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Is Cell Therapy FDA Approved?

Patients from the USA are rightly concerned about the quality and safety of the products being used. Treatment regimens that are administered outside the USA cannot be FDA approved. This does not mean that they are dangerous or even unregulated. Most countries have strict requirements that have to be met in order to produce and sell medical products and dietary supplements.

In Germany, most live cell extracts are produced and administered by the same doctor or clinic. The law allows medical practitioners to produce supplements and pharmaceuticals for use on their patients at their own facility. The local health office requires the facilities to meet stringent regulation standards when producing, mixing and administering medication. Facilities are inspected regularly to ensure that health and safety standards are upheld.

Cell Therapy products that are imported or produced in the USA are not intended to be used as drugs or to treat any specific ailment. For this reason, they are packaged and labeled for oral use only. The cell extracts are not injected, but held in the mouth for several minutes, allowing the contents to be absorbed into the body through the mucus membrane.

That being the case, these products need not be registered or approved by the FDA. They are packaged, sold and administered as nutritional supplements. The labeling indicates all information as required by the FDA.

For this reason, it is especially important to be selective when purchasing products claiming to be live cell extracts. Independent testing for many of these extracts has shown that they contain little or no active ingredients. When purchasing live cell extracts, it is recommended that you ask the supplier for the results of laboratory tests performed on their product showing the content of active ingredients.