FDA Targeting Vitamin Companies

FDA News, an industry
information source, put it succinctly a couple weeks ago:

“Dietary
supplement makers: The party’s over. The grace period on
inspections has expired and the FDA is on the hunt. More warning
letters were issued in 2012 than in the previous two years
combined. GMP compliance is the FDA’s focus…”

“FDA
is concerned with the current lack of GMP compliance and is preparing
to take a closer look during inspections. FDA
has also said they are circling back to companies who have already
been inspected. Dr. Daniel Fabricant, director of FDA’s Division of
Dietary Supplement Programs recently stated, “’the majority of
inspections [the FDA] have done have resulted in a non-compliance
atmosphere, whether resulting in a warning letter or just
observations on the 483s.’…”

One
FDA Compliance Officer told me:

“Your
company, as label-owner, must be in a state
of control with
its training, labels, claims, manufacturer, shipping & customer
service…”

In
the past I would tell my dietary supplement clients that they might
be inspected by the FDA once in a decade, or not at all. Today, every
company that owns its own labeled products can expect yearly or
almost yearly inspections. The supplement industry is being held to
strict standards and those companies that are well-organized
businesses will have a competitive advantage.


To
make the best of that advantage, or even to effectively communicate
to the customers, “your papers must be in order…” Gone are the
days when “mom and pop” vitamin companies could bottle their own
products and just start marketing. Today, companies need to have a
sophisticated approach to doing business. 


Standard Operating
Procedures are intended to ensure that the public is offered products
that are consistent as to “purity,
identity, composition and strength…”


But
it is not enough to have written procedures, according to FDA (Federal Register, pages 34811:

“…each
person engaged in an activity covered by these CGMP regulations
must have the education, training, or experience to perform the
person’s assigned functions. Some employees will be
considered qualified based in part on training taken as company
employees. To show that such training is appropriate to the
employee’s functions and has in fact occurred, the training must
be properly documented. 

This documentation is an important
aspect of ensuring adequate training and, therefore, helping to
ensure the result of having qualified employees who perform
their functions properly.” Federal register, page 34811.
The
FDA introduced the cGMPs by reminding us all:


“The
dietary supplement market has changed significantly since the passage
of DSHEA. The industry itself has grown exponentially and so has the
number of Americans buying these products. Access to dietary
supplements has also changed. Today a wide range of dietary
supplements can be purchased in supermarkets or through the
Internet…”

Conducting the Certification Training at
Global Healing Center, Houston, Texas
www.VitaminIndustryCompliance.com

The
Federal authorities understand that Americans want their supplements. 


The strong public support that caused Congress to do that which it
hardly ever does, adopt a controversial law unanimously,
with no dissent, proves that. Nonetheless, the natural tendency of
bureaucracy is to expand into every nook and cranny of voluntary
human action. The unregulated is seen as a threat. Marketers, on the
other hand, see the unregulated as an opportunity to meet consumer
demands expeditiously. The tension between American industry and
bureaucracy has grown for generations.



The
regulatory pendulum swings this way and that way. Today, with a
Federal bureaucracy emboldened by gridlock in Congress, and with ever
more taxpayer or borrowed money to spend for enforcing regulations,
those regulations are being interpreted in the most onerous manner,
leaving little room for small companies to continue their critically
important roles as innovators.


What
is to be done? An aware public needs to keep the pressure on the
Congress so the bureaucracy is not able to ratchet-up controls
without limit. As one of the trustees of Natural Solutions Foundation
– Health Freedom USA.org – I am very aware of the strong support
that our dietary supplement market has from the public. You can help
educate decision-makers here: http://tinyurl.com/SaveOurSupplements.




Dietary
supplement company management will do what management must always do:
manage.
That means complying with the cGMPs to assure the public that
Americans can still buy the best, highest quality and potency
nutrients available anywhere on earth. To do that, the companies need
to get much more serious about how they organize the ways and means
they have to satisfy the consumer. My experience is that very few
dietary supplement companies are in full compliance with all
requirements.


The
Natural Products Association sees the same issue:


“Dietary
supplement manufacturers are facing a high level of regulatory
scrutiny from the government as
a result of the study … by the U.S. Dept. of Health & Human
Services Office of the Inspector General. This study raises new
concerns that structure/function claims are not accurate and
misleading to consumers.  A sample of 127 dietary supplements
were reviewed and concluded ‘Overall, substantiation documents for
the sampled supplements were inconsistent with FDA guidance on
competent and reliable scientific evidence.’…”


The
science behind the benefits of dietary nutrients continues to
advance. 


The problem the market faces is how to substantiate the claims that
can be made about those nutrients. WHO, the World Health
Organization, told us in 2002 that the chronic diseases of modern
life – cancer, heart disease, diabetes, obesity, are all the
“noncommunicable diseases of mal- and under-nutrition.” It is
the role of the dietary supplement companies, whether large or small,
new or well-established, to educate the public about the tremendous
health benefits of good nutrition.



To do that, the companies need to stay in business by effectively
meeting the increasing regulatory standards.


Education
is the key. 


The companies are now required to adopt written Standard
Operating Procedures and engage in third-party training and
certification,
to meet the higher standards expected from companies that are
providing essential nutrition for our health and well-being.



That’s
why I’m working with some of the leading educators in the natural
products field, to form the Regulatory
Compliance Network.
Learn more here: www.VitaminIndustryCompliance.com