NUTRITIONAL PRODUCT QUALITY

Contents

The statements contained below have not been evaluated by the FDA.
This product mentioned and information is
not intended to diagnose, treat or prevent any disease.

QUALITY CONTROL OF ALL PRODUCTS

Who oversees the quality of our health and wellness products?

Dr. Mark Lange is the Director of Quality Control. Dr. Lange has a PhD in analytical chemistry and 15 years experience in pharmaceutical and Nutraceutical manufacturing and testing.

What steps are taken to assure the quality of our products?

Market America follows this process to assure the quality of our products:

· Specifications are set for raw materials and finished products. They products are compounded with the highest quality raw materials from some of the foremost pharmaceutical and chemical companies in the world: Hoffman-LaRoche, Pfizer and Malinckrodt, for example.

· Raw materials are sourced with Certificates of Analysis.

· All raw materials are assayed and evaluated at the time of receipt, using suppliers’ protocols and available testing methods.

· Raw materials are purchased only when the current inventory is low and used as soon as possible.

· Products are manufactured using Standard Operating Procedures.

· Products are inspected at the MA warehouse prior to release for damage, label accuracy, appearance, taste and odor.

· Product is quarantined if failing to pass inspection.

· Products are assayed by independent labs for isotonic capability, micro contamination, and potency on a random basis.

· Manufacturing facilities are audited for GMP compliance and proper documentation.

· All ingredients are USP or NF grade or better.

· The USP (United States Pharmacopoeia) and the NF (National Formulary) are official compendiums of approved ingredients. The U.S. Food and Drug Administration list the USP and NF in the Food Chemical Codex (FCC).

· There is no ingredient in Isotonix that cannot be found in any highly respected and traditional nutrient supplement. Only the formulation and the delivery to the body make it a unique product.

· Costly quality control procedures are used in its manufacturing to assure potency and quality.

· The products are manufactured in dehumidified rooms to prevent damaging moisture is part of the process.

Is the nutrient amount of the label, quantified as actually in the product?

Product contains Over 100% of label claim are used in every product formulation.

120% for Vitamins and 105% for Minerals. [FDA only required that 90% of what is listed on label be in the bottle.]

Are the ingredients used in our products all natural?

Our ingredients come from both natural and synthetic sources. We choose what is the best in the given circumstance. Natural ingredients are use as long as that is the optimal source. Sometimes it make sense to use a synthetic. The advantages of synthesis are that purity is better controlled, there are no allergens, it is non-GMO, and there is no microbial contamination. Our vitamins and non-active ingredients meet USP specifications for identity, quality and purity

Some ingredients are derived from the electrolysis of sea water, such as the calcium carbonate, or extracted from plants, like Pycnogenol and grape seed extract. Some ingredients, like calcium phosphate, are synthesized. .

The vitamins and minerals are of the highest purity available and they are obtained from reputable manufacturing companies known for their quality raw products. If we use herbal extracts, then there are a variety of laboratory/industrial methods used to isolate specific active components.

Market America firmly believes in and promises to provide only the highest quality products that will deliver maximum effectiveness. All the ingredients in our products are backed by proven science and technology and we will continue to search out the best of the best to maintain our promise to our customers.

Where are the product ingredients sourced from?

We work with our vendors to carefully select the highest quality ingredients available. Our products are sourced from wherever the best raw material is found and our quality control extends to each ingredient as well as the overall product.

Some examples

The fish oil in our Omega III is derived from sardines, anchovies, mackerel and Clupea generally caught off the coast of Peru. FYI: The waters of the coast of Peru provide a biologically sustainable population of fish. The waters are nutrient rich. Small fry are used to ensure less likelihoods of contaminants.

Aloe needs special conditions to grow such as full sun and well-drained soil, with temperatures always above freezing. It takes 18-24 months for an aloe plant to be ready for harvesting. Each plant produces about three good leaves that can be harvested four times per year. Market America’s aloe is grown in Mexico below the Tropic of Cancer. Plants are processed within 4 hours of harvesting.

Our OPC contains a natural plant extract from the bark of the maritime pine tree which grows exclusively along the coast of southwest France in Les Landes de Gascogne. This unspoiled and natural forest environment is the unique source of Pycnogenol®.

Some companies publish Certificates of Analysis (COAs) to prove the quality of their products. Can I get a COA for nutraMetrix products?

