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
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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.]
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1. Codex and EU: Health Claims Substantiation
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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.”
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2. Web Ring and Wiki for Advanced Health Care Update
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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!
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3. Professional Practice SOPs
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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.
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Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
Showing posts with label Health Claims Substantiation. Show all posts
Showing posts with label Health Claims Substantiation. Show all posts
Tuesday, August 12, 2008
Saturday, March 8, 2008
03/08/08 - Substantiation Resource
This issue:
1. Substantiation Resource
2. Has the DS Industry Reached “Maturity”?
3. AER SOP
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Blog Update: Healthcare vs the Illness Industry
http:// vitaminlawyerhealthfreedom.blogspot .com
Support Health Freedom: join the eAlert Newsletter at:
www. healthfreedomusa .org
[Please note: all links in this email are incomplete, with the “http://” and/or “www.” removed and an extra space before the .com, to avoid this message being treated as “spam” by AOL or other services.]
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1. Substantiation Resource: Natural Standard Research
I’ve recently taken a look at a good source of substantiation information. If you think this may help your company, please contact Jason (contact info below) and tell him The Vitamin Lawyer sent you. He is knowledgeable and very helpful. I think this service may be quite useful for both substantiation and with Adverse Event Reporting.
“About The Natural Standard Research Collaboration
”The Natural Standard Research Collaboration provides high quality, evidence-based information on dietary supplements (including herbs, vitamins, and minerals), and functional foods to manufacturers. Natural Standard is the trusted professional reference of the National Institutes of Health and provides patient information to MD Anderson Cancer Center, Susan Komen Breast Cancer Foundation, The Mayo Clinic and Harvard Medical School.
”The Natural Standard Electronic Database
”The Natural Standard Database is an evidence based clinical database that will expedite and consolidate the literature retrieval process, assist researchers in new product development, promote safety and efficacy when labeling and marketing products, and assists in registering products or making structure function claims.
”Relevant Database Features:
”All available human studies provided with the level of evidence for each one are included (RCT, meta-analyses, systematic review, case reports, etc). Each clinical trial is rated for methodological quality with limitations discussed.
”Recommendations are made for future high quality studies. An ID program that allows users to search for related terms, substances, synonyms, foreign language terms, constituents, Latin terms and common names.
”Standardized grading criteria for effectiveness that is completely reproducible and based on the US Preventative Services Taskforce Sections that include anecdotal evidence, traditional uses, manufacturer reports, potentially biased publications, internet hearsay, popular opinion, and those that report controversy between secondary and primary data Brief safety summaries that includes maximum dose and duration as well as interactions with conditions Adverse, Effects/Precautions/Contraindications Interactions
Pregnancy/Lactation Data.
”Dosing/Toxicology section that provides brand names of products, dosing, frequency, duration, level of evidence, standardization and toxicology Mechanism of Action, Pharmacodynamics/Kinetics Evidence table and discussion of individual studies.
Brand names with ingredients Interactions cover herb/supplement, food, lab, name brand products, generic products, name brand drug and generic drug interactions Condition databases that allow user to compare effectiveness and include both conventional and integrative therapy treatment options News for product recalls, contaminants, and industry news RSS feeds,
”For more information please contact:
Jason Petralia
JPetralia@NaturalStandard.com
Director of Business Development
Natural Standard
www. naturalstandard .com”
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2. “Supplement Market Nears Maturity, Nutraceuticals Report
By Lorraine Heller
February 29, 2008 - The US, Europe and Japan will continue to drive the global nutraceuticals market, although growth in dietary supplements is expected to slow, according to a new report. Published by Global Industry Analysts, Nutraceuticals: A Global Strategic Business Report examines the leading markets for functional foods and dietary supplements, and the factors driving growth.
The report, which analyzes the past, current and future market dynamics over the period 2000-2010, projects "healthy growth" for the nutraceuticals market over the next few years, with global sales expected to reach $187bn by 2010.
Leading markets
According to GIA, the United States, Europe and Japan dominate the global market, with a combined share estimated at 86 percent last year... Primary reasons for the strength of these markets are the high-income levels of consumers, greater awareness and widespread preferences for specialty nutritional and herbal products, and trends promoting preventive medicine and self-treatment.
The US alone accounted for 37 percent of 2007 nutraceutical sales, but Asia Pacific is expected to emerge as the fastest growing market, boosted by the "robust" Chinese and Indian markets, and increasing economic prosperity, said the report.
Growth drivers
According to the report, rising consumer desire for leading a healthy life continues to drive sales of nutraceutical products… Other factors include an expanding elderly population, as well as escalating costs associated with healthcare, which is pushing the demand for self-medication and healthy foods.
Functional Foods
According to the report, functional foods constitute a fast moving segment in the nutraceuticals market, driven by the rising health awareness among consumers…
Supplements
Growth in the dietary supplements segment is expected to slow, as the category fast approaches maturity levels, said the report. This is particularly the case in developed regions…
Competition
As the global nutraceuticals industry continues to grow, competition will also increase. This will be driven by factors such as price, safety, efficacy, packaging and brand loyalty, said the report… nutraingredients-usa .com/news/printNewsBis.asp?id=83651”
My view is that the natural products / natural remedies / nutrition market will continue to experience significant growth as Baby Boomers seek to maintain and regain youthfulness.
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3. AER SOP
The Vitamin Lawyer .com Consultancy retainer clients have received updated versions of Standard Operating Procedures detailing procedures for Adverse Event Reporting (AER) and other changes.
If you would like a copy of the AER SOP, just send me an email with AER in the subject line and I’ll send you a copy… with my compliments.
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Ralph Fucetola JD
www. vitaminlawyer .com
http:// vitaminlawyerarchives.blogspot .com
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