Food Safety Modernization Act
passed into law in January of last year.
Below is a very good summary of the retailer business, Whole Foods, concerns about
the new regulations covered in the new law:
·
Registration with FDA was once per life, now
every 2 years
·
How to prove a product was on the market prior
to 1994 since there's no list
·
What if an ingredient was on the market before
1994, but is now being extracted through new technology
·
Ingredient suppliers not exempt from Hazard
Analysis and Critical Control Points (HACCP) practices in their facilities,
creating more costs
·
Vulnerability assessments will be conducted and
regulations be issued to protect against the intentional adulteration of food
in such categories as weight loss, sexual enhancement, and body building
·
Gives FDA some additional recall authority and
the ability to collect fees for re-inspection, from car mileage to overhead
costs, plus no strict definition of "re-inspection," which could be considered
anywhere from weeks to decades as it stands now
·
If there is ever a government shut-down, due to
a debt ceiling deadline being missed, there would be funding issues on how much
the FDA would be allowed to do
·
2009, the Global Organization for EPA and DHA
Omega-3s (GOED), Salt Lake City, UT, and 10 other organizations submitted a
citizen’s petition to the Food and Nutrition Board of the Institute of Medicine
(IOM) asking for a panel to review the data on the health benefits of omega-3s
now that the report on Vitamin D has been published--IOM is studying the review
process itself, not sure whether they will eventually choose EPA/DHA or choose
choline as the next nutrient to study--takes 2 years for a report to be
established once the study is completed
·
Messages have been very mixed about what makes
an acceptable health claim since the FTC has indicated that 2 human studies are
sufficient to support a claim, and other times indicating it has to be
evaluated on a case-by-case basis; the FTC recently asked some companies to
sign consent decrees saying they can’t make future claims without first having
two independent double-blind, placebo-controlled randomized trials and having
pre-approval from FDA for any health claims. This is despite the fact that FTC
doesn’t formally require such FDA pre-approval under the law. So far, two
companies have been served this order, but the industry is concerned that this
is becoming a de facto standard
·
Confusion on Codex standard for fish oils vs.
marine oils
·
FDA cracking down faster on more illegal,
tainted products out of legitimate dietary supplement industry, sending message
to criminals that their drug spiking is being watched more closely
·
Good Manufacturing Practice Watch (GMP's)
increased by FDA, giving a pattern of the FDA's priorities for these
inspections, but not sure how it will continue based on the debt ceiling
funding
·
There are strong scientific data that in a very
short period of time—three to five years—organic crops will be tainted with GMO
pollen, causing problems for both the organic farmers and the consumers
·
In other news, the USDA recently deregulated
some genetically modified organisms (GMOs); now GMO sugar beets, alfalfa and
feed corn can be planted. The concern is that as crops get deregulated to use
GMOs and to plant GMO crops, the inadvertent contamination of organic crops then
becomes an enormous problem for farms—which then becomes an enormous problem
for retailers--At this time, the only recourse for the industry may be
litigation, such a lawsuit would not be raised by the OTA, but by others
concerned about the threat to organic crops. Unfortunately, there may be
upwards of 20 potential GMO crops that may be deregulated
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