Saturday, March 8, 2008

03/08/08 - Substantiation Resource

Vitamin Lawyer Update Memo: March 8, 2008

This issue:
1. Substantiation Resource
2. Has the DS Industry Reached “Maturity”?
Blog Update: Healthcare vs the Illness Industry
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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
Director of Business Development
Natural Standard
www. naturalstandard .com”

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…


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…


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.


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.

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