FAQs - HCP

1. What is COLD-FX^®?
2. What is the difference between COLD-FX and COLD-FX^® Extra?
3. What is ChemBioPrint^®?
4. Does COLD-FX have a Natural Product Number?
5. How does COLD-FX work?
6. How is COLD-FX metabolized?
7. Are store/house brands the same as COLD-FX?
8. Have clinical trials been conducted to support safety and efficacy?
9. What is the dosing regimen for for COLD-FX and COLD-FX Extra?
10. Are there any side effects with COLD-FX?
11. Are there any cautions against taking COLD-FX?
12. Will COLD-FX over stimulate my immune system?
13. Does COLD-FX interact with over-the-counter or prescription medications or other natural products?
14. Is COLD-FX safe for individuals with certain medical conditions (e.g. lupus, diabetes, high blood pressure)?
15. Is COLD-FX safe for women who have or are at risk for developing cancer and does it “feed” hormonal cancers?
16. What is a polymolecular botanical drug?
17. What is in COLD-FX?
18. Why has the recommended dosing for COLD-FX EXTRA changed from the 3-day (6-4-2) regime to  1 capsule twice daily?
19. How do I know which product to recommend to my patients?
20. Will COLD-FX become less effective if taken for long periods of time?
21. Can COLD-FX be used in combination with the flu shot?

COLD-FX Frequently Asked Questions

1. What is COLD-FX^®? (back to top)
   COLD‑FX® is a proprietary, patented, naturally sourced product indicated to help reduce the frequency, severity and duration of colds and flu by boosting the immune system. It belongs to a unique category of polymolecular botanical drugs for over-the-counter indications. It is considered by Health Canada’s Natural Health Product Directorate to be
   a non-traditional, non-monograph-based botanical product with specific therapeutic claims, differentiated from traditional herbal medications.
   
   
2. What is the difference between COLD-FX and COLD-FX^® Extra? (back to top)
   The difference between the two products is the amount of active ingredient. COLD‑FX contains 200 mg per capsule and COLD‑FX Extra contains 300 mg per capsule of CVT-E002. Offering these two products allows patients to choose the COLD‑FX that best suits their needs. 
   
   
3. What is ChemBioPrint^®? (back to top)
   ChemBioPrint is an enabling technology for the discovery of proprietary products and product standardization. ChemBioPrint involves both chemical and biological fingerprinting to provide assurance that all ChemBioPrint products have precise identities, and offer proven health benefits. The ChemBioPrint process also utilizes a precise and reproducible manufacturing process to ensure high quality and consistency from batch to batch.
   COLD-FX: 80002849 |  COLD-FX Extra: 80015586
   
   
4. Does COLD-FX have a Natural Product Number? (back to top)
   Both COLD‑FX 200 mg and COLD‑FX 300 mg were granted a product license and NPN. The approved comprehensive treatment claim for COLD‑FX states that the product “helps reduce the frequency, severity and duration of cold and flu symptoms by boosting the immune system.” Comprehensive therapeutic claims require support by the highest level
   of scientific evidence: randomized, double-blind, placebo-controlled clinical trials.
   
   
5. How does COLD-FX work? (back to top)
   COLD‑FX is an innate immune modulator. It works in a unique manner by targeting an early warning system of Toll-like receptors (TLRs). COLD‑FX increases the number and enhances the function of immune cells within both the innate and adaptive immune systems. The active ingredient stimulates macrophages and natural killer cells to release inflammatory
   mediators and cytokines. These are well known to directly attack the infectious agent (virus or bacteria) as well as activating T-cells and B-cells. Activation of the T- and B-cells results in both an immediate and long-term defence against infection, with a memory-immune response as well as the production of virus-specific antibodies.
   
   
6. How is COLD-FX metabolized? (back to top)
   The unique large chain poly-furanosyl-pyranosyl-saccharides in COLD‑FX are broken down like other long-chain polysaccharides, into smaller simple carbohydrates (e.g. glucose). These large polysaccharides do not need to enter the bloodstream to exert their immune-enhancing effects. The majority of the body’s immunity is localized to specialized
   regions of the digestive tract (gut-associated lymphoid tissue) which form the first response and communicate to the rest of the body’s immune tissues to generate specific virus-fighting responses in other organs (throat, lungs, etc.). The active polysaccharides in COLD‑FX may work in part by modulating these specific gut-associated lymphoid tissues.
   
