LAS VEGAS (KLAS) — Could Real Water be back on store shelves someday? Court documents filed by the Food and Drug Administration (FDA) say yes, but only if the company hires outside experts to oversee doing things the right way.
A consent decree that has been signed by Real Water President and Director Brent A. Jones orders the company to hire a food safety/preventative controls expert, a labeling expert and an independent auditor.
That order stands whether the company ever sells another bottle of water again. There is work to do.
First, Real Water is supposed to be busy meeting the requirements laid out in another consent decree for the recall and destruction of products that have been blamed in acute non-viral hepatitis cases.
That must happen before any new approvals take place.
The 19-page court document dated May 19 lays out a complex path of regulations and checks that must be followed. And the path is an expensive one.
Real Water must pay for these experts to oversee production and labeling to comply with FDA regulations, and it’s also on the hook for any further FDA costs for investigators or experts — to the tune of $102.39 per hour. If any analysis or review is required, that will cost $122.71 per hour. The FDA gets to decide what’s necessary.
The FDA requirements are meticulous — quite the opposite of the apparent lack of training or qualifications that came to light when our I-Team interviewed the man who was in charge of mixing the alkaline water product before.
Jones has not stated publicly whether he intends to go on with the product.
In the meantime, the new employees would be required to establish written plans for sanitation, bottling and food safety, as well as conducting a hazard analysis and establishing a written training program for new employees.
Also under the decree, Real Water must notify the FDA within 15 days of any “change of ownership, name, or character of their business that occurs after entry of this Decree, including an incorporation, reorganization, creation of a subsidiary, relocation, dissolution, bankruptcy, assignment, sale, or any other change in the structure or identity of AffinityLifestyles.com, Inc., Real Water, Inc., or the sale or assignment of any business assets or inventory that may affect obligations arising out of this Decree.”
A regular schedule of audits is laid out for two years if the company resumes production.