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QUALITY ASSURANCE
A Critique of the Standardized Information on Dietary
Ingredients Protocol, Part I
Rick Liva, ND, RPh
Disclosure: Dr Liva is the president, CEO, and director of Quality
Control and Quality Assurance at Vital Nutrients, a company certi-
fied by the Natural Products Association for current Good
Manufacturing Practices.
Editor’s Note: This is the first of a 2-part article. The second part will
run in the next issue, April-May 2010 (IMCJ. 2010;9.2).
he Standardized Information on Dietary Ingredients (SIDI)
T Protocol was developed by the Standardized Ingredient
Information Protocol (SIIP) Working Group, a joint trade
association effort with participants representing both dietary
supplement (DS) ingredient suppliers and finished product man-
ufacturers. Members of the working group include the Council for
Responsible Nutrition (CRN), the American Herbal Products
Association (AHPA), the Natural Products Association (NPA), and
the Consumer Healthcare Products Association (CHPA).
The objective of the working group is to develop standard-
ized guidelines and protocols that suppliers of vitamins, miner-
als, botanicals, and other dietary ingredients can voluntarily use
to help convey relevant and required information to finished
product manufacturers that make capsules, tablets, liquids, etc,
from these raw ingredients. The guidelines are intended to be
both comprehensive and flexible so as to apply across all prod-
uct categories. The reason for the guidelines is to address the
prevailing need for communicating information in a standard-
ized manner, effectively reducing paperwork and resources cur-
rently dedicated to this process.
The SIDI protocol achieves 3 main functions:
1) The program integrates information on raw sourcing for
dietary ingredients (from suppliers or their brokers and/or dis-
tributors; hereinafter just referred to as suppliers) into volun-
tary, standardized forms (templates), thereby eliminating the
need for each manufacturer to have its own questionnaire to
certify a supplier;
2) through these templates, the program defines the minimum
type and scope of information that should be covered; and
3) these templates provide a forum for suppliers to develop
their own dietary ingredient data sheets (DIDS) to be sent to
manufactures in lieu of answering disparate questionnaires from
each manufacturer.
The protocol provides 3 templates: Botanical Materials, Non-
Botanical Materials, and a Site Quality Overview Data Sheet.
34 Integrative Medicine • Vol. 9, No. 1 • Feb/Mar 2010
SIDI Documents
• Various documents on the Standardized Information on
Dietary Ingredients (SIDI) program can be found at
www.ahpa.org/SIDI/documents.html.
• The Standardized Information on Dietary Ingredients
(SIDI) Protocol can be found at www.ahpa.org/SIDI/
PDFs/SIDIProtocolV2.1Feb08.pdf.
Though SIDI’s goals are both much needed and well inten-
tioned—my hat is off to the SIIP Working Group who has
worked so diligently and hard to make this come about; it was
surely no easy task—I ask that before you read further you
remember the words of one of my colleagues: “Paper never
refuses ink.” In other words, people can say whatever they like
on a piece of paper because, in the end, the information will
most likely be accepted at face value—rarely does the recipient
spend time validating the information given, and, hence, nobody
is the wiser. In the vernacular: It’s often assumed that everything
is cool and as it should be because the paper says it’s so.
A Look at FDA Regulations
To best understand SIDI, let me give some background on
the June 2007 US Food and Drug Administration (FDA) Dietary
Supplement current Good Manufacturing Practices (cGMPs)
regulations. The regulations are laws subject to legal penalty if
not followed by DS manufacturers.
FDA’s definition of quality per the cGMP regulations means
that a dietary supplement consistently meets established specifi-
cations for identity, purity, strength, composition, and limits on
contaminants of raw materials as well as that it has been manu-
factured, packaged, labeled, and held under conditions to pre-
vent adulteration. Since SIDI deals only with the first half of
these requirements—specifications for identity, purity, strength,
composition, and limits on contaminants of raw materials—
that’s all I’ll be addressing in this article (so nothing on finished
products). SIDI also addresses labeling and regulatory informa-
tion as it relates to raw materials, but I won’t delve into that
either until Part II.
Although the FDA’s definition of quality for raw materials
sounds neat and tidy, there are 3 glaring omissions: 1) To date,
the FDA has established only a requirement for mandatory iden-
tity testing of each incoming batch of material—but it has given
no specifics (and very, very little guidance) on how to meet the
quality requirements for purity, strength, composition, and
limits on contaminants of raw materials. 2) The final FDA DS
Liva—Quality Assurance
cGMPs do not (preposterously) apply to ingredient suppliers.
Thus, the responsibility for ensuring the quality of dietary ingre-
dients falls on the finished product manufacturer rather than the
ingredient supplier. 3) Since the FDA has given no specifics on
how to meet the quality requirements for purity, strength, com-
position, and limits on contaminants of raw materials, the exact
specifications are set by each individual manufacturer itself and
are open to no end of interpretation and fiddling.
