James Neal-Kababick
Director, Flora Research Laboratories
Adjunct Faculty, Bastyr University Botanical Medicine Dept
Fellow AOAC International
©2012 Flora Research Laboratories
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Warning: The Speaker Comes from
a State that Allows Dogs to Drive
You should
keep this in
mind when
considering
his advice.
©2012 Flora Research Laboratories
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DISCLAIMER
 This presentation is not a substitute for qualified legal
advice from competent, expert counsel
 Information provided is based on a variety of resources
including speakers experience, FDA guidance
documents, cGMP’s and regulatory actions- due to the
dynamic nature of the industry, changes may occur
rendering some of this information inaccurate
 Names of companies or case histories are for
educational use only and are neither an endorsement
nor a condemnation of said entities
©2012 Flora Research Laboratories
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Changes and More Changes
 The industry many of us grew up with has changed
dramatically in the last twenty years
 Changes continue to accelerate at a greater pace as the
industry continues to mature
 Basing decisions on the “good old days” is likely to
result in arrest, inventory seizure, class action suits,
and large fines not to mention negative media
attention to your company
 To address the dynamic market, FRL developed &
utilizes Phytoforensic Science to help protect clients
©2012 Flora Research Laboratories
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Phytoforensic Science
 The application of various techniques from
microscopy to mass spectroscopy to protect the global
food supply chain
 A special emphasis on dietary supplements
 Application of novel and “outside the box” approaches
to problem solving
 Bringing together data from various instruments to see
the “big picture” and solve the problem at hand
 Resolution of confusion through sound science
©2012 Flora Research Laboratories
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Private Label-Risk Free?
 Utilizing a CMO to manufacture your products does
not relieve you of any compliance requirements under
21CFR part 111
 FDA warning letters make this point painfully clear
 Every CMO, contract testing lab, regulatory affairs
consultant, distributor, packer, fulfillment service and
shipper is considered an extension of your company
 You are liable for all of their actions under the cGMP’s
as if they were parts of your internal organization
 That means that…
©2012 Flora Research Laboratories
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Private Label – High Risk!
 If ANYTHING is out of compliance with 21CFR part 111
with ANY aspect of your CMO’s manufacturing chain
in respect to your products that you are responsible
under the cGMP’s!
 If ANY product manufactured by your CMO for ANY
company is declared misbranded and or adulterated,
the FDA can declare all products made by the CMO
misbranded/adulterated and subject to recall
REGARDLESS of whether or not your product was
manufactured in compliance with 21CFR part 111!
©2012 Flora Research Laboratories
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Private Label-CMO Issues
This isn’t my beautiful industry.
What happened here?
©2012 Flora Research Laboratories
So now you have to worry about
what your CMO is doing with
other companies in the same
facility that your product is made
in.
AND
Worry about your products,
about your CMO and about
everyone else's products made by
your CMO!
SO MAYBE IT’S
Time for some chamomile tea (or
maybe a chamomile IV )
8
Is There Hope?
 Should we just drink the Kool-Aid now or is there hope
to survive in such a highly regulated industry?
 Consider this- The State of Utah’s largest industry is
now the dietary supplements industry over all others
topping $7 billion USD annually.
 Now about 60% of MD’s are using and recommending
supplements to their patients up from <10% in 1997
 The idea of a highly regulated industry, an agency with
teeth and strong science & research add to consumer
and practitioner confidence = more sales
©2012 Flora Research Laboratories
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Why?
 Why would this be so?
 The “pass the buck” parachute loop was closed by
these regulations
 The FDA went through all of this with the pharma
OTC industry – they know all the tricks
 Study the Barr Labs decision for a blow by blow of
what is coming
 You ain’t seen nothing’ yet as they are just warming up
 Don’t think it can’t happen to you
©2012 Flora Research Laboratories
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You Don’t Want This
I selected
this warning
letter for a
reason
which we
will examine
more closely
©2012 Flora Research Laboratories
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Relevant Section
 “As an own-label distributor that contracts with other
manufacturers to manufacture dietary supplements
that your firm releases for distribution under your
firm’s name, FDA considers you to be a
manufacturer of such dietary supplements. You
have ultimate responsibility for the dietary
supplements that you introduce or deliver for
introduction into interstate commerce.”
