What is Quality
You Get What You Pay For
There are two factors that contribute to the overall quality of a dietary supplement--the formula itself and the quality standards that govern the manufacturing process.
Even with regulatory guidelines, both of these factors can vary greatly from one supplement brand to another.
Sound supplement formulas are developed based on scientific research and clinical studies that establish efficacy and determine optimal delivery methods and dosages.
The FDA has established basic standards for manufacturing practices based on meeting three quality criteria:
Authenticity: The ingredients listed on the label are in fact the ingredients contained in the product.
Potency: The amounts of each ingredient listed on the label are the minimum amounts contained in each capsule, tablet, or teaspoonful, at its expiration date.
Purity: There are no unlisted ingredients added to the product. The ingredients do not contain biological or chemical contaminants, fillers or additives.
While these three measures are easy to define, they are, in manufacturing practice, quite complex. Within the industry, problems in each of these areas have been extensively reported in medical journals and by independent analytical laboratories. However, there is a solution to all three--independent lab testing. Each manufacturer is responsible for determining what level of testing is adequate to insure authenticity, potency and purity.
For example, when a manufacturer receives a shipment of raw materials, the supplier provides a "Certificate of Authenticity" that identifies the substance. At this point, the manufacturer can trust that the document is truthful and accurate, or they can send a sample to the lab to authenticate the substance. CNCA Health not only uses independent labs to test all raw materials for authenticity, it also subjects raw materials to a battery of tests for all known or suspected contaminates.
Is The Extra Cost Worth It?
Based on the harmful contaminants we've found in raw materials that most companies don't even test for, we believe comprehensive quality tests are worth the cost of a few extra pennies a day. You deserve peace-of-mind in knowing that your supplement is supporting your health -- not harming it! Because we do extensive testing for maximum purity and optimal potency, our products are trusted and recommended by some of the country's leading medical practitioners every day – to thousands of patients every year.
What Do They Tell Us?
In 1999, Tod Cooperman, MD, started a consumer watchdog company called Consumerlab.com to empower consumers with objective information to measure the quality of dietary supplements sold in supermarkets and health food stores. Using tests performed under expert supervision, they have analyzed 3,400 products, 450 brands and 69 different types of supplements. Typically, 20-50% or more were found to be sub-potent (the amounts of ingredients found in the supplements were below the amounts listed on the label), contaminated, or both.
The products with the worst track records were herbal supplements, including Ginseng, Ginkgo, Milk Thistle, Green Tea, and St. John's Wort, some of which were significantly sub-potent. In some cases, the products were sufficiently contaminated with dangerous heavy metals to render them illegal under the State of California laws.
At CNCA Health, we have a "toolbox" of over 200 tests that we can choose from to qualify our raw materials and finished products to carry our label. Through extensive testing, CNCA has found dangerous and occasionally illegal levels of contaminants in raw materials that Consumerlab.com doesn't test for. Examples include the very toxic solvent, 1,2 dichloro-ethane and dangerous levels of aflatoxins, a toxic fungal by-product.
Intro to FDA CGMPs
Supplements Really Are Regulated
Contrary to popular opinion, nutritional supplements are heavily regulated by the US Food and Drug Administration. Prior to 1994, "dietary supplements" (the legal term for these products) were regulated under laws governing food manufacturing. That changed when the Dietary Supplement Health and Education Act (known as "DSHEA") was passed in October, 1994.
As a result, there are (literally) hundreds of regulations that define what a dietary supplement is and isn't, what can and cannot be said about dietary supplements, and the minimum standards required for manufacturing, packaging, holding and distributing dietary supplements (these regulations are referred to as Current Good Manufacturing Practices for Dietary Supplements, or "cGMPs").
FDA cGMPs require that all supplement manufacturers test for identity, potency, and "reasonable" purity for all raw materials. But just as quality differs for everything from electronics to handbags to automobiles, some companies are just more demanding than others. Our testing standards are higher to establish identity or authenticity, to avoid counterfeit and "look-alike" substitute ingredients. We test for a broader range of potential adulterants and contaminates than the "reasonably expected" standard that is set by each individual manufacturer, not federal regulations. The problems associated with poor dietary supplement quality generally fall into these two categories:
Sub-potency: No health improvements are experienced due to sub-potent ingredients (example: it takes 650 mg of aspirin to relieve a headache, if the two tablets only delivered 300 mg, you would still have a headache). It's similar for dietary supplements.
Contamination: Low levels of chemical or biological contaminants place an unnecessary toxic burden on the body, threatening future health. Low levels of contaminants often found in foods and supplements cannot always be "felt" today, but may be felt in the future. CNCA identifies and rejects raw materials containing unacceptable levels of unhealthy contaminants. Simultaneously, we guarantee product potency by performing extensive, independent testing of both raw materials and finished products. However, many other supplement manufacturers do not test their ingredients and finished products to the extent that CNCA does. Additional testing costs more. But CNCA recognizes that products intended to support good health should NOT contain dangerous contaminants. Period! This is the CNCA approach to help you preserve and protect your health. For CNCA, it's a moral imperative.
What's Not on the Label: Many Harmful Toxins Can Go Undetected
There are two kinds of impurities. One type, known as adulterants, or substitute raw materials, is deliberately added to supplements enabling the seller to make more money. Impurities found in raw materials or caused by poor manufacturing practices are known as contaminants. Some contaminants occur in the ingredients used to make dietary supplements (and drugs, and foods) and are not completely removed prior to manufacturing. Others are a result of industrial "accidents", such as cross contamination (e.g. not properly cleaning equipment after each use). Adulterants and contaminants have been reported in foods, in prescription drugs and in dietary supplements.