FDA quite grievously missed the boat on all 3 of these
points—and more besides; to see detailed information, please
see my article “New FDA cGMPs for Supplements: Smoke or
Substance?” (IMCJ. 2007;6.5:28-32) as well as an article by
Joesph Pizzorno, ND, in this same issue, “FDA’s Natural Product
cGMPs—A Missed Opportunity” (IMCJ. 2007;6.5:8-10).
To belabor the last point: Although FDA regulations revolve
around setting specifications for DS raw materials and finished
products, the exact specifications are determined by individual
manufacturers who are provided no standardized requirements.
That is to say, the rule requires that manufacturers, not the FDA,
define quality specifications for their products—and those
specifications can (with very few exceptions) be as loose or as
tight as determined by each manufacturer. The law simply
requires the manufacturer to define the specifications for iden-
tity, purity, strength, composition, and limits on contaminants
and to make certain that the processes in place guarantee that
the finished products meet those specifications.
It seems pretty obvious that the regulations are extremely
weak since FDA gives no guidance as to the minimum specifica-
tions that must be met. Ergo, 1 DS manufacturer can set mini-
mal specs that it decides will comply and another can set a
comprehensive spec that actually does cover all the necessary
bases. Unfortunately, however, there is a financial incentive to
set minimal specifications because it will cost less money over
time to meet them. And no one will really be any the wiser,
because the manufacturer has followed the letter of the law.
In specific, the FDA regulations state the following. Note
that identity is the only required test1:
Subpart E § 111.75 What must you do to determine
whether specifications are met?
Before you use a component [also known as a raw
material], you must:
(1) Conduct at least one appropriate test or examina-
tion to verify the identity [author emphasis] of any
component that is a dietary ingredient; and
(2) Confirm the identity of other components and
determine whether other applicable component speci-
fications established [are met]. . . .
To do so, you must either:
(i) Conduct appropriate tests or examinations [this
means for each lot received]; or [if you are not going to
test every lot, you can do the following]
Liva—Quality Assurance
(ii) Rely on a certificate of analysis from the supplier of
the component that you receive, provided that:
(A) You first qualify the supplier by establishing the
reliability of the supplier’s certificate of analysis
through confirmation of the results of the supplier’s
tests or examinations;
(B) The certificate of analysis includes a description of
the test or examination method(s) used, limits of the
test or examinations, and actual results of the tests or
examinations;
(C) You maintain documentation of how you qualified
the supplier;
(D) You periodically re-confirm the supplier’s certifi-
cate of analysis; and
(E) Your quality control personnel review and approve
the documentation setting forth the basis for qualifi-
cation (and re-qualification) of any supplier.
As written, these regulations are nonspecific and leave
much room for cheating or doing the very least and falling short.
Consider the following:
(2) (i) above states that if you are going to follow regulations
for each lot received, you need to “conduct appropriate tests or
examinations.” The problem is, as explained before, these
“appropriate” tests and examinations are never specified so are
thus determined by each manufacturer.
If you are not going to test each lot received, so are therefore
going to do skip lot testing, there are also serious deficiencies in
the regulations.
(2) (ii) (A) above states that you must confirm the results of
the supplier’s tests or examinations listed on the certificate of
analysis (COA). The begged questions are 1) what are the mini-
mum tests or examinations that need to be performed for each
type of material and 2) since no specific tests are required, how
are you to determine if the tests/examinations that the manufac-
turer chose to do are any good? The answers: For #1, the DS
manufacturer gets to choose because no FDA guidance is pro-
vided; for #2, unless you have a qualified lab person to ask, you
aren’t going to know.
There is also a third question: How many times should said
tests/examinations be performed (to gain confidence in the sup-
plier) before you can start skip lot testing? No guidance is pro-
vided. How often do you skip? No guidance is provided. This is
(obviously) extremely unclear and left wide open.
(2) (ii) (D) states that “You periodically re-confirm the sup-
plier’s certificate of analysis.” I ask again, “How often?” No guid-
ance is provided. So will it be every 2, 3, 4, 5, or 10 years? Who
knows how the FDA left that important detail out! But because it
did, there is a lot of wiggle room for doing the least amount of
due diligence possible.
Another problem is that (2) (ii) (B) states that the COA
should include “a description of the test or examination
method(s) used, limits of the test or examinations, and actual
results of the tests or examinations.” In reality, most COAs don’t
Integrative Medicine • Vol. 9, No. 1 • Feb/Mar 2010 35
 include this information. Although this should technically mean
that a manufacturer shouldn’t do skip lot testing because 1 of the
COA requirements is not met, the question remains whether the
manufacturer actually adheres to this requirement—since, in
reality, so few COAs include it and a large number of manufac-
turers do skip lot testing.
