FAQ - COLD-FX^® Extra

1. Ingredients: What is COLD-FX Extra?
2. What is ChemBioPrint^® (CBP^®)?
3. How is COLD-FX Extra different from other ginseng products?
4. What is COLD-FX Extra intended for?
5. How does it work?
6. What evidence do you have to support its efficacy and safety?
7. What is the difference between COLD-FX Extra and COLD-FX?
8. What is the difference between COLD-FX Extra and the acute dosing regimen previously marketed?
9. Are there any side effects associated with COLD-FX Extra?
10. Will COLD-FX Extra overstimulate my immune system?
11. What about interactions with other drugs such as NSAIDs, antibiotics, lipid-lowering medications, oral contraceptives, blood pressure medications, antidepressants, beta blockers and synthroid?
12. I have an autoimmune disorder. Would it be safe for me to take COLD-FX Extra?
13. I have diabetes. Would it be safe for me to take COLD-FX Extra?
14. I have high blood pressure. Would it be safe for me to take COLD-FX Extra?
15. I am on blood thinners and I have been advised not to take ginseng products. Would it be safe for me to take COLD-FX Extra?
16. Someone mentioned to me that taking COLD-FX Extra might be dangerous for women who have or are at risk for developing cancer and that it "feeds" hormonal cancers. Is this correct?
17. Can I take COLD-FX Extra if I am pregnant or nursing?
18. Is COLD-FX Extra recommended for children under the age of 12?

1. Ingredients: What is COLD-FX Extra? (back to top)
   COLD-FX Extra is a highly purified ChemBioPrint product derived from the roots of North American ginseng (Panax quinquefolius). Each capsule contains 300 mg of, CVT-E002, a unique extract of polysaccharides that has been shown in laboratory and clinical studies to strengthen the immune system. Through Afexa Life Sciences' proprietary process, COLD-FX Extra undergoes vigorous testing to ensure that every batch has consistent chemical identity and biological activity.
   
   
2. What is ChemBioPrint (CBP)? (back to top)
   ChemBioPrint stands forChemical Biological FingerPrinting, proprietary standardization technology used to ensure the quality of all ChemBioPrint products. In the case of COLD-FX Extra, Chemical FingerPrinting identifies a "print" of the active chemical components that strengthen the immune system. Biological FingerPrinting identifies the effect of the extract on the immune system through a series of laboratory evaluations. As a result of Afexa Life Sciences' proprietary technology, COLD-FX Extra undergoes vigorous testing to ensure that every batch has consistent chemical identity and biological activity.
   
   
3. How is COLD-FX Extra different from other ginseng products? (back to top)
   Most ginseng products on the market are Asian ginseng (Panax ginseng). COLD-FX Extra is a highly purified extract derived from North American ginseng (Panax quinquefolius) which has a very different chemical and biological profile than Asian ginseng. Because COLD-FX Extra is comprised of specific active viral-targeted, immune-enhancing molecules, polysaccharides, it doesn't exhibit the other effects typically associated with ginseng products such as enhanced vitality, mental alertness and mood improvements. In addition, although COLD-FX Extra is an extract of North American ginseng, its highly purified and precise chemical composition makes comparison with "ginseng" in general, inappropriate. Comparing COLD-FX Extra with raw ginseng roots is like comparing acetylsalicylic acid (the active ingredient in Aspirin) with willow tree bark (the source material of acetylsalicylic acid).
   
   
4. What is COLD-FX Extra intended for? (back to top)
   COLD-FX Extra is for strengthening the immune system when you are feeling run-down, going to be exposed to large groups of people or at the first sign of cold or flu symptoms.
   
   
5. How does it work? (back to top)
   A number of studies, including both experimental and clinical, have shown that the active ingredient of COLD-FX Extra works by strengthening the immune system. These effects were found on both the innate and the acquired immune responses and both cell-mediated and humoral (antibody)-mediated immunity.
   
   
6. What evidence do you have to support its efficacy and safety? (back to top)
   Unpublished and published pre-clinical and clinical studies support COLD-FX Extra.  These studies have shown COLD-FX Extra to be safe and effective when taken at the first sign of symptoms.
   
   
7. What is the difference between COLD-FX Extra and COLD-FX? (back to top)
   COLD-FX is to be used daily year-round, whereas COLD-FX Extra is a higher dosage intended to be used short-term at the first sign of cold or flu symptoms or in situations where you are feeling run-down or in contact with groups.
   
   
8. What is the difference between COLD-FX Extra and the acute dosing regimen previously marketed? (back to top)
   Consumers have been seeking a convenient, higher potency per capsule of COLD-FX, to be taken at the first sign of cold or flu symptoms. We have therefore decided to increase the amount of active ingredient per capsule from 200 mg to 300 mg and introduce it to the market place as COLD-FX Extra.
   
   
9. Are there any side effects associated with COLD-FX Extra? (back to top)
   No side effects are observed in laboratory studies when given at 500 times higher than the recommended dose at 1 time and 25 times higher than the recommended dose for 30 days. In clinical studies, side effects have also not been associated with the recommended dosing regimen. Although there are no known interactions with herbs, drugs or medical conditions, individuals with serious medical conditions or taking medications should consult a health care practitioner before taking COLD-FX Extra.
   
   
10. Will COLD-FX Extra overstimulate my immune system? (back to top)
    Laboratory studies have indicated that the active ingredient of COLD-FX Extra does not overstimulate the immune system, but rather induces more moderate changes which reflect healthy levels of immune system components such as cytokines and Natural Killer (NK) cells.
    
