1. Is
Cedar Bear Naturales® owned by an herbalist? If so, what
are the advantages to an herbal products company being owned by herbalists?
2. Is
the "Genuine TincTract® Made" process really the genuine one,
and if so, what about the copy-cat attempts or those claiming to be a "Plus" version of a TincTract process?
3. Are
herbs really as safe as is claimed?
4. I've
read, seen on TV and been told that herbal and dietary supplements
are unregulated. Is this true?
5. Does Cedar Bear Naturales® comply with FDA, FTC and the 1994 Dietary
Supplements Health Education Act (D.S.H.E.A.)?
6. What
is the difference between "Alcohol-Free" and "'true'
Alcohol-Free" products?
7. Is glycerin really as good or better than alcohol in the making of
liquid herbal products and preserving them?
8. Is glycerin as safe a preservative as alcohol? And if so, what is
the preserving differences between the two?
9. What
do you feel is the most intrinsic problem inherent in an alcohol produced
product that is not a problem for a glycerin produced product?
10. Referring to dynamic microscopy analysis of alcohol versus glycerin's cellular absorption, some are interpretating the observational results and claiming that alcohol has better cellular penetration than glycerin does. Is this true?
11. Have
Cedar Bear Naturales® products been subjected to efficacy studies?
12. What
are the quality standards upon which Cedar Bear Naturales® operates?
13. What
is the difference between a cGMP manufacturing standard and the cGMP/HACCP
compliant manufacturing standard used by Cedar Bear Naturales™?
14. With
Cedar Bear Naturales™ being fully Kosher certified, what benefit
does this add to your already existing cGMP/HACCP compliant standards?
15. Cedar
Bear Naturales™ states that its products are based on a standardized 'whole'
herb poly-constituent approach, not an isolate/fractionate mono-constituent
phyto-pharmaceutical driven 'Standardized' approach. What's the difference,
and is one better than the other?
16. Cedar
Bear Naturales® products sometimes appear to cost more than other
glycerite based products, but when the per-dose cost is taken into
consideration this appears to not be the case. Could you explain this?
_______________________________________________________
1. Q.
Is Cedar Bear Naturales® owned by an herbalist? If so, what
are the advantages to an herbal products company being owned by herbalists?
A
(Brief). Yes, two herbalists are owners of the company - LoR. Caarl
(L. Carl) Robinson (a clinical & formulary herbalist) and his wife and business
partner, Jhoane Robinson (a literary & traditional herbalist).
The advantages to this are that we know herbs, are expert at compounding multiplex formulas, how to effectively
and safely use them, what the clinical and consumer based ramifications
are, and are able to work with store and clinic staff closely who
often are herbalists themselves.
A
(Detailed). Yes, we are owned by two herbalists - LoR. Caarl (L. Carl) Robinson
(a clinical & formulary herbalist) and his wife and business partner,
Jhoane Robinson (a literary & traditional herbalist). In fact,
Cedar Bear Naturales® (and its former iteration) was originally
co-founded by Mr. Robinson and a former president of the American
Herbalists Guild, Steven H. Horne. The advantages to an herbal products
company having owners who are clinical-based herbalists is that these individuals bring
years of study, and clinically based experience and observation to
the products that are developed, formulated and manufactured for sale.
This means products are not made just to meet the current fad or newest
idea, but instead are based on solid clinical based evidence, continued
practitioner use, and socially relevant considerations aimed at benefitting
the consumer, society and our living planet in a sincere legacy oriented
way. The world is full of confused health values and questionable
vanity based products that's rife with amoral marketing expediency.
As a general rule, herbal products companies founded and owned
by experienced herbalists who administer a company's product offerings consistently produce products that are meaningful
and relevant to the times, possess a quality that bespeaks competence, cares for all living creatures and the planet,
with the core values of the company and its founder reflected in the finished products that consumers depend on year after year. This
is further borne out in that the company is a member of the American
Herbal Products Association (AHPA), the company and founder/president are a member of the Herb Society of America (HSA), and the founder/president
of the company is a member of the American Herbalists Guild (AHG).
2. Q.
Is the "Genuine TincTract® Made" process really the genuine
one, and if so, what about the copy-cat attempts or those claiming to be a "Plus" version of a TincTract process?
A
(Brief). Yes, Cedar Bear Naturales™ utilizes the only multi–generationally enhanced TincTrac®
technology approved and endorsed by its originator, LoR. Caarl (L. Carl) Robinson. The federally registered
trade name "TincTract®" is owned by him as well. All
"Genuine TincTrace® Made" products are made using cGMP/HACCP
compliant and Kosher certified 6th generation proprietary trade
secret commercial enhancements and improvements to the TincTract®
process, while the copy-cats and those claiming to be a "Plus" version of a TincTract process utilize only the 1st generation 'home
kitchen' based process (reflected in their inferior quality, unsophisticated taste anomolies, and lack of verifiable cGMP and HACCP standards). The copy-cat
attempts claim to be the same or more, even going so far as to use the term "Plus" when in fact they don't even use all the aspects and
steps outlined in the core "Genuine TincTract® Made" technology, and none are fully cGMP/HACCP
compliant or Kosher certified by an OU (Orthodox Union) recognized kosher certifying agency.
