Hello and Happy December!
FDA has been busy in the past few months, publishing several
draft guidance documents and proposed rules for food safety—including a
proposal that would ban partially hydrogenated oils in foods. They also published updated guidance on
cosmetic GMPs but have been relatively quiet about dietary supplements. However, in September FDA’s Center for Food
Safety and Applied Nutrition (CFSAN) published their “Plan for Program Priorities,
2013-2014” that included quite a list of goals for the dietary supplement
program (http://tinyurl.com/nx6hsse). Since
there are less than 30 days left in 2013, it will be interesting to see whether
FDA will publish a flurry of proposed rules or miss their proposed deadline.
CFSAN’s overall plan for the dietary supplement industry is
to “take steps to improve the safety and labeling of dietary supplements and the
supply chain.” It is interesting that the
supply chain was mentioned since many dietary supplement manufacturers have complained
that the dietary supplement GMPs do not extend to the suppliers, making it
difficult for manufacturers to convince raw material suppliers of the
importance of good documentation and record keeping that would help
manufacturers comply with the GMPs (http://tinyurl.com/lj3z35f).
The CFSAN Plan for Program Priorities goes on to list 5 planned
steps to address the safety and labeling of dietary supplements:
1.
Modernize the postmarket surveillance system
for regulating dietary supplements. This was a recommendation from the
Department of Health & Human Services Inspector General’s 2012 report, “Dietary
Supplements: Structure/Function Claims Fail To Meet Federal Requirements” (http://tinyurl.com/keq4b27). By the way,
this document details a study in which the Inspector General’s Office reviewed
label claims and the manufacturer’s substantiation dossiers for 72 dietary
supplement products.
2.
Develop and implement risk-based compliance
and regulatory strategies to address dietary supplement safety issues. FDA typically takes a risk-based approach in
their oversight and regulatory enforcement actions in regulated industries. In the past FDA had indicated that they were
particularly interested in monitoring the marketplace for claims relating to
cancer, diabetes and influenza H1N1; they also watch for supplements that claim
to affect memory, sexual function and weight loss. It is unclear whether FDA will publish their
regulatory strategies but we will be watching for updates to their compliance
policy and inspection manuals.
3.
Publish
revised draft guidance on new dietary ingredients (NDIs) to increase premarket
oversight of dietary supplements. This
highly anticipated guidance could prove to be very interesting. The first draft was published in July of 2011. FDA received over 12,000 comments on this
document that appeared to the dietary supplement industry to be a substantial
overreach by the agency that in effect, would put into place a premarket
approval process for dietary supplements; a proposal that appears to violate the
enabling legislation of the dietary supplement regulations. It is unlikely that publication of the revised
draft guidance would be received as good wishes for a prosperous new year by
industry.
4.
Publish
final guidance on new dietary ingredients (NDIs) to increase premarket
oversight of dietary supplements. While
this step is set for 2014, the short timeline indicates that the agency does
not expect as many comments as there were for the first draft. Perhaps they have thoughtfully considered the
industry’s previous comments and the document will be something that both industry
and regulators will find workable.
5.
Publish
final guidance to help dietary supplement and beverage manufacturers and
distributors determine whether a liquid food product (such as energy drinks)
may be labeled and marketed as a dietary supplement. In December of 2009 FDA published a guidance
document on “Factors that Distinguish Liquid Dietary Supplements from Beverages…”
(http://tinyurl.com/nxjuswg). FDA issued the guidance at a time when many ‘functional
beverages’ were making their way to store shelves. The apparent aim was to rein in the industry;
however the plethora of liquid products available that claim to be dietary
supplements but look like beverages is testament to the fact that the 2009
guidance has been largely ignored.
If CFSAN does publish all those proposed documents, we will
do our best to keep you up to date without inundating your inbox. In the meantime, the associates at
FDALabels.com and Bioscience Translation & Application are ready to help
you ensure that your products are compliant with FDA regulations so that you
can enjoy uninterrupted market success.
As always, we hope you find these
occasional updates interesting. Please use this link http://eepurl.com/Imbjv
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All the best to you!
Evelyn & Associates
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