Grace Speed got top grades at school. After graduating from Oxford University with an honours degree in Biomedical Sciences, she did an MBA (Master of Business Administration) at the HEC in Paris. Qualified and bilingual, she was ready to become a significant contributor to the EU’s economy.
For a few years, Grace’s career progressed promisingly with an international investment bank. But something in her life was missing. Perhaps it was that somewhere along the line her higher needs were being neglected? Or maybe it was the stress of life in the fast lane. Perhaps it was both.
Whatever the causes, Grace’s health started going downhill. She went up 3 dress sizes, she was exhausted every evening after work and her GP then diagnosed pre-diabetes. It was time for reflection.
Grace remembered how much fun she’d had as a student, playing a wide range of sports competitively at university. Back then she knew how important it was to look after her body. In fact, she’d always go natural if she suffered aches and pains after strenuous rounds of tournament volleyball. She had no desire to take the anti-inflammatories her teammates would pop like candies after intense matches. Some supplementary vitamins and minerals, amino acids, a bunch of herbs and some Omega-3 oils had become her standard go-to combo.
Grace realised it was time to make profound changes in her life. It was time to do something different. Getting her health back now she’d hit the big 4-0 was another priority. Well, she achieved both in 6 months – and she also resigned from the bank. Grace changed her diet, became a lot more physically active, changed her mindset, became a regular consumer of food supplements. She, the whole Grace, not just her body, literally changed. Her pre-diabetes disappeared without trace, she lost almost 20kg of weight and resumed—now in her mid-forties—the fitness she’d had over two decades earlier.
It was time to put her business skills into action and to benefit not just herself but others who wanted what she had found, from a health perspective. Grace secured a loan of over €100,000 to set up. She established a new company, recruited a clinical nutritionist to help her develop a focused range of products to support better blood glucose control as well as natural anti-inflammatory botanicals. She found a contract manufacturer which also helped her develop appropriate advertising and marketing collateral.
Only then did she discover the roadblocks in her way. The biggest obstacles were courtesy of a trio of EU laws that were intended, ironically, to facilitate the functioning of the single market and promote the fair use of health claims. So much for that. To her, these EU laws did quite the opposite.
Let’s look more closely at each of her three biggest barriers:
Barrier 1: health claims
Grace wanted the branding of her product range to carry her name. The company carried her name and her idea was to carry this over to the brand name. She wanted to use the target body system as the brand identifier alongside the company name. So her multi- nutrient and herb blend aimed at supporting healthy joints was to be called Grace Speed Joints. Her blood sugar product was to be called Grace Speed Glucontrol.
Sorry, Grace; no can have. She applied to have the product notified as a food supplement for sale in 3 out of the 6 EU markets she wanted to sell the products in, initially via online retailers. It was this notification that raised the first flags. Interestingly, she didn’t need to notify in the UK, Holland or Sweden. But she did in Ireland, France and Germany – so much for a level playing field! The authorities challenged the use of the brand names saying they were, among over 2000 others, non-authorised health claims under the terms of the EU Nutrition and Health Claims Regulation. Grace couldn’t even benefit from any of the transitional measures that allow company’s, among other things, to use non-compliant health claims in brand names or trade marks on the condition that they were in use before January 2005 (Article 28(2)).
Grace argued that Grace Speed Joints was hardly a ‘health claim’ – it was just her name followed by a body part that gave the consumer some idea of the intended target for the product. It said nothing specifically about function or health benefit. The regulators simply wouldn’t have it. They cited an old piece of case law, Van Bennekom 1983 from the Netherlands that referenced the “averagely well informed consumer”. They said her reasoning was irrelevant. It mattered only what impression a consumer might get of the product’s presentation, labelling and claims. Here they argued that a consumer might gain the impression that taking Grace Speed Joints might help a person’s joints to function gracefully and speedily even though these adjectives originate from Grace’s name.
Oh, to really put a lid on things, the authority also said that any health claim was also illegal because the product contained glucosamine and chondroitin. Both of these failed to get authorised health claims when all the studies, despite showing beneficial effects, were discarded by the European Food Safety Authority panel that evaluated it because the studies involved unhealthy populations. Yes, they often involved, strange (note sarcasm) as it might sound, subjects with some degree of knee or hip osteoarthritis. In 2012 an attempt to get claims under the emerging science (Article 13(5)) provision of the Regulation also failed.
