Formulation

There are many different vitamins, minerals and herbs and the large variety of brands, confuse some consumers, making it difficult to decide what is really necessary and which quality brand they can trust. In this six part series entitled, "The BIRTH of a Vitamin," Maxi-Health Research® Inc would like to share with you REAL facts about the quality and manufacturing of vitamins & nutritional supplements and important factors needed in order to insure you are taking a proper supplement.

The first step in creating a vitamin product is FORMULATION. In other words, what is the product going to be used for and what raw materials should be included to maximize the effect of the product itself for its intended use.

Let's discuss what determines a high quality ingredient. There are many different grades in raw materials, some have more of the active ingredient and some less, as it depends on which region they come from and the season in which they are harvested. A key element of raw material sourcing is "assurance of cleanliness". Some raw materials contain high levels of certain bacteria, yeasts and mold particles. Unwanted elements like heavy metals including lead, mercury, cadmium and arsenic can be found in raw materials.

The USP/NF (United States Pharmacopoiea/ National Formulary) has set forth methods and standards for raw material testing to identify these unwanted elements. Some raw material manufacturers don't bother to test for these materials, as they are cost effective,
hence they can offer their raw materials at a much lower cost thus creating a barrier
for high quality raw materials which are tested for their safety.

Another important aspect in the quality of raw material ingredients is the efficacy and bioavaliablity. An ingredient, which does not absorb properly in the body can do more harm than good and offers close to zero therapeutic effect. Let's start with vitamin E, which is one of the most widely, used supplements. The expensive form, which is used in all Maxi Health®, products, is the natural d-alpha- tocopheryl, which comes from vegetable oils, and the less expensive form is, dl-alpha- tocopheryl, which is synthetic and petroleum-derived. Recent human studies indicated that the bioavailabilty (absorption rate) of natural vitamin E is approximately twice that of synthetic vitamin E, as the natural form is retained longer in body tissues. One of the most stable forms of natural vitamin E is d-alpha- tocopheryl succinate. The most promising studies on vitamins E`s anticancer properties have used the succinate form, which is found in all Maxi Health® products containing vitamin E, like Circu E 400, CircuMax etc.

Another example is chromium. The most common and least expensive chromium supplements are inorganic chromium salts such as chromium chloride, oxide and acetate. These forms are poorly absorbed and tend to accumulate in the kidneys and ovaries as opposed to the liver, where biologically active chromium is normally stored. Amino acid chelated chromium is better absorbed than inorganic chromium, but it does not exhibit GTF (Glucose Tolerence Factor) activity, which is responsible for binding insulin to cell membrane receptor sites.

Maxi Health Research® products, including Chromium Supreme, D&S Control etc. contain highly bioavailable chromium called ChromeMate®, which is a unique, patented oxygen-coordinated niacin-bound chromium complex that significantly increases the bioavailabilty and biological activity of chromium. Studies have shown ChromeMate® to be 18 times more potent than other forms of niacin-bound chromium tested. It`s absorbed and retained in the body more than 600 percent better than inorganic chromium chloride and 300 percent better than chromium picolinate.

Maxi Health Research® purchases raw materials from reputable raw material manufacturers from around the globe which have been in the industry for many years and are known to rigorously test their ingredients for any impurities and manufacture products which are safe, effective and bioavailable. Some of these manufacturers have obtained World Health Organization (WHO) certification for their manufacturing operations.

There is a tremendous amount of information available via research texts, clinical papers, hype from self interest companies manufacturing vitamin and herbal ingredients and of course the internet. The formulators and researchers at Maxi-Health Research® invest copious time and effort in acknowledging "real" scientific information from scientific sources. Maxi-Health Research® Inc. does not formulate their products based on the hype of a new ingredient that is receiving lots of media attention, but on solid clinical research conducted by the most reputable companies in the industry showing the ingredient to be safe, effective and bioavailable.

From this point, our purchasing and sourcing department spends numerous hours searching literally the world for the finest, most effective, safest, vegetarian-based, stable and kosher components in which to manufacture a product. This may takes weeks if not months.

Maxi Health Research® focuses on quality rather than price. We know that the very best does not come easily or inexpensively but we also believe that you get what you pay for. As a clever entrepreneur once said "The bitterness of poor quality will remain long after the sweetness of low price is forgotten."

In Process Testing of Raw Materials

Much of the raw material used in the production of nutritional supplements is bought from a distributor or broker who purchases the material in large quantities and repackages it for distribution. Extra caution must be taken at this step since during repackaging a product has the potential to become contaminated or adulterated. Since the industry does not require a product to be further tested, many vendors of raw materials "trust the manufacturers word" on the testing and rely on the face value of the Certificate of Analysis.

A Certificate of Analysis, is a sheet of paper provided by the manufacturer or distributor of raw materials in which the product specification is described including, the lot#, color,
potency, bacteria count and other testing and technical information.

To insure the quality and authenticity of the raw material, Maxi Health Research® goes beyond industry requirements, and implements the Good Manufacturing Practices (GMP), set forth by some of the leading industry organization (USP and NNFA) and has their raw materials tested by doing in house laboratory analysis. The laboratory will verify and assay every lot of the material making sure the material is 100% pure and accurate.

