Our President, Danielle Baumgart & Dr. Ben Reebs in a video chat

Danielle Baumgart, President of Priority One Vitamins, joined Naturopathic Medicine Institute and Dr. Ben Reebs, to chat about #naturopathic medicine, #vitalism, and the future of #integrative medicine.

Priority One is a proud sponsor of the up-and-coming The Vital Gathering 3 conference, a #naturopathic medical conference on Fri/Sat Oct 12-13 in Norwalk, CT.

Priority One's President, Danielle Baumgart, Discusses Naturopathic Medicine with Naturopathic Medicine Institute and Dr. Ben Reebs

Danielle Baumgart, President of Priority One Vitamins, will join the Naturopathic Medicine Institute and Dr. Ben Reebs, to chat about #naturopathic medicine, #vitalism, and the future of #integrative medicine. Join us at 11:10am PST (2:10pm EST) on Thurs, 9/13, on Facebook Live TV, from http://facebook.com/naturopathicmedicineinstitute. You can click on the link to get a reminder, or you can head on over to the NMI's Facebook page to view.#PriorityOne is a proud sponsor of the up-and-coming The Vital Gathering 3 conference, a #naturopathic medical conference on Fri/Sat Oct 12-13 in Norwalk, CT.Learn more here: https://www.naturopathicmedicineinstitute.org/…/vital-gath…/From Danielle Baumgart's LinkedIn Page:"The nutritional business you could say is "in my blood" growing up the daughter of a nutritional salesman, and a health conscious mother. I started attending natural products shows when I was small enough to sit under the table and listen to the doctors speak to my father. As I got older my interest in health grew. My father started his own company with the help of several physician friends in the 1980's, as his company grew, he found he needed help on the business end. "This is where I slowly began my journey into the nutritional world. In the early 2000's I was the President of Priority One long enough to find out that trying to control the quality end of our product line was becoming my biggest concern. My husband and business partner decided it was time we controlled all of our production assuring the quality that we demanded would be consistent batch after batch. First Priority Manufacturing Inc was started in the spring of 2000, it has bloomed into a full contract manufacturing company. We are a cGMP facility manufacturing brands for retail, wholesale and well know international brands. Its been an interesting education, but its what I love, and that is a "Priority""From the Priority One website:"Priority One is a privately held company, founded and operated by the same family since 1988. We currently have three generations working together in the nutraceutical industry. We have not lost touch with you the health-care provider, and your patients. We are available to listen to you, and we value your thoughts."Visit http://www.priorityonevitamins.com to learn more.To learn more about how to become an associate of the Naturopathic Medicine Institute (NMI), visit www.naturopathicmedicineinstitute.org.Celebrate the healing power of nature with The NMI.#naturopathic #vitalism #naturopathicmedicine #naturopathy #nmi #naturecure #naturopathicmedicineinstitute #integrative #functional #functionalmedicine #medicine #healing #supplements #naturopathicdoctor #alternative #holistic #homeopathy #homeopathic #botanicalmedicine #herbalmedicine#herbs #tinctures #healthcare #health #priorityone

Posted by Naturopathic Medicine Institute on Thursday, September 13, 2018

Learn more here: https://www.naturopathicmedicineinstitute.org/

From Danielle Baumgart’s LinkedIn Page:

“The nutritional business you could say is “in my blood” growing up the daughter of a nutritional salesman, and a health conscious mother. I started attending natural products shows when I was small enough to sit under the table and listen to the doctors speak to my father. As I got older my interest in health grew. My father started his own company with the help of several physician friends in the 1980’s, as his company grew, he found he needed help on the business end.

“This is where I slowly began my journey into the nutritional world. In the early 2000’s I was the President of Priority One long enough to find out that trying to control the quality end of our product line was becoming my biggest concern. My husband and business partner decided it was time we controlled all of our production assuring the quality that we demanded would be consistent batch after batch. First Priority Manufacturing Inc was started in the spring of 2000, it has bloomed into a full contract manufacturing company. We are a cGMP facility manufacturing brands for retail, wholesale and well know international brands.
Its been an interesting education, but its what I love, and that is a “Priority””

From the Priority One website:
“Priority One is a privately held company, founded and operated by the same family since 1988. We currently have three generations working together in the nutraceutical industry. We have not lost touch with you the health-care provider, and your patients. We are available to listen to you, and we value your thoughts.”

To learn more about how to become an associate of the Naturopathic Medicine Institute (NMI), visit www.naturopathicmedicineinstitute.org.
Celebrate the healing power of nature with The NMI.