A
(Detailed). Yes, Cedar Bear Naturales™ utilizes the only TincTract®
technology approved and endorsed by its originator LoR. Caarl (L. Carl) Robinson. Further, the trade
name TincTract® is federally registered with the United States
Patents and Trademarks Office in Washington, DC, under Mr. Robinson's
name exclusively (exclusive use rights are Cedar Bear Naturales™
to use). The TincTract® brand processing technology as carried
out by Cedar Bear Naturales™ (and its divisions/units) is the only one
that uses ALL of the principles and practices as detailed in the TincTract®
philosophy (and its resultant technology) as originated by Mr. Robinson.
In an attempt to appear 'genuine' other companies have gone so far
as to give their pseudo copy-cat versions of the process a "Plus"
designation. This has left many, both within Cedar Bear Naturales™ and outside Cedar Bear Naturales™, to ask the question, "How can it
be a "Plus" since all aspects
and primary steps of a basic TincTract® based process are not even being utilized in the first place?"
Add to this the fact that over the years since the 1st generation
TincTract® process was first developed, Mr. Robinson has continued
to move the TincTract® process way beyond that 1st generation
'home kitchen' applications (that all others refer to, since that
is all that has ever been published, taught or made public) to its
cGMP/HACCP compliant & Kosher certified 6th generation of
proprietary trade secreted commmercial enhancements and improvements.
These proprietary trade secreted generational enhancements are evidenced by both their patentability and
by the super potent, consistent quality and efficacy,
and best tasting liquid herb glycerites unmatched by any others. Analysis,
lab tests, clinical pilot studies, decades of practitioner provings,
and consistent converting of stores, clinicians, practitioners and
accounts to our products when the comparisions to others is made all
bears this out. Even though our ounce-per-ounce MSRP is slightly higher than
the competition (often the same or less in many instances), our pricing actually proves to be more economical
when objective head-to-head dosing/efficacy/compliance factors are
weighed into a cost/value assessment of Cedar Bear Naturales™
products compared to the competition. (For a more detailed explanation
of this latter point refer to the last Q/A at the end of this page.) Our Kosher certification is also recognized by OU, OK, Star K, KOF-K and KSA, the 5 biggest in the kosher certifying world.
3. Q.
Are herbs really as safe as is claimed?
A
(Brief). As a general rule reputable companies that are cGMP compliant
(even better, if alcohol-free glycerite producing companies are also HACCP compliant) and use the safe herbs
as listed in the current 'Herbs of Commerce' publication will produce
herbal products that are safe and beneficial. For example, if a compounded formula contains the herb Lobelia (Lobelia inflata) which is not considered G.R.A.S. and is not listed as safe formost product liability insurance purposes, then such a product and the company producing that product would be considered to NOT be conforming to cGMP standards and be considered as uninformed in their compounding formulary knowledge and expertise. Here we are talking of 'whole' poly-constituent based herbal products, not the fractionate/isolate mono-constituent based phytopharmaceutical Standardized herbal products which are too often NOT safe for dietary/nutritional based supplemental use. Also consider the following –
nutritive poly-constituent based herbs and many spice herbs are considered very safe,
even in large amounts. As herbs progressively possess stronger properties they should
be used in progressively lesser amounts and only for shorter periods of time. Non-chemical
based solvent liquid extracts (such as glycerite produced products) are typically very safe, but should still be used under parental direction where children's use are concerned. And
remember, herbs are highly concentrated foodstuff, even in their natural
unprocessed state, therefore they should be treated as supplements
and taken in dosages and daily amounts accordingly.
A
(Detailed). That depends on three things. One, is the actual herb
being referred to where safety is concerned. Two, is the form (how
processed) of the herb being referred to. And three, how is the herb
actually being utilized. Concerning point one, as with all things
in the world, the safety and danger of something is predicated on
how much of and how something is used. Herbs are no different. There
are categories of herbs as relates to their relative safety. Category
1 and 2 are considered very safe herbs, even in large continious consumed
amounts. Category 3 herbs are safe when used ocassionally and in moderate
doses, but can become problematic when used in too high a dose, for
too long or for the wrong application. Category 4 herbs are considered
toxics that can pose real and imminent danger, and should only be
used in dose managed amounts and under the direct care of a qualified
clinical herbalist or physician adequately trained in clinical herbalism.
