Here you will find our most frequently asked questions. If you have a questions not listed, please email us at email@example.com and we'd be happy to assist you.
1. Why do your labels keep changing?
Due to the implementation of FDA cGMP labeling guidelines Priority One has continued to update our labels in compliance with these laws. Our quality assurance labeling team monitors our labeling to insure it is compliant. Our full disclosure labels give you confidence that there are no hidden ingredients, everything that is in our products is listed on the label.
2. Why are there so many other ingredients now?
Due to FDA cGMP guidelines Priority One continues to update our labels in compliance with these laws. These FDA guidelines require all components of a raw ingredient to be listed including the starting materials.
The oxide or carbonate starting components in minerals is listed.
All excipents in the manufacturing of botanical extracts should also be listed. An example would be maltodextrin. Priority One does not add this to any formulation. Maltodextrin is commonly used in the raw ingredient industry.
Priority One is at the forefront of full label disclosures. As a manufacturer of supplements our quality assurance requires from each raw ingredient brought into our warehouse a full disclosure from this ingredient supplier not only the 8 major allergens but also all excipents used in any ingredient manufacturing. Yet this is not the end of the process. Our in house laboratory confirms that our raw ingredient suppliers paperwork is accurate with our own testing, also we use 3rd party laboratories to assist in accuracy.
Each label is made specifically for each lot number or product run so that you have full confidence if it is the product it will be listed on the label.
3. Why do your products contain soy?
A small list of Priority One products contain soy. Due to ingredient sourcing a component of an ingredient may have soy in a minute amount. This is not Priority One adding soy to a formulation, this is coming from the raw ingredient supplier or an individual ingredient may have been sourced from a soy based component.
The only product that Priority One has specifically added soy to a formulation would be our Estro-Flash this product contains the patented ingredient AvoVida.
Currently we have worked very hard to find alternative sources for any ingredient that may have be derived from soy such as natural vitamin E. In this effort we have sourced a natural vitamin E sourced from NON-GMO sunflower oil.
4. Are Priority One's products NON-GMO?
This is a very current question. We strive to locate and use only NON-GMO ingredients for our products. Utilizing high quality ingredients, ones 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 all list NON-GMO if this can be confirmed through our raw ingredient suppliers.
5. 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 very individual to each person we couldn’t possibly list each and every possibility of an allergen. This is why our labeling program is so important, by assuring that you know the starting components and the raw material components you can identify any allergen that is unique to you or your patient. Remember most of our competitors are failing to disclose this information.
Priority One has spent years updating all raw ingredients and verifying all excipients or components in individual raw ingredients that a supplier could add to each ingredient. Our labels are absolutely up to date and are fully disclosed as to FDA cGMP guidelines.
All allergens are separated in our warehouse from all other ingredients at all times.
Since we source our own ingredients, each ingredient suppliers have to pass our rigorous hazard analysis program and mitigations. All ingredients are tested individually in our in house laboratory as well as our third party laboratory, our products are manufactured in house, and each label is done specifically for each lot number and run this gives you complete confidence in our Priority One line. If it is in the product it will be listed on the label.
6. Why doesn't the Complete Daily contain Vitamin C?
Complete Daily does not contain Vitamin C due to the fact that we could not possibly include a therapeutic dose of vitamin c in a one capsule as Complete Daily is formulated to do. This is due to space requirements in the one capsule.
7. Do you conduct heavy metal testing on your finished products? What testing do we conduct on products?
Yes Priority One does send all finished product for the following heavy metal testing:
This is done by a our primary third party laboratory that we have hand selected. This laboratory holds the coveted international ISO 17025 certificate.
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.
8. Are priority one products gluten free?
Gluten is from wheat, rye, and barley. All Priority One products are gluten free unless listed otherwise stated on the label under the warning at the bottom of the Supplement Facts Box that says Contains:
An example of Priority One products that contain this materials are Environmental Defense 1, Elmnx, and Adrenal Focus.
9. How long are Priority One products good for? Why does my product no longer have an expiration date?
For many years vitamins were regulated as a food supplement by FDA. In June of 2010 all supplement companies were required by law to be compliant with the federal code of regulation 21 CFR Part 111. This code is an integral part of maintaining access to quality nutritional supplements in the United States. All reputable manufactures have supported these timely and needed codes of conduct. This has necessitated many changes in our industry. Expiration dating procedures are a good example of this. Accordingly we can no longer use the stability data that we have relied upon in the past to issue expiration dates on our products. FDA does not require expiration dates on nutritional supplements under 21 CFR Part 111, but if we choose to assign an expiration to our product it must meet USP guidelines for stability testing. ( or any other scientifically valid protocol)
Even though many of Priority One's products have been on the market for over twenty years, and this has given us ample data to back up the expiration, and best by dates that we were using, this data can not be used to authenticate the expiration date by USP standards due to the following facts:
1. All data must be obtained from market ready products. Meaning that it must be determined to be stable as found in the exact packaging that it is being offered in at this date. This includes each bottle size.