#naturopathic#vitalism  #naturopathicmedicine #naturopathy #nmi #naturecure#naturopathicmedicineinstitute #integrative #functional #functionalmedicine#medicine #healing #supplements #naturopathicdoctor #alternative #holistic#homeopathy #homeopathic #botanicalmedicine #herbalmedicine#herbs #tinctures #healthcare #health #priorityone

 

♥    Comment below on how Priority One Supplements have helped you to win a $100 Priority One Gift certificate and goodie bag!

 

 

 

Hazard Analysis – Environmental Testing


Environmental testing for microbiological bioburden hazards is an integral part of the testing program designed by Priority One. 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 by Priority One voluntarily, from the pharmaceutical codes. Dietary supplement regulations do not require this, but we believe it is imperative for quality.

Large plantation of medicinal plants Echinacea purpurea

Organic and Whole herbs are subjected to irradiating, and ETO(a pesticide) for sterilization in many cases.  Even though irradiation is not approved by the United States and the European Union, it still is prevalent, especially in “organic “ materials due to their naturally high microbial contents.

Fresh Herbs

Priority One guarantees that all our botanical’s are radiation-free. Unlike many of our competitors, we have a standard monitoring program to insure that no radiation is used in the sterilization of our botanical’s. When sterilization is needed, we use a dry-steam technology or other non-destructive technologies. (Note: only whole unprocessed herbs require treatment, and only when their total aerobic counts are found to be out of compliance.)

Priority One was one of the first companies to recognize the danger of wild crafted herbs. We use our international sources to achieve the ultimate benefit of natively grown plant sustainably cultivated  in its natural habitat. This has lessened the use of pesticides or fertilizers. While protecting endangered herbs.

Every day worldwide 2500 acres of raw land are disturbed by man. According to GSA Today  as of 1995, ~43% of Earth’s surface area had experienced human-induced degradation (Daily, 1995). Ellis and Ramankutty (2008) concluded that more than 75% of Earth’s ice-free land area could no longer be considered wild. Of earth’s ice-free land area, 83% is likely directly influenced by human beings (Sanderson et al., 2002). Our pollutants affect plant and animal physiology worldwide (McKibben, 1989, e.g., p. 38, 58)

Needless to say the world’s gene pool of wild herbs is dwindling.  By searching out strong stable international connections Priority One maintains eco friendly sources for our formulations.  Lending our support to companies that are good stewards of the earth, such as Naturex who has a proven record of sustainability-program-principles.

We have developed an industrial networking relationship with international companies who have developed unique complex systems for animal health, environmentally responsible botanical harvesting, and 100% radiation free sterilization techniques.

Diagram of risk

70% of ALL antibiotics sold in the United States are consumed by HEALTHY animals.  56% of Australian antibiotics are consumed by their healthy animals, and while not publishing the percentage of antibiotic use for their healthy animals New Zealand’s Foodsafety.govt.nz supports the needed continued use of antibiotics for “preventative or prophylactic use”

90 % of our our glands are sourced from Denmark, and unlike Australian, or New Zealand glands, Denmark is the only country that has been antibiotic, and growth hormone free for all bovine and and porcine glands since 1998.  This means that our glands are pure, untreated, and retain the best balance of naturally occurring hormones available on the market.  The last 10% are sourced from New Zealand. See our blog on Glandular Sources for more information on Denmark’s record.

Floods, droughts, fires, and earthquakes are major causes of adulteration in the food chain.

Through our Hazard Analysis Program we are able to block natural event adulteration’s. All raw ingredients have potential risk  of contamination, bioburden, and other dangers. By identification of such risks ahead of time, the mitigation process enables us to significantly reduce such hazards.  Priority One has developed a robust Hazard Analysis Program that does just that.

Our Quality Assurance team use this program to  identify hazards in the ingredient supply chain and then develop testing protocols unique to each ingredient.  These mitigation’s create targets for testing.  Designing a minimum of 1 upstream and one downstream precaution for each hazard that is identified. Our Hazard Analysis Review post called  “A peek into our rigorous vendor approval program” provides more information on how we block adulteration’s.

We do not rely on COA (Certificate of Analysis) from raw ingredient manufacturers. We test all raw ingredients for purity, potency, and well as environmental or bioburdens that may be present before we allow any raw materials be used in our manufacturing process. All ingredients are quarantined until they have been approved and released for production.

