IINH is actively involved in the campaign to save our therapeutic vitamin/mineral supplements, herbal remedies, essential fats, amino acids etc from extinction due to a series of EU Directives.

As concerned stakeholders in this issue, we must alert everyone to the imminent reality that within a few short years, our access to therapeutic nutrient formulations and a rich tradition of safe and effective herbal remedies - often the fruits of centuries of accumulated wisdom and experience - will be banned by Europe, with the enthusiastic support of our own Food Safety Authority of Ireland (FSAI).

UNIQUE ONE-DAY INFORMATION SEMINAR Saturday January 23, 2010

The full bite of EU legislation will be felt throughout the European natural health sector during 2010 and 2011. Key elements of the legislation remain to be agreed and your understanding of the issues will help you to make your voice heard so that together we can make a difference. Draconian restrictions to freedom of health choice and freedom of speech could negatively impact your business.

Dr Robert Verkerk and Meleni Aldridge of the Alliance for Natural health, hosted by the Irish Institute of Nutrition & Health will present a one-day, not-to-be-missed, CPD seminar covering the key regulations set to affect your business, your freedom of speech and your health. Whether you are a practitioner, a retailer, distributor or simply have a keen interest in natural health, this seminar is for you. The module aims to give participants the necessary skills to understand the key existing European laws affecting the sale, marketing and use of natural health products, while providing unique insights into what’s likely to come down the Brussels pipeline in the near future. This knowledge will help you to stay on the right side of the legislation, whilst also helping you to be part of the growing body of informed individuals, organisations and businesses working together to positively shape the regulatory environment affecting the natural health sector.

If you are a practitioner, manufacturer, distributor or consumer this legislation WILL DEFINITELY affect you, your business and your freedom of choice.

Nutritional Therapists of Ireland www.ntoi.ie will award 7 CPD hours to this event.

For further information download pdf, email or phone 01 272 3003.

www.anhcampaign.org

FDA One Step Away From Declaring Dietary Supplements Drugs

President Barack Obama has appointed two experts, one in food the other in drugs, to head up the soon to be reorganized Food & Drug Administration in preparation for an agency split that would separate the FDA into two - one agency to oversee foods and the other to regulate drugs. But just exactly where does that leave dietary supplements?
The Dietary Supplement Health & Education Act of 1994 (DSHEA) declares dietary supplements to be products intended to supplement the diet. But the FDA contends DSHEA severely limits the FDA in regulating a growing industry. A recently issued report from the General Accounting Office claims the FDA does not have the resources to adequately regulate dietary supplements. The GAO report appears to be part of an orchestrated effort to soften the public up for a major change in the classification and regulation of dietary supplements.
Unlike drugs which must be approved for safety and efficacy before entering the market, dietary supplements marketed before 1994 are presumed to be safe. FDA must demonstrate that a product presents a significant or unreasonable risk to the public to get it off the market. But that may change.

An ominous sign of things to come - the FDA just classified a form of vitamin B6 (pyridoxine) as a new drug (Pyridorin, Biostratum).
Despite recent outbreaks of foodborne disease (Salmonella in peanuts) and approval of deadly or problematic drugs (recently Vioxx, Seroquel, many others) compared against few if any reported deaths in the newly implemented Adverse Event Reporting for dietary supplements, the Federal government is aiming its regulatory muscle at vitamin, mineral and herbal pills.

Despite the fact that dietary supplements are far safer than table salt, aspirin, vaccines and many FDA-approved drugs, they are being demonized. Year after year, surveys conducted by poison control centers show dietary supplements to be the safest products of all.
In a misdirection, it appears food supplements are being mischaracterized as potentially dangerous and in need of greater regulatory oversight. This leads to the possibility of FDA placing supplements under the same regulatory body that oversees drugs.
The FDA appears to be covering for the sins of the drug companies, which is pushing for faster approval of new drugs, which led to the Vioxx fiasco (it is estimated 20,000 Americans died prematurely from taking this anti-inflammatory drug that should have never been approved by the FDA). Vioxx, if you recall, was touted as being safer than other anti-inflammatory drugs such as ibuprofen and aspirin.