©2012 Flora Research Laboratories
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Even More Relevant
 “The inspection revealed serious violations of the
Current Good Manufacturing Practice (CGMP) regulation
for Manufacturing, Packaging, Labeling, or Holding
Operations for Dietary Supplements, Title 21, Code of
Federal Regulations, Part 111 (21 CFR Part 111). These
violations cause your dietary supplement products to
be adulterated within the meaning of section 402(g)(1) of
the Federal Food, Drug, and Cosmetic Act (the Act) [21
U.S.C. § 342(g)(1)], in that the dietary supplement
products have been prepared, packed, or held under
conditions that do not meet CGMP regulations for
dietary supplements.”
©2012 Flora Research Laboratories
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Look Again
 “These violations cause your dietary supplement
products to be adulterated within the meaning of
section 402(g)(1) of the Federal Food, Drug, and
Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)],
 in that the dietary supplement products have been
prepared, packed, or held under conditions that
do not meet CGMP regulations for dietary
supplements.”
©2012 Flora Research Laboratories
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That Means
 Unlike ANY other food category of regulations, dietary
supplements can be declared ADULTERATED because
of cGMP violations
 We think of that word meaning some contamination
such as fibers, hairs, wrong ingredient, rodent excreta
and so on but
 It can be a violation of protocol
 What do you think consumers think ADULTERATED
means?
©2012 Flora Research Laboratories
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What FDA Said-Private Label CMO
 “As an own-label dietary supplement distributor that
contracts with a manufacturer to manufacture a
dietary supplement that you distribute under your own
label, you have an obligation to know what and how
manufacturing activities are performed so that your
firm can make decisions related to whether your
packaged and labeled dietary supplement products
conform to established specifications and whether to
approve and release the products for distribution [See
72 Fed. Reg. 34752, 34790 (Jun. 25, 2007)]. “
©2012 Flora Research Laboratories
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Your Firm’s QAU
 “Your firm's quality control personnel must ensure
that your manufacturing, packaging, labeling, and
holding operations ensure the quality of your dietary
supplements and that your dietary supplements are
packaged and labeled in accordance with established
specifications, as required by 21 CFR 111.105 and 21 CFR
111.120(b).”
 Not ‘their firm’s QAU” but “your firm’s QAU”
©2012 Flora Research Laboratories
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Important FDA Statement
 “Your firm failed to make and keep written procedures for the
responsibility of quality control operations, as required by 21 CFR
111.103 and 21 CFR 111.140(b)(1). As an own-label dietary supplement
distributor that contracts with a manufacturer to manufacture a dietary
supplement that you distribute under your own label, you have an
obligation to know what and how manufacturing activities are
performed so that your firm can make decisions related to whether
your packaged and labeled dietary supplement products conform to
established specifications and whether to approve and release the
products for distribution [See 72 Fed. Reg. 34752, 34790 (Jun. 25,
2007)]. Your firm's quality control personnel must ensure that your
manufacturing, packaging, labeling, and holding operations ensure the
quality of your dietary supplements and that your dietary supplements
are packaged and labeled in accordance with established
specifications, as required by 21 CFR 111.105 and 21 CFR 111.120(b).”
©2012 Flora Research Laboratories
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And This
 “Your firm failed to establish a specification
for any point, step, or stage in the
manufacturing process where control is
necessary to ensure the quality of the dietary
supplement and that the dietary
supplement is packaged and labeled as
specified in the master manufacturing
record, as required by 21 CFR 111.70(a).”
©2012 Flora Research Laboratories
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Oh, And This Too
“Your firm failed to establish
specifications for each component
that you use in the manufacture of
your dietary supplement products,
as required by 21 CFR 111.70(b).”
