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Following are some frequently asked general questions about Metagenics products:
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Probiotics
Q: What is the source of the probiotics (friendly intestinal flora) used in Metagenics products? I have heard that human strains of probiotics are the best.
A: While the Lactobacillus acidophilus, Bifidobacterium lactis, and other identity-certified probiotic strains found in Metagenics formulas were isolated from human colonic bacteria strains, it is important to remember that at birth, the human digestive tract is virtually sterile. The bacteria that will grow there following birth are due to exposure from the mother in the birth canal or at the breast during breast-feeding. Historically, our diet has contained additional sources of probiotics, including yogurt, buttermilk, fermented cheeses and even sauerkraut. So-called "human strains" of probiotics did not originate in humans, therefore, but came originally from consuming them as part of a healthy diet.
There are hundreds of different strains of bacteria living in the colon of a healthy person. Some of them confer benefits to humans, others are potentially harmful, and some can be either. A better question would be to determine the potential the specific strains of bacteria in question have for providing reliable and consistent health benefits. Metagenics took great care in developing for the marketplace the most thoroughly-researched commercially available strains of healthful bacteria.
Q: Recently, I noticed the labels on your non-dairy probiotic formulas were modified. Have there been any changes to these formulations?
A: You may be aware of the Food Allergen Labeling and Consumer Protection Act (FALCPA), which took effect on January 1, 2006, and required manufacturers to disclose in plain language on the labels whether products may contain any of the top eight food allergens—wheat (gluten), milk, eggs, fish, crustacean shellfish, peanuts, tree nuts, and soy.
In compliance with the newly enacted food labeling law, many of the Metagenics’ product labels have been revised. This law specifically affects the labels of Metagenics’ probiotic products because lactobacilli and bifidobacteria are cultured in media containing specific milk-derived nutrients. Currently, ALL stable probiotic strains of lactobacilli and bifidobacteria are grown using a similar food source. Although the bacteria consume these milk-derived nutrients as a food source during the fermentation process; the new law mandates that all materials utilizing any of the aforementioned eight food allergens, even during production, must declare its presence in plain language on the ingredient list via the word “Contains” followed by the name of the food allergen.
Please be informed that the product labels of Metagenics’ probiotics have been modified solely due to FALCPA and NOT as a result of any new changes in formulation. Therefore, the appearance of these allergen statements should not be a cause for concern. In fact, as one of the few NPA, NSF, and TGA GMP-certified manufacturers, Metagenics remains a leader in implementing strict quality assurance programs and our product purity is unsurpassed in the nutraceutical industry. We will continue to adhere to all applicable laws and regulations, and commit to providing you and your patients with efficacious products marked by predicted safety.Minerals
Q: Why doesn't Metagenics carry colloidal minerals?
A: Metagenics' research and development team of scientists is always on the lookout for new and innovative products to bring to the marketplace. But simply being new is not enough. Metagenics' selection of raw materials for use in products begins with assurances of safety, and then efficacy. Measures of efficacy include the amount and quality of scientific research published in well-respected scientific journals.
"Colloidal minerals" generally refer to a product mined from the ground containing a blend of a large number of minerals. Some of these minerals are important for life, while others have less evidence to support their need in humans, and some are even known to be toxic. The minerals are then added to a fluid such as water to form a colloid (suspension), with the belief that this improves absorption. At this time, the amount of research and safety data on colloidal minerals is insufficient to justify Metagenics' developing a product containing this source of minerals.
Q: Why does Metagenics use predominately amino acid chelates as a source for minerals?
A: For improved absorption. In order to be absorbed, minerals, whether from foods or in supplements, have to be combined with a "carrier" molecule. When this molecule is a fragment of protein (an amino acid), and the mineral-amino acid compound forms a stable molecule, it is referred to as an amino acid chelate. Because the body is very efficient at absorbing amino acids, chelated minerals are more easily transported across the intestinal wall than are non-chelated minerals. Metagenics uses amino acid chelates from Albion® for improved absorption.
