Inspections, Compliance, Enforcement, and Criminal Investigations
Wilderness Family Naturals 09-Nov-05
Department of Health and Human Services
Public Health Service
Minneapolis District Office
November 9, 2005
RETURN RECEIPT REQUESTED
Refer to MIN 06-13
Kenneth H. and Annette C. Fisher
Wilderness Family Naturals
99 Edison Boulevard, Suite 1
Silver Bay, Minnesota 55614-1211
Dear Mr. and Ms. Fischer:
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 Boulevard, Suite 1, Silver Bay, Minnesota, and by a review of your Internet sites, http://www.wildernessfamilynaturals.com and http://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 http://www.fda.gov.
Disease and Structure/Function Claims
Under section 201(g) (1) (B) and 201(g) (1) (C) of the Act (21 U.S.C. 321(g) (1) (B) and 21 U.S.C. 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 http://www.wildernessfamilynaturals.com and http://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 U.S.C. 321(g)(1)(B) and 21 U.S.C. 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 http://www.regaininghealthnaturally.com, include:
"Magnesium [a mineral in cacao beans] . . . lowers blood pressure. .. . .I know a physician (neurologist) who is curing migraines simply with magnesium supplementation .. . . Magnesium has been shown to stop 80% of premature labor!"
"Theobromine [an alkaloid from cocoa bean] . . .has been used to treat high blood pressure. It is also a mild diuretic and have[sic] been used as a medicinal drug when heart attack resulted in an accumulation of body fluid."
Examples of disease claims for your Coconut Oil, Extra Virgin product found on your immediate container label include:
"Coconut Oil is rich in Lauric acid. . . . Lauric Acid becomes 2-Monolauren in the stomach which has been shown by research to have anti-bacterial, antiviral, and anti-parasitical properties."
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 http://www.regaininghealthnaturally.com include:
"As the medium chain fatty acid in coconut oil travel throughout the body they are actually antimicrobial compounds. For example, Lauric acid [in coconut oil] . . . dissolves the lipid envelope that protects most pathogenic bacteria and viruses. It also attacks pathogenic yeast and parasites . . . . [I]ts anti microbial properties have been helping people for thousands of years."
"[D]iabetics can get good energy into their cells without insulin. .. ."
"Lastly, on the skin the medium chain fatty acid in the coconut oil . . . .allows the skin to have a slightly acidic pH ideal for keeping pathogens away. .. ."
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 http://wildernessfamilynaturals.com include:
"It [coconut oil] can help to keep the skin from developing liver spots, and other blemishes caused by aging and over exposure to sunlight. It helps to keep connective tissues strong and supple so that the skin doesn't sag and wrinkle. In some cases it can even restore damaged or diseased skin. The oil is absorbed into the skin and into the cell structure of the connective tissues, limiting the damage excessive sun exposure can cause."
"Using the coconut oil as a pre-wash conditioner can rid a person of dandruff better than a medicated shampoo."
"Antiseptic fatty acids in coconut oil help to prevent fungal and bacteria! infections in the skin, when it is orally consumed, and to some extent, when it is applied directly to the skin."
"By using a coconut oil cream, lotion or just pure coconut oil you can quickly help reestablish the skin's natural antimicrobial and acid barrier."
"It [coconut oil] will help to reduce chronic skin inflammation within days and be soothing and healing to wounds, blood blisters, rashes, etc. . .. People have used a coconut oil . . .at night to eliminate plantar's warts and athlete's foot with excellent results."
Examples of disease claims for your Flax Hull Lignans product, found on the immediate label include:
"Researchers have studied its effects on hormone related tumors . . .and heart disease."
Examples on disease claims for your Flax Hull Lignans product on your website at http://www.wildernessfamilynaturals.com include:
"There has been lots of research done on the use of flax seed in the treatment or prevention of sickness and disease."
"Scientific studies have suggested that the lignans interfere with the development of breast, prostate, colon and other cancers . . .Research has also shown that people who excrete high amounts of lignans in their urine (indicative of a high intake) have markedly lower cancer rates. Conversely, investigators reported that the level of lignans in the body were lower in patients with breast cancer than in tumor free patients."