©2012 Flora Research Laboratories
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Another one
 “Your firm failed to prepare and follow
a written master manufacturing record
for each unique formulation of dietary
supplement that you manufacture, and
for each batch size, to ensure
uniformity in the finished batch from
batch to batch, as required by 21 CFR
111.205(a).”
©2012 Flora Research Laboratories
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Standard Closing Paragraph
 “You should respond in writing within fifteen (15)
working days from your receipt of this letter. Your
response should outline the specific things you are
doing to correct the violations noted above. You
should include in your response, documentation and
any other useful information that would assist us in
evaluating your corrections. If you cannot complete all
corrections before you respond, you should explain the
reason for your delay and state when you will correct
any remaining violations.”
©2012 Flora Research Laboratories
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And Finally (this is not from FDA)
 Sincerely,
 Your local FDA Office who will be watching you from
now on very closely and will bring federal Marshalls in
next time to seize your inventory, arrest your
management and shut down your company if you fail
to adequately respond to our warning letter.
 Oh, any by the way, we might just do that while you are
responding to the letter because we can.
©2012 Flora Research Laboratories
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This is not an idle threat
 The FDA has become very aggressive in enforcing the
cGMP regulations and rightly so
 The fact that the industry had over a decade of
warning about what would be expected means FDA is
not very empathetic to those that just decided to start
working on compliance now
 FDA and FTC work closely together and that means
everything from trade show literature to import of raw
materials used in your product are subject to review
©2012 Flora Research Laboratories
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The 6 Stages of cGMP Acceptance
 1. The cGMP’s will never get issued
 2. The cGMP’s will never be enforced
 3. Only the big guys will get hit now and then
 4. Only the bad players with major deficits will be hit
 5. Only those making the products (CMO’s or in-house
manufacturing facilities will be hit
 6. Oh my god, I’ve been hit! I need to comply.
©2012 Flora Research Laboratories
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Steps to take with your CMO and factors to consider
when you engage a CMO to make any product in
427,000 easy steps…
(Just kidding, there are only 18,000 critical steps)
©2012 Flora Research Laboratories
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Considerations
 A flashy website is nice and so are glossy brochures,
pictures of lab equipment and people in lab coats
 So what? Really, so what? Does this actually reflect
the real CMO’s focus or is their marketing
department?
 As you scratch the surface, it can be like pulling the
thread on a sweater that suddenly unravels
 Better to come apart in front of your audit team than
the FDA CO!
©2012 Flora Research Laboratories
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Gaps? Me? Not Prestigious Me?
 Nobody knows everything- we all have knowledge gaps
 You may not know what you don’t know until you have
the counsel of qualified experts
 Rapidly assessing the gaps in your expertise and
determining the best way to fill them is essential to
success (hire in our outsource)
 Take advantage of those in the know to help make your
product line rock solid & regulatory compliant by
conducting a gap audit & evaluation
©2012 Flora Research Laboratories
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Get Boots on the Ground!
 There are many very good CMO’s out there
 However, nobody is perfect & issues arise
 Don’t be the retailer that has never seen the CMO’s
facility that makes your private label products
 Don’t go it alone unless you are an auditor and
analytical chemist and microbiologist and regulatory
affairs specialist and have x-ray vision and read minds
(if you do, I have a job opening for you at the tables
tonight in that poker competition)
 Hire some qualified help to fill in the gaps you have
©2012 Flora Research Laboratories
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What am I saying?