(One example of a Category 4 herb is Lobelia (Lobelia inflata). If a compounded formula contains the herb Lobelia (Lobelia inflata), which is not G.R.A.S. and is not listed as safe for most product liabiity insurance purposes, then such a product and the company producing that product would be considered to NOT be conforming to cGMP standards and should be viewed as being uninformed in their compounding formulary knowledge and expertise. Cedar Bear Naturales® products contain mostly Category 1 and 2
herbs. Concerning point two, many herbs contain compounds that in
their whole ratio intact poly-constituent state to other secondary and tertiary compounds
are safe, even when used in larger sustained amounts, however, when
these singular compounds are phytopharmaceutically mono-constituent 'Standardized'
to unnaturally high concentrations in a finished product these formerly
safe compounds (previously found as part of complex poly-constituent compounds) now become problematic in a real drug-like fashion,
as was the case with the "ephedra problem." Products derived
from 'whole' herb ingredients that aim at maintaining poly-constituent
synergy and ratio integrity are definitely the safest, and most closely
meet the definition for a 'dietary' supplement as embodied in the
intent of D.S.H.E.A. and as overseen by FDA. Concerning point three,
when the accepted use for an herb has been established and proven
over millennias, and then on hokie science it is used for something
else that is totally outside of established 'traditional' use, then
the possibility for an herb being misused, mis-marketed and misrepresented
looms big, with very negative consequences. Again, ephedra was the
most important example of this problem in our current lifetime. Based
on millennias of established traditional use Ephedra is best used
in its 'whole' derived form (see point two) and only should be used
for respiratory indications in small amounts with other herbs (ephedra
is not taken alone in traditional herbalism) and not as a thermogenic/weight
loss aid in combination with added caffene (see point three). Cedar
Bear Naturales® products are developed and formulated with equal
consideration given to efficacy AND safety.
4. Q.
I've read, seen on TV and been told that herbal and dietary supplements
are unregulated. Is this true?
A
(Brief). Absolutely not! Though we are not regulated to the same 'critical' level drug companies are (because we don't make highly chemicalized mono-constituent pure isolate based drugs from artifical substances) our industry is all the same regulated, including inspections and stringent rules of compliance, by (depending of the State) local, county, state and federal regulatory agencies. Fact is, there are still more areas we are regulated on than the drug companies are. Don't believe us? Click here to get the facts. In fact, the FDA now has published stringent cGMP standards (current Good Manufacturing Practices) our industry is now required by law (previously, compliance with a cGMP standard was voluntary) to comply with aimed at assuring consistent product quality and safety for the consumer. Cedar Bear Naturales™ has been in voluntary compliance with FDA recommended cGMP standards for a number of years prior to FDA publishing its final binding cGMP rules and regulations for our industry, that we were already fully compliant with upon its publication.
A
(Detailed). Absolutely not! the herbal and dietary supplements is
more regulated than even FDA has been forthcoming to admit. For a
real eye opener, click here to get the facts and see that our industry has more areas we are regulated on than the drug industry is.
To say (or believe) we're not regulated is simply untrue and misleading.
Remember, as a herbal and dietary supplements industry we don't make,
distribute or sell 'drugs!' Therefore, our regulatory aspects should
be very different and not nearly as onerous as that for drug regulation.
That's common sense! Still, we're still more regulated than is generally known or acknowledged. (Admittedly, there are small 'cottage' or 'back-room' producers of herbal products that are small enough to be under the regulatory/FDA radar, and these are the companies one should be most concerned about... not the companies that comply with cGMP and HACCP standards, are quality certified (i.e. Kosher, NSF, etc.) and carry A.H.P.A. approved industry standard product liability insurance, etc.) We produce and sell nutritional based supplements,
that may have functional and structural enhancing benefits, but dietary/nutritional
all the same. Even so, FDA has published its stringent cGMP rules, regulations and standards for our industry of which all companies are required to now comply with. Cedar Bear Naturales™ was already in full compliance with the final legally binding cGMP rules and regulations upon their being published. As long as the food/herb based ingredients we process
and concentrate maintain the intrinsic polyconstituent profile and
do not concentrate a specific single constituent to unrealistically
high levels (which is in fact crossing over into becoming a drug,
or at least a pseudo-drug), in a finished product we can (and should)
only be considered to simply be producing food/herb products as 'general'
dietary based concentrates, only making the properties of a food or
herb more readily digestible and concentrated so as less can be used
than in the raw state, not too different from concentrated orange
juice when you get right down to it, which no one in their right mind
would ever equate with being drugs and needing to be regulated in
such an onerous fashion accordingly. Proper regulation we totally
agree with, but only when tailored to the context of that industry
and its businesses. Again, that's common sense!
5. Q.
Does Cedar Bear Naturales® comply with FDA, FTC and the 1994 Dietary
Supplements Health Education Act (D.S.H.E.A.)?
A
(Brief). Yes. We comply with all current FDA, FTC and D.S.H.E.A. regulatory
standards required of our industry in general and our business specifically. We do not leave our published information policy in the hands of 3rd party individuals or companies, but instead handle, reveiw and approve all published and disseminated information in-house thereby guaranteeing compliance with all local, State and Federal rules, regulations and laws concerning product labeling and product claim issues.
