Friday, October 26, 2007

10/26/07 - EU Regs; CAM; GMPs


1. Health Freedom Blog Update, Factoid & Client Notice
2. EU – taking over world food regulations?
3. CAM & Natural Products… perfect together…
4. Public support for CAM reimbursement
5. Fighting over GMP requirements

1. Vitamin Lawyer Health Freedom Blog –
New Posting -

“With food supplements, we have an extremely cost effective and very safe tool to better public health.”
S. Hasslberger -

Notice: Due to the continuing decline of the Dollar and increased costs, The Vitamin Lawyer Consultancy hourly rate has increased.

To get on to the Global Health Freedom eblast list, please go to:

2. EU – taking over world food regulations?

Sepp Hasslberger’s Health Supreme Blog often has a very good knowledge of pending issues. He explores the claim that EU “Napoleonic Code” regulation of foods – including natural remedies, dietary supplements and functional foods – is being spearheaded by the European Union. The most serious problem from the viewpoint of the American wellness marketplace is the old legal distinction between “Code” countries, where whatever is not approved is prohibited, and Common Law countries, like the US, where whatever is not forbidden is allowed; the centuries-old struggle between free markets and mercantilism continues!

Sepp quotes one unnamed source: “One American official says flatly that the EU is ‘winning’ the regulatory race, adding: ‘And there is a sense that that is their precise intent.’ He cites a speech by the trade commissioner, Peter Mandelson, claiming that the export of ‘our rules and standards around the world’ was one source of European power. Noting that EU regulations are often written with the help of European incumbents, the official also claims that precaution can cloak ‘plain old-fashioned protectionism in disguise’.”

“Protectionism” is certainly not a friend of advanced healthcare and wellness companies, especially in our globalized world marketplace. Sepp’s article, on the dangers of “HARMonization” with Codex is a must read.

And what would be the effect of the EU takeover on your business? On your vitamin use? Here is what one UK nongovernmental organization, ANH, noted in a report critical of the “science” behind upper limits: “upper levels being considered for nutrients such as beta-carotene could be exceeded by eating two carrots…”

3. CAM and Natural Products… perfect together…

From The Integrator Blog: Parallel Play or a Potent Alliance? Alternative Medicine Practitioners and the Natural Products Industry are Stronger Together - David Matteson, MPM, MURP, MS

"The Natural Products Industry (NPI) and the complementary and alternative medicine (CAM) industry are each in the midst of a major transformation. Their ability to learn how to 'play' together may be crucial to how well these industries grow and succeed over the next few years.

"There is a natural relationship between these two industries. Many policy makers and many consumers see them as flip sides of the same coin. Yet, these two industries have not really acknowledged their interconnectedness, let alone taken active steps to collaborate on their common political and market interests.”

4. Public support for CAM reimbursement

While I am no fan of licensing laws (‘A license is a limitation…”) An Iowa health reform poll shows 68% of voters want licensed CAM professionals covered in basic insurance benefits.

”A broad-ranging survey on health reform topics by the Gilmore Research Group found that 68% of voters believe basic health care benefits should include coverage for any licensed health care professionals.
Licensed professionals directly noted in the survey of 601 Iowa voters were ‘naturopathic physicians, acupuncturists and chiropractors.’ The survey was commissioned by Code Blue Now! - a national, non-partisan, not-for-profit citizen organization formed to build public consensus in health care policy. The Iowa population was strategically selected to have a maximum influence on the healthcare reform debate.”
5. Fighting over GMP requirements

The FDA’s new Good Manufacturing Practices will be phased in over two years, giving smaller companies some time to get ready… the most difficult area as been the new requirement for “100% Identity Testing” with many companies complaining that there may be no available lab tests that can determine identity where a product has a dozen or more ingredients, some in such low amount as to be nearly nano dilutions.

“The FDA (US Food & Drug Administration) published the final rule on Good Manufacturing Practices, known as GMPs, in June. The soon-to-be-implemented GMP legislation forms part of the 1994 Dietary Supplements Health and Education Act (DSHEA) and is set to provide standards specific to the industry for inspectors to check for purity, safety and legality in manufacturing. Both the Natural Products Association (NPA) and the American Herbal Products Association (AHPA) find fault with the fact that under the current GMPs, only supplement manufacturers, but not ingredient suppliers, can submit petitions for exemptions from 100 percent identity testing.”

It is expected that FDA will accommodate the needs of companies with specialized products that may not be susceptible to the required lab testing.

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