Inositol & MSM
Q: One of the Metagenics products contains myo-inositol. How does that differ from "regular" inositol?
A: Myo-inositol is one of eight naturally occurring forms that make up the nutrient inositol. Each one has a slightly different shape and are individually referred to as isomers. The myo-inositol isomer is the most abundant form found in the central nervous system, where it can be converted into phosphatidyl inositol, a second messenger neurotransmitter. Inositol is the term used to describe the entire group of isomers together.
Q: What is MSM, and does Metagenics have a product containing MSM?
A: Methyl-sulfonyl-methane (MSM) is a highly biologically valuable source of sulfur. Sulfur is important for maintaining joint and connective tissue health, as well as for supporting the detoxification process in the liver. MSM is found in Collagenics® and ChondroCare®.
Kosher/Vegetarian
Q: Are Metagenics products kosher?
A: While Metagenics has many vegetarian products that are guaranteed to be free of animal products and raw materials that are certified kosher, our manufacturing is not certified kosher.
Animal-Derived Ingredients
Q: Metagenics uses porcine enzymes. What does porcine mean?
A: Porcine means derived from pig. The digestive tract of the pig is almost identical in both structure and function to humans', so enzymes derived from pigs have been shown in numerous studies to be virtually identical to those naturally produced by humans.
Q: Where does Metagenics derive the bovine raw glandulars used in its products?
A: Metagenics bovine glandular materials are all derived from free-range fed, BSE-free New Zealand animals.
Excipients & Binders
Q: What is polyethylene glycol?
A: Polyethylene glycol (PEG) is a common, non-active ingredient in foods (gum, sport drinks, surface-treated fresh fruit), dietary supplements, pharmaceuticals (eye salves, interferon injections, suppository bases), and personal care items (skin creams, toothpaste). It is non-toxic, odorless, neutral, nonvolatile, nonirritating, and approved for use as a food additive by the General Standard for Food Additives (GSFA) of the Codex Alimentarius Commission, considered the world authority on food ingredients.
In dietary supplements and pharmaceuticals, small amounts of PEG are commonly used in the manufacture of coatings for both tablets (protecting contents from oxidation) and capsules (maintaining flexibility for coating adherence). In addition, PEG may be used as either a “flow” agent to ensure consistent fill of both capsules and tablets, or as an emulsifier in liquid-based supplements to keep the ingredients in a mixture well dispersed. While PEG aids in maintaining the quality of the final product, it does not play a role in its therapeutic activity. In fact, toxicology studies show that gastrointestinal absorption of orally administered PEG is generally poor—i.e., not bioavailable—and it exits the body through normal waste patterns in a relatively short period of time without further breakdown. (Higher doses of PEG are also used in pharmaceutical applications such as nasal sprays—recommended even in children and the elderly due to its established safety and efficacy.)
Polyethylene glycol should not be confused with the similar-sounding ethylene glycol (anti-freeze, detergents) nor diethylene glycol (household cleaners, disinfectants, and tainted import or counterfeit toothpaste), which have a completely different chemical composition and are NOT intended for human consumption. Accidental ingestion of ethylene or diethylene glycol requires immediate attention. On the other hand, PEG is used intentionally in items for human consumption. PEG is approved for use in products worldwide and maintains an excellent record for predicted safety.
Q: I noticed that some Metagenics products contain stearic acid. I was reading a report that magnesium stearate suppresses the immune system through T cell suppression. Is this true and should I be worried?
A: Stearic acid is a naturally occurring fat that is present in all of our bodies. Some nutritional supplement manufacturers, however, would like you to believe that stearic acid (or its salt, magnesium stearate) is a bad thing. They've focused on one small ingredient and created widespread misconceptions about its use and its effects on health. Most formulations—whether in tablet or capsule form—require some added ingredients to assist in manufacture. A manufacturer of high quality nutritional supplements will ensure that excipients, binders, or dilutents are derived from natural sources.