"The lignan compounds. . .have been studied . . .for their cancer preventative properties. The SDG lignan not only has anti-cancer properties, it has antiviral, anti-bacterial, and anti-fungal properties."
Examples of disease claims for your Green Food Feast capsules and powder product found on your website at http://www.regaininghealthnaturally.com include:
"Chlorella [an ingredient in the product]. ..has been shown . . .to help with cancer, and tumors . Chlorella has been shown to have protective factors from radioactive exposure and from infectious bacteria and viruses."
"Alfalfa leaf [an ingredient in the product] has been shown to help with all kinds of disorders including diabetes, cancer..and bleeding disorders."
"Nettle leaf [an ingredient in the product] . . . can be used for hypothyroidism. . . . It neutralizes uric acid and helps prevent crystallization, aiding in its elimination from the system, thus relieving gout and arthritis."
"Red Clover [an ingredient in the product] . . .contains molybdenum that . .. . helps retard the spread of infection . Molybdenum . . .possess the ability to form special antibodies of protection from rattlesnake, scorpion and other poisonous bites and stings. It is one of the best herbs for treating all varieties of cancer anywhere in the body. For over 100 years Red Clover has been used to treat and prevent cancer."
"Dandelion [an ingredient in the product] leaves contain 7,000 units of Vitamin A per ounce. It is important to realize that there is always a vitamin A deficiency in a person found to have cancer."
"Algin [an ingredient from seaweed in the product] is responsible for cancer prevention in Japan. . . . The seaweeds. . . dissolve firm masses and tumors, treat enlarged thyroids, lymph node enlargement, swollen and painful testes and reduce edema."
"Vitamin C from rose hips and acerola berries in the product] from these natural sources has been used to treat cancer and to prevent and treat infections."
"Barley grass [an ingredient in the product] has been shown to have antiinflammatory action, . .. helps people who have arthritis . ..Wheat grass has been used to combat cancer. Oat grass . ..has antiseptic properties. . . ."
"Spinach, Broccoli, Kale, and Cabbage [ingredients in the product] . . . . are high in protein and contain the B complex, lutein, iron, magnesium, potassium and zinc. The vitamins, phyto-chemicals, indoles, and aromatic isothiocynates may be responsible for boosting certain enzymes that help to detoxify the body. These enzymes help prevent cancer, diabetes, heart disease, osteoporosis, and high blood pressure."
Examples of disease prevention claims for Kefir cultures Starter found on your immediate label include :
"Clinical studies have associated kefir with many beneficial effects including. .. anticancer properties."
Examples of disease claims for Chest Rub Salve found on your website at http://www.wildernessfamilynaturals.com, include :
"Chest Rub is a natural salve to use for upper respiratory infections on the chest."
Examples of disease claims for Goldenseal-Comfrey Salve found on your website at http://www.wildernessfamilynaturals.com, include:
"This is a salve with tremendous anti-fungal and antibacterial properties. It can be used with wonderful success on athlete's foot, ringworm, and to prevent infections where the skin is broken. Besides containing Goldenseal root, this salve also has Tea Tree Oil and Grapefruit seed extract which are very good at fighting infection."
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 U.S.C. § 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) :
Part 333, Subpart C - Topical Antifungal Drug Products
Part 333, Subpart D - Topical Acne Drug Products
Part 341, Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products
Part 347 - Skin Protectant Drug Products
Part 358 - Subpart B - Wart Remover Drug Products
Part 358 - Subpart H - Drug Products for the Control of Dandruff
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 U.S.C. § 321(p)]. Under section 505 of the Act [21 U.S.C. § 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 U.S.C. § 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 http://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:
"Contents of" 1 packet instead of "serving size;"
Information on calories must immediately follow the heading "Amount Per Serving" and must be declared in one line and separated by a hairline;
The column heading "% Daily Value" must be separated from information on calories by a bar;
The protein and sodium must be declared if they are greater than zero;
and sugars, which are present in insignificant amounts, should not be included in the simplified format.
Your reply should be sent to the attention of Compliance Officer Tyra S. Wisecup at the address on the letterhead.
W. Charles Becoat