Here
you will find our most frequently asked questions. If you have a question not
listed, please email us at [email protected] and we'd be happy to
assist you.
1. Why are there so many other ingredients listed on your labels?
We
go beyond the requirements of FDA cGMP’s with full disclosure labeling. Our
labels list starting components, and all excipients used in the manufacture of
raw ingredients.
Examples:
The oxide or carbonate starting component in minerals is listed. All excipients in the manufacturing of botanical extracts are also listed. An example would be maltodextrin. Priority One does not add this to any formulation. Maltodextrin is commonly used in the raw ingredient industry.
2.
Are Priority One's products NON-GMO?
We
strive to locate and use only NON-GMO ingredients in our products. Utilizing
high quality ingredients that are sustainable is beneficial for the end user
and the local farmers who produce them. We have made it our mission to only
source NON-GMO ingredients. We are currently 99% GMO free, the 1% does not
constitute a guarantee that the ingredient is genetically modified, it
represents a group of ingredients that currently are not back up by testing
methods to establish their GMO status. We are working diligently with our
sources to establish this status. Our labels list NON-GMO if this can be
confirmed through our supply chain.
3.
Why do we only list the 8 major allergens?
FDA
cGMP guidelines require the 8 major allergens to be listed. We strive to
reduce the occurrence of these major allergens in all Priority One
formulations. Since allergens are individual to each person, we couldn’t
possibly list every possibility of an allergen. Therefore our labeling program
is so important, by listing the starting components and the raw material
components you can identify any allergen that is unique to you or your patient.
Allergens are stored
separated in our warehouse from all other ingredients.
4.
Why doesn't the Complete Daily contain Vitamin C?
Complete
Daily does not contain Vitamin C since we could not possibly include a therapeutic
dose of vitamin C in a one capsule.
5. Do you conduct heavy metal testing on
your finished products? What testing do you conduct on your products?
Yes,
we test all finished products for the heavy metals’ arsenic, cadmium, lead and
mercury.
Our testing protocols are established utilizing an NSF-designed hazard analysis program. Since every raw material has a unique microbial or environmental adulteration hazard, each material has a predetermined testing protocol suited to its own risk level. Regardless of how low the risk level is determined to be, every raw material is tested using the USP and or AHPA recommended standards.
We conduct 100% testing
using USP method 1119 Near-Infrared spectroscopy, a scientific process that
uses chemometric models to identify all raw materials. Our reference standards
are third-party laboratory-verified certifying their validity. We conduct
regular audits of our outside laboratory partners and qualify their results
eliminating “dry labbing” dangers.
Environmental testing for microbiological bio-burden hazards is an integral part of the testing program designed by First Priority (First Priority Manufacturing is our sister company manufacturing facility; we are housed in the same building). Introduction of microbial adulterants during holding or processing is monitored utilizing USP Method 1116 for continued evaluation of microbial limits in controlled areas. This method was adopted voluntarily from the pharmaceutical codes.
We have also developed
a program utilizing spectroscopy USP method 1119 to establish chemometric
models of finished products. These testing models are then used to assure that
products meet all intended identity, strength, and composition specifications unique
to each finished product batch. Finally, every finished batch is tested again
for microbial adulteration, thus assuring that every batch meets the highest
purity standards.
First Priority
Manufacturing (our sister company) maintains a robust hazard analysis program
that reviews the potential for risks associated with each manufacturer of
ingredients following NSF guidelines. All ingredients have risks and require
systems to block sources of contaminants.
We do not rely on the
supplier for ingredient purity. Risks such as irradiation, heavy metals, E.
coli, salmonella, staph, dangerous spores, and economic adulteration are
monitored by our rigorous testing methodology. By identifying such risks ahead
of time, the mitigation process enables us to block these hazards.
6.
Are priority one products gluten free?
All
Priority One products are gluten free unless listed otherwise on the label
under the warning at the bottom of the Supplement Facts Box that says: Contains:
Wheat.
7.
Why are our glandular products (Thyroid in general) either bovine or porcine?
Most
of the glandular ingredients in our products are sourced from Denmark. Denmark
is the only country that has been antibiotic, and growth hormone free for all
bovine and porcine glands since 1998. Our non-Denmark source is New Zealand or
Argentina. This means that our glands are pure, untreated, and retain the best
balance of naturally occurring hormones available.
Denmark,
New Zealand and Argentina are listed as negligible or very unlikely by the EU
for sources of BSE.
Priority One uses mainly porcine glands due to the chemistry being closer to human chemistry. Our thyroid and thymus are sourced from New Zealand bovine due to sourcing demand.
8.
Where does chlorella come from?
Our
Chlorella is currently sourced from France.
9.
Is your Lithium organic?
Our
Lithium Orotate is organic as in the material is a natural mineral from the
ground, not synthetic.
10.
Why does your Lithium orotate say orotate/carbonate on the label?
Lithium
carbonate this is the starting material used to produce Lithium Orotate.
The
elemental lithium content is 9%. In order to claim 5mg of lithium we used 56mg
of lithium orotate.
11.
Why do you use magnesium stearate?
Our encapsulated products never include magnesium stearate. Magnesium stearate is not a good filler in that it can inhibit absorption in large amounts. Rice chelate is used in encapsulation as a filler to ensure potency because it is hypoallergenic for most individuals. No binders’ lubricants or flow agents are used in our capsules.
Each tablet of Super Bio vegetarian is 1,319mg with 2mg of this being magnesium stearate, this comes out to 0.15% of the tablet. This is not enough to interfere with absorption.