2. USP stability testing takes a minimum of 1 year per product/size of product to initially establish the expiration date, then real time studies must back up this accelerated process. These studies include microbial testing, and potency testing at equal intervals.
Priority One is dedicated to completing this process. With over 180 products to conduct studies on we estimate that this project will take two to four years to complete. We will be updating progress on our website. You can find this under the section News.
In the interim we have decided to use the designation DOM (Date of Manufacture) on our label. Even though we can no longer claim expiry times during this interim, we would like to remind all of our loyal clients that historically closed containers kept in a cool, dry environment have had a two year shelf life.
10. Depending on the Lot#... Why is our glandular products (Thyroid in general) either bovine or porcine?
Why does it go back in forth?
As the front of our catalog under Integrity the 3rd page talks about our glandular sourcing. Priority One for years has sourced all glandulars primarily from Denmark except our thyroid product. Our thyroid comes from New Zealand and is sourced from bovine. Due to supply and demand glandulars may occasionally be sourced from Argentina another respected country of glandulars.
95% of Priority One glands 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 glandulars due to the chemistry being closer to human chemistry. Our thyroid and thymus is sourced from New Zealand bovine due to sourcing demand.
11. Where does chlorella come from?
Our Chlorella is currently sourced from France.
12. Is Lithium organic?
Our Lithium Orotate is organic as in the material is organic from the ground a natural mineral. It is not certified organic as in the popular USDA organic certified.
13. It says Lithium orotate but newer labels say lithium orotate/carbonate... why did we change the source/ingredient?
Our sourcing of ingredients for our Lithium Orotate has not changed. The way we are listing it has changed due to FDA GMP guidelines. You will see that it is listed carbonate this is the starting material from which Lithium and Lithium Orotate is derived.
14. What is the percentage of Lithium orotate/carbonate?
The elemental lithium content is 9% lithium. In line with FDA GMP guidelines for labeling minerals only the elemental amount is listed. In order to claim 5mg of lithium we used 56mg of lithium orotate. The carbonate component displays the starting lithium carbonate element that our ingredient manufacturer uses to produce lithium orotate.
15. What is the correct way to answer why a product has been discontinued?
Priority One chooses to discontinue products due to supply and demand. Often before a product is discontinued we make an effort to update a formulation or ingredient. We also will try to do a marketing effort on this product or a sale. Often once it has been discontinued it is due to the demand not being large enough to continue to manufacture it. We often will suggest another product in our line or we will bring in a newer formulation.
16. Why do we use magnesium stearate?
In our exclusive healthcare professional line Priority One offers many encapsulated products including glandular or vegetarian, we never include magnesium stearate in our capsules. Magnesium stearate is not a good filler in that it can inhibit absorption in large amounts. We use as a main filler if needed a vegetarian rice chelate. Rice chelate is used because of it is hypoallergenic in nature for most individuals. No binders, lubricates or flow agents are used.
Our labels are compliant to cGMP and FDA , fully disclosed labels that never hide what is in your supplements.
Our optimal tableted products are important due to the potency they offer that is not available in encapsulated form. The quantity of capsules you would be required to take for the same tableted dosage would turn off many patients. Priority One has always strived to offer unsurpassed high potency products, this is due to our being able to manufacture tableted products such as Bio Vegetarian. In our tableted products we use a in minute amounts a plant derived kosher source of magnesium stearate not as a filler as some claim. It helps keep the tableting ingredients from not sticking to the tablet punches in full conglomeration. Each tablet of Super Bio vegetarian is 1319mg with 2mg of this being magnesium stearate, this comes out to 0.15% less than half of one percent.
This is not enough to interfere with absorption but it provides you with the choicest method of an elevated potency tableted supplement.
17.Why don't we specify which products are either vegan or gluten free?
All products are gluten free unless stated specifically that they are not. Very few Priority One products contain gluten. At this time we do carry vegetarian products but not vegan certified products.
18. Why don't we make liquids/oils/lotions?
According to 21 CFR Part 111, dietary supplements are classified as substances that can be ingested, thus, lotions, and non digestible oils are not covered under these regulations and therefore can not be produced by an FDA compliant manufacturing facility. As for liquids, we do not specialize in these.