The MHRA has now determined that a product named ‘Jack3D’, which is popular among sports supplement users, is a medicinal product that falls within both limbs of the definition of a medicinal product and is subject to the provisions of Part 5 of the Human Medicines Regulations 2012 (S.I. 2012/1916).
The status of Jack3D has been fully reviewed using the Statutory Determination Procedure. The MHRA’s view was supported by the Independent Review Panel for Borderline Products.
It has been determined that Jack3D is ‘medicinal by presentation’ because it is promoted in a way which draws links to substances that are themselves presented as having properties for treating or preventing disease in human beings. Accordingly the MHRA takes the view that taking the material as a whole and given those links the product is presented as having properties for treating or preventing disease in human beings.
It has also been determined that Jack3D is ‘medicinal by function’ because it contains the substance 1,3-Dimethylamylamine or Methylhexamine (DMAA). This substance is regarded as being capable of significant modification to human physiology. Products containing DMAA have already been subject to regulatory controls in various countries around the world following a series of suspected links to serious adverse effects. It is the MHRA’s view that the uncontrolled sale and supply of products containing DMAA poses potential risks to public safety.
Relevant companies are advised to remove Jack3D from sale and to take similar action for other products containing DMAA, which is also is known by the names Methylhexanamine, methylhexanenamine, dimethylamylamine, 4-methyl-2-hexanamine,4-methyl-2-hexylamine, 2-amino-4-methylhexane, 1,3-dimethylamylamine, 1,3-dimethylpentylamine, Geranamine, Geranium oil and Cranesbill.