Life Without SIDI
Typically, quality-minded companies send supplier certifi-
cation questionnaires asking a myriad of questions designed to
elicit information regarding a supplier’s quality practices.
Sadly, I’ve always felt that most of these questionnaires are yet
another useless paper tiger for 2 reasons: 1) as with SIDI, sup-
pliers can say whatever they want and the sender is still clueless
as to the veracity of the info (again, “paper never refuses ink”),
and 2) if your supplier is itself a broker or distributor that is
getting ingredients from many places (as is often the case with
products such as vitamins, amino acids, minerals, etc), the bro-
ker or distributor you use may change the supplier it used for
previously “certified” material(s) and never tell you. So, even if
your broker/distributor provides accurate and complete infor-
mation today, next week you may be getting raw material that
originated from a different supplier, thus negating the original
information sent.
It is due to all these shortfalls that I created “The IMCJ
Supplement Quality Audit Form.” (This can be found at www.
imjournal.com. In the menu bar, click on “Resources and
Content.” The second listing on the drop-down menu is “Quality
Assurance.” On the corresponding web page, you will find the
form.) The benefit of this form above others I’m aware of is that
it directs suppliers to answer a series of questions but also asks
for documentation that helps provide verification that they are,
in fact, doing what they claim to be doing. The questionnaire
asks for proof as well as yes-or-no answers. It is easy to answer yes
to a question on a form; it is more difficult to provide proof.
SIDI Shortfalls
The SIDI program concept is to have every supplier use the
same template so everyone is providing the same level of com-
prehensive information to the manufacturer. While that may be
very useful (because it might save both sides time and energy,
which equals dollars) it may not be practical for numerous rea-
sons. The 5 main reasons are as follows:
1. The program is voluntary and not enforceable.
2. Many of the questions on the template are broad and
open ended, leading to potentially inadequate answers.
(This occurs even on the example template filled in by
SIDI—next issue I will show you this as I go over an
example of a completed SIDI Botanical Template.)
3. It does not specifically include all the categories of
information that it should. (Again, next issue I will give
comments on what the templates are missing.)
In regard to both 2 and 3, we hope that the SIIP Working
Group will consider upgrading the templates.
36 Integrative Medicine • Vol. 9, No. 1 • Feb/Mar 2010
4. Rather surprisingly, the appearance and format of the
template provided to the manufacturer is left to the dis-
cretion of the ingredient supplier—SIDI only “strongly
recommends” that the format and organization of the
provided SIDI template be followed. I have a major
problem with this, as the template can be changed by
the supplier, which could lead to confusion and incon-
sistency as well as undermine the “template” nature of
the program. What is the point of having a “template” if
it is left so flexible?
5. And the most major drawback, as I stated earlier, is that
the templates are merely ink on paper—how does any-
one know that what is written is true? No one knows
without the DS manufacturer verifying much of the
information provided. Hence, the templated SIDI info
that suppliers provide is just the tip of a very large ice-
berg. Why? Because even after a manufacturer is handed
a filled-out SIDI template, the information still has to be
vetted through the same scientifically valid comprehen-
sive testing I write about each issue.
SIDI is a good first step, but the trade groups that put it
together would be wise to tackle 4 much more monstrous prob-
lems befouling the industry: 1) a paucity of scientifically valid
methods and standards to test these materials, 2) a paucity of
trustworthy labs to use those methods and standards, 3) a gov-
ernment that does not set quality standards and enforce compli-
ance of those standards on the labs that test these products, and
4) as shown above, the FDA GMPs’ provision of very wobbly
guidance, if any, for what testing is “required” under the regula-
tions to vet a dietary ingredient or finished product or to certify
a dietary ingredient supplier’s COA for a specific material.
Beyond these limitations that are critical enough to derail
any of the good the SIDI program hopes to do, there are numer-
ous other shortcomings:
1. Suppliers can just say, “No, I’m not going to be part of
the SIDI program.” And, for now, that is that. Although,
to their immense credit, the SIIP Working Group has
started the ball in motion to have such a program be a
mandatory part of running a DS company.
2. I mentioned in the beginning of this article that the rea-
son for the SIDI guidelines is to “address the prevailing
need” to reduce paperwork and resources currently ded-
icated to the process of determining supplement quality.
In the end, however, SIDI could cost the ingredient sup-
pliers more time and money to develop, write, and pro-
vide the comprehensive amount of information the
templates require. The reason is simple enough: Say you
are a supplier with hundreds of raw materials. You
would have to pay to have someone to write, compile,
and store all of the required SIDI documents—no small
task for that many raw materials. In addition, you
would have to keep someone on the payroll to revise
documents as needed and to prepare new documents as
new materials come on line.
