TAGS: Skin Care
Johnson & Johnson Consumer Inc. has reaffirmed that its Johnson’s Baby Powder is safe and free of asbestos after a comprehensive investigation into the US FDA earlier reported finding of sub-trace levels of asbestos (no greater than 0.00002 percent) in samples from a single bottle of Johnson’s Baby Powder.
Tests Conducted by Two Third-party Labs
Tests conducted by two third-party labs show asbestos was not present in the single bottle that FDA’s contracted lab, AMA Analytical Services, Inc. (AMA), tested, nor was it present in retained samples of the finished lot from which the bottle was produced.
Additionally, the Company’s investigation revealed that the testing protocol at AMA deviated from standard practice and that AMA did not execute a full asbestos confirmation as required by their lab’s test method.
The Company’s investigation concluded that the most probable root causes for the FDA’s reported results were either test sample contamination or analyst error at the AMA lab.
More Than 150 Tests Show No Asbestos
Over the course of the investigation, a total of 155 tests were conducted by two different third-party labs using four different testing methods on samples from the same bottle tested by AMA, the recalled lot of Johnson’s Baby Powder, as well as three lots manufactured before the recalled lot and three lots manufactured after the recalled lot. All results confirmed that there is no asbestos in talc.
The Company has ruled out the mine and manufacturing supply chain as root causes for AMA’s sub-trace asbestos findings. In its investigation, Johnson & Johnson’s also confirmed that the milling and mixing of Johnson’s Baby Powder results in a uniform product, ensuring that its testing would reveal asbestos if it was present in the product.
Johnson & Johnson’s investigation into AMA’s test results has now concluded and the Company has shared its findings with the FDA and continues to work with the Agency in support of consumer safety.
Source: Johnson & Johnson