Though each ingredient has a Certificate of Analysis – The COA results require specialized knowledge and education to interpret correctly. The results are compared against pharmacopeia standards and the method error must be factored in. We do not release COAs into the public because they can easily be misused or misinterpreted. The quality of a product batch cannot be assumed to be acceptable just because the previous batch was within specification. Therefore, even if we did publish a COA for a particular lot #, it would be out of date with respect to the lot# being shipped from the warehouse within weeks. Checking batch records and test results is the responsibility of the Director of Quality Control. Market America acts as an independent QC check between the manufacturer and the consumer. We have no financial interest in any batch and if anything is not right, we quarantine the product and ship it back to the supplier.

Is Market America GMP certified?

There are several organizations and companies performing third-party GMP certification. These include NNFA, Shuster Labs, NSF International and USP. Our vendors must be certified by one of these parties. Because Market America is a product broker and not a manufacturer, third-party GMP certification is not applicable. However Market America is regularly inspected for sanitation and proper record keeping by the FDA.

What are Good Manufacturing Practices (GMPs)?

On March 7, 2003 the FDA published its “Proposed Rule for Current Good Manufacturing Practices (cGMPs) in Manufacturing, Packing, or Holding Dietary Ingredients or Dietary Supplements”. The proposed regulations intended to ensure that dietary supplements are not adulterated with contaminants or impurities, and are labeled to accurately reflect the ingredients in the product. The FDA expects to build consumer confidence in all dietary supplements by insuring the identity, purity, quality, strength, and composition that the label proclaims.

How can we assure the quality of products when they are manufactured at offsite facilities?

By working with a contract manufacturer, in contrast to being the onsite manufacturer, an extra layer of quality control is in place. Since we act as an intermediary between you and the manufacturer, we have no incentive or interest to receive, accept or ship out inferior, defective or a sub-par product. In fact, just the opposite. Our name and reputation is on every carton, bottle, etc. making us especially committed to the best quality control measures.

Products must be manufactured using predefined ingredients to meet finished goods specifications. Batch records for each lot are sent to the nutraMetrix™ Quality Control (QC) department for review, approval and retention. Batch records document the ingredients used, blending times, equipment used and who did the work.

Laboratory test results performed in the manufacturer’s lab are copied to nutraMetrix™ QC. Some products are sent to an independent laboratory to assure adherence to specifications before shipping to the distribution warehouse.

Upon receipt at the warehouse, we examine for damaged goods, proper labeling, and consistency in taste, odor, and appearance. Our in-house lab tests isotonic products for osmolarity confirming that when the product is made as directed, the solution is in the isotonic range.

Furthermore, any product found to be less than optimal is quarantined for destruction or return to the supplier. The manufacturer will bear the cost of returned goods. nutraMetrix™ is committed to accepting and distributing only superior, high quality products adhering to strict quality control procedures.

I heard that the supplements industry is not regulated. Is this true?

Unfortunately, many people think that dietary supplements aren’t regulated, which simply isn’t the case. Dietary supplements are regulated by the U.S. Food and Drug Administration (FDA), although not like drugs, but instead like foods.

In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA), which established new standards for dietary supplement products. Specifically, the FDA has the power to:

· Stop any company from selling a dietary supplement that is “adulterated” or misbranded

· Stop the sale of a dietary supplement that makes false or unsubstantiated claims

· Take action against any dietary supplement that poses “a significant or unreasonable risk of illness or injury”

· Stop any company making a claim that a product cures or treats a disease

· Require dietary supplements to meet strict manufacturing standard, including potency, cleanliness and stability

The FDA assures that products are safe and accurately labeled, and dietary supplement manufacturers must notify the FDA of intended label claims and ensure that they can be substantiated.

The FDA has regulations on good manufacturing practices (GMPs) for dietary supplements. Under the rule, manufacturers are required to evaluate the identity, purity, quality, strength, and composition of their dietary ingredients and dietary supplements.

In December 2006, Congress passed The Dietary Supplement and Non-Prescription Drug Consumer Protection Act (the “AER Bill”.) This legislation requires the reporting of “serious” adverse events for dietary supplements. Many people believe that over time this reporting requirement will provide additional proof of the safety of dietary supplements.

So if you’re wondering if dietary supplements are safe, the answer is yes, if used responsibly. However, as a consumer, you should be aware of what supplements and amounts you’re taking and how this may affect your health or interact with prescription or over-the-counter drugs. Make sure to read all labels, and if you have any questions or concerns, ask your professional healthcare provider.

ISOTONIX PRODUCTS

Are there fillers in Isotonix?

There are NO preservatives or fillers, binders, excipients, artificial colors or flavors are used.

Are the natural ingredients used in our supplements screened for pesticides?

All ingredients extracted from natural sources (such as pine bark, citrus, bilberry, and grape seed) are tested using gas chromatography for pesticide residue.