The regulators liked Glucocontrol even less. While it was technically a fancy name and therefore one that didn’t exist in the English dictionary, it was also viewed as a non-authorised health claim because amla fruit rind, copper and chromium, all present in the multi-nutrient blend, were viewed as key actives. The icing on the cake came from the fact that the regulators also thought the name might be confused with the drug, Glucotrol (glipizide), a sulfonyl urea drug used to treat type 2 diabetics. Grace was reminded that the drug companies always have supremacy over foods or food supplements, despite the fact that licensed drugs are – certainly in human evolutionary terms – the newcomers on the block.
Barrier 2: Unlicensed medicines
The second roadblock had nothing to do with Grace’s chosen names for her products. It was about the function. The regulators in more than one country told her that her product was had would be classified as a drug because it was pharmacologically effective. They cited the second, ‘functional’ limb of the EU definition of a medicine (Directive 2001/83/EC, as amended), which states in Article 1.2(b):
“Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.”
Grace recognised this definition was scoped so broadly it would make anything you consumed a drug. It was like the regulator had been handed a loaded gun which could be fired arbitrarily, especially whenever a food, supplement or cosmetic might interfere with the sales of a drug. The cosy relationship between regulators and the pharmaceutical industry was of course well known.
Grace had hoped that the, albeit legally weak, exemption for foods, food supplements and cosmetics given in the preamble (Recital 7) of the Human Medicines Directive might help her. It states that products that “clearly” represent one of these categories should be exempt from medicines law. But Grace couldn’t persuade the authorities that her products were exempted. The regulators said that because there was doubt, they would invoke the second limb of Article 2 of the Human Medicines Directive that states that in cases of doubt, “They were not going to be considered unlicensed drugs,” and for all her good intentions, Grace was going to be made to feel she was an illegal drug dealer.
Because of the herbal content of her products, one of the bureaucrats who had classified both of Grace’s products as unlicensed drugs told her that all was not lost, and that she wouldn’t have to raise the millions required to get a drug license. There was now, she was told, the simplified drug licensing system specifically intended for herbal medicines. It’s called the Traditional Herbal Medicinal Products Directive, the THMPD. What a relief, Grace thought. This might be just the ticket and the entry costs would apparently be a fraction of a normal drugs license, probably around €100,000 to €200,000 all told.
Wondering just how she might raise the additional capital to cover the registrations, Grace sought the advice of a specialist on herbal registration in the EU. It turned out she faced another roadblock. Since she had included biologically meaningful amounts of various vitamins (e.g. D, K) and minerals (e.g. chromium, copper) in her herbal blend, the products were not eligible to the THMPD. She was locked-out.
Barrier 3: Novel food
The final straw came when Grace was informed that one of her products conflicted with the EU’s Novel Food Regulation. This law, originally intended to protect people from genetically modified organisms, since given its own EU regulatory regime, now acts as roadblock for many interesting botanicals of non-EU origin. It’s got nothing to do with safety. Quite simply, if you cannot prove that a given food or ingredient has had significant sale in the EU prior to May 1997 when the Regulation passed, it would deemed a novel food. In such cases, the food or ingredient would then be illegal unless authorised as a novel food, a process requiring heavy investment. The Novel Food Regulation also stifles innovation. That’s actually how Grace got caught. She fell victim to the last provision of Article 1 (namely paragraph (g)) of the Regulation. It states:
“(f) foods and food ingredients to which has been applied a production process not currently used, where that process gives rise to significant changes in the composition or structure of the foods or food ingredients which affect their nutritional value, metabolism or level of undesirable substances.”
It turns out that the supercritical, CO2 extraction method that was used for her amla (Indian gooseberry) ingredient was sufficient for the regulators to say, sorry. The natural chemical signature would be slightly different from a common water-based extract that had long been sold on the EU market. But now, there would be a requirement for Grace to prove safety if she wanted the supercritical extract. That was something she just couldn’t afford.
The moral of this story…
Grace Speed’s story may be fiction. But each of the obstacles she encountered are ones that happen repeatedly to dozens of new or existing businesses across the EU. We are intimately familiar with all of them, along with many more.
Individually, some of the EU laws are, at least, ridiculously over-prescriptive. Together they laws are an ass. They represent a massively disproportionate obstacle to public access to and information about natural health products.
Action: help us to help you – and future generations
Please donate to help our lobbying efforts in the European Parliament when it resumes next month so that we might raise awareness of the need to drastically reform EU laws to allow both freedom of choice and freedom of expression in the field of natural healthcare.
For the sake of future generations, let’s work together to achieve this end.