Maxi Health Research® employs a well equipped in house analytical and microbiological
laboratory with the use of highly technical and extremely sophisticated equipment. Infra-red spectroscopy, atomic absorption, U.V./VIS spectrophotometers and computerized high pressure liquid chromatography are some of the various testing equipment used to be certain that only the highest quality products possible get the Maxi Health Research® stamp of approval.

The first step in testing is known as "skip lot". This consists of testing the first five to ten batches of the raw material that are used for production to see if the material meets the manufactures initial standards and to see how the test results compare with the Certificate of Analysis. This testing should be repeated two or three times annually to assure that the quality of the material does not change. The lab routinely conducts pesticide, and/or any other natural toxin analysis as well.

The next step is "identity testing" which verifies if the raw material is indeed the material that was requested, for example is it really vitamin E. Identity testing is required by GMP
regardless whether or not the raw material was subject to skip lot testing. After the initial testing, the raw materials are stored in their specific location.

As part of Good Manufacturing Practices (GMP) the raw materials are stored in an air- conditioned facility with dust collecting systems. A monthly environmental monitoring program maintains relative humidity and temperature.

In early March of 2003, the FDA proposed a set of rules that would, for the first time, establish standards to ensure that dietary supplements do not contain contaminants or
impurities, and that product ingredients are listed accurately. Among the proposals are requirements for design of physical plants, quality control procedures, product testing, maintaining records, and others. These proposed regulations will become mandatory within in the next few months. Manufacturers who are not presently following GMP regulations will most likely fall out of the market unless they are financially capable to meet those requirements. Maxi Health Research® has followed these guidelines prior to the FDA announcement and their facility has been GMP certified by the NNFA making it much easier to follow the new upcoming FDA regulations.

The ultimate goal of Maxi Health Research® has been and is to provide high quality scientific based and kosher unique nutritional supplements with a difference, making
them one of the leaders in nutritional science

Formulating Nutritional Supplements

When formulating a dietary supplement, many important factors need to be considered. The first step is determining the purpose of the supplement, for example: creating a supplement for eye or brain health. The next step is picking the proper ingredients.

Maxi Health Research®'s team of nutritional experts have set forth basic criteria when choosing ingredients and creating nutritional formulas, including dosage, safety, bioavailability, scientific research and Kosher.

Dosage

The National Academy of Science has recommended dosages for vitamin and minerals known as Daily Values (%DV), previously named the Recommended Daily Allowance (RDA). These dosages are the minimum amount necessary to insure good health, however, new nutritional research is leading researchers and clinicians to estimate that these doses may not be high enough to support optimal health in today's stressful world. There are many conditions in which the Daily Value dosages did not show any significant benefits, while at higher doses they have. For example, a peer-reviewed study stated that Vitamin C doses of 250 mg to 500 mg per day produced no effect on the reduction of cold symptoms, while doses from 1000 mg to 3000 mg per day decreased common cold durations by an average of 21%.

When buying a nutritional supplement it is highly recommended to check the supplement facts panel to see at what levels the dosages are, as some companies "try to fool the consumer" by adding some exciting ingredients into their Multi`s or other products, but at the same time those ingredients are at very low levels which have no nutritional value.

Safety

Even though dietary supplements are generally quite safe, consumers occasionally report adverse effects associated with their use. It is important to be aware of potential problems and how to avoid them. There are two general categories of concern regarding the safety of dietary supplements: toxicity (the possible negative effects inherent in a supplement) and contamination (impurities introduced during production, as discussed in part 1).
Toxicity refers to the degree to which a substance interferes with normal physiological functions. Many substances can be toxic if consumed in extreme quantities. Most dietary supplements enjoy very low toxicity. Very few deaths in the United States were ever confirmed to be attributable to the toxic dose of a dietary supplement. Compare this with over 100,000 deaths per year caused by the toxic effects of prescription drugs.
Most dietary supplements can have negative side effects when taken in excessively large quantities. Supplements that need to be taken with caution include the fat-soluble vitamins A and D, niacin, all minerals, and some of the stronger herbal products. Recommended dosage levels on products labels provide guidance as to what levels may cause unwanted side effects.

Some people are allergic to dietary supplements just as they are to food or drugs. Some substances such as certain herbals are contraindicated for conditions such as pregnancy. Some substances can interact with other drugs or recently consumed supplements, thereby causing negative side effects. To avoid these problems, read all warnings on the product label. Ask a physician or nutritionist to assess whether any other substance you are taking or any medical condition you are experiencing precludes safe use of a dietary supplement. Safety of any consumable product should never be ignored. Yet consumers can take comfort in knowing that dietary supplements, when taken as recommended, are exceptionally safe.

