Friday, January 23, 2009

01/23/09 - Mood Foods and the Future of Nutraceuticals

0. News  - Health Freedom – Change for the Good?
1. Mood Foods – the Latest Trend in Functional Foods
2. The Future of Nutraceuticals

0. VL Blog News

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1. Mood Foods – Functional Foods TrendNew report breaks down global mood foods market
By Lorraine Heller, 21-Jan-2009

“Mood foods are emerging as the latest niche in the functional foods market, and are expected to experience continued growth, according to a new market report.
“Mood-enhancing foods are those that contain ingredients said to uplift mood, boost mental health or improve cognitive function. Although the category is still in its development stages and lacks a standard definition, it is an area attracting significant interest from consumers around the world… in countries with a developed and distinct functional foods market – such as the United States – foods making mood, emotional and cognitive health claims are emerging as an increasingly important category. .. ‘..the mood foods market will continue to experience a robust growth rate… As food scientists and marketers strive to infuse new ideas and incorporate new benefits, the focus of the functional foods industry is widening beyond the traditionally offered physiological functional benefits. In this context, functional foods and beverages that stimulate mental and emotional wellness emerge as an interesting market niche.’
“The mood food market saw ‘significant activity’ after 2000, with the first actors in the market being companies that were prepared to invest in the commercialization of products containing innovative ingredients. Small and medium-sized firms that capitalized on traditional mood-enhancing foods and ingredients – such as chocolate, ice cream or tea – were also at the starting line… the market will ‘continue to experience healthy growth rates’, boosted by an aging population prepared to spend more on prevention rather than cures… As well as the growing and more active baby-boomer population, other drivers for the growth in the mood-food market include changing lifestyles, rising consumer expectations and increased innovation...”
nutraingredients-usa .com/Consumer-Trends/New-report-breaks-down-global-mood-foods-market/?c=gbrnO2ewSG1JubPkBv3SmQ%3D%3D

2. The Future of Nutraceuticals

Many in the Natural Foods industry are asking what the future holds with the new Federal administration. lists "A crack-down on imported drugs and dietary ingredients that contain undeclared spiked pharmaceuticals." as one of the possibilities.

nutraingredients-usa .com/Regulation/What-Obama-means-for-functional-foods-and-supplements-Part-I/?c=gbrnO2ewSG0Sw5U%2B7Y9%2BBQ%3D%3D

This may also include the category of “Nutraceutical.” The Wikipedia definition of Nutraceutical is:

"Nutraceutical, a portmanteau of nutrition and pharmaceutical, refers to extracts of foods claimed to have a medicinal effect on human health.... More rigorously, nutraceutical implies that the extract or food is demonstrated to have a physiological benefit or provide protection against a chronic disease..."

Certainly such substances can come within the AMA Ethics Code Opinion 3.04 rubric of "therapies that may benefit" rather than "treatment of disease" and therefore not restricted to physician prescription.

See: lifespirit .org/Alternative-Practices.htm

The legal status of Nutraceuticals remains ambiguous. If the substance is:

1. grandfathered under DSHEA, it can be sold as a Dietary Supplement (sold since June 1994).
2. FDA approved new dietary ingredient, it can also be sold as a DS.
3. subject to an OTC monograph, it must be sold as an OTC medicine.
4. an approved prescription drug it must be sold as a prescription drug.
5. an unapproved drug, it may not be sold in the US (but US citizens can import from overseas under FDA regulation for personal use only; 3 months supply at a time).
6. just be an ordinary food it would be importable under those rules (including "Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act…",

See: vitaminlawyerarchives.blogspot .com/2008/11/110808.html

The article also cites, "June 2009 is the effective date for the majority of the supplement industry for GMP compliance. Will FDA dramatically increase inspections, and will we see a true reform of
manufacturing quality as a result?"

Clearly, “change is in the air…” What change, remains to be seen.

Your papers must be in order. Do you have your SOPs (Standard Operating Procedures)? Is your web site Site Use Statement up-to-date? Learn more at my web site, www. SiteUseStatement .com or on my SOP page, http:// tinyurl .com/2eu6yj – Is your Substantiation Notebook ready? Your papers need to be in order before the FDA inspection!

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

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