An Orem company accused of making unapproved therapeutic products has agreed to a nationwide recall and to halt manufacturing, marketing and distribution until it is authorized.
Nature-All Corp. - doing business as Spinal Touch Formulas Inc. and Makes the Difference Formulas Inc. - agreed "to make a reasonable effort to secure the return from their agents and distributors" of its product line, said the consent decree released Friday.A civil complaint filed in July against Nature-All; its president, Gary Barnes; past president, Lamar Rosquist; and vice president, Gary Whitley, said they failed to apply for approval of new drug applications for each product or for an exemption prior to introducing them.
The suit said the company was engaged in packaging, labeling and distributing more than 40 products intended to cure, treat or prevent human illnesses.
A list of products attached to the suit said the company claimed one of its products, Candida Enzymes, fights infections that cause mental and nervous disorders, digestive and respiratory problems and impaired sex drive.
Among other ailments the company represented its products would treat were arthritis, high cholesterol, iron deficiency anemia, kidney problems, liver or nerve disorders, stress, and internal parasites, prosecutors said.
The agreement, signed by U.S. District Judge David Winder, federal prosecutors and Nature-All officers, permanently bars the company from promoting, labeling, advertising or representing its products are safe or effective in the cure, treatment or prevention of any disease until they have received approval by the U.S. Food and Drug Administration.
After submitting proposed product names, labeling or other promotional materials, the FDA must notify Nature-All of acceptance or rejection within 45 days, the agreement said. Failure to do so will constitute temporary acceptance.