The U.S. Food and Drug Administration has announced that Wilderness Family Naturals LLC of Silver Bay, Minn., and its owners have signed a consent decree that prohibits them from manufacturing and distributing any products with unapproved claims that the products cure, treat, mitigate or prevent diseases.
Wilderness Family is a manufacturer and distributor of conventional foods, dietary supplements and various salves, all branded under the Wilderness Family name. The company promoted several of its products for the treatment, cure, mitigation or prevention of disease by making claims on their products' labels, their Web site, and on other Web sites accessed by links found on their Web site.
“The FDA is acting to protect the American public from companies making unapproved disease treatment claims for their products,” said Michael Chappell, the FDA's acting associate commissioner for regulatory affairs. “Claims made by Wilderness Family might distract consumers from seeking products that have been shown to be safe and effective in treating disease.”
Wilderness Family has a history of promoting its products for the treatment of diseases, and recently referred customers to seemingly independent Web sites that were actually controlled by Wilderness Family. The Web sites claimed benefits for its products against diseases such as cancer, diabetes, heart disease, hyperthyroidism, chronic fatigue syndrome, HIV and AIDS, and arthritis.
Under the terms of the consent decree, the company and its owners, Kenneth H. Fischer and Annette C. Fischer, cannot promote claims related to their products’ ability to fight diseases unless the products receive FDA approval as new drugs or satisfy FDA’s investigational new drug requirements.