    
11. What about interactions with other drugs such as NSAIDs, antibiotics, lipid-lowering medications, oral contraceptives, blood pressure medications, antidepressants, beta blockers and synthroid? (back to top)
    There are no known interactions of COLD-FX Extra with other medications. Laboratory studies have demonstrated no effect of its active ingredient on the major drug-metabolizing enzymes of the liver. Additionally, the polysaccharides that it is comprised of, are very large molecules. This means they are unlikely to enter the bloodstream and instead exert immune-stimulating effects in the gastrointestinal tract, although this remains to be confirmed in scientific studies. Thus, COLD-FX Extra is thought to exhibit a low likelihood of interaction with other drugs. However, since specific clinical trials have not been conducted to investigate interactions with other medications consult a health care practitioner before using COLD-FX Extra.
    
    
12. I have an autoimmune disorder. Would it be safe for me to take COLD-FX Extra? (back to top)
    COLD-FX Extra has been demonstrated safe and effective in healthy individuals. Clinical trials have not been conducted specifically in populations with autoimmune diseases. For those with an autoimmune disorder, we recommend consulting a health care practitioner before taking COLD-FX Extra. Our laboratory studies suggest that the active ingredient of COLD-FX Extra is unlikely to interact with other medications, including drugs used to treat autoimmune conditions, but to be safe, please speak to a health care practitioner if you are taking these medications before consuming COLD-FX Extra.
    
    
13. I have diabetes. Would it be safe for me to take COLD-FX Extra? (back to top)
    COLD-FX Extra has been demonstrated safe and effective in healthy individuals. Clinical trials have not been conducted specifically in diabetic populations. To ensure that COLD-FX Extra is safe to consume for individuals with diabetes, we recommend consulting a health care practitioner and monitoring of general health and glucose levels when taking COLD-FX Extra . Our laboratory studies suggest that the active ingredient of COLD-FX Extra is unlikely to interact with other medications, including anti-diabetic drugs, but to be safe, please speak to a health care practitioner if you are taking these medications before consuming COLD-FX Extra.
    
    
14. I have high blood pressure. Would it be safe for me to take COLD-FX Extra? (back to top)
    COLD-FX Extra has been demonstrated safe and effective in healthy individuals. Clinical trials have not been conducted specifically in populations with high blood pressure. To ensure that COLD-FX Extra is safe to consume for individuals with high blood pressure, we recommend consulting a health care practitioner and monitoring of general health and blood pressure when taking COLD-FX Extra. Our laboratory studies suggest that the active ingredient of COLD-FX Extra  is unlikely to interact with other medications, including antihypertensive drugs, but to be safe, please speak to a health care practitioner if you are taking these medications before consuming COLD-FX Extra.
    
    
15. I am on blood thinners and I have been advised not to take ginseng products. Would it be safe for me to take COLD-FX? (back to top)
    High doses of some forms of ginseng which are high in ginsenosides have been shown to affect the metabolism and effect of blood thinners such as warfarin. Although COLD-FX Extra is composed of molecules, polysaccharides, which are not thought to cause drug interactions, and laboratory and clinical studies have indicated that the likelihood of drug interaction with COLD-FX Extra is greatly reduced, to be safe, individuals taking blood thinners thinners should avoid the use of COLD-FX.
    
    
16. Someone mentioned to me that taking COLD-FX Extra might be dangerous for women who have or are at risk for developing cancer and that it "feeds" hormonal cancers. Is this correct? (back to top)
    No, this is not correct. COLD-FX Extra has been clinically demonstrated to be a safe and effective product. There is no evidence suggesting that COLD-FX Extra is unsafe for patients with cancer, or specifically, hormone-related cancers. The active ingredient of COLD-FX Extra has not demonstrated any carcinogenic effects in toxicity studies in any of the clinical trials or through the extensive usage by the general population.
    
    This false impression may relate to some un-confirmed laboratory studies suggesting that crude ginseng containing chemicals known as ginsenosides may have estrogen-related effects. During the manufacturing process of COLD-FX Extra, these ginsenosides are removed so that the final product is comprised of a proven safe ingredient: polysaccharides (specifically, poly-furanosyl-pyranosyl-saccharides).
    
    There is no clinical evidence to suggest that ginseng in general is unsafe for women who have or are at risk for developing hormone-related cancers. In fact, a recent study published in the American Journal of Epidemiology, February 16, 2006 (Cui Y et al, 163(7):645) demonstrated that regular users of ginseng had improved survival and quality of life in breast cancer patients. A well-controlled Mayo Clinic study sponsored by the National Cancer Institute of the U.S. NIH, further investigated the potential benefits of American ginseng in cancer patients, including women. On June 3, 2007, the results of this rigorous pilot study were presented. Researchers found that a form of American ginseng provides greater improvements in fatigue and vitality in patients who received the highest doses tested, compared to lower doses or no treatment. The treatment also appeared to be safe and well tolerated (no statistically significant differences in various safety parameters between each of the study groups). The active ingredient of COLD-FX Extra has also demonstrated anti-cancer effects through immune enhancement in pre-clinical laboratory studies of a leukemia model.
    
    Although there is no evidence to suggest COLD-FX Extra is un-safe for women who have or are at risk for developing hormone-related cancers, it is recommend that individuals with any serious medical condition consult with their health care practitioner prior to taking COLD-FX Extra.
    
    
17. Can I take COLD-FX Extra if I am pregnant or nursing? (back to top)
    Clinical studies have not been conducted on the use of COLD-FX Extra during pregnancy or nursing. Therefore do not use product if pregnant or nursing.
    
    
18. Is COLD-FX Extra recommended for children under the age of 12? (back to top)
    Studies have not been conducted to assess the efficacy or safety of COLD-FX Extra among children under the age of 12 and therefore we do not recommend the use of this product for children in this age group.