Inspections, Compliance, Enforcement, and Criminal Investigations
The Power Mall 28-Jun-06
Department of Health and Human Services
Public Health Service
Kansas City District
June 28, 2006
RETURN RECEIPT REQUESTED
Ref. KAN 2006-17
The Power Mall
P.O . Box 85
Versailles, MO 65084-0085
Dear Ms. Riley:
The Food and Drug Administration (FDA) has reviewed your web site at the following address: http://www.thepowermall.com. This review shows serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) . You can find the Act and implementing regulations through links on FDA's Internet home page at www.fda.gov.
Under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)], articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease are drugs. Your web site claims that your products Taurine Spray, AsmaSpray™', D-Lenolate, Curcumin98™, OxySorb™, Eskimo 3 Fish Oil, Gastro Enzymes, Q Gel", and AstaXanthin are useful in the prevention, treatment, cure, or mitigation of numerous diseases . For example, the web site labeling of these products bears the following claims:
"Its medicinal clinic [sic] functions are : antiphlogistic, antalgic, antifebrile, reducing blood sugar . . . ."
"Taurine is an endogenous amino acid having the physiological functions as follow [sic] : antipyretic, alleviating pain . . . . It is used in the treatment of common cold, fever, neuralgia, tonsillitis, bronchitis, rheumatic arthritis, eye
disease and medicine poisoning."
"AsmaSpray™ with Coleus Forshkolii & Tylophora Asthmatica for Asthma and Skin problems such as Eczema"
"Forskolin stimulates the enzyme adenylate cyclase to release cAMP. cAMP levels rise that inhibits the release of chemical mediators. This relaxes bronchial smooth muscle and prevents. bronchi-spasm [sic]."
"Coleus Forshkolii supplementation show [sic] benefits where low cAMP is a known factor for various conditions such as:
* Low Thyroid
* Glaucoma . . .
* Neurological Disorders"
In addition, the name "AsmaSpray" suggests that the product is intended for use in the treatment, mitigation, or prevention of asthma, a disease.
"D-Lenolate olive leaf extract is an effective, all natural, and nontoxic scientific break through which has proven to be effective using its powerful active ingredients which can actually eliminate the viruses, fungi, bacteria and other parasites that cause disease."
"From immune disorders to the common cold, from Epstein-Barr virus to Genital Herpes, from Hepatitis C to Lyme disease, from Ebola Zaire virus to HIV, . . . d-Lenolate olive leaf extract herbal remedies can be a very powerful adjunct to any program of healing . . . . .."
"D-Lenolate will reduce the symptoms of chronic yeast infections by greater than 50% within 60 days of use, with no apparent side effects. This was the finding and conclusion of [redacted] FACS."
"Curcumin . . . has been implicated in the treatment of certain eye diseases . . . . One of those is known as chronic anterior uveitis (CAU), an inflammatory condition of the vascular layer of the eye; particularly the area comprising the iris. In one small study, Curcumin was given orally to 32 chronic anterior uveitis patients . . . . Amazingly, all of the; patients treated with Curcumin alone improved . . . . The researchers concluded that Curcumin was just as effective as anterior uveitis at present, adding that `the lack of side effects with Curcumin is its greatest advantage compared with corticosteroids."
"Similar research using rats and rabbits found that Curcumin effectively inhibited chemically induced cataract formation . . . . .."
"Curcumin98™ . . . is an anti-inflammatory, antibacterial, antiviral, antifungal " "Curcumin, the active ingredient in the herb turmeric, is being investigated for use in Alzheimer's disease due to its potent anti-inflammatory action . . . . "
"Curcumin may block the progression of Multiple Sclerosis (MS)"
"OxySorb™ can improve the healing process in the case of chronic illnesses and work preventatively for the long term."
"(testimonial under heading "Asthma") "I tried OxySorb™. . . .Best of all a week later it has reduced my symptoms of my Asthma, and although I have been continuing with my inhaler, my consumption of Ventolin has dramatically decreased & my breathing is less laboured."
Eskimo 3 Fish Oil
"Overview of Benefits : . . . Arthritis . . . Alzheimer's"
"Papaya leaf [an ingredient in the product] . . . protects the stomach from damage and the formation of ulcers."
"Indications (3 capsules) : . . . Ulcers, Colitis, . . . Duodenal ulcer, Gastritis, . . . Unexplained blood in urine, Back pain"
"Can provide effective treatment of heart disease, chronic fatigue and support during cancer treatment."
"Clinical trials have shown that Astaxanthin . . . [h]elps prevent Neurodegenerative diseases, [h]elps Cardiovascular Diseases . . . [a]lleviates the effects of carpal tunnel syndrome . . . . .."
The claims establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease [Section 201(g)(1)(B) of the Act, 21 U.S.C. § 321(g)(1)(B)]. Because the 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(a) of the Act, 21 U.S.C. § 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. These products do not have approved applications. Therefore, they are unapproved new drugs and their introduction or delivery for introduction into interstate commerce violates section 301(d) of the Act [21 U.S.C. § 331(d)].
Further, these products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, Taurine Spray, AsmaSpray™, D-Lenolate, Curcumin98™, OxySorb™, Eskimo 3 Fish Oil, Gastro Enzymes, Q Gel', and AstaXanthin are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that the labeling for these drugs fails to bear adequate directions for their intended uses.
In addition, the web site labeling for your product Mild Silver Protein 400 bears the following claims:
"MSP is a natural antibiotic and the most effective disease, germ, virus, and fungal killers around. May be used to help cure colds, flu, or any other infection due to bacteria, fungus, or virus. MSP can also be taken daily to help prevent colds, flu and infections."
Mild Silver Protein 400, to the extent that it is labeled and promoted as a drug for over the counter (OTC) use, is subject to 21 CFR § 310.548, which states that there is a lack of adequate data to establish general recognition of the safety and effectiveness of colloidal silver ingredients or silver salts for OTC use in the treatment or prevention of any disease. These ingredients and salts include, but are not limited to, mild silver protein. See 21 CFR § 310.548(a). Any OTC drug product containing mild silver protein that is promoted, labeled, or represented for the treatment or prevention of any disease is regarded as a new drug within the meaning of section 201(p) of the Act [21 U.S.C. § 321(p)] and requires an approved application under section 505 of the Act for marketing. Mild Silver Protein 400 does not have an approved application.
Therefore, it is an unapproved new drug and its introduction or delivery for introduction into interstate commerce violates section 301(d) of the Act [21 U.S.C. § 331(d)]. Absent an approved application, the Mild Silver Protein 400 is also misbranded under section 502 of the Act [21 U.S.C. § 352]. See 21 CFR § 310.548(b).
The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations.
The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of such products. You should take prompt action to correct these deviations and prevent their future recurrence. Failure to do so may result in enforcement action without further notice.
Please advise this office, in writing and within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur. Include any documentation necessary to show that correction has bepn achieved. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.
Your reply should be addressed to Compliance Officer, Nadine N. Johnson at the above address.
John W. Thorsky
Kansas City District