 You do what you do best but if that is not qualifying a
CMO, get someone that can or a team
 Saying “But I did not know that…” falls on deaf ears at
FDA because by law it is your responsibility to know
 You did read the 900+ page preamble to the cGMP
final rule right? If not you should as it spells out the
FDA’s thinking on each point
 This is a common problem– CMO’s making products
for private label and the client never audits them until
its too late
©2012 Flora Research Laboratories
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CMO Evaluation
 Auditing by a third party auditor with expertise in
21CFR part 111
 Evaluation of the overall facility and logistics
 Knowing everything from how the ingredients arrive
and are evaluated to how the final product is boxed
and shipped out is your requirement so know it solid
 Make sure all aspects are compliant including
documents
 There are common warning letter themes that we see
repeatedly in situations like this
©2012 Flora Research Laboratories
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CMO Partnerships
 Your liability exposure is significant so you need to
have a CMO that operates transparently and
cooperates with your team
 That means being an open book of sorts
 A spirit of cooperation towards a more compliant
product, company and industry should be the
philosophy
 If you get the runaround then run away to another
CMO
 They work for you & need to comply too
©2012 Flora Research Laboratories
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MMR/Product/Ingredient Specs
 YOU need to work with your CMO to establish a
written master manufacturing record for each and
every product you sell
 YOU need to work with your CMO to establish written
specifications for each ingredient used and for each
product made
 YOU need to work with your CMO to make certain
that ALL of these specifications are properly
implemented and AUDIT them to the specifications
©2012 Flora Research Laboratories
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Common Issues- IDENTITY
 FDA’s biggest fear is based on historical disasters
involving the mix-up of botanicals which resulted in
consumer injury or death- hence IDENTITY
 YOU must establish and test incoming dietary
ingredients to ensure proper identity and that the
product is free from reasonably anticipated
contaminants (RAC’s)
 You must use one or more scientifically valid
examinations to meet this identity requirement
©2012 Flora Research Laboratories
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Common Issues-IDENTITY
 We all know an onion from an apple but do we know if
that yellow powder is goldenseal root extract
standardized to 5% alkaloids?
 If you are a veteran in this industry, you can probably
differentiate goldenseal from closely related
adulterants based on taste, smell and appearance
(organoleptic) but…
©2012 Flora Research Laboratories
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Common Issues-IDENTITY
 If your product specification is GS extract
standardized to 5% alkaloids you MUST ensure that
the product meets this IDENTITY specification
 That will include making sure it is not adulterated
with other botanicals or synthetic berberine (RAC’s)
 And that it contains the right amount of alkaloid
content (assay)
 So you just have it tested in a lab right?
©2012 Flora Research Laboratories
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Common Issues-LABORATORY
 Not all labs are created equal
 Do they know what they are doing and does the
analyst have the training and qualifications to do what
they are doing?
 Is the instrument calibrated and is the incoming
standard characterized properly?
 Is the equipment being utilized correctly and do they
have the proper equipment to do the test that they are
supposed to be doing for you?
 Who is checking the checker?
©2012 Flora Research Laboratories
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How Forensic TV Crime Shows Have
Made Our Job Harder
©2012 Flora Research Laboratories
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How We Wish Analysis Worked
Unfortunately, this is not how it works except for the
Tricorder on Star Trek & On CSI
RESULT
SAMPLE
BLACK BOX SCIENCE
©2012 Flora Research Laboratories
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How It Really Works
Plus sweat!
©2012 Flora Research Laboratories
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CRO’s & the Big Picture
 DS products and ingredients are highly complex (with
some exceptions) and thus each test is really a study in
itself
 A good CRO will step back and get the big picture of
what is going on to assure that critical factors are not
missed
 The Phytoforensic process starts with information
gathering at all levels BEFORE analysis
 It requires outside-the-box thinking and high skill
levels & a passion for excellence
©2012 Flora Research Laboratories
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Laboratories
 Some labs are mills that put out data at a low price and
high pace to make profit
 All profit is based on high throughput testing
 High throughput testing mandates limited scope,
short time focus on any sample and low operator skill
levels (people with jobs not careers)
 How much personalized attention is your sample
going to get in this environment?
 How many problems slip by? More than you think…
©2012 Flora Research Laboratories
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A Case Study- Phytoblab 9000
 Phytoblab 9000 is a fictitious product that I am going
to use for this exercise so that you can better
understand the process – let’s say PB9K
 Situation, the CMO tests Phytoblab 9000 with the
“machine that goes bing” (actually it is FTIR) and it
does not go bing 
 The material appears to be OOS
 The material is sent to an outside lab for evaluation
©2012 Flora Research Laboratories
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The Laboratory & PB9K
 Laboratory sample receiving- the lab must have
protocols in place for the receiving and handling of
samples even if it is the laboratory inside the CMO’s
facility- PB9K is received into the lab
 PB9K is tested by HPTLC using the laboratories
compendia reference for the actual botanical in the
formulation and it is legit- PASS?
