ for Codex, and ensures that its wishes for ‘free and fair’ trade are maintained. Natural health products are an annoyance to the WTO – a flea on the elephant’s back – so there will be little political will to help keep the door open for effective herbs and dietary supplements.

4) Quality control requirements – these are increasingly being proposed in such a way as to impose near-pharmaceutical requirements on natural health products. This is not only very costly, but it in some cases, is nigh on impossible given the intrinsic variation in naturally-sourced products. We are seeing parallels here with what’s going on in the USA and Canada, and while the controls are being instigated under the pretence of reducing the risk of contaminants and not misleading consumers, the ulterior motive is likely to ‘lock out’ players that can’t afford the often irrational quality control requirements.

WHERE TO FROM HERE?

The European legislative model, unlike that of Canada with its Natural Health Products Regulations, or the USA with its Dietary Supplement Health & Education Act (DSHEA), is actually a complex of many different European directives and regulations, coupled with national laws. For outsiders trying to sell products in the EU, it’s often seen as a maze. For many, the maze is so confusing and unintelligible, it’s considered best to stay clear of it unless the opportunity seems overwhelming.

Another point – no one has yet experienced the full might of Europe’s regulatory plans. That’s because they are presently only partially implemented. In fact, all the worst bits have yet to be implemented at all. These include:

• Bans on traditional medicines that don’t comply with the EU directive on traditional herbal medicines. This includes most herbal products from non-European traditions such as Chinese and Ayurvedic herbal products that have been sold up until now as food supplements. Effectively, the EU plans to axe these traditions within its boundaries. D-day for these botanicals is April 1, 2011

• Bans of almost all health claims for foods and supplements, other than vitamins and minerals. This is the way things are going by virtue of EFSA’s current evaluation of health claims. These claims will be imposed, at the latest, when EFSA completes its evaluations, probably around the end of 2011

• Imposing EU-wide maximum levels of vitamins and minerals (MPLs). If nothing is done to re-shape the approach to risk management, these levels might be so low that, for example, the beta-carotene level in a supplement might be less than that typically found in a single carrot, and the selenium level less than that found in two brazil nuts. The European Commission was meant to issue its MPL proposal in 2007….”

Read the whole thing in Vitality magazine.