FDA Announces Consent Decree with Supplement MakerDec 10, 2008 | Parker Waichman LLP
The U.S. Food and Drug Administration (FDA) just announced that Wilderness Family Naturals LLC and its owners—Kenneth H. Fischer and Annette C. Fischer—have signed a consent decree banning the supplement and health food distributor from producing and distributing any products with unapproved claims that its products “cure, treat, mitigate, or prevent diseases.” This is not the first time that Wilderness Family has been at the center of controversy with the FDA. In 2005, the FDA issued an extensive warning letter to the company citing similar problems. Wilderness Family is located in Silver Bay, Minnesota.
The FDA describes Wilderness Family as a manufacturer and distributor of conventional foods, dietary supplements, and various salves, which are all branded under the Wilderness Family name. The Wilderness Family site touts a company location of pristine beauty, wilderness, and purity in which healthy, nutritious foods and supplements are manufactured. According to the FDA, Wilderness Family marketed a variety of products via false claims on its labeling, its Website, and linked Websites.
Michael Chappell, the FDA's acting associate commissioner for regulatory affairs said that, “The FDA is acting to protect the American public from companies making unapproved disease treatment claims for their products. Claims made by Wilderness Family might distract consumers from seeking products that have been shown to be safe and effective in treating disease.” The FDA also stated in its press release that Wilderness Family has a history of promoting its products for the treatment of diseases, recently referring its customers to Websites that appeared to originate from other companies, but were actually controlled by Wilderness Family. The sites hyped product benefits against diseases that included cancer, diabetes, heart disease, hyperthyroidism, chronic fatigue syndrome, HIV and AIDS, and arthritis.
The consent decree mandates that Wilderness Family and its owners not make claims that its products can fight diseases unless those products receive FDA approval as new drugs or if such drugs satisfy FDA’s investigational new drug requirements (NDRs). In response, Wilderness Family and its owners agreed to remove disease claims from its products’ labels and other labeling, its Websites, and references to other sites. Wilderness Family and its owners agreed to hire an independent expert to review its product claims and certify to the FDA that it is not making any illegal claims.
The 2005 FDA letter to Wilderness Family followed the agency’s May 2005 investigation and cited the company’s manufacturing, distribution, and promotion of its products and a review of two of its Internet sites—www.wildernessfamilynaturals.com and www.regaininghealthnaturally.com—were conducted to determine if Wilderness Family was complying with the Federal Food, Drug, and Cosmetic Act (the Act), among other regulations. The investigation revealed that, according to the FDA, its review of the company’s products and promotional claims showed “serious violations of the Act.”
The FDA notes that it can order Wilderness Family to stop manufacturing and distributing any product if Wilderness Family fails to comply with any portion of the consent decree, the Act, or FDA regulations, adding that defendants must pay $1,000 per violation per day if they fall into noncompliance.