   
7. Are store/house brands the same as COLD-FX? (back to top)
   No. Store brands are not the same as COLD‑FX. COLD‑FX is a proprietary patented product that cannot be duplicated. COLD‑FX consists primarily of poly-furanosyl-pyranosyl-saccharides extracted from North American ginseng using a patented and proprietary technology. Store-brand ginseng products have a wide variety of formulations and are often crude American ginseng extracts “standardized to 4% ginsenosides,” and may have added Echinacea. Research has shown that these ingredients have a very different chemical profile, pharmacological properties, side effects and their complex
   chemical composition may interfere with the desired beneficial effect.Patients will not get the same results from these products as with COLD‑FX and may experience side effects.
   
   
8. Have clinical trials been conducted to support safety and efficacy? (back to top)
   CVT-E002 (COLD‑FX) has been studied in over 10 randomized and placebo-controlled clinical trials, many of which have been published in respected peer-reviewed medical and scientific journals. These clinical trials involved a diverse population of subjects including healthy individuals, athletes, seniors, children and patients with chronic lymphocytic leukemia. In these trials, CVT-E002 was found to be effective, safe and well tolerated. Research is ongoing.involving a diverse population of subjects including healthy individuals, athletes, seniors and children have been carried out using COLD-FX or COLD-FX Extra dosages. In these trials, these dosages were found to be effective, safe and well-tolerated. Research on both dosing regimens is ongoing.
   
   
9. What is the dosing regimen for COLD-FX and COLD-FX Extra? (back to top)
   COLD-FX is for adults and children 12 years of age and over.
   
   
   
   
10. Are there any side effects with COLD-FX? (back to top)
    No adverse effects are observed in laboratory studies (in vivo) when the active ingredient in COLD‑FX and COLD‑FX Extra is given at 500 times higher than the recommended dose at one time and 25 times higher than the recommended dose for 30 days. In clinical studies, there was no statistical difference in adverse events between placebo and treatment groups for COLD-FX and COLD-FX Extra. Although no known interactions with herbs, drugs or medical conditions
    have been demonstrated, individuals with serious medical conditions should only take COLD-FX under the guidance of their healthcare practitioner.
    
    
11. Are there any cautions against taking COLD-FX? (back to top) 
    - Individuals requiring anti-coagulant therapy such as warfarin should avoid use of COLD-FX products
    - Do not use if pregnant or breastfeeding
    - Not recommended for individuals with impaired liver or renal function
    - Do not exceed the recommended daily dose
    - Individuals with known allergies to ginseng should avoid use of COLD-FX products
    - Individuals with serious medical conditions or on medication should consult with their health-care professional before   taking COLD-FX
    
    
12. Will COLD-FX over stimulate my immune system? (back to top)
    COLD‑FX modulates the immune system in a very targeted way. In clinical studies and in postmarket surveillance, COLD‑FX intake has not been associated with symptoms of overstimulation of the immune system. In lab studies, COLD‑FX has been shown to have a moderate immune-enhancing effect, but substantially lower than the effects of known agents that overstimulate the immune system.studies have shown that the active ingredient in COLD-FX and COLD-FX Extra does not over stimulate the immune system, but rather induces more moderate changes in the immune system which reflect healthy levels of immune system components such as cytokines and natural killer (NK) cells. Clinical studies have also demonstrated that COLD-FX consumption is not associated with over stimulation of the immune system.
    
    
13. Does COLD-FX interact with over-the-counter or prescription medications or other natural products? (back to top)
    There are no known interactions of COLD-FX with other medications, however, there have been indications that ginseng and anti-coagulant therapies, such as warfarin, should not be taken together. Thus, patients requiring anti-coagulant therapy should avoid the use COLD-FX. Laboratory studies have demonstrated no effect of the active ingredient on the major drug-metabolizing enzymes of the liver (cytochrome P450, cytochrome b5, NADPH-cytochrome, P450 reductase, monooxygenase, conjugation enzymes). In addition, the active ingredient of COLD-FX is a unique extract rich in polysaccharides. Polysaccharides are very large molecules that are unlikely to enter the bloodstream directly but rather are broken down in the digestive tract and absorbed as simple sugars. Thus, COLD-FX is thought to exhibit a low likelihood of interaction with other drugs. Patients with serious medical conditions should only take COLD-FX under the direction
    of their healthcare practitioner.
    
