Inspections, Compliance, Enforcement, and Criminal Investigations
Healthwest Mineral 29-Sep-05
Department of Health and Human Services
| Public Health Service |
Food and Drug Administration
|Seattle District |
22201 23rd Drive SE
Bothell, WA 98021-4421
September 29, 2005
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 05-36
Frank T. Stout, Chief Executive Officer/Founder
Healthwest Minerals, d.b.a. Mt. Capra Cheese
279 SW 9th Street
Chehalis, WA 98532
Dear Mr. Stout:
The Food and Drug Administration (FDA) inspected your firm located at 279 SW 9th Street, Chehalis, Washington, on July 6-7, 2005. During the inspection, our investigator collected labeling for your products, including literature that is included in product shipments. In addition, we reviewed your website at the Internet address www.mtcapra.com. Our review of the labeling collected during the inspection and listed on your website identified numerous violations of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and FDA's regulations through links on FDA's Internet web site at http://www.fda.gov.
Your products' labeling includes the following violations of the Act:
Products with Disease Claims.
Under section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(13)], articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease are drugs. Based on claims that appear in the product literature you distribute with product shipments, and claims made on your website at http://www.mtcapra.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) of the Act [21 U.S.C. 321(g)(1)(B)]. The therapeutic claims establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease.
Examples of some of the claims observed in your products' labeling, including your website and literature accompanying your products, include the following:
From your literature and website:
"Vital Energy™" is . . . formulated to benefit a wide spectrum of individuals including those choosing to ... REDUCE AND NEUTRALIZE INFLAMMATORY ACTIVITY (fibromyalgia, arthritis, gout, injuries/trauma) with specialty nutrients like tart cherry juice, confirmed by leading university studies to exhibit the following health-enhancing properties: . . . Perillyl Alcohol-a natural compound extremely powerful in reducing incidence of all types of cancer."
"Key Ingredients . . . Brain Energy Blend . . .
GINGKO BILOBA EXTRACT . . . . [U]sed in therapeutic protocols for cerebral insufficiency, dementia, tinnitus . . . .
MUIRA PUAMA EXTRACT . . . [A] neuromuscular tonic for weakness and paralysis, dyspepsia, . . . chronic rheumatism, sexual impotency, grippe and central nervous system disorders."
From your literature and website:
" WHAT ARE THE BENEFITS OF COLOSTRUM SUPPLEMENTATION? . . . Support compromised immune system . . . . Contain lactoferrin, an iron-binding protein with antiviral, antibacterial and anti-inflammatory properties"
"Effectiveness in treatment of the following disorders, but not limited to: Thrombocytopenia - Anemia - Myasthenia Gravis - Guillain Barre Syndrome - Multiple Sclerosis - Systemic Lupus - Rheumatoid Arthritis - Chronic Fatigue Syndrome - Crohn's Disease"
"Caprobiotics + Plus"
From your literature and website: "Bifidobactirum Longum [an ingredient in the product]: . . . . May help reduce cholesterol levels."
From your literature: "CapraZyme . . . contains botanical ingredients historically known for their therapeutic effects in repairing damage from leaky gut syndrome, ulcers . . . ."
From your website:
" CAPRAZYME™"Contains the Following Synergistically Balanced Ingredients: Plant Enzyme Blend . . .
Isolase™: . . . . Isoflavones have shown cancer-preventive properties as well as positive effects on osteoporosis, and cardiovascular disease. . . .
I-glutamine: . . . . [H]as been used therapeutically for the treatment of peptic ulcer . . . ."
From your literature and website: "Eliminates parasites . . . ."
Because these products are not generally recognized as safe and effective when used as labeled, they are also new drugs as defined in 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). These products are also misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] in that the labeling does not bear adequate directions for use.
Other Labeling Deviations
Even if your Vital Energy™, CapraColostrum™, Caprobiotics + Plus, and CapraZyme™ products did not contain disease claims in their labeling which cause them to be drugs, they would still be misbranded as dietary supplements.
Vital Energy™, CapraColostrum™, Capra Mineral Whey, Caprobiotics, Caprobiotics + Plus, CapraFIex™, CapraCleanse™, and CapraZyme™ are misbranded under sections 403(i)(1) and 403(s)(2)(B) of the Act [21 U.S.C. 343(i)(1) and 343(s)(2)(B)] because the labels fail to identify the products with the term "dietary supplement" (or an appropriate alternative) as part of the statement of identity, on the principal display panel, as specified in 21 CFR 101.3(d) and (g).
This letter is not intended to be an all inclusive review of your products and labeling. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.
We request that you take prompt action to correct these violations. Failure to immediately cease distribution of your violative products could result in enforcement action by FDA without further notice. The Act provides for the seizure of illegal products, injunctions against the manufacturers and/or distributors of violative products, and criminal sanctions against persons responsible for causing violations of the Act.
Furthermore, we note that some of your products appear to contain ingredients that are not declared on the label. For example, the product Caprobiotics is in a capsule form but the label does not appear to list the ingredients that comprise the capsule itself. All ingredients in the products must be declared on your product labels as specified by 21 CFR 101.4 and 21 CFR 101.36.
Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct these violations, including any steps taken with respect to violative products currently in the marketplace, and an explanation of each step taken to ensure that violations do not recur. Your reply should be sent to the Food and Drug Administration, Attention: Lisa Elrand, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421.
Charles M. Breen