 PB9K is tested by FTIR using a Phytoforensic
examination and it is different than prior lots-FAIL?
©2012 Flora Research Laboratories
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Phytoforensic Science Matters
 So you have a pass and a fail and that is initially
inconclusive or confusing but very typical
 The lab reaches out to the supplier and they say that
PB9K is made using an ancient Chinese process used
for thousands of years but it is proprietary and they
can only give us the ingredients/excipients used
 This is very common and it does not really fly in the
face of new regulations- black box specs are not FDA
OK!
©2012 Flora Research Laboratories
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So What Else Is There?
 The scientists notice that the solubility parameters are
not the same between the samples
 The insoluble part is mostly excipient
 That would easily explain the pass on HPTLC and fail
on FTIR
 If the excipient ratios changed is it okay?
 NO- FDA considers that a deviation from the MMR
and it requires a documentation process and OOS
report!
©2012 Flora Research Laboratories
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Phytoforensic Science Matters
 The PB9K sample that failed QC at the CMO’s facility
is compared to older lots and we see differences in the
minor compounds by HPTLC which is common for
extracts
 Does it matter? Maybe. What does the spec say about
the compounds in PB9K? That is the answer
 FTIR differences appear to be related to declared
excipient changes so the material is OOS
 Conclusion- Failed Material or Deviation for OOS
material use
©2012 Flora Research Laboratories
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FDA Warning for an excipient?
 Would FDA really give a warning letter to a company
because they had an excipient change?
 Yes they would and they did in a case where a company
changed an excipient involving cellulose
 This caused the product to be misbranded and
adulterated
 FDA takes this very seriously
 You should too if you want to thrive and you can thrive
by doing the right things
©2012 Flora Research Laboratories
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CRO A Partner for You
 A Contract Research Organization (contract
laboratory) can be your partner in making sure that
the CMO maintains compliance and in investigating
issues like PB9K’s OOS incident
 Again, all labs are not created equal
 Look for a CRO that has expertise and the capability
and ability to apply advanced techniques and multiple
disciplines to the problem at hand (which may be
highly variable over your products life cycle)
 Shopping on price alone will bite you eventually
©2012 Flora Research Laboratories
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VISIT YOUR CRO!
 You should pay a visit to the facility and meet the team
 See the equipment and inspect work performed on
your behalf
 Make sure that the employees are properly trained to
do what they are doing
 Be certain that the CRO has the ability to apply many
technologies and techniques to solve your problems
 Too often, labs pound square pegs into round holes
and you don’t want that-DS products are complicated
©2012 Flora Research Laboratories
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CRO’s Continued
 Don’t use a non-transparent CRO! They should be an
open book for your partnership or their data is not
usable for FDA compliance issues
 Proprietary means it can’t be evaluated so this old way
of the lab world in the industries early days is no good
 The lab should be willing to assist you in an FDA
inspection and agree to allow FDA to inspect their
facility and data for your samples
 If they say no then go to another lab that you can use
 The CRO works for you!