What is the difference between Isotonix and oral sprays?

Isotonix shows up in saliva in 10 minutes. Spray can not get entirely into system, PLUS oral spray is considered a DRUG!!

How much “sugar” is in them?

Sweetened with natural fructose. Analogous foods, in both calories and natural sugar content, are 2 or 3 average grapes, ½ teaspoonful of honey, or a single bite of a peach or apple. The consumption of fructose does not produce the extreme “highs” and “lows” in blood sugar levels as ordinary table sugar might.

What about the sugar content of the Isotonix?

Some people do not understand the concept of our Isotonix products. Nutritive sugars have multiple uses including being:

1. Bulking agents for active ingredients in the powder to improve uniformity of blend,

2. Masking agents for covering the off-tastes of various nutrients (think: copper, zinc, B-complex vitamins),

3. Osmotic agents that exert osmotic pressure and create isotonic solutions (what Isotonix products are all about), and

4. Active transport agent such as glucose that helps to drag selected nutrients across enterocyte membranes.

Most of the sugar in Isotonix products is fructose. Fructose has a good, clean flavor-enhancing profile, it covers a lot of off-tastes in vitamins and minerals, it has a very low glycemic index (19 out of 100), it contributes about 4 calories per gram, and both fructose and glucose contribute in a major way to the isotonicity of Isotonix products.

What about stevia or xylitol as alternative sweetener sources?

Stevia is a high-intensity, very low bulk sweetener. It cannot be used in Isotonix products for blending active ingredients, because only a pinch of this natural sweetener is used per serving. It exerts no appreciable osmotic pressure. It has been under significant regulatory pressure as a GRAS-approved sweetening agent. At least one group has petitioned the FDA to declare Stevia to be an active compound, because it has pharmacological value in treating high blood pressure.

Xylitol is a sugar alcohol exhibiting less caloric value than fructose or glucose. It is not a high-intensity sweetener so it could be used for its bulking property. Nonetheless, we know little about its ability to exert osmotic pressure in solution. We also don’t know whether it would be a food source for Candida albicans in the gut. We do know that it can cause substantial problems with gas formation, irritation and cramping in the colon in normal individuals.

Are Isotonix lactose, soy and gluten free?

Isotonix products are definitely free of milk casein, grain-derived gluten, soy and its by-products, and dyes. We make that claim on all of our Isotonix labels, and we have tested for these substances using sensitive ELISA methodologies. We use nutrients such as riboflavin and beta-carotene to impart color in our products.

What about Maltodextrin?

We do use a minimal amount of one corn-derived compound—maltodextrin—as a particle-coating agent to prevent Isotonix powder from clumping. It is a high-purity material and we again - keep its use to a minimum.

Maltodextrin is a so-called alpha-limit dextrin, derived from the hydrolysis of starch. If you can imagine starch as being a “molecular” tree with a main stem and branches, then maltodextrin is a tree in which all of the branches have been cut at their attachment points, the alpha-limit. Starch and maltodextrin are polyglucose compounds which offer caloric value. It is true that in many foods maltodextrin acts as a bulking agent, but that is not the case with Isotonix products. Depending on the specific Isotonix product, there are about 30-50 mg of total maltodextrin in a 3.33 gram serving. So you can see that this material is not proving much caloric value (4 calories X 0.050 grams = 0.2 cals/serving). Maltodextrin is used as a coating agent.

Maltodextrin — a soluble polysaccharide or polymerized glucose molecules—is chemically not the same thing as MSG or monosodium glutamate (AKA: glutamic acid, sodium salt). MSG is a flavor-enhancing agent used in foods. Glutamic acid is an amino acid that is complexed with sodium, and this molecular complex helps improve flavors as it interacts with receptors on taste buds. The trouble is, migraine headaches can be triggered by MSG in some individuals. To do this, MSG travels to the brain. In contrast, maltodextrin is converted by enzymes in the small intestine to glucose molecules and glucose is then actively absorbed. It makes sense for those folks to steer clear of MSG. MSG is found in quite a few pre-packaged foods, as well as foods prepared in restaurants.

Are Isotonix hypoallergenic?

Current scientific literature cites no known instances of “vitamin allergies”. Many vitamin tablets available include dyes, fillers, binders, coatings and extenders that may cause allergic reactions in some people. The exclusion of these substances in Isotonix products was carefully planned; therefore, no reports of allergic reactions are expected.

Is there an advantage to Isotonix products?

