Tuesday, August 12, 2008

08/12/08 - EU, Codex: Health Claims Substantiation

Vitamin Lawyer Update eMemo: August 12, 2008

This issue:

0. News & Practice Notes:
1. Codex and EU: Health Claims Substantiation
2. Web Ring and Wiki for Advanced Health Care
3. Professional Practice Record Keeping SOP Available

0. VL Blog and News and Practice Notes

Blog: http:// vitaminlawyerhealthfreedom .blogspot .com

Weaponized Avian Flu Current Intelligence Estimate
http://www .healthfreedomusa .org/?p=755

Practice Note: How Not to Make Claims

I was recently asked to consult in a case where there might be an indictment for selling an “unapproved drug.” The product is a mix of a half dozen herbs with tea, a combination traditionally used to support normal immune function in case of influenza. The problem is: the product was advertised by an “off shore” distributor as “effective treatment for Avian Flu…” The US manufacturer made no such claims, but an off shore distributor did. Although the label was affixed off shore, the authorities want to impute the claim to the US entity, since the product was sold to Americans. This is another case where much trouble could have been avoided had the distributor structured the claims with attention to US permitted language in the first place. The US manufacturer never intended a “drug” use, but now needs to demonstrate that fact. Having your paperwork in order, including clear Standard Operating Procedures, good sales and purchase Records, can go a long way to demonstrating your legal intent.

[Please note: all URL web page links in this email are incomplete, with the “http://” and/or “www.” removed and an extra space before the .com or .org, to avoid this message being treated as “spam” by AOL or other services.]

1. Codex and EU: Health Claims Substantiation

Nutraingredients .com/Regulation/IADSA-keeps-pressure-on-Codex-over-science-for-health-claims/?c=gbrnO2ewSG3cp4pUuVpXUw%3D%3D

“August 11, 2008 (By Stephen Daniells) The International Alliance of Dietary/Food Supplement Associations (IADSA) is keeping up pressure on changing how health clams are substantiated by Codex. te science to substantiate health claims should bring together all studies, and putting too much emphasis on clinical trials is “not practical” …Professor David Richardson, scientific adviser to the UK Council for Responsible Nutrition (CRN) and IADSA - “Much of what is already known about human health cannot be validated using ‘gold standard’ clinical trials. These studies are, of course, important, but they provide only one source of information. All sources of scientific data have inherent limitations, hence the need to focus on the totality of the available data and weighing of the evidence.”

Codex agreed at the end of 2007 that its draft rules on health claims needs further work following concerns over what evidence should be required for scientific substantiation. And the calls for a wider consideration of the overall science by IADSA will keep up the pressure on Codex ahead of a review and redraft by a France-led working group, which will present its conclusions at the next Codex Nutrition Committee meeting in November 2008. …

In Europe, the EU has already unveiled its own health claims regulation - which says claims about foods and drinks should be supported by science - and has caused uncertainty for the industry since coming into force in July because parts of the law have not yet been finalized… The text, as it currently stands, states that short-term human intervention studies in healthy subjects should be the prime source of evidence in claims substantiation…

“The scientific evidence to support the diet and health relationships for dietary guidelines and health claims for fruits and vegetables, and for whole grain cereals, are based mainly on human observational studies, not clinical interventions,” said Richardson. Sources of scientific evidence can include generally accepted authoritative information that has been verified and validated over time; human intervention studies; human observational or epidemiological studies; animal and in vitro studies, and traditional knowledge and experience of use. The scientific data that will be accepted for a health claim for botanical problems in EU law has also caused some concern. Lobbyists have called for the traditional use of a botanical to be acceptable as evidence and are opposed to clinical trials.”

2. Web Ring and Wiki for Advanced Health Care Update

There were some “glitches” since the last update, but we now expect the Web Ring sign-up page to go live this coming weekend. I will send you all a special link for The Vitamin Lawyer.com Consultancy clients and contacts. I know you will want to sign-up for this important new Internet feature.

You can get a sneak preview at: http:// healthcare-aware .com (for the Web Ring) and www .advancedhealthwiki .com (for the Wiki). In previous issues of this Update eMemo I discussed the powerful search engine value of the Web Ring. In the near future I will be providing you with a detailed explanation about how the Web Ring can help your Online presence. I’ve been working on this project since last November, as some of you know. The wait will be worth it!

3. Professional Practice SOPs

The Vitamin Lawyer .com Consultancy offers standardized formats for various Standard Operating Procedures – for companies in the nutritional and natural products industry, as well as for advanced health care “CAM practitioners. The Professional Practice Record Keeping SOP describes record keeping standards for the practitioner who provides nutrients and natural remedies to his or her clients.

You can see a list of the topics covered by the SOP at: http:// tinyurl. com/2eu6yj

If you would like a copy of the Professional Practice SOP, please send me an email with “PP-SOP” in the subject line; I charge ½ hour for this service.


Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com

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