People throughout the world are increasingly shunning mainstream medicine in favour of more natural approaches to improving their health and wellbeing. Not coincidentally, the attacks on natural healthcare continue to mount. Media attacks – such as comparisons of the food (dietary) supplement industry with an unregulated ‘Wild West’ – are only one side of the story. They reflect a wider threat from certain quarters of the scientific, regulatory and media establishments, which must be resisted at all costs.

Bad science spreads unchallenged in the media

It appears all too easy for commentators like Greg Webb in the Charlottesville Legal Examiner to paint dietary supplements in a bad light. Since Mr Webb is an attorney, one is entitled to expect scrupulous information gathering and fact checking on his part. So let’s briefly examine some of his claims.

First off, let’s remind ourselves that food (dietary) supplements represent nothing other than concentrated sources of nutrients delivered in dose form. Webb initiates his criticism of supplements by taking on green tea (Camellia sinensis) extracts: “The amount of extract in these pills is not regulated,” he claims. “Catechin, the potent antioxidant found in green tea, can be quite dangerous when taken in larger doses, leading to toxicity of the liver.” But of course dietary supplements in the USA are, in fact, regulated by the Dietary Supplement Health and Education Act (DSHEA). Section 2(14) of DSHEA recognises that “Dietary supplements are safe within a broad range of intake, and safety problems with the supplements are relatively rare” – a state of affairs confirmed by the report presented by the author in support of his own assertion. “Given the wide spread consumption of green tea and its extract in various HDS [herbal and dietary supplements], liver injury from green tea is rare,” it admits. The report goes on to note that liver toxicity in people taking green tea extracts occurred in the context of “environmental features such as obesity, fasting or glutathionine depletion”. Finally, the report points to removal from the market by French and Spanish authorities of a green tea extract called Exolise as the most damning evidence against green tea extracts – overlooking the fact that the authorities acted on shockingly flimsy evidence. A more comprehensive analysis by the US Pharmacopoeia found that any potential safety concerns can easily be dealt with by appropriate labelling.

The hollow claim: ‘Supplements are unregulated’

Elsewhere, Mr Webb wheels out a highly one-sided article from the New York Times to push the idea that some kind of pre-market approval system is required for food supplements in the USA. Such a scheme would be similar to the Food Supplements Directive (FSD) in the European Union (EU), and it’s not hard to tell that US regulators are in close communications with EU ones. Both the New York Times article and Mr Webb’s piece claim that, because supplements are “largely unregulated,” consumers can’t know what’s in the products they are buying and are therefore at risk. Yet they both overlook the fact that US supplement manufacturers must comply with stringent Current Good Manufacturing Practice (CGMP) standards for their products. The US Food and Drug Administration (FDA) has full powers to prosecute companies who flout CGMP rules, for example by adulteration with pharmaceuticals or contamination. If there is a problem, it’s one of lack of enforcement rather than lack of legislation: as our colleagues at ANH-USA point out, “FDA approval does not, and cannot, prevent contamination or adulteration. It certainly hasn’t done so for FDA-approved drugs!”

Frankly, given the shallowness of his analysis, we’d be extremely worried if Mr Webb were our lawyer.

Europe’s regulatory sledgehammer

Considering that food supplements are among the safest substances we put into our mouths, the ever-tightening noose of regulation threatening them globally is akin to the proverbial sledgehammer cracking a nut. In Europe, a complex set of interlocking, draconian laws creates a hugely challenging situation for not only food supplements, but the entire natural health industry.

EU pattern looms in the USA, Canada and Australasia

As we’ve pointed out, this EU model is being introduced step by step around the world, including in the USA and in Canada.

The FDA appears to be doing its level best to steer the USA in a similar direction to the EU, only using different methods. Despite the fact that DSHEA is apparently working well to regulate supplements, further legislation is rightly constantly being resisted through the actions of organisations like ANH-USA and its thousands of grassroots supporters. Senator Durbin’s Dietary Supplement Labeling Act, for example, would shift things in the USA toward a premarket approval system for supplements, and ‘New Dietary Ingredient’ (NDI) legislation is being proposed which is very similar to the EU’s Novel Food Regulation. Moves are also being made to widen the scope of what is considered ‘commercial communication’, contravening the First Amendment to the US Constitution.

EU-style elements are also being introduced in Australia and New Zealand.

Codex takes the threats global

The intergovernmental Codex Alimentarius Commission sets guidelines and standards to ensure ‘fair trade practices’ and consumer protection in the global food trade. Unelected, bureaucratic and skewed toward corporate interests, Codex is substantially responsible for moves toward regulation of health claims and setting of maximum and minimum permitted levels (MPLs) for vitamins and minerals in food supplements in Europe.

ANH action and solutions to counter these threats

Your support helps the ongoing efforts by ANH-USA and ANH-Intl to counter the bad science and bad law that threatens food supplements and other aspects of natural health. Given that many countries are looking to the EU as a leader in regulation of dietary (food) supplements, here are some of the key challenges being faced in Europe:

  • The food/medicine borderline. A very broad definition of a medicine (as is the case in the EU) that has the potential to make almost any product a medicine, especially if it works therapeutically
  • The delivery of a product in a form (in terms of its chemical composition or the relative amounts of its constituents) that makes it a ‘novel food’ (in the EU, this means simply that no evidence can be furnished to show it was sold in this form in “significant amounts” before 15 May 1997), so requiring pre-market authorisation
  • Highly restrictive health claims that prevent the commercial communication of health benefits about food supplements
  • The harmonisation of maximum and minimum levels of vitamins and minerals in food supplements, the scientific basis of which is now being evaluated by the Dutch independent research organisation TNO following its commissioning by ANH-Intl.

These are all issues that are central to our European work at ANH-Intl. We work to raise awareness of the issues and we work politically, scientifically and legally to re-shape the legislative framework. Last but not least, we use our expertise to help keep businesses in the sector, from clinics to major manufacturers, afloat in the tricky water of the EU.

Natural health, including the use of food supplements, represents the healthcare system of the future. It’s certainly no time to give up on it just because of what you read in the newspapers.