A
(Detailed). Yes. We are a FDA registered facility and operation and all information that goes on product labels, printed and media material, including product claims, are crafted, reviewed and approved in-house only with the input of government & trade association publications on the issue and qualified legal counsel. The
core of regulatory compliance for the herbal products industry is
the D.S.H.E.A. of 1994. cGMP standards, product labeling and improper product
claims are issues that come under direct jurisdiction of FDA, and
so long as no medical, cure or diagnosing claims are made for a product
that product is considered a dietary supplement and outside FDA jurisdiction concerning product claims. FTC's role has to
do with unsubstantiated claims as relates to product claims, advertising, promotionals
and marketing matters. Today, FDA and FTC work closely together where
product safety and claims infractions are concerned. We are compliant
with all regulatory standards both as to State and Federal law. For
example, regarding the label format/information regulations for product
labels, we chose at the time we implemented full label compliance
not to take advantage of the exemption from this regulation that exists
for smaller companies, and instead chose to put the consumer first
and provide them with the necessary information this regulation is
intended to provide for consumers making informed decisions concerning
our products. All our literature, media, labels, etc. are D.S.H.E.A.,
FDA and FTC compliant as well.
6. Q.
What is the difference between "Alcohol-Free" and "'true'
Alcohol-Free" products?
A
(Brief). 'true' Alcohol-free means that no alcohol is used at any
time whatsoever in the making of our products.
A
(Detailed). Many other companies products say 'Alcohol-Free' on their
labels, meaning that they are free of alcohol in the finished product
(actually a small percentage always remains), however, the product
was made using alcohol. The problem is that many companies don't divulge
this fact to their consumers conspicuously on the product labels with
statements such as 'This Product Made With Alcohol,' or 'Alcohol Removed.'
The term "'true' Alcohol-Free" means that no alcohol has
ever been used in the making of CBN™ TincTract® products...
not ever!
7. Q.
Is glycerin really as good or better than alcohol in the making of
liquid herbal products and preserving them?
A
(Brief). We believe so, as it's not even an arguable subject given the research
(foods, medical, industrial), published texts on the subject, well
established history of glycerin's uses in the foods, beverage and
confectionary industries, and our own years of experience that is backed by independent 3rd party lab analysis that validates our assertion that glycerin
really is as good and in many instances better than alcohol.
A
(Detailed). Absolutely! But only if a company thoroughly understands
the nature of glycerin and works with it accordingly, since the rules
for alcohol extraction standards that are typically imposed on glycerin
extraction methodologies simply do not work for glycerin and so glycerin
must be dealt with from a completely different perspective to that
of alcohol. There is published texts and scientific studies
on the solvent/extractive and preservative qualities of glycerin compared
to that of alcohol. The preservative mechanisms for each are very
different, but both are highly effective in their own right. Glycerin
is much more versatile and is listed as possessing the highest and
most versatile solvent qualities known, exceeded only by water itself
(due only to water's ability to take on the 3 forms of matter). Glycerin
is much more widely used in the food and beverage products industry
for a myriad of uses than alcohol, and whereas alcohol preserves (actually
steralizes) through a denaturing and inert rendering sterile action
that nulifies the biological viability of many constituents, glycerin
is a true preservative in that it preserves a product without denaturing
or rendering inert the biological viability intrinsically found in
botanicals. Both as an extractive agent and a true constituent preserving
agent glycerin excells alcohol on numerous counts. In fact, we have
an independent 3rd party lab analysis that verifies the extractive
potential of a Cedar Bear Naturales® TincTract® glycerite
process being 5 to 7 times more effecient than a 50:1 pharmaceutical
grade high pressure gas extraction (HPG) of a botanical (it was for
Cordyceps, one of the hardest materials to liquid extract from known).
8. Q.
Is glycerin as safe a preservative as alcohol? And if so, what is
the preserving differences between the two?
A
(Brief). Yes, glycerin is as safe a preserving and aseptic agent as
alcohol when used according to well defined standards for doing so
(as Cedar Bear Naturales® does). The aseptic actions for the two
work very differently – alcohol works through a decidedly 'septic'
action (i.e. bacterioseptic, etc.) whereas glycerin works through
a 'static' action (i.e. bacteriostatic, etc.). Both septic and static
activity are very efficient purity/safety and preserving actions.
A
(Detailed). Yes, glycerin is as safe an aseptic agent as alcohol when
used in the proper amounts, especially when the glycerite product
is made according to stringent cGMP/HACCP compliant standards - like
Cedar Bear Naturales® products are. Our unique and innovative
TincTract® made glycerite products contain no added preservatives
or chemicals, have a listed 3 year expiration date and do not require
refrigeration after opening. Whereas alcohol attains product
safety through its steralizing action (cidal), glycerin attains product
safety through its preserving action (static). Alcohol outright kills
contaminant organisms through its stearilizing bacteriacidal action
whereas glycerin renders contaminant organisms inert by its hygroscopic
bacteriastatic (water depriving/desiccant) action. Problem is, where
the biological viability of enzymes, vitamins/co-factors and aromatic
components are concerned, alcohol's sterile action is all-inclusive
and non-discriminatory which means that it renders these components
inert and denatures them, whereas glycerin's preservative qualities
preserve the biological viability of these compounds while making
the product safe, making glycerin the preferred medium for extraction
and preserving where subtle therapeutic and important nutritional
and vitality aspects are concerned for a whole herb product. Fact
is, Cedar Bear Naturales® was the first liquid herbal product
to post a 3 year expiration on its product labels. We have samples
of TincTract™ herbal glycerites that are opened every 3 or 4
years and organoleptically analyzed for intrinsic quality and lab
safety analyzed for contaminant activity. In every instance the samples
have not precipiated or inverted and maintain their rich color (unchanged),
consistent aroma, taste and texture, with no contaminant activity
whatsoever..... after 20 years!