Stearic acid, for example, may be of a vegetable origin. Stearic acid enables providers to manufacture tablets of uniform size, weight, texture, and shape that help to ensure a pure, safe, and effective product. Both the Federal Drug Administration (FDA) and the United States Pharmacopeia (USP) recommend the use of stearic acid and magnesium stearate in the production of high quality nutritional and pharmaceutical products. According to Vitkova and Chalabala, "Magnesium stearate is the lubricant of choice in the production, found in up to 80% of all industrially produced tablets."1 It is important to note that the levels of stearic acid found in Metagenics products are very low—much lower than the levels used in human studies surrounding stearic acid.
Your question regarding magnesium stearate and immune dysfunction comes up a lot. While stearic acid is not considered a "beneficial" fat (such as those found in cold-water fish and flaxseed), it has not been shown to contribute to immune dysfunction in humans. In fact, most research documents just the opposite effect:
1. Stearic acid is a normal constituent of the body and immune system, including lymphocytes (a type of white blood cell) and red blood cells."Lecithin of leukemic lymphocytes contained more palmitinic acid and oleic acid and a lower level of stearic acid than the same fraction in normal lymphocytes."
Bleiber R, Kunze D, Reichmann G, et al. Leukocyte lipids in mature cell leukemia. Acta Haematol 1976;55(2):81-88.
"The fatty acid compositions of 1,2-diacylglycerol and polyphosphoinositides have been determined in human erythrocyte membranes [red blood cells]…it appears that these plasma-membrane polyphosphoinositides and their derived diacylglycerols are rich in stearic acid and arachidonic acid."
Allan D, Cockcroft S. The fatty acid composition of 1,2-diacylglycerol and polyphosphoinositides from human erythrocyte membranes. Biochem J 1983;213(2):555-57.
2. Stearic acid seems to activate components of the immune system (i.e., neutrophils) instead of suppress it.
"…the polyunsaturated fatty acid arachidonic acid, the triglycerides tricaproin, tricaprylin, and trilaurin as well as the fatty acids lauric acid, palmitic acid, stearic acid, and arachidic acid all induced oxygen radical production in neutrophils…"
Wanten GJ, Janssen FP, Naber AH. Saturated triglycerides and fatty acids activate neutrophils depending on carbon chain-length. Eur J Clin Invest 2002;32(4):285-89.
Vitkova M, Chalabala M. The use of some hydrophobic substances in tablet technology. Acta Pharm Hung 1998;68(6):336-44.
Q: What about silicon dioxide? I know it is used in Metagenics products. Why? And does it present any health hazards?
A: Almost every tablet produced by Metagenics contains approximately 10 mg of silicon dioxide (i.e., silica or sand). Silicon dioxide is an excipient—an ingredient that is added to a formula to aid in the manufacture of tablets and capsules that are of uniform size, weight, texture, and shape. Some companies that market formulas in capsules state that their formulas contain only the active ingredients with no added ingredients such as excipients. Although some simple formulas may not require the use of excipients, most formulations require some added ingredients to aid in manufacture. This is true for both tablets and capsules. For example, formulas may require the addition of excipients to aid powder flow during encapsulation, to ensure even dispersal of the raw materials, and to protect ingredients during storage. Without excipients of this type, the end product may have variable amounts of active ingredients—resulting in an inconsistent and potentially unfavorable formula.
Silicon dioxide, in particular, is generally added to tablets to encourage tablet disintegration or breakdown (which ultimately helps with absorption of the nutrients by the body) during digestion. Silicon dioxide is commonly used in oral and topical pharmaceutical and nutraceutical products. While inhalation of large amounts of silicon dioxide are associated with respiratory irritation, silicon dioxide as an excipient is generally regarded as safe and nontoxic.
Kibbe A. Handbook of Pharmaceutical Excipients. 3rd edition. Washington D.C.: American Pharmaceutical Association; 2000.
Flavors & MSG
Q: I have heard that when "Natural Flavors" is used on the label, it is really referring to monosodium glutamate (MSG). Have you heard anything about this?
