Understanding FDA & Health Canada's Regulations | Unicity Balance Fiber
May 03, 2023Discover the world's highest standards for Natural Health Products and their regulation in the United States versus Canada, along with the health benefits of Unicity Balance Fiber.
Article at a Glance:
- Natural Health Products (NHPs) are regulated differently in the US and Canada, with Canada having the most stringent regulations worldwide for NHPs.
- Unicity Balance Fiber is an NHP approved by Health Canada, meeting regulatory requirements for safety, efficacy, and quality.
- Unicity Balance Fiber is a plant-based dietary supplement designed to support overall health and wellness, available in powder form for oral consumption.
- Unicity Balance Fiber provides multiple benefits, including supporting healthy cholesterol and glucose levels, promoting bone and teeth health, maintaining normal muscle function and blood glucose levels, and supporting healthy skin, hair, nails, and immune function.
- Unicity Balance Fiber contains a combination of vitamins, minerals, and plant-based ingredients, along with non-medicinal ingredients.
Many people wonder if the Feel Great System products are FDA approved, but in the United States, dietary supplements are regulated as a category of foods and not subject to specific FDA approval. However, in Canada, dietary supplements are categorized as "Natural Health Products" (NHPs) and treated as non-prescription drugs by Health Canada.
Health Canada Natural Health Products (NHP) regulations
Canada has the most stringent regulations worldwide for approving products under their Natural Health Products (NHP) regulations. It is worth noting that even if you are not living in Canada. The Feel Great products are approved by Health Canada's Natural Health Products program, and this NHP approval signifies that the Feel Great System products have met the highest global standards.
All NHPs sold in Canada must have a product license, and manufacturers must comply with specific labeling and packaging requirements, follow good manufacturing practices, and provide adequate safety and efficacy evidence, including clinical trials, to obtain product licenses.
Clinical trials are studies that use human subjects to examine Natural Health Products' effects, identify any related adverse events, study absorption, distribution, metabolism, and excretion, and test for safety and efficacy. After Health Canada finishes evaluating the product's safety, efficacy, and quality, including medicinal ingredients, source, dose, potency, non-medicinal ingredients, and recommended use(s), a Health Canada NPN is assigned.
The NHP label's principal panel must contain an 8-digit identifier number that indicates that Health Canada has approved the health product for sale in the Canadian market. Proper evidence must support the safety and efficacy of NHPs and their health claims to ensure that consumers and Health Canada know the products are safe and effective. Evidence may include clinical trial data, published studies, journals, pharmacopoeias, and traditional resources, depending on the proposed health claim and overall risks of the product.
Health Canada has licensed Unicity Balance Fiber as a Natural Health Product (NHP) with a Natural Product Number (NPN) of 80061515, indicating that the product has met the regulatory requirements for safety, efficacy, and quality. This certification allows Unicity Balance Fiber to be sold in Canada, and it has been approved for marketing in the country.
Unicity Balance Fiber is a dietary supplement manufactured by Unicity Canada Ltd, available in a powder form that is taken orally. The product is designed to support overall health and wellness and is made from a combination of vitamins, minerals, and plant-based ingredients.
Dosage and Administration
According to Health Canada, the recommended dose of Unicity Balance Fiber varies based on the subpopulation. For adults, the recommended dosage is one scoop (1.0) to two scoops (2.0) per day, depending on the specific product variation. The product can be taken daily with or without food.
The specific dosage instructions for Unicity Balance Fiber can be found on the product label. It is important to follow the recommended dosage and not exceed the recommended daily intake.
Benefits and Uses
Unicity Balance Fiber is a multi-functional supplement that supports various aspects of health and wellness. According to Health Canada, the product is intended to:
- Help lower blood total and low-density lipoprotein (LDL) cholesterol
- Help in the development and maintenance of bones and teeth
- Help maintain normal muscle function
- Help prevent biotin, folate, and vitamin deficiencies
- Help maintain normal blood glucose levels
- Help maintain healthy skin, hair, and nails
- Help support immune function
- Support healthy cholesterol levels
- Support healthy glucose metabolism
Ingredients
The ingredients in Unicity Balance Fiber include a combination of vitamins, minerals, and plant-based ingredients. Some of the key ingredients are:
- 3-Pyridinecarboxamide: 26.0 milligrams
- Acacia: 654.0 milligrams
- Avena sativa: 350.0 milligrams
- Beta-carotene: 450.0 micrograms
- Biotin: 20.0 micrograms
- Calcium: 60.0 milligrams
- Ceratonia siliqua: 607.0 milligrams
- Chromium: 100.0 micrograms
- Chrysanthemum x morifolium: 12.5 milligrams
- Cyamopsis tetragonoloba: 1.246 Grams
- Folate: 220.0 micrograms
- Free plant sterols: 400.0 milligrams
- Pectin: 425.0 milligrams
- Policosanol: 6.0 milligrams
- Riboflavin: 2.0 milligrams
- Thiamine: 2.0 milligrams
- Vitamin B12: 25.0 micrograms
- Vitamin B6: 7.0 milligrams
- Vitamin C: 45.0 milligrams
- Vitamin E: 13.4 mg AT
- Zinc: 2.33 milligrams
The product also contains several non-medicinal ingredients, including citric acid, D-mannitol, dicalcium phosphate, gum arabic, hydroxypropyl methylcellulose, maltodextrin, orange juice powder, orange flavour, and sucralose.
Cautions and Warnings
Health Canada has provided several cautions and warnings regarding the use of Unicity Balance Fiber. Individuals who are allergic to plants of the Asteraceae/Compositae (daisy) family should consult a healthcare practitioner before using this product. Those who are taking blood thinners or anti-platelet drugs should also consult a healthcare practitioner.
Understanding the regulatory differences between the US and Canada for natural health products is crucial. Unicity Balance Fiber, an NHP approved by Health Canada, meets the highest global standards for safety, efficacy, and quality, making it a trusted choice for those looking to support their overall health and wellness. If you're interested in trying Unicity Balance Fiber for yourself, place your order below or learn more by visiting the related articles.
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