9. Q.
What do you feel is the most intrinsic problem inherent in an alcohol
produced product that is not a problem for a glycerin produced product?
A
(Brief). Even though an alcohol solvent may remove many constituents,
its intrinsic nature only serves to render many of those removed components
inert or denature them... so why remove them in the first place, even in a super-saturate fashion, if
they're no longer going to possess their former biological viability?
Glycerin possesses no inert rendering or denaturing properties, but
in fact preserves the biological viability of removed components and
constituents.
A
(Detailed). It's the denaturing and inert rendering character of alcohol
itself. It's natural to alcohol and cannot be changed, even for super-saturate type cencentrating processes. This is most
problematic for subtle therapeutic aspects and nutritionally supporting
biologically viable components in any herbal (and non-herbal) product.
On the plus side, alcohol actually possesses many qualities as an
extractive agent (solvent) that are very conducive to liquid processing
of herbs, especially for freshly harvested botanicals and resinous
compounds, but on the negating side of the issue alcohol still possesses
the intrinsic character of denaturing many important therapeutic qualities
of a plant's extracted aromatic components, and renders many enzymes,
co-factors and complex poly-compounds inert, often the very components
an alcohol process is seeking to extract. This effectively diminishes
the biological viability of the very components an alcohol extraction
is attempting to remove from plant matter. Even plant resins, which
alcohol is by far the better solvent for more efficient dissolving
of and putting into suspension, are themselves complex aromatic compounds
that alcohol's intrinsic characteristics ends up denaturing many aspects
of. Alcohol in solution with water also appears to possess a
higher REDOX than does glycerin in solution with water. A higher REDOX
means that a product will oxidize, particulate and invert faster than
one with a lower REDOX, meaning that a Cedar Bear Naturales® herbal
glycerite will sustain finished product quality longer on the shelf
than will an alcohol containing liquid herbal product.
10. Q. Referring to dynamic microscopy analysis of alcohol versus glycerin's cellular absorption, some are interpretating the observational results and claiming that alcohol has better cellular penetration than glycerin does. Is this true?
A
(Brief). Where internal tissues are concerned, no, it is not true, and given certain considerations the same for external tissues. First of all, what does this test have to do with the safe and efficacious 'oral' ingestion and effective "in-vivo" absorption of glycerites (glycerin based products) versus alcohol based products? None! Even so, the over simplistic intrepretation of alcohol possessing greater 'intrinsic' cellular penetration efficiency than glycerin under dynamic microscopy analysis is both flawed (from a scientific perspective) and highly assumptive and misleading. The reviewer intrepreting this test has not taken peripheral factors into consideration that heavily effect the outcome of the analysis, not the least of which the factors intrinsic to an isolated non-nerve system influenced in-vitro cell culture do not automatically comport to that for a complex nerve system connected in-vivo cellular system as naturally found in the body. Fact is, glycerin is intrinsically more compatable and readily absorbed into intact in-vivo living cells, while alcohol, due to its intrinsic nature, is less compatable with and not readily absorbed into the same cells. This is one of the most basic proven premises of medical chemistry regarding the pharma-dynamics of fluid chemistry and cellular physiology, especially concerning the oral cavity!
