FDA Announces Permanent Injunction Against Wilderness Family Naturals LLC

Main Category: Complementary Medicine / Alternative Medicine
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 19 Dec 2008 - 0:00 PST

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Company used Internet to claim its unapproved products treat serious health conditions The U.S. Food and Drug Administration 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.

Wilderness Family and its owners also have agreed to remove disease claims from their products' labels, labeling and Web sites, as well as references to other Web sites that contain such claims. The company and its owners have also agreed to hire an independent expert to review the claims they make for all of their products and to certify to the FDA that they are not making any illegal claims.

The FDA can order Wilderness Family to stop manufacturing and distributing any product if they fail to comply with any provision of the consent decree, the Federal Food, Drug, and Cosmetic Act, or FDA regulations. Defendants are also required to pay $1,000 per violation per day if they fail to comply with the consent decree.

The decree was signed by Judge Donovan W. Frank on December 8, 2008 in the U.S. District Court for the District of Minnesota.

U.S. Food and Drug Administration