Examples of Adulterants
Perhaps, the best example of an "adulterant" entering our food supply is "melamine". In 2007, melamine found its way into pet foods. In 2008, it was found in milk products, instant coffee products and candy manufactured in China, and imported and sold into the United States. Melamine was deliberately added to milk powder to artificially boost the nitrogen content of the food. Why? Nitrogen is a marker for protein content.
By boosting the nitrogen content with melamine, the product appears to have higher protein content than it actually does. The milk can be watered down, and spiked with melamine. Higher protein equals higher profit. Unfortunately, melamine is very toxic to human kidneys. This example of adulteration was lethal: babies died, thousands more were hospitalized, and animals died as well.
Examples of Contaminants
Examples of common contaminants found in raw materials or introduced through manufacturing practices include:
- Heavy metals (e.g., lead, arsenic, cadmium, mercury, etc – naturally occurring in the material and/or introduced via contaminated air or water).
- Pesticides, herbicides, fungicides (due to poor farming practices and insufficient controls over water purity)
- Solvents (used in processing and/or cleaning equipment; incompletely removed from the raw material and/or equipment prior to packaging).
- Microbiological contamination (including aflatoxins)
Consumerlab has found unacceptable levels of heavy metals in numerous dietary supplements, including popular brands of multiple vitamin/mineral products and various herbal products. Though they very rarely test for pesticides, herbicides and fungicides, these too have also been found in several products.
At the time of this writing, Consumerlab.com does not test products for the presence of solvent residues; however CNCA Health does conduct such testing. CNCA Health has rejected raw materials that contained unacceptable levels of toxic solvents. The FDA has identified a small number of solvents as being Class I solvents. Essentially, the Class I solvent means, "This solvent is extremely toxic. Use only if you remove most of it out of your manufactured product before it reaches consumers". Strict limits are defined for Class 1 solvents.
One of these Class I solvents is 1, 2 DCA (1,2 dichloro-ethane). Because CNCA Health tests for DCA, one raw material containing five times the FDA limit for this toxic solvent was found. The material was rejected by CNCA Health. It is estimated that very few incur the cost of this level of testing. Microbiological contaminants are yet another issue. That's why CNCA Health, and most other companies, test ingredients and finished products for the presence of these microorganisms before they are distributed to consumers. Tests are reliable and fairly inexpensive to perform. But in recent instances, CNCA Health has refused material with microbial contamination that met the "acceptable" level for FDA standards. Our patients simply cannot be exposed to any avoidable contaminants, and stringent testing and high standards does make it avoidable
A more expensive test that few companies regularly perform on herbal ingredients is a test for aflatoxins. Aflatoxins are fungal by-products that are very toxic to the human liver. So toxic, in fact, that FDA has upper allowable limits for aflatoxins in certain food products, such as corn. CNCAHealth found levels of aflatoxins above the FDA allowable limit in Milk Thistle. Milk Thistle is very helpful for supporting healthy liver function. When high levels of aflatoxins were found in this batch of Milk Thistle, we rejected the material and the supplier apologized. They do not test every lot for aflatoxins; they only test a certain percentage of lots (this is known as "skip-lot" testing). CNCA Health has every lot tested for these impurities. That's why CNCA Health found it, and they didn't.
The good news is that CNCA Health proves its commitment by only using proven, ultra-pure ingredients each and every day. CNCA Health tests for things that other companies simply do not test for in every batch.
Doctor Recommended. Hospital Approved.TM
Our goal is to consistently deliver authentic, potent, and ultra-pure dietary supplements. We rely upon qualified third party analytical labs to validate all ingredients and verify finished products. What's NOT in the product is as important to us as what is IN the product. In an effort to protect the public health, we assure maximum freedom from unwanted contaminants.
Purity is important to us as it is to you.
The real challenge, for doctors and consumers alike, is choosing which supplement provider to trust. The doctors at Cancer Treatment Centers of America know that these problems exist. That's why CNCA Health was created – to provide dietary supplements that physicians could consistently trust.
Doctors and hospitals trust CNCA Health nutritional supplements. You can too.
Quality Certifications - USP/NSF
Do They Go Far Enough?
Phrases such as "GMP-Certified" indicate that the manufacturer has voluntarily submitted to a facility inspection by representatives from the Natural Products Association (NPA), United States Pharmacopeia (USP) and/or National Sanitation Foundation (NSF). Company programs look for compliance with elements of "good manufacturing practices." These inspections looked for evidence of GMP compliance in several areas:
- Facility cleanliness, lighting, pest control, etc.
- Staff competency and training
- Documentation of Standard Operating Procedures (SOPs) and compliance with SOPs.
- Manufacturing controls
- Labeling controls
The above inspections do not assure that all raw materials used in dietary supplements are sufficiently tested for authenticity, potency and purity.
In various websites, and on various dietary supplement labels, several variations on this "certification" theme can be found (phrases such as "Laboratory Tested", "GMP-Compliant", "Independently Tested", "USP Compliant", etc.). But without mention of the specific tests performed, how much value do these certifications hold… in our view, not much.
CNCA Product Certification: On every CNCA Health product label, there is QUALITY PLEDGE. This quality pledge lists the tests performed consistently on that particular product and its ingredients. It is standard CNCA Health practice to provide doctors and consumers with factual, relevant information which support our superior quality claims.
Our extensive testing and quality checks give you supplements with maximum freedom from harmful contaminants. That's why we confidently say CNCA Health supplements are:
Doctor Recommended. Hospital Approved.TM.