A
(Detailed). Concerning alcohol being better than glycerin's penetration into internal tissues, no, it is not true and given certain mitigating factors, the same applies to external tissues. This is a test whose results have actually been taken out of context and erroniously transposed to somehow have relevancy to where the 'oral' ingestion and absorption into intact in-vivo living cellular systems of a glycerite (glycerin based) product versus an alcohol based one is concerned. From a scientific perspective there is no relevancy between this particular in-vitro based test results and intact in-vivo living cellular dynamics. Regarding the assumption however, there has been misinformation floating both in print and on the web where a doctor is referring to a dynamic microscopy study regarding whether alcohol has better intrinsic cellular absorption than glycerin does. On first blush the results of this in-vitro test would appear to validate the premise that alcohol does have greater intrinsic cellular absorption than glycerin does as the alcohol appears to absorb quicker into a cell culture than when the same dynamic microscopy analysis is performed with glycerin. However, those intrepreting the test in the manner done are breaking one of the prime rules of microscopic studies. For the intrepretation to be considered valid and of scientific value, the peripheral factors must also be factored into the review of the results to arrive at an accurate intrepretation. What the reviewer/interpretor of the test appears to have not considered is that the intense light and heat caused by the microscope's lighting to illuminate the specimen has a direct physically altering effect on the alcohol sample by exponentiatingits already reactive and rarified nature (by driving the low volatility/low vaporizing index actions intrinsic to alcohol (i.e highly volatile and easily vaporized characteristics), even in low heat circumstances) thereby actively influencing the alcohol being more readily 'driven' into the cell cultures faster than if done in a more natural passive 'cold' state (which should have been the case for the test to be considered valid). Glycerin possess almost the complete opposite volatility and vaporizing indexes to that of alcohol, therefore the intense light and increased temperature upon the glycerin sample would have much less to no effect on the glycerin, thereby making it appear that it has a lower cell penetration action than alcohol, in the prior improperly induced dynamically influenced state, appears to have. Another problem with the interpretation of this test is that the reviewer(s)/interpretor(s) erroniously assume that an in-vitro result will have the exact same result in an in-vivo state, which is definatley not the case, especially where bad-science interpretation (or better yet, misinterpretation) of this particular microscopy testing protocol is concerned. When these primary and ancillary facts are factored into this particular mocroscopy-based test they mitigate the assumption made for the intrepretation that alcohol has better cellular absorption rates than does glycerin. One of the most well understood premises of tissue physiology concerning alcohol versus glycerin's effects on in-vivo complex nerve connected tissue systems is that alcohol's cellular uptake is actually blocked! This is due to alcohol's intrinsic contact-based contracting/drying effect on tissue, which is a primary contact action consistent with alcohol's initial sterilizing action, whereas glycerin is readily absorbed by cells (due to its possessing a softening/moistening effect). This is most profound where oral tissues are concerned. This is so basic that it is taught in most pre-med and 1st year pharmacy courses, often demonstrated in medical physiology labs. Alcohol's immediate action causes the constriction of and drying (via a dehydration modality) of oral tissues, thereby blocking absorption (with the same dehydrating/drying action seen throughout the body when ingested), whereas glycerin is a succulent that moistens oral tissues, thereby enhancing absorption. Isolated in-vitro cell cultures are devoid of nerve system driven sensory feedback, which if present (as it is in a normal bodily physiological systems) would have a profound effect on cellular activity where sensory driven nerve feedback contact dynamics are concerned (i.e. the oral cavity for example towards alcohol). To presume and then promote that an isolated non-nerve connected in-vitro cell culture's test results can be transposed over to that for complex nerve connected sensory driven in-vivo cellular systems is patently unscientific, highly assumptive, smacks of expediency and is misleading. Now add to this the amateurish interpretation (by a doctor no less) of a poorly executed mocroscopy study to support a totally inaccurate premise and the whole thing simply becomes ludicrous.
11. Q.
Have Cedar Bear Naturales® products been subjected to efficacy
studies?
A
(Brief). Yes. Independent 3rd party pilot studies and clinical trials
(one large study at the largest asthma & allergy clinic in the
United States) and over 20 years of proven practitioner use, many
who themselves have raised their own children on our products exclusively. No other true alcohol-free glycerite-based liquid herbal product line has this distinction!
A
(Detailed). Yes, we make products that have been subjected to independent
3rd party pilot studies and clinical trials, all rendering excellent
results both as to efficacy and compliance (due to the great taste
of our products). Two studies are worthy of mention. One was for a
'joint relief' product at a pain relief clinic in the Southwest United
States where all individuals subjected to the pilot study showed positive
measurable results, and the other was for a unique rhizome product
originating out of the South Pacific that we make that was subjected
to an extensive pilot study involving a large number of participants
at the largest asthma & allergy clinic in the United States, where
the product showed overall improvement for general respiratory health
in all participants and over 80% positive results for specific indications
being tested for. It should be noted that in both of these clinical
pilot studies our nutritionally dense polyconstituent based herbal
glycerite products were used, not isolate/fractionate pseudo-drug-like
'Standardized' extracts, which the latter clinic's study noted a need
for further study on not only constituent content, but if processing
technology itself, such as that used by Cedar Bear Naturales™,
might also somehow contribute to the efficacy of a botanical product.
Our products have also been dispensed by clinicians and practitioners
for over 20 years with excellent and consistent results. In those
years many of these clinicians and practitioners have also raised
their children exclusively on Cedar Bear Naturales® Children's
products, noting that no other company's children's herbal products
(either dried or liquid) has been as consistent in efficacy and tasted
as good as ours. Ours is the only true alcohol-free liquid herbal products to hold the unique distinction of having been subjected to actual efficacy studies and efficacy-based trials over 20+ years!
12. Q.
What are the quality standards upon which Cedar Bear Naturales®
operates?
A
(Brief). We are FDA registered. cGMP and HACCP compliant manufacturing operations
and products, and have a HACCP standards environmentally contained lab-grade clean room for special projects. We are fully Kosher certified. Halal and Vegan compliant. Raw
materials used are: Kosher, USP, COG (Certified Organic), organic
verified, wild cultivar (organic), ethically wildcrafted and select
CBN™ approved trusted vendor sources.