Just recently it was revealed that salespeople for a U.S. drug company told doctors that an anti-psychotic drug (Seroquel- $4.45 billion in sales 2008) didn't cause diabetes more than two years after the drug maker warned physicians in Japan of possible links to the disease. Twelve serious cases (including 1 death) of hyperglycaemia, diabetic ketoacidosis and diabetic coma here causally linked with the drug. What penalties a drug company will receive from the FDA for this type of apparent misdeed is unknown.
Massive efforts have been taken to convince the public to be wary of dietary supplements. Just when DSHEA was being deliberated for passage in Congress in October of 1994, suddenly a report was published in New England Journal of Medicine claiming beta carotene pills increased the risk of death among smokers in Finland. But examination of the published paper showed beta carotene hardly increased mortality rates at all (by less than 1%).

For years the FDA drug its feet in publishing Good Manufacturing Practices (GMP) for the dietary supplement industry, while pointing fingers at and sanctioning supplement makers who made marginal quality products, often mislabeled for dosage or for making false advertising claims. Only recently has the FDA completed GMP guidelines for food supplements.
In 2006 the FDA drew fire when it declared tart cherry supplements to be "new drugs" because manufacturers claimed their products had potent anti-inflammatory properties. Another agency of the government, the US Department of Agriculture, published a study showing tart cherry extract is as effective as ibuprofen in reducing inflammation. Ibuprofen can cause gastric problems that can lead to bleeding ulcers and even death. Tart cherry extract has no reported side effects. In this manner the FDA restricts free speech and the public is deprived of learning ways to stay healthy naturally and practice self care.

In 1994 Americans wrote more letters to Congress to maintain access to dietary supplements than on any other piece of legislation to date.
Imagine you are on a cruise ship where people are getting sick from Norovirus in contaminated shellfish, and the ship's doctor is dispensing poorly-made sea-sick medicine that is making people ill as well, and the captain overlooks these problems, declares he doesn't have enough authority over people taking vitamin pills below-decks and demands everybody dump their vitamin pills overboard. This is what is going on at the FDA today.

Thank You

Many thanks to all who lobbied MEPs ahead of last week's meeting in Brussels re the setting of maximum permitted levels under the Food Supplements Directive. It lent a huge amount of weight to our case and resulted in a lengthy hearing, which we might not otherwise have got. The lobbying also resulted in cross-party (qualified) support for our petition from Irish MEPs, which was unheard of until now.

Your hard work has paid off and we now have all seven MEPs on the European Parliament's Petitions Committee in "broad agreement" with our issues. This does not, of course, mean that we have won the day. Far from it. Ireland, UK and the Netherlands are the only Member States of the 27 where higher level supplements are available. The other 24 Member States have never enjoyed this 'freedom' so our campaign is irrelevant to them. This is a political numbers game. Several new initiatives are now underway, but to have any chance of succeeding it is critical that you continue to engage with your MEPs, TDs etc. It is only by consumers making a big noise ahead of both the European elections in May and Lisbon 2 in the autumn that we will get anywhere with the campaign, which has been going for six years now! We are now at the eleventh hour, so minds are focussed....

Remember to check out www.saveoursupplementsireland.com, as well as new items on www.anhcampaign.org and www.irishhealthstores.com.

EU reviews vitamin limits after Irish petition (Fiona Gartland)

January 21, 2009. RESTRICTIVE VITAMIN supplement standards due to be set by the EU are to be re-examined following an Irish petition. The standards, introduced by EU directive, would restrict doses of vitamin D to the equivalent of that produced by 25 seconds of sunlight and prevent the sale of high-dose vitamin C products without prescription. The EU food supplements directive was given the go-ahead in 2005. However, the maximum permitted levels of ingredients to be contained in supplements has not yet been set. The standards currently being considered would restrict the sale of vitamins and minerals to very low doses. It would become illegal to sell vitamin A in a dose that can be found in more than half a carrot or to sell selenium, an important mineral, in doses larger than in a quarter of a Brazil nut. Presenting to the EU Petitions Committee, Dr Rob Verkerk and Jill Bell, on behalf of the Irish Association of Health Food Stores, told MEPs the proposed standards were based on poor out-of-date science. Munster MEP Kathy Sinnott, who is vice-president of the petitions committee, said the minimalist levels allowed were only enough to keep away deficiency diseases, like scurvy or rickets, but not enough to enhance health. “This directive is unreasonable and controlling,” she said. “It will put European producers and health food shops out of business while forcing people to obtain their vitamins and minerals from outside the EU via the internet.” The petitions committee asked the European Commission to re-examine the issues raised by Ms Bell’s group. This article appears in the print edition of the Irish Times.

Irish natural health organisations call on European leaders to respect Irish ‘No’ vote (Press release for December 8, 2008)

Consumer organisations launch campaign demanding right to referendums (Press release for March 4, 2008)