February Special – Hormone Clear is 20% off

Hormone Clear is a unique combination of amino acids, antioxidants, and nutrients that support the liver’s detoxification pathways of endocrine disrupting chemicals, EDCs, and the body’s own production of hormones. This is an exclusive product formulated by Dr. Marianne Marchese designed to be used for both men and women’s health conditions as well as detoxification and cleansing plans. Dr. Marianne Marchese is a leader in both environmental medicine and women’s health.

Dr. Marchese formulated Hormone Clear by choosing ingredients that assist the liver in metabolizing the body’s own production of hormones and EDCs.  The ingredients in Hormone Clear include: Vitamin B-12 (as methylcobalamin), Folate (as (6S)-5-methyltetrahydrofolic acid), Calcium (as calcium d-glucarate), BioResponse DIM, Alpha Lipoic Acid, and N-Acetyl L-Cysteine.

Methylcobalamin and methyltetrahydrofolic acid both provide co-factor and methylation support for phase one and phase two liver metabolism of hormones and EDCs.  Calcium d-glucarate (CDG) and Diindolylmethane (DIM) support multiple detoxification pathways and provide hormonal support. Both DIM and CDG support testosterone and estrogen balance and assist with metabolism of endocrine disrupting compounds. Alpha lipoic acid (ALA) and N-acetyl cysteine (NAC) are powerful antioxidants that also support glutathione production in the body. These directly aid in the metabolism of chemicals that disrupt men’s and women’s hormonal health.

Both patients and practitioners are constantly seeking ways to restore balance and aid the body’s natural ability to clear hormones. Hormone Clear is designed for people interested in optimizing their hormonal system or for those who have known exposure to EDCs. It can be used as a stand-alone product or in conjunction with her other formulas from Priority One, Cofactors Support and Hepa Cleanse. This product is contraindicated in pregnancy and with lactation.

As a special offer to our loyal customers, we are offering 20% off of Hormone Clear in the month of February. Please use code “CLEAR20” to receive this offer on your website or phone order!

Valid for up to 12 bottles, this offer cannot be combined with other offers (such as a percentage off for a show special) and is not available for distributors. It can be combined with our premium specials. 

Please join us for upcoming events where Dr. Marianne Marchese will be speaking:

March 27 – 29, 2020
Southwest Conference on Botanical Medicine

April 03 – 05, 2020
Environmental Health Symposium

References

  1. Crinnion, Walter, Pizzorno, Joseph. Clinical Environmental Medicine. Elserver. 2018
  2. Marchese, M. 8 Weeks to Women’s Wellness. The Detoxification Plan for Breast Cancer, Endometriosis, Infertility and other women’s health conditions. Smart Publications. 2011.
  3. Hodges RE, Minich DM. Modulation of Metabolic Detoxification Pathways Using Foods and Food-Derived Components: A Scientific Review with Clinical Application. J Nutr Metab. 2015:1-23.
  4. Cline JC. Nutritional aspects of detoxification in clinical practice. Altern Ther Health Med. 2015 May-Jun;21(3):54-62.

Announcement & Collaborations

I am so excited to announce two huge collaborations for Priority One.

As many of you may know my philosophy has always been that gleaning knowledge from entrenched hands of physicians is the best way to develop and study cutting edge formulations.  We have worked with many respected physicians throughout the years on the development of some of our most beloved formulations. Continuing on this voyage we are proud to announce two exiting projects in 2017!

First we have formed an exclusive relationship with Dr. Mona Morstein for the development of her ground breaking formulation Diamend!

If you are not yet familiar with her work with patients to maintain healthy #glucose levels then please visit her website and read her Bio at http://azimsolutions.com/morstein/  and on her website www.lowcarbdiabetes.org It’s fascinating! @YourAIMSolutions @DrMonaMorstein 

She has been featured in #NDNR and will be featured in the #TownsendLetter soon discussing her support for patients striving to achieve healthy lifestyles and beat back the “American Diet”  See our website for more information on Diamend for maintaining normal glucose.

Secondly, we are pleased to announce our continued relationship with Dr. Paul S. Anderson – Medical Director of Advanced Medical Therapies, CEO as a professor who speaks worldwide he continues to share his expertise in #oncology, #chronicillness, #IVtherapy #genomicconditions #autoimmune and #infectiousdisorders.

ConsultDrAnderson is a valuable peer supported information to help naturopathic students with board exams, support for complex clinical cases and protocols, webinars, blog, and his most current research.

If these were not enough Dr. Paul Anderson has taken his expertise to another level in developing a new revolutionary industry changing conference series. Advanced Applications in Medical Practice or AAMP. Priority One is proud to be a sponser of this event in two locations this year Scottdale, AZ this month and Portland, OR in October. This new series of conferences enables physicians to elevate their educational learning to another level, beyond just the basics. This conference is offering case study discussions, evening workshops, webinars, Q&A, think tank break outs, and so much more. 

Dr. Paul S. Anderson has developed two new products for us Methyl Balance and Biofilm Phase-2 Advanced both of which have been used in his clinic. As an international lecturer on #SIBO, #oncology support and #methylation with clinical data to support his findings, he is a leader in this field of medicine.

These two amazing cutting edge formulations are just what you’ve been looking for!

Research is showing that small intestine bacterial overgrowth is a subject that many physicians are keenly interested in, and one that is sure to impact your practice and patients even more as awareness grows.  We were privileged to attend the recent SIBO convention in Lombard, Illinois where Dr. Anderson was a leading speaker on the subject.

More exciting events are coming from Priority One this spring!   We are eagerly looking forward to the opening of our newly expanded laboratory the end of this month.  Check back for pictures soon!

As always wishing good health to you!

Danielle Baumgart, President

Danielle S. Baumgart, President

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

We offer tours of our Quality! I mean factory……

Businessman with an open hand ready to seal a deal

When I say quality is an action word, I really mean it.  This isn’t a glossy advertisement it is quality at work everyday with every product, and every employee.  I am proud to say we are a third generation privately held company, and our family would love to show you what we do every day that makes us different than our competitors.

front-of-our-facility

Yes we have an open door policy, we recommend touring and visiting our facility. We find that this helps physicians and students become more familiar with the manufacturing process as well as the terminology that comes with the manufacturing process. We feel it gives physician’s a strong voice in answering their patient’s questions. Such as where their supplements come from and details of the manufacturing process. We would be happy to familiarize you with CGMP or current good manufacturing practices, and labeling guidelines. As part of their education many students have toured our facility.

bastyr-touring-studentsStudents, from Bastyr University, NUNM, and SCNM as well as many many practitioners have already enjoyed visiting us yearly, please we extend you a warm welcome……be our guest.

 

 

Danielle S. Baumgart, President

Priority One Nutritional Supplements Inc

danielle

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