A
(Detailed). We are a cGMP/HACCP compliant lab-grade based manufacturing operation
that's FDA registered, with all operations, processes, procedures,
policies and standards being detailed and fully documented. The facility,
operations and all products are fully KOSHER certified, including our HACCP standard environmentally contained special projects lab-grade clean room. All
of our products are also Halal and Vegan compliant. A number of ingredients
are USP certified grade and meet the highest standards for foods
and dietary use. We use certified organic, organic verified, wild
cultivar (organic), ethically wild-crafted, and select CBN™
approved trusted vendor provided botanicals in our products. Our products
are not irradiated, and no added preservatives or chemicals are added
to any of our Cedar Bear Naturales® brand products. Stringent
analysis of all incomming botanicals is done to assure intrinsic quality,
and ongoing safety analysis of random samples of finished product
is done to assure product purity and safety. Cedar Bear Naturales™
is also a member of the American Herbal Products Association, our
industry's trade organization of which one of their goals is industry
compliance with high manufacturaing standards and product safety.
13. Q.
What is the difference between a cGMP manufacturing standard and the
cGMP/HACCP compliant manufacturing standard used by Cedar Bear Naturales™?
A
(Brief). cGMP deals mainly with quality control (QC) issues for facility,
operations and product, including support documentation for QC purposes. HACCP includes the cGMP standard and deals
with the sandwiching (underlying and overriding) aspects of quality
assurance (QA) that is aimed at ensuring that quality happens and
QC standards are held to, that typically includes extensively detailed documented
scenarios and related matters relative to possible quality control infractions
(called 'critical control points'), the mitigation, preventation and
corrective measures used for assuring and maintaing quality control
of a company's endeavors. Being both cGMP and HACCP compliant is part of what makes Cedar Bear Naturales, Inc. manufacturing operations closer to being a 'Lab-Grade' based operation.
A
(Detailed). cGMP means 'current Good
Manufacturing Practices' and is
a standard that reputable companies comply with so as raw material
identification, manufacturing equipment and processes, employee cleanliness,
and numerous finished product quality standards are met. GMP/HACCP
means 'current Good Manufacturing
Practices/Hazard Analysis
Critical Control Points'
and is a standard that embraces and moves beyond cGMP by defining,
tracking and documenting all possible points (called 'critical control
points') of contamination (from procurement of raws to finished products)
that could possibly take place in any given situation. While one standard
(cGMP) deals with the manufacture and safety of products, i.e. the
Quality Control issues, the other (HACCP) deals with Quality Assurance
(QA) that in turn ensures Quality Control happens, i.e. the detailed
reference/referenced documentation for expedient and accurate tracking
down of a problem, or potential problem – the 'critical control
points,' that includes identifying at any given point in a products
manufacture/finishing/etc., potential problems and establishing protocols
to prevent, mitigate and/or resolve problems promptly. An HACCP standard
denotes that a product is given 'detailed,' 'expanded' and 'possibility
scenarios' safety considerations not included in a cGMP standard alone.
It also makes QC accountable to QA. Because Cedar Bear Naturales®
is a liquid based manufacturing operation we voluntarily chose to
have all Cedar Bear Naturales™ products produced in accordance
with a HACCP compliant standard for manufacturing, management and
tracking of our operations and its products from start to finish. Being a fully documented cGMP/HACCP compliant operation is part of what makes Cedar Bear Naturales, Inc. manufacturing operations 'Lab-Grade' based in its standards.
14. Q.
With Cedar Bear Naturales™ being fully Kosher certified, what
benefit does this add to your already existing cGMP/HACCP compliant
standards?
A
(Brief). Getting Kosher certified actually verified and validated
our cGMP/HACCP compliant standard and that we were indeed genuinely
Kosher compliant from the moment we implemented this standard back
in 2000. It also validates beyond a doubt that we take all aspects
of quality control and assurance seriously. We also manufacture OU approved Passover supervised/certified products – a first for a liquid herbal products company. Surprisingly, over 70%
of the individuals who seek out and purchase Kosher certified products
are not part of or have affiliation with the cultural context that
Kosher originated from. They simply want a quality standard that has
stood the test of time and holds up to modern scientific food safety
considerations.
A
(Detailed). Being Kosher certified actually verifies through an independent
3rd party review that our documentation, ingredients and operations standards for cleanliness,
safety and uniformity are indeed real, and not just hype or puff.
A reputable and fully recognized Kashrus standard, as we operate under,
includes numerous aspects also embodied in a high grade HACCP standard,
with the additional advantage that a Kosher standard is the most time
honored and scientific proven health and safety standard originating
from a cultural context. Our Kosher certification process was substantially
aided by our already existing extensive HACCP documentation as opposed
to a GMP standard alone. In our case, Kosher certification had the
added advantage of also validating for us that we have already been
doing it correctly since becoming cGMP/HACCP and Kosher compliant
back in 2000. Further, our Scrill K Kosher certification is
recognized by the biggest of kosher certifiying agencies - OU, OK,
Star K, KOF-K, KSA and many other certifying agencies. Cedar bear Naturales™ also manufactures Orthodox Union (OU) approved Passover supervised/certified products. Research of
consumer buying patterns has shown that Kosher certified products
are some of the most sought for class of products out there. In fact,
it has been established that over 70% of all Kosher certified related
sales is by individuals who are not part of the Hebrew community or
its culture. These individuals see products that are Kosher certified
as being of a higher quality standard than those that are not, and
their satisfaction with these products, verified by their purchasing
patterns, validates this premise.