The advantage of ISOTONIX^tm is that they do not have to be digested to be absorbed. When taken as directed on an empty stomach they go immediately into the small intestine where nutrient absorption takes place. According to The Physician’s Desk Reference Page 1542 of this reference shows that vitamins and minerals in a pill form are only 10 to 20% absorbed by the body.

Once a person is over age 30 and the body does not have enough enzymes and hydrochloric acid to dissolve pills, the percentage drops significantly. With Isotonix, this is not a problem as it goes straight into the bloodstream without the use of enzymes or acid. Any age gets full amount. Little nutritive value is lost. Isotonix does not require digestion before being absorbed into the body’s system.

Are there papers in the scientific literature that explain and support the “isotonic advantage?”

Isotonix products make the label claim of being “isotonic capable”. When prepared as directed, the solution is within a range of tonicity matching the human body. The basis for the isotonic line is physiologic. Isotonic solutions work via normal body physiology to deliver nutrients quickly as compared to solid forms. These physiologic principles have well been described in medical references and in the medical literature. Here are a few sample references:

Ganong, WF Review of Medical Physiology, 13^th ed. Norwalk, CT Appleton & Lange, 1987.

Graham, DY, Smith, JL, Bouvet AA “What Happens to Tablets in the Stomach” Journal of Pharmaceutical Sciences 79 (5): 420-24, 1990.

Hunt, “Mechanisms and Disorders of Gastric Emptying” Annual Review of Medicine, 1983.

Seigel, JA “Biphasic Nature of Gastric Emptying” Gut 29: 35-39, 1988.

Erdman, JW “Bioavailability of Trace Minerals from Cereal and Legumes”, Cereal Chemistry 58(1), 1981

Are there particular benefits to the isotonix products for certain consumer groups?

People needing fast nutrient absorption: Isotonix B-12, for example, is absorbed faster (on an empty stomach) than an intra-muscular injection of B-12.
Geriatrics: As the body ages, the digestive system becomes less efficient at breaking down food - including vitamin pills, capsules, and tablets.
Stomach surgery and gastric bypass patients: who experience malabsorption issues.
Children: Children do not enjoy swallowing tablets, and do not like the aftertaste of vitamins.
Athletes: Most coaches recommend not eating 2 to 4 hours before participating in athletics. They can take an ISOTONIX.
People who cannot hold their food down: Recovering alcoholics, anorexics, bulemics.
People on a liquid diet: Post surgical patients, oral surgery patients.
AIDS Victims: One of the symptoms of people suffering from AIDS is that quite frequently the ingestion of solid food causes increased discomfort.
People who cannot swallow pills: Not a problem with Isotonix.
People with weak stomachs: People suffering from ulcers, upset stomachs, nausea, flu, or fever who don’t want solid foods.
People with colon problems: Some people with colon problems have experienced excruciating pain when undissolved vitamin pills become lodged in the colon area. Because Isotonix is a liquid nutrient, this problem is completely eliminated.
People undergoing chemotherapy: 25% to 40% of patients undergoing chemotherapy experience nausea upon eating solid food. Therefore, many chemotherapy patients deprive themselves of nutrients by not eating. Isotonix addresses this problem by providing much needed (and rapidly absorbable) nutrients in a pleasant tasting liquid.
Lactating and pregnant women: Many women in this group become nauseous upon eating solids. Thus a pleasant tasting liquid with many nutrients provides important health insurance

GENERAL PRODUCT INFO

ALOE
OMEGA 3
OPC3
SPECTRUM

ALOE

What is the process used to produce Ultimate Aloe?

Market America’s Ultimate Aloe is formulated from all-natural ingredients. Aloe gel is mostly water, but contains polysaccharides which give the gel thickness. These polysaccharides have a laxative effect when taken internally, therefore they are removed, while still preserving the vitamins, minerals, complex amino acids and simple sugars.

Aloe needs special conditions to grow; full sun and well-drained soil, with temperatures always above freezing. It takes 18-24 months for an aloe plant to be ready for harvesting. Each plant produces about three good leaves that can be harvested four times per year. Market America’s aloe is grown in Mexico below the Tropic of Cancer. Plants are processed within 4 hours of harvesting.The Aloe material that we use starts as a whole leaf juice that is separated from its fiber and spray-dried in a cold, dry chamber under vacuum. The resultant powder is then packaged in air-tight containers (the Aloe powder attracts water vapor avidly) and shipped to our contract juice blender.

The juice is then reconstituted with purified, filtered water and mixed with special flavor extracts, small amounts of sugars, and preservatives including vitamin C, sodium benzoate and potassium sorbate. Raw Aloe juice is bitter-tasting, and it needs to have its natural flavor covered up. Colorant and ascorbic acid concentrations are each less than 0.1%.

