0. News - Health Freedom – Change for the Good?
1. Mood Foods – the Latest Trend in Functional Foods
2. The Future of Nutraceuticals
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0. VL Blog News
Blog: http:// vitaminlawyerhealthfreedom .blogspot .com
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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
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2. The Future of Nutraceuticals
Many
in the Natural Foods industry are asking what the future holds with the
new Federal administration. Nutraingredients.com 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
Nutraingredients.com 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.
WILL “ FDA DRAMATICALLY INCREASE INSPECTIONS…” – ARE YOU READY?
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!
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Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
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