Department of Health and Human Services' logo Department of Health and Human Services

Public Health Service
Food and Drug Administration
Central Region
Minneapolis District

 

212 3rd Ave S
Minneapolis, MN 55401
Telephone: (612) 758-7114
FAX: (612) 334-4142

November 9, 2005
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

Kenneth H. and Annette C. Fisher, Owners
Wilderness Family Naturals
99 Edison Blvd #1
Silver Bay, MN 55614-1211

Ref. No. MIN-06-13

Dear Mr and Ms Fisher:

This letter is in reference to your firm's manufacturing, distribution and promotion of various products documented by our inspection conducted May 9-11, 2005, at your facility located at 99 Edison Blvd #1, Silver Bay, MN, and by a review of your Internet sites, www.wildernessfamilynaturals.com and www.regaininghealthnaturally.com. These activities were conducted to determine your firm's compliance with the Federal Food, Drug, and Cosmetic Act (the Act) and applicable implementing regulations contained within Title 21 of the Code of Federal Regulations (21 CFR).

Our review of your products and promotional claims shows serious violations of the Act. You can find the Act and implementing regulations through links on FDA's Internet home page at www.fda.gov.

Disease and Structure/Function Claims

Under section 201(g)(1)(B) and 201(g)(1)(C) of the Act (21 USC 321(g)(1)(B) and 21 USC 321(g)(1)(C)], articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and articles (other than food, including dietary supplements) intended to affect the structure or any function of the body of man are drugs. Based on claims that appear on your immediate product labels, and claims made on your website at www.wildernessfamilynaturals.com and www.regaininghealthnaturally.com, we have determined that some of your products are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) or 201(g)(1)(C) of the Act (21 USC 321(g)(1)(B) and 21 USC 321(g)(1)(C)]. The claims establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease or are intended to affect the structure or any function of the body.

Examples of disease claims for Raw, Organic Cacao Nibs, found on your Internet website at www.regaininghealthnaturally.com, include:

Examples of disease claims for your Coconut Oil, Extra Virgin product found on your immediate container label include:

Examples of disease claims for your Extra Virgin Centrifuge Extracted Coconut Oil and Extra Virgin Traditional Philippine Coconut Oil products found on your website at www.regaininghealthnaturally.com include:

Examples of structure and function and disease claims for your Extra Virgin Centrifuge Extracted Coconut Oil and Extra Virgin Traditional Philippine Coconut Oil products found on your website at wildernessfamilynaturals.com include:

Examples of disease claims for your Flax Hull Lignans product, found on the immediate label include:

Examples on disease claims for your Flax Hull Lignans product on your website at www.wildernessfamilynaturals.com include:

Examples of disease claims for your Green Food Feast capsules and powder product found on your website at www.regaininghealthnaturally.com include:

Examples of disease prevention claims for Kefir cultures Starter found on your immediate label include:

Examples of disease claims for Chest Rub Salve found on your website at www.wildernessfamilynaturals.com, include:

Examples of disease claims for Goldenseal-Comfrey Salve found on your website at www.wildernessfamilynaturals.com, include:

New Drugs

These claims cause your products to be drugs, as defined in sections 201(g)(1)(B) and 201(g)(1)(C) of the Act [21 USC 321(g)(1)(B) and (C)]. The antifungal claims (including those for athlete's foot), the anti-dandruff, antiacne, anti-wart, and upper respiratory infection claims, and the claims for skin protectant use (for soothing and healing wounds, blood blisters, rashes, etc.) make your Coconut Oil products, Chest Rub Salve, and Goldenseal-Comfrey Salve subject to the requirements of one or more of the following Over-The-Counter (OTC) human drug final monographs regulations at Title 21, Code of Federal Regulations (21 CFR):

These products fail to comply with the applicable requirements in these monographs. Thus, they are not generally recognized as safe and effective (GRAS/E) and are "new drugs" under section 201(g) of the Act.

In addition, all of the remaining claims on your products that are not subject to applicable monographs cause these products to be new drugs. We are not aware of these products, as formulated and labeled, being marketed with such claims on or before December 4, 1975, so as to qualify for evaluation under FDA's OTC Drug Review. For example, we are not aware of any Coconut Oil products marketed on or before December 4, 1975, with antimicrobial or anti-infective claims, with skin bleaching claims (to reduce brown, freckle-like spots or liver spots) with claims to restore damaged or diseased skin, or with claims to reduce chronic skin inflammation so as to qualify these products for evaluation under FDA's OTC Drug Review. Further, we are not aware that these products are GRAS/E for these labeled claims. For example, we are not aware of any evidence that a product like Goldenseal-Comfrey Salve is GRAS/E when labeled for use in preventing infection where the skin is broken.

For the reasons given above, these products are new drugs under section 201(p) of the Act [21 USC 321(p)]. Under section 505 of the Act [21 USC 355], a new drug may not be legally marketed in the United States without an approved New Drug Application (NDA). FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.

Further, these products are misbranded within the meaning of section 502(f)(1) of the Act in that the labeling for these drugs fails to bear adequate directions for use. For the orally administered products not subject to a final OTC drug monograph, adequate directions cannot be written because the uses for which they are offered are not amenable to self-diagnosis and treatment. For the products covered by final OTC drug monographs (i.e., your Coconut Oil products, Chest Rub Salve, and Goldenseal-Comfrey Salve), they are misbranded under section 502(f)(1) of the Act because they fail to bear the uses and directions specified by the applicable final monographs.

Other Labeling Violations

Your Kefir Starter, Canadian Jumbo Wild Rice, Hand Parched Wild Rice, Coconut Chips, Small Desiccated Coconut Flakes, Coconut Flour/Fiber, and Coconut Milk Powder products are misbranded within the meaning of section 403(q)(1) of the Act [21 USC 343(q)(1)] in that the product is labeled with a Nutrition Facts panel that is not in the format required by 21 CFR 101.9.

This letter is not intended to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that all labels and labeling for products distributed by your firm are in compliance with the Act and its implementing regulations. FDA regulations are available on FDA's website at www.fda.gov.

We request that you take prompt action to correct these violations. Failure to promptly correct these violations may result in enforcement action being initiated by the Food and Drug Administration without further notice. The Act provides for the seizure of illegal products and/or injunction against the manufacturer and/or distributor of illegal products.

Please notify this office in writing within 15 working days of receipt of this letter of the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify and make corrections to assure that similar violations will not recur. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be implemented.

We note that you labeled your Kefir Starter product as a conventional food. However, the Nutrition Facts panel and directions for use are not consistent with other labeling representing your product as a dietary supplement, e.g., dietary supplement disclaimer under section 403(r)(6) of the Act, dietary supplement format of proprietary blend and "Other ingredients" for ingredient statement declaration. A product that is represented as a conventional food is not a dietary supplement [see section 201(ff)(2)(B) of the Act] and the formatting styles in the respective Facts panels are not interchangeable.

We also note for your Kefir Starter product that the nutrition information deviates from the format as required by regulation. See 21 CFR 101.9. The format deviations include:

Your reply should be sent to the attention of Compliance Officer Tyra S. Wisecup at the address on the letterhead.

Sincerely,
/s/
W. Charles Becoat
District Director

This page was posted on March 28, 2006.

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