Bioavailability

One good definition of bioavailability is the amount of a nutrient ingested that is absorbed and thus available to the body for metabolic use. Bioavailability is important because all nutritional intake must be available to various body systems for growth, maintenance of body tissues, reproduction and other performance factors. No matter how high the nutrient levels or how well formulated the product, if it is not available then money and effort has been wasted.
Let`s take a look at minerals as an example, there are many different minerals in a variety of forms. The highest quality forms for minerals are the chelated minerals. When minerals such as zinc, manganese, magnesium, copper, iron, calcium, and others become surrounded by and bonded to amino acids in a stable form, this is referred to as chelation. Chelation is the natural means for the body to transport minerals across the intestinal wall as part of digestion.

Amino acid chelates are emerging as state-of-the-art technology for delivering selected mineral and trace elements with maximum bioavailability, tolerability and safety. Amino acid chelates protect the minerals from unwanted interactions during digestion. These chelated minerals are less likely to bind to antagonistic food components that sometimes lower bioavailability. They are also less likely to cause adverse drug interactions and, true mineral amino acid chelates do not interfere with each other's absorption as free ionized minerals do. The characteristic structure also prevents irritating effects of free ionic minerals in the gastro-intestinal tract that are often the cause of intolerance (especially common with iron supplements).

Maxi Health Research® products contain only the finest mineral amino acid chelates from Albion Laboratories, formulated to survive the gastrointestional system and protect the sensitive mucosal membranes of the stomach and intestines from irritation. Only Albion Laboratories has developed the ability to closely duplicate the natural chelation process, which occurs in the body. Essentially, Albion has the ability to turn inorganic rocks (mineral sources) into small organic molecules. This makes them highly bioavailable and therefore more effective.

In addition to selecting high quality ingredients, which have high bioavailability, Maxi Health Research® products are formulated with an extra assurance of absorption and bioavailability. We include Enzymax, a digestive enzyme complex, in all our products. Digestive enzymes break down the foods ingested into smaller particles, so that the body can better absorb vitamins, minerals, and other nutrients. They control the entire metabolic process and are essential for digesting and absorbing food, producing energy, maintaining healthy function, and clearing toxins from the body. Without sufficient enzymes the body cannot break down the food ingested for assimilation.

Scientific Research

There are many different nutritional supplements on the market which claim to be helpful for a variety of conditions. Some make abnormal claims, which are not backed by any scientific research but myth and hype, however there are many quality manufacturers, including Maxi Health Research®, which base their formulas and health claims on real scientific research and clinical studies. The nutritional experts at Maxi Health Research® have been studying and experimenting nutritional supplements for over 25 years with the help of world-renowned researchers and physicians, thus developing a full line of nutritional supplements with many satisfied consumers.

Kosher supervision

Vitamin production involves the use of numerous materials that are kosher sensitive. As such, the kosher consumer should look for vitamins with a reliable certification. A kosher consumer should be concerned with the raw ingredients, fillers, binders, lubricants, coating agents, flavors and the manufacturing process.

Questionable ingredients include stearates, which could come from animal origin, lactose (dairy), fish oils, clams, eggs, gelatin (animal/fish derived) etc. There are also starches, alcohol and gluten, which are concerns for Passover use. Some may have a dairy-and-meat derived product in the same item, which is another concern.

Vitamins and health foods that are all "natural" need kosher supervision as well. Some natural sources for vitamins are: Vitamin A - butter, milk, liver, fish oil, green and yellow fruits and vegetables. Vitamin B1 - liver, kidney, eggs, pork, brewers yeast, nuts and cereal grain. The Vitamin B group - organ meats, cheese, milk, eggs, fish, wheat germ, royal jelly, nuts and grains. Vitamin D - fish oils (cod liver oil), eggs and milk products. Vitamin E - wheat germ, green vegetables, vegetable oils, milk products, eggs, liver and meat by-products.
Liquids may contain glycerin, often derived from an animal source, which is non-kosher. Capsules and coated pills may contain gelatin, most often derived from non-kosher animal sources. Acidophilus may have a dairy base and be listed wrongfully as PARVE. Flavors and all inactive ingredients may have questionable ingredients and /or the carrier may have alcohol from non-kosher wine. The carrier or base of certain supplements may have non-kosher ingredients. Many of the minerals and nutritional supplements may inherently be kosher but the process or equipment may not be kosher. It is very common to use a spray dryer to make products into a powder form. The spray drier must be kosher-sterilized. It is very common to use many non-kosher animal parts such as Taurine, an extract of ox-bile or shark blood used in all baby formulas (which is available in vegetarian). Other animal parts commonly used are the glandular parts, thyroid, pancreas, cartilage and shellfish etc.

In order to properly kosher certify health foods, vitamins, health supplements and especially natural products, one must be very astute and knowledgeable in food chemistry. One should be very cautious about the qualifications and standards of the kosher certifier. Maxi Health Research®'s products are kosher-certified by the Orthdox Union and Udvari Kashrus and some by the Chof K. The combination of Maxi Health Research® and the OU and Udvari Kashruth of America gives you guaranteed assurance that no effort or expense has been spared in the formulation, production, testing and extensive examination for strict kosher certification. This effort results in Maxi Health Research® constantly providing the most effective, safe, strictly kosher nutritional supplements in the world.

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