#PNW

We realize our integrity in this regard is relied upon by yourself and your patients. With this in mind we are meticulous in our procuring, testing, verifying and producing the highest quality and clinical strength supplements, that you can stand behind with confidence.

Danielle Baumgart, President

Mitigations – More From Our Hazard Analysis Program

Raw herbs
Raw herbs

Our ingredient mitigations are  determined by risk level.

Mitigations describe how a risk level is reduced by the design of our quality systems. Immediate precautions are designed to block hazards in normal conditions. Also included in these mitigations are at least one upstream and one downstream protection to block the hazard from entering the processing chain.

Blocking the Risks
Blocking the Risks

These mitigations are ingredient-specific and are added to each ingredient specification sheet, assuring that each time that ingredient is received it is reviewed and tested for its unique hazard(s). All ingredients have risks and require systems to block sources of contaminants. 

We do not rely on the supplier for your patient’s safety. Risks such as radiation contamination, 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.

Antimicrobial Susceptibility
Antimicrobial Susceptibility

All finished products are tested for the heavy metals arsenic, cadmium, lead, and mercury. This is done by our primary third party laboratory that we have hand selected. This laboratory holds the coveted international ISO 17025 certificate.

Danielle Baumgart, President

 

Danielle S. Baumgart, President
Priority One Nutritional Supplements Inc

Understanding Glandular Sources and Animal Health

First,  90% of Priority One’s glandular’s are sourced from Denmark, and unlike Australian, or New Zealand glands, Denmark is the only country that has been antibiotic, and growth hormone free for all bovine and and porcine glands since 1998.  This means that our glands are pure, untreated, and retain the best balance of naturally occurring hormones available on the market.  glandular-sources-2014

Second, we source farm to processor, this means that not only do we have the ability to trace our glands to the country, but we retain all of the veterinarian release forms, that trace each and every animal to the farming region, and processor in which they were obtained from.  This not only assures us that the glands are indeed from Denmark, but it also assures us that the glands are handled in a timely fashion, allowing them to retain the optimal freshness before processing.  Most companies can not trace their glands beyond the country or region of origin.

Antibiotic prescription.
Antibiotic prescription.

Third, The link between antibiotics in the food chain and human resistance is striking, look at this quote: from a recent CBS report on Denmark and their success in removing this danger from the food chain.

” I think the Danish and European experience indicate that there will be real and measurable public health benefits,” she said. “There’ll be improvements in food safety and actually in the prevalence of drug resistant infections in people.”   says Dr. Ellen Silbergeld

Finally, here is the link to the Australian viewpoint on antibiotics in their meat processing, and food chain, just as an excerpt, it clearly states that they feel it is highly unlikely that antibiotic resistance can develop from antibiotics in the food chain, and that farmers use antibiotics for the health of the animals. Australia’s viewpoint on antibiotic use in animals in the food chain.

Danish Porcine Producers and Food Safety

Danish Porcine Industry Quality Manual pg-116-117

Danielle Baumgart, President
Danielle Baumgart, President

Priority One Nutritional Supplements, Inc. 

Full Label Disclosure

R.E.M.Priority One is the only company on the market with a complete label
disclosure policy.  

This means we require our raw material suppliers to provide us with flow charts and full disclosure of process materials so that we in turn can disclose this to you the customer!  If a supplier chooses not to submit these documents our quality control personnel reject these incoming raw materials and they are not allowed in our Priority One product line.

Adrenoplex label PriorityOneVitamins
Adrenoplex label PriorityOneVitamins

Most companies limit their disclosure to only ingredients actually added at the time of manufacture, this as you will learn in later posts is not the whole picture, allergens, glutens, animal products and preservatives have all been found by our quality control department at the review stage and these ingredients have been rejected for use. Does your supplement company have this type of commitment to quality?

Priority One Vitamins Labeling
Priority One Vitamins Thyroid 65mg Labeling

Priority One does not try to mislead the physician or patient in the labeling of our supplements. Since we manufacture in house and source our own raw ingredients we are able to know exactly what is in our products and make sure you do also!

For a label to label comparison I will be updating this post in the next few weeks so stay tuned, and you will see examples of what other supplement companies are refusing to show you on their labels!

danielleDanielle S. Baumgart, President

Priority One Nutritional Supplements Inc

A Peek Into Our Rigorous Vendor Approval Program

We call it a Hazard Analysis Review

Raw herbs
Raw herbs

Because no matter how good your sources are all ingredients and companies have inherent hazards and it is our duty to protect our customers from these, and to provide the best ingredients available from the best sources.