15. Q.
Cedar Bear Naturales™ states that its products are based on
a standardized 'whole' herb poly-constituent approach, not an isolate/fractionate
mono-constituent phyto-pharmaceutical driven 'Standardized' approach. What's
the difference, and is one better than the other?
A
(Brief). The differences is best described with the following example.
standardized poly-constituent is like a whole carrot that's been juiced. It has
all the carrot's nutritional and constituent properties present in
their natural ratio-intact state and synergy, only the fiberous part
of the carrot is missing. Mono-constituent phyto-pharmaceutical "Standardized" is like that same whole
carrot having only the vitamin A super concentrated while all the
other nutritional and constituent properties are dramatically reduced
or altogether discarded along with the fiber, leaving only the isolate/fractionate
mono-constituent based vitamin A part present in the finished product...
sort of like a faucet only in a kitchen but with no sink, countertop,
drains or plumbing for it to work with. From a purely health building
perspective we believe the standardized 'whole' poly-constituent approach is the
most health restorating and supplemental approach for improving and
sustaining health and well-being. In other words, Cedar Bear Naturales™ 'standardized' is poly-constituent based, while the "Standardized" of the isolate/fractionate phyto-pharmaceutical driven approach is mono-constituent based.
A
(Detailed). The difference between standardized poly-constituent and mono-constituent "Standardized"
is simple but substantial in its ramifications. A poly-constituent
approach seeks to obtain and sustain the naturally occurring synergy,
interrelated ratios and biological viability of the broad base of
constituents and compounds that are intrinsic to a 'whole' unprocessed
herb, whereas the mono-constituent approach seeks to isolate, fractionate
and concentrate a singular 'active' constituent from an herb without
consideration for the myriad of other secondary and tertiary constituents
and compounds the 'Standardized' constituent was originally a part
of. In the simplest of terms, the poly-constituent approach is more
supplemental, nutritive, tonifying, building, regenerating/revivifying,
etc., whereas the mono-constituent approach, is more drug-like and
better suited for prescribing by a qualified clinically trained and
pharma-experienced individual. As for one being better than the other,
Cedar Bear Naturales™ is of the opinion that 'whole' poly-constituent
based herbal products are best suited for general distribution and
sales to the public and most closely meet the intent of the D.S.H.E.A.
standard, whereas the mono-constituent phyto-pharmaceutically driven 'Standardized' potency based
products are best suited for restricted distribution and sales through
qualified clinically trained practitioners. The bad media, negative
press and public scares concerning certain herbs since the late 1980's,
and especially since 1994, has been caused by the misuse, mislabeling,
over-reaching and misplaced confidence in the phytopharmaceutical
isolate/fractionate mono-constituent based 'Standardized' potency
category of products, not the whole herb poly-constituent based herbal
products like Cedar Bear Naturales® produces . (Ephedra is a good
example of this observation. Of 1,400 or so cited cases concerning
Ephedra adverse events, only one case cited a whole ephedra product
(as a simple steeped tea) as being a "possible" contributor
to the event recorded - and then, only as a 'possible' contributor,
meaning the evidence was lacking to affirmatively substantiate that
a whole herb based product of ephedra was ever a problem at any time
in the adverse event reporting process. It was the phytopharmaceutical
'Standardized' drug-like ephedrine products that cuased the ban, not
the 'whole' herb based products.)
16. Q.
Cedar Bear Naturales® products sometimes appear to cost more than
other glycerite based products, but when the per-dose cost is taken
into consideration this appears to not be the case. Could you explain
this?
A
(Brief). Our "Genuine TincTract® Made" products are
more concentrated and potent than the competitions (which equates
to less product used per dose – sometimes up to 3 times less),
and our efficacy standard is more consistent (meaning less product
overall is used to get resolve), and the compliance and consistently
positive benefits derived from using our products are unmatched by
any others. Do the math and you'll see exactly what we mean.
A
(Detailed). A Cedar Bear Naturales® per bottle price may appear
more than that paid for another competitor's glycerite product, but
the dosing instructions tell a different (and more accurate) tale
of what the real costs for a product are. For example, Cedar Bear
Naturales® Children's products are listed at 1/4 teaspoon (30
drops) per dose (serving). Other competitor products are typically
listed at 1/2 teaspoon (60 drops) to as high as a full teaspoon (120
drops) per serving, placing the cost of their products on a parity
based per-dose basis to Cedar Bear Naturales® dosing standard
being at a higher cost than that for our products. Do the math on
a point-for-point basis to see for yourself. You'll be surprised at
just how cost effective on a parity based dose-per-dose and efficacy
basis Cedar Bear Naturales® products are when compared to other
companies similar type products. The consistent efficacy and results
our products are known for also speak for themselves where cost and
value are concerned. And that doesn't include the fact that our products
keep longer, retain their purity and quality, and possess a better
shelf life after they are opened, even requiring no refrigeration!