©2012 Flora Research Laboratories
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CRO Partnership
 Your CRO should be able to advise you on this from a
long history of working in the industry and on
products
 The CRO may not know a particular material but they
certainly, as scientists, should be able to rapidly figure
out what the issues might be and what should be
evaluated
 This goes back again to choosing the right CRO
partner
©2012 Flora Research Laboratories
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Common Issues- State of Science
 In cases where the state of science does not allow for
the testing of a given ingredient in a finished product
the cGMP’s allow for exemptions
 For instance, if your final product contains 1 mg of PS,
it is not possible to test that with current science
(without a tremendous multi-million dollar multi-year
research project)
 However…
©2012 Flora Research Laboratories
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Common Issues-State of Science
 In the last five years, technology jumps have made
possible what was impossible only a short time ago
 Your CMO and CRO must be on top of the science
because FDA is and if you are making decisions on old
data you are at risk
 We can now see compounds at about 100-1000 times
lower levels than before due to technology jumps
 That means that the 25ug of selenium methionate in
your finished product can be tested for the Se level and
the raw material can be tested for identity
©2012 Flora Research Laboratories
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Common Issues-State of Science
 FDA does not consider the cost of technology required
to comply with the cGMP’s in evaluating this issue
 If you need a million dollar instrument to do the test
then you either buy it or find a lab that has it and
knows how to use it for your testing needs
 This is especially true for situations where the tests are
for RAC’s that are a safety concern
 Put up or get out is the FDA stance on this matter and
it shows in warning letters
©2012 Flora Research Laboratories
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Common Issues RAC’s
 RAC’s are contaminants that are “reasonably
anticipated” and you MUST assure that your
ingredients and products are free from them
 While the law does allow you to use the suppliers C of
A for all but identity, you must validate that
information with your own testing
 Typical protocol is to test 6 lots and it all pass then do
skip lot testing – for ingredients not finished product
 Some RAC’s should ALWAYS be tested for anyways
©2012 Flora Research Laboratories
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Common Issues RAC’s
 How do you know what the RAC’s are for a given
product?
 Utilize historical incidents to set precedence- i.e.
melamine in protein, pesticides in ginseng, selenium
super potency etc.
 Consider what would be used on or for a productpesticides for botanicals, dyes in bilberry, lead in
calcium, carageenan in chondroitin
 What if you don’t know the RAC history or potential
RAC’s to test for?
©2012 Flora Research Laboratories
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RAC’s- API Spiking
 Clandestine API adulteration has become epidemic in





the industry
Some products are more at risk than others but NO
PRODUCT is immune
Testing a sample for known compounds is not enough
Non-targeted screening is essential in high risk
products
Don’t risk it. This is the stuff that you can go to jail for
Be sure your CRO is a leading expert in clandestine
adulteration testing and that you are covered
©2012 Flora Research Laboratories
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How Bad is Spiking?
 Samples sent for clandestine adulteration testing at
FRL are adulterated more often than not
 It is not unusual for a 90% failure rate to occur in prelost shipments or offshore encapsulated/tableted
products
 Raw material suppliers often add API’s to make the
product appear high quality for repeat business
 The people doing this are very sophisticated and new
compounds are continuously being discovered
©2012 Flora Research Laboratories
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Systematic Phytoforensic Approach
 It is not uncommon for FRL to detect major
pharmaceutical adulteration at active levels in
products that were passed by labs in the US and
Europe!
 Labs performing targeted screening miss novel
analogues and pro-drugs
 SPA takes hours or days of expert time per sample in
some cases-hence production labs miss many API’s
 This is a top concern of FDA
©2012 Flora Research Laboratories
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Economic Adulteration
 Less than 1% of all products entering the US are
inspected.
 Global trade is greater than ever before in the history
of the US
 There are continuous cases of product contamination
due to ingredient substitution
 Economic adulteration is at minimum a financial loss
but is more often catastrophic
 Making sure the whole shipment is authentic is a
challenge
©2012 Flora Research Laboratories
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Representative Sample?
Someus drumus
Biggus contanerous
Latin binomials from excessive
roadrunner cartoons
Micro sizeus test
Dubious datus
LOT
REPRESENTATIVE
TEST RESULT???
Stratificus bagus
©2012 Flora Research Laboratories
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Common Issue- Sampling
 As we see from the prior slide, what you get in a
shipment and what the laboratory tests may not always
be consistent
 Tonnage of material can’t be evaluated with a ten gram
sample
 The way the samples are taken, composited (if that is
proper for the given test) and how the lab processes
the sample before testing are all vital to getting lot
representative data
 Why is this important?