A: This is incorrect. According to current FDA regulations, products that contain MSG must be denoted separately on the corresponding label. According to the Code of Federal Regulations, grouping MSG under a "natural flavor" category does not suffice:
"Any monosodium glutamate used as an ingredient in food shall be declared by its common or usual name 'monosodium glutamate.'" (Code of Federal Regulations, Title 21, Volume 2, Revised as of April 1, 2002, From the U.S. Government Printing Office via GPO Access, CITE: 21CFR101.22)
Metagenics products are labeled in accordance with this regulation—that is, if a product were to contain MSG, it would be clearly listed as a separate ingredient. (However, this is not an ingredient Metagenics includes in any products.)
The term "natural flavor" or "natural flavoring" as used on Metagenics products refers to an "…essential oil, oleoresin, essence or extractive, protein hydrolysate, distillate, or any product of roasting, heating or enzymolysis, which contains the flavoring constituents derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf or similar plant material, meat, seafood, poultry, eggs, dairy products, or fermentation products thereof, whose significant function in food is flavoring rather than nutritional." (Code of Federal Regulations, Title 21, Volume 2, Revised as of April 1, 2002, From the U.S. Government Printing Office via GPO Access, CITE: 21CFR101.22)
Gluten and Other Allergens
Q: Do any of your products contain gluten or other common allergens?
A: According to the allergy labeling law in place starting January 1st of 2006, any product containing any of the top 8 allergens—wheat (gluten), milk, eggs, fish, crustacean shellfish, peanuts, tree nuts, and soy—must have that ingredient stated in plain English on the label. In general, all Metagenics products are formulated away from gluten. For any of the above noted ingredients, if they are found in the formula or as an excipient, it must be stated in plain English on the product label. However, if there is any concern related to a particular product or ingredient, patients are encouraged to ask their healthcare practitioners directly. Healthcare practitioners with Metagenics accounts are welcome to contact Metagenics directly.
Q: Why does your product label carry the allergen warning?
A: All Metagenics products carry this caution on the label: “This product is produced in a facility that produces products containing soy, fish, dairy, and crustacean shellfish. These allergen statements are required by law as of January 2006 and are not the result of any new manufacturing changes. In other words, the appearance of these allergen statements should not be a cause for concern. Metagenics’ manufacturing has not changed and our product purity remains unsurpassed in the industry. As one of the few NPA, NSF, and TGA GMP-certified manufacturers, Metagenics is the leader in implementing strict quality assurance programs to ensure that our products are manufactured without undisclosed allergens. For example, our UltraMeal® Medical Food contains isolated soy protein. Soy is a common allergen, as identified by the FDA, and is clearly listed in the ingredient listing. If soy is not listed in an ingredient listing, it is not added to the product and the product should be safe for an individual with a soy allergy.
Metagenics has an advanced Allergen Program that includes extensive quality control procedures to ensure that products contain only those ingredients that are listed on the label. Metagenics employs a meticulous process that allocates allergen ingredients (such as soy or whey) to an isolated area of the manufacturing plant, making certain that they do not come into contact with other ingredients in the storage area. Additionally, processing equipment is dedicated for allergen or non-allergen ingredients to avoid the possibility of cross contamination. Metagenics also has a validated cleaning process for equipment, utensils, and flooring that includes a primary rinse, a special detergent rinse, sanitizing, and drying. After this extensive process is complete, the equipment is swab tested for total organic residue and microbial residue. These quality assurance procedures exceed GMP requirements and are an example of Metagenics’ commitment to excellence.
Q: Are MetaFiber® and Herbulk® gluten free?
A: Gluten is a protein found exclusively in wheat and the family of grains developed from wheat. MetaFiber and Herbulk are formulated without gluten. MetaFiber does contain oat fiber and a trace amount of gluten from this source, which for some celiacs may cause reactions. If you are a celiac patient and are concerned, please ask your healthcare professional. For many celiac patients, oat fiber does not seem to be a concern.
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