TGA Creates Advertising Guidance for Providers of Cell and Tissue Products

TGA has published advertising guidance for providers of stem cells and other human cell and tissue (HCT) products. The agency created the guidance after learning that companies are using terms such as “stem cells” in the promotion of HCT products, in violation of the advertising rules.

To help companies comply with the rules, TGA has published guidance explaining that products it regulates as biologicals, such as stem cells, cannot be advertised directly to the public. Companies can promote health services that involve HCT products, but only if they avoid any references to the therapeutic good.

TGA walks through the implications of the ban on all references to HCT products in the guidance, noting that it affects what people can call their business and products, plus the images they use in their materials…