©2012 Flora Research Laboratories
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Common Issue- Sampling
 Because the cGMP’s and FDA say that the sample
under examination by the laboratory must be lot
representative
 Sampling is a science unto itself and we see most
CMO’s do not take lot representative samples and are
not in compliance thus the lab data is not in
compliance thus the product made from the materials
is MISBRANDED AND ADULTERATED!
©2012 Flora Research Laboratories
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Representative of the Lot?
Hypothetical Containers of Lot 123 Ice Cream
Supplement for Mood Elevation
©2012 Flora Research Laboratories
Scoop sample sent
to lab for
organoleptic
testing- 65
Sampling Must be Validated!
 The cGMP’s require that sampling protocols be
documented and validated to assure that they are lot
representative
 All too often, samples sent to labs for testing are
scoops off the top 6 inches of one container
 In a supertote or 20 drum shipment, that is not lot
representative
 USP Articles of Botanical Origin requires multiple
container sampling including core samples from
different sections of the drums
©2012 Flora Research Laboratories
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Typical Stratified Sample
It takes more time
for a laboratory to
properly prepare the
composite sample
from this container
than it does to
conduct the
analysis. What does
your lab do? You
need to know and it
needs to validated!
©2012 Flora Research Laboratories
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Laboratory Compositing
The Scientifically Valid Sampling Plan for our
Laboratory Sampling of Protein Powder for
steroid testing takes about two hours to
conduct.
Dr. Mason (seen here) is a
preeminent expert in statistical sampling
plans. He has developed sampling plans
used on some of the largest superfund sites.
This method is an elaboration of the USP cut
and quarter mix method but utilizes 8
stainless bowls to ensure uniform sampling
of the large protein container. The final lab
sample will be 100 grams. What is your lab
doing? Bad sample = bad data.
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Take Away Points
 There is more to choosing a CMO than just getting a
quote and checking their flashy website
 Even the nicest facilities I have been inside of had
some raw materials that would never be considered
compliant by FDA or methods that were not valid
 Many ingredients are very hard to characterize and
because you must have specifications you must be
certain to assure material identity
 How samples are taken for laboratory testing is the
first critical control point in the ingredient evaluation
process. Bad sample technique = cGMP violations
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Take Away Points
 CMO’s run the range from scumbags in rat infested
warehouses to sincere and diligent first class facilities
with great talent and skill
 The more you to do ensure your products are made to
compliance with cGMP’s and to your product
specifications, the less liability and exposure you have
 When you do not know how to do something, you
should have trusted partners- a good CMO will work
with you to help establish specifications and other
necessary documents or bring in an expert to help
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Take Away Points
 Always have outside evaluation on a CMO by qualified
experts (independent auditors) because it is your
reputation and company that is at risk
 It is not about mistrust, it is about due diligence and
making good business choices
 In the nearly 20 years I have been working with DS
products, I have seen plenty of well intentioned CMO’s
and retailers with private label products in serious
trouble
 Work with trusted partners and trust nobody (within
reason)
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Take Away Points
 Remember, FDA considers EVERYONE involved in the
production, packaging, testing, holding and
distribution of your product to be an extension of your
company
 You are ultimately responsible for all of your partners
actions so choose partners that will work with you
 CMO’s and CRO’s work for you and that means that
they should support you in an FDA inspection
 Partners not willing to do this are not partners you
want to work with
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The Good News
 The DS industry continues to grow even during the
economic downturn
 More and more doctors and consumers are using DS
products to maintain health
 Soon, most insurance companies will start covering
supplements that are essential to preventing disease
(such as a supplement program for metabolic
syndrome)
 There is more technology and resources than ever
before to help you succeed in the industry
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Finally
 While your CMO and CRO work for you, we all work
for one common goal (or at least we should)
 That goal is to provide high quality dietary
supplements made in compliance with the cGMP’s to
the consumers that will buy and use them
 If we all do our job right and you make good products
that help consumers, the recipe is win-win-win for all
involved
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THANK YOU!
Milo helps with research
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