Liva—Quality Assurance
 3. Along these same lines of workload and resources, any
changes to a product would require updating of all the
SIDI forms, whereas now the supplier only has to change
its COA—an inherently simpler process.
4. And an insurmountable limitation: Although I wish this
wasn’t the case, in my experience, most ingredient sup-
pliers keep their COA and Specification Sheets vague
and simple so they don’t have to reveal potentially dam-
aging information such as inadequate testing or the
presence of toxins or chemicals.
Case in point: In the past 2 years I rejected 3 batches
of diindolymethane (DIM) because of high levels of ben-
zene (500-600 parts per million, ppm). The presence of
benzene was not even listed on the COA. I found it
because we test all materials for 51 solvents—for the
exact purpose of catching contaminants not revealed on
COAs. The truth is, if the supplier were to reveal this sol-
vent residue on the COA at that level, nobody would buy
it due to its toxic nature. If it chose to honestly follow the
SIDI protocol of supplied information (and it is doubtful
that it would do so then when it did not do so now), it
would have to clean up the product to eliminate the ben-
zene, which would cost it money and time—2 costs it
doesn’t have now. I can only surmise that this economic
disadvantage would keep them out of the SIDI program.
To continue the story, I found a new supplier of
DIM. Two batches in the past 2 years passed solvent res-
idue testing with no problems. Then, just recently, the
third batch showed 280 ppm of chlorobenzene, a less
toxic solvent than benzene but one that, in my opinion,
doesn’t belong in a “health” supplement. It also was not
declared on the COA—yet, as I found out, it is routinely
used in the manufacturing process to whiten the materi-
al, and then the supplier doesn’t spend the required
time to blow it off in the drying phase. So once again, if a
supplier chose to honestly follow the SIDI protocol of
supplied information, it would have to clean up the
product to eliminate the benzene, which would cost it
money and time—2 costs it doesn’t have now.
It should also be noted that, without the testing I
did, neither the SIDI forms nor the FDA cGMPs would
have caught either issue.
5. Some of the information that the templates ask the sup-
pliers to provide is possibly of a proprietary nature
(intellectual property), such as a method of analysis or
an extraction or production process.
The SIDI Program’s Claimed Promises
Even with the limitations above, the SIDI program prom-
ises that
• increased standardization of any process has the poten-
tial to reduce risk of error and
• a more organized system of vendor qualification could
increase the safety and quality of products.
Liva—Quality Assurance
For both, I don’t see how, just because I’m putting more
information on a piece of paper that is not required to be veri-
fied, this is going to reduce risk of error or increase the safety and
quality of products. It just offers a starting point, while the stated
goal of certification is accomplished only by scientifically valid
comprehensive testing to vet what is written. If asked, anyone
would agree that the safety and quality of dietary supplement
products is paramount. However, the SIIP Working Group
doesn’t give specifics as to how the program could increase
safety and quality (they just allude to it). It would be useful for
them to provide detailed, specific information on the points of
safety and quality.
Hence, I would like to see the SIIP Working Group give sug-
gestions and guidelines for minimum (but adequate) scientifically
valid testing requirements for botanical and nonbotanical materi-
als that a DS manufacturer can use to vet a supplier’s information.
Since the FDA has chosen to be vague, why can’t the industry step
in and provide quality testing guidance parameters for all DS
manufactures to follow? It would certainly help to diminish the
confusion as to what might meet FDA requirements.
As mentioned, next issue I will discuss the sample Botanical
Template filled in by the SIIP Working Group and offer sugges-
tions as to what would make the templates stronger.
The intent of the SIDI protocol is clearly positive and of sig-
nificant value for dietary supplement manufacturers. I suggest
that it needs a more detailed structure that is not variable and has
mandatory compliance if a supplier is willing to adopt it.
Rick Liva, ND, RPh, graduated from Temple University School of Pharmacy in
1975 and National College of Naturopathic Medicine in 1982. He is the manag-
ing physician at the Connecticut Center for Health, located in Middletown and
West Hartford. Dr Liva is a founding member of the American Association of
Naturopathic Physicians and past president of the Connecticut Society of
Naturopathic Physicians. As mentioned in the disclosure, he is also the presi-
dent, CEO, and director of Quality Control and Quality Assurance at Vital
Nutrients, a company certified by the Natural Products Association for current
Good Manufacturing Practices.
Reference
1. Department of Health and Human Services. US Food and Drug Administration.
§111.75 What must you do to determine whether specifications are met? Current
Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding
Operations for Dietary Supplements: Final Rule. College Park, MD: Food and Drug
Administration; 2007:773.
Integrative Medicine • Vol. 9, No. 1 • Feb/Mar 2010 37