Is the Feel Great System FDA Approved? | Unimate Yerba Mate & Balance Fiber Matrix

The other day I was asked the question if the Feel Great System products were FDA approved and where can one find the college research studies, as there doctor had suggested they are not FDA approved.

My response was that “the FDA does not approve supplements like they are drugs. Other countries have approval and licensing requirements for supplements such as in Canada, UK, and Australia".

In the U.S., dietary supplements are regulated as a category of foods, but in Canada for example, dietary supplements—or what Health Canada calls “Natural Health Products” (NHPs)—are treated as non-prescription drugs.

The FDA approves new human drugs and biological products.

According to the FDA website, “new drugs and biological products for people must be FDA approved before they are marketed in interstate commerce. This means that a company must demonstrate that its drug or biological product is safe and effective for the intended use, and that it can manufacture the product to federal quality standards. If the FDA grants an approval, it means the agency has determined that the benefits of the product outweigh the risks for the intended use."

FDA Does not authorize supplements

As for supplements specifically, on the FDA website, it states that “the FDA is not authorized to approve dietary supplements for safety and effectiveness. In fact, many dietary supplements can be marketed without even notifying the FDA. Dietary supplement companies must ensure their products are safe before marketing and comply with other labeling and quality requirements, such as good manufacturing practices. The FDA has authority to inspect regulated facilities to verify that they comply with current good manufacturing practices".

The manufacturers and distributors of dietary supplements are responsible for making sure their products are safe BEFORE they go to market. The FDA’s enforcement efforts focus on products after they are already for sale.

Manufacturers are required to produce dietary supplements in a quality manner and ensure that they do not contain contaminants or impurities, and are accurately labeled according to current Good Manufacturing Practice (cGMP) and labeling regulations.

FDA can take dietary supplements off the market if they are found to be unsafe or if the claims on the products are false and misleading.

This is often the concern with nutritional supplement industry and medical professionals, essentially anyone who can package, market and distribute supplements with herbal ingredients can do so with no oversight by the FDA. As such, supplement companies can make wide claims concerning the benefits their products.

Additionally, a study published in 2003 found that 70 percent of patients who used supplements and visited a physician didn't tell their doctors they use them, largely because the patients feared being told to discontinue their use. While the market has moved forward in the last decade there is still hesitancy from both consumers and medical professionals.

The Feel Great System Approvals

Unicity International is the founder and manufacture of the Feel Great System. Unicity is an innovative metabolic health sciences company doing business globally in more than fifty countries providing world class food-based nutritional products to improve health.

All of the ingredients in Unimate Yerba Mata and Unicity Balance fiber matrix are listed under the GRAS (Generally Regarded as Safe List) by the FDA. More than a billion dollars’ worth of the Balance fiber matrix having been sold since 1990 with no negative or harmful side effects, you can feel confident you are using a safe product.

Unicity strictly adheres to following all FDA-approved guidelines regarding any, all, or a small portion of the chemicals listed by Prop 65. All products will have to be consumed according to their labels.
Quality and safety are the hallmarks of Unicity products, which are manufactured in FDA- approved facilities under stringent good manufacturing practices (GMP), as defined by government regulatory procedures. The team of scientists at Unicity works in partnership with the scientists and technicians at our manufacturing plants to ensure that the product’s quality is unequivocal.

Additionally, the products are back by science and listed in the Physician Desk Reference (PDR) and have thousands of medical doctors, health practitioners, nutrition specialists and professional athletes who endorse the Feel Great System products. Below are links for more information and references:

The Company – Unicity International

• World Leader In Metabolic Health
• The Company Behind the Feel Great System
• How Unicity Products Are Made

Clinical Research

• University of Sydney Blood Glucose Study - Balance
• Zurich Clinical Study - Unimate
• Cleveland Clinic Study - Balance

What Doctors are Saying

• Medical Doctors Speak Out
• What Doctors are Saying About Balance
• Healthcare Approved

PDR – Physicians Digital Reference

• Why the PDR Matters 
• Unicity Unimate Yerba Mate: Listed in the PDR
• Unicity Balance Fiber Matrix: Listed in the PDR

Feel Great System 

• Instructions & Benefits
• Unicity Balance Fiber Matrix Ingredients
• Unicity Unimate Yerba Mate Ingredients