    
14. Is COLD-FX safe for individuals with certain medical conditions (e.g. lupus, diabetes, high blood pressure)? (back to top)
    Clinical trials and postmarket surveillance have shown that COLD-FX has a strong safety and efficacy profile. To date, over 1 billion capsules of COLD-FX have been sold in Canada with a very low rate of adverse events. Clinical trials have not been conducted specifically in populations with medical conditions and therefore it is recommended that individuals with serious medical conditions should only take COLD-FX under the direction of their healthcare practitioner.
    
    
15. Is COLD-FX safe for women who have or are at risk for developing cancer and does it “feed” hormonal cancers? (back to top)
    Clinical trials and postmarket surveillance have shown that COLD-FX has a strong safety and efficacy profile. There is no evidence suggesting that COLD‑FX is unsafe for patients with cancer, or specifically, hormone-related cancers. The active ingredient in COLD‑FX has not been associated with any carcinogenic effects in any of the clinical trials or through the extensive usage by the general population. 
    Although there is no evidence to suggest that COLD‑FX and COLD‑FX Extra
    are unsafe for women who have hormone-related cancers, it is recommended that individuals with any serious medical condition should only take COLD‑FX under the direction of their healthcare practitioner.
    
    
16. What is a polymolecular botanical drug? (back to top)
    Polymolecular botanical drugs, also known simply as “botanical drugs,” are therapeutics with multiple active constituents that are derived from natural sources. They are not nutritional supplements or “alternative therapies” but are mainstream drugs whose therapeutic use is fully supported by clinical evidence of safety and efficacy similar to that of any conventional medication.
    
    
17. What is in COLD-FX? (back to top)
    COLD‑FX is a highly purified ChemBioPrint^® product derived from the root of North American ginseng (Panax quinquefolius). Each capsule contains CVT-E002, a unique extract rich in polysaccharides (polyfuranosyl-pyranosyl-saccharides) that has been shown in laboratory and clinical studies to strengthen the immune system.
    
    
18. Why has the recommended dosing for COLD-FX EXTRA changed from the 3-day (6-4-2) regime to 1 capsule twice daily? (back to top)
    The new dosing regimen was adopted based on the significant clinical evidence which demonstrates that COLD‑FX can be safely used at higher dosing levels over a longer period of time. This higher dosing (600 mg daily) may provide added protection for some individuals. Other advantages of this new dosing are:
    
    • It provides a more simplified dosing of COLD-FX for better compliance
    • It encourages more proactive dosing leading to better clinical outcomes
    • The ability to take 600 mg daily prior to and throughout the duration of a cold allows consumers to support and strengthen their immune system throughout the cold and flu season
    
    
19. How do I know which product to recommend to my patients? (back to top)
    Patients will typically gravitate to one product or the other based on their individual needs and preferences. A large percentage of Canadians prefer an “extra” version of over-the-counter products.
    
    The largest body of clinical evidence for COLD‑FX^® confirms the proactive use of the product to support and strengthen the immune system throughout the cold and flu season. We have an NPN license approval for a dose of 600 mg per day with a strong safety profile for long-term use. Patients can choose either the 200 or 300 mg capsule dosing.
    
    For patients who want to remain healthy throughout the cold and flu season, recommend 2 capsules daily of either COLD‑FX or COLD‑FX Extra throughout the cold and flu season (September through March). Although COLD‑FX has not been tested in patients with chronic conditions such as asthma or COPD, or patients prone to secondary infections such as bronchitis, otitis media and pneumonia, these patients may benefit from reduced frequency, severity and duration of colds and flu as a result of taking COLD‑FX daily. Patients with medical conditions should only take COLD‑FX under the guidance of their healthcare practitioner.
    
    For patients who want to proactively manage a cold or flu, for best results recommend the use of COLD‑FX Extra for 10 days when feeling run-down, in contact with groups or experiencing the first sign of a cold or flu. The 10 days represent the average length of a cold.
    
    To ensure this product is right for your patients, always direct them to read the label.
    
    
20. Will COLD-FX become less effective if taken for long periods of time? (back to top)
    There is no evidence to suggest that the effectiveness of COLD‑FX will diminish if taken over longer durations.
    
    
21. Can COLD-FX be used in combination with the flu shot? (back to top)
    Clinical studies involving patients who received the annual flu shot and were taking COLD‑FX for extended periods of time have shown the combination to be safe.
    
    In a recent multi-city trial (McElhaney, 2011 – Influenza Research and Treatment), COLD-FX was shown to provide additional protection from colds and flu, on top of the protection provided by the flu shot. The study showed that COLD-FX intake was associated with a further one-third reduction (p=0.04) in colds and flu in generally healthy community-living seniors that had received the flu shot