The pH of Whole Leaf Ultimate Aloe is 4.0, and the pH of the other flavored Aloe juices is 3.5. As you know, using an acidic pH is critical in suppressing bacterial growth, spore hatching and so forth. However, keeping an acidic pH is not sufficient, and that is why we add potassium sorbate and sodium benzoate at low levels to block bacterial growth even farther.

OMEGA 3

Is the Omega-III fish oil tested to be free of heavy metals?

The fish oil used in our products is laboratory tested for PCB, Dioxin, and Heavy Metals. We only use fish oil that meets or exceeds standards set by Canada (CFIA), European Union (EU) and the United States (CRN). For example, cadmium, lead and arsenic cannot exceed 0.1 ppm and mercury cannot exceed 0.01 ppm in the fish oil. FYI: That is the highest purity rating available for fish oil.]

OPC3

What about the ingredients in OPC3?

The companies that manufacture the high purity, raw ingredients for OPC-3 are some of the biggest names as suppliers of quality dietary supplements and food extracts. They are international in scope. We mention one of those companies on our OPC-3 label---Horphag Reasearch Ltd. Please note that the Horphag/pine bark Pycnogenol® method of extraction is accepted as the standard technique and is published in the United States Pharmacopoeia.

The term “red wine extract” is used loosely to designate this ingredient. In fact it would be more accurate to call the material “red grape skin extract.” We have gotten more questions about that single ingredient than the other 4 extracts combined.

The red grapes are crushed (as they normally would be to prepare them for wine making) and allowed to stand in their juice for a substantial period of time to allow the flavonoids to leach from the skins and pulp. The grape pip is then macerated even further, and the solids are either filtered or centrifuged from the juice. The juice is then extracted for its OPCs and other flavonoids. Yeast is not added to the juice, and so fermentation never occurs. So you see that calling it red wine extract is a misnomer. Also, you can imagine how expensive a real red wine extract would be if aged wine were extracted for its yeast-modified flavonoids.

During the extraction process, many non-phenolic compounds are removed. In the unlikely event they would have formed at all, nitrites/nitrates would be excluded from the polyphenolic fraction.

Here is more on the extraction methodology used to isolate polyphenolic compounds from grape seed, red wine (grape pip), pine bark, bilberry, and lemon. Organic solvents, namely acetone (a ketone) and butanol (an alcohol), were used in the extraction of polyphenols, and this methodology was one that was included in our Isotonix information packets. Even using this solvent extraction technique, the certificates of analysis of the raw extract powder always indicated the solvents either were not detectable or were present in the low parts per billion range. You could eat fresh fruit and get more organic solvents from the pulp than were present in a bottle of OPC-3. Nonetheless, chemical extraction techniques for proanthocyanidins, other flavonoids, and organic acids have changed to the technique developed and refined by Dr. Jacques Masquelier and now used by Horphag Ltd. and Berkem S.A.

We went through a registration process for Isotonix OPC-3 in Australia with the Therapeutic Goods Administration (TGA) where our Isotonix manufacturer had to list each extract along with the production technique used to extract the active ingredients. In each of 5 extracts, the preferred technique is hot water (120 degrees Fahrenheit) extraction of powdered raw material (ground seeds, bark, rind, fruit), followed by a secondary extraction with ethanol (an organic solvent). The ethanol extract is dried, meaning the ethanol is evaporated under vacuum, and the resultant powder “cake” is ground to a fine powder. The powdered material from each extract source is then blended in the correct proportions with the base ingredients (fructose, glucose, silica, maltodextrin, potassium bicarbonate, calcium sulfate) to produce the finished OPC-3.

SPECTRUM PRODUCTS [children]

How do our Isotonix spectrum [for children with autism spectrum disorder] compare to Kirkman products?

We keep hearing that pills and foul-tasting liquids are routinely rejected by individuals with autism. We took our lead from Dr. James Sensenig, a naturopathic physician who sees many autistic individuals in his practice and who has observed good compliance with taking adult formulations of Isotonix products.

Our competitor, Kirkman uses sucrose as their sweetener. We think that usage is a big no-no. We have taken a look at their catalog and think that we’ve improved upon their formulations. We’ve listened to parents of autistic children who do not like Kirkman products. We gotten some encouraging initial feedback from these folks.

We think our initial offering of Isotonix products will help calm the intestinal tract of autistic individuals and improve nutrition, leading to changes in behavior, digestion, and development. We are working on new, good-tasting formulations that will continue this approach of good nutrition and encourage daily product use.