Why Synflex® is not Certified by the FDA

For those who use the Synflex® line of liquid Glucosamine and their other products, the question often arises as to why they are not certified by the U.S. Food and Drug Administration. (FDA) It is a simple question to answer.

Synflex® products are “nutraceuticals” and as such, they are not regulated by the FDA. By definition, a nutraceutical is a combination of the words “nutrition” and “pharmaceutical.” As a practical matter, these products are regulated as drugs; dietary supplements; food ingredients; or, food. And, every jurisdiction applies different rules to this category of products.

In the United States, a “nutraceutical” has no meaning but depending on the ingredients and the claims made when it is marketed, it falls under one of the categories named above. Nutraceuticals are a class of products that are derived from food sources that should add additional health benefits. That is, some value beyond the nutrition found in the food source.

Dietary supplements like Synflex® require no approval by the FDA prior to marketing them. However, companies like Synflex America, Inc. have to submit information regarding their manufacturing facilities with the FDA. And, there are other restrictions.

Dietary supplements may only be sold and marketed to support the function or structure of the body. Claims may not be made that they treat, cure or prevent a disease or medical condition. And, all product labels must state that, “This product is not intended to diagnose, treat, cure, or prevent any disease.”

It is fairly complicated set of rules but that is why Synflex® is not certified by the FDA.