 

Risk Level
Risk Level

Priority One maintains a robust hazard analysis program that reviews the potential for risks associated with each manufacturer of ingredients following NSF guidelines.

First, four members of our quality team review the quality program of a potential vendor, utilizing physical audits, interviews, testing method validations, and background checks for past or current regulatory issues.

Next, all compiled information is brought to a classification session. During this session, a review of the documents and ingredients supplied by the potential vendor is conducted.

Diagram of risk
Diagram of risk

Potential hazards are proposed such as country of origin, inherent ingredient hazards (mold, E. coli, Salmonella…) or economical adulteration potentials.

After all potential hazards have been agreed upon and classified, the probability of such hazards occurring is determined, using a classification from frequent (1 in 5 purchases) all the way down to extremely unlikely ( 1 in 10,000 purchases). These are determined by scientific methods, observations, real-life testing protocols, and industry inside knowledge of economically generated adulterations. Last, using the severity and probability, a risk level is determined.

By determining the risks and risks levels of a potential vendor we can identify testing protocols and mitigations even for the best of vendors to ensure that they maintain their quality standards, and by validating their quality before they are approved for use we are able to eliminate substandard vendors and their ingredients from our process.

Remember your end result is only ever as good as the sum total of the quality of your ingredients.

danielle

Danielle S. Baumgart, President

Priority One Nutritional Supplements Inc

Quality isn’t glossy advertisements!

Everyone screams quality when talking about dietary supplements.Pestle and Mortar with Herbal Complementary Medicine

Learn how to ask the right questions about vitamin quality, herbal purity, and sustainability.

Throughout this blog I hope to lead you down this path in understandable, non-governmental language.

FDA Approved

Dietary Supplements are a type of food product for which specific food CGMPs (Current Good Manufacturing Processes) are needed.  I think everyone would agree with that.

Manufacturing process controls are needed to ensure that a dietary supplement contains what the manufacturer intends.

Process controls must be in place to ensure the tablet or capsule contains what it purports to contain and are different than those that must be in place to ensure a food is manufactured, processed, packed and held under sanitary conditions.

The FDA is the governing administration that oversees the dietary supplement industry and rightfully so, without oversight those who wish to create safe, effective supplements are crowded out by those who solely wish to make a profit, at the public’s expense.   As an industry we need process control, we needed something to control the quality of supplements and foods coming on the market. CGMPs or current good manufacturing Portrait of smiling scientist holding a clipboardpractices are essential to this.

In order to achieve consistency and reliability, there must be process controls in place to ensure for example, that appropriate tests and examinations are conducted, a master manufacturing record is prepared, each batch production follows the master manufacturing record, and the finished tablet or capsule is placed in the intended package with the intended label.

Well-established principles of CGMP require controls at each step of the manufacturing process as early in production as possible. Quality cannot be tested into a product at the end. Instead the quality of the dietary supplement must be built into the product. Each step of the way, by every workforce member who touches it.scientist observed green leaf in laboratory glass

It is not sufficient, nor effective, to rely solely on end product testing to assure the quality of the individual dietary supplement product sold to the consumer.

CGMPs are intended to establish a comprehensive system of process controls.

Manufacturing according to CGMP means that the manufacturing process incorporates a set of controls in the design and production processes to assure a quality finished product.Highest quality assurance, high quality level guarantee

The term “quality” comes up repeatedly in comments in the dietary supplement industry. Quality is more than a glossy marketing advertisment. Quality related to dietary supplement industry is having identity, purity, strength and composition intended for each specific batch. And being able to prove this with available documentation.

Flowers and plants in test tubesWe agree that a critical aspect of CGMP is achieving control over the manufacturing process. Controls are necessary to ensure that you manufacture what you intend so that the characteristics and/or attributes desired in a final product will be consistently and reliably achieved.

OLYMPUS DIGITAL CAMERA

Many companies claim quality, but true quality requires continual action. Our full-service CGMP manufacturing facility is certified under 21 CRF Part III. We truly care about what is happening in your practice and strive to support you and your patients with clinical strength supplements that you can have confidence in.  We have been inspected by FDA many times and with each inspection we gain further knowledge and understanding for improving our processes.

Vitamins

So next time you see the word “quality” being used in advertisements, ask yourself what is the record, can they stand by this claim, and if asked can they produce proof that they are a Quality manufacturing company.

 

 

Sincerely,

Danielle S. Baumgart, President

danielle