Inspections, Compliance, Enforcement, and Criminal Investigations
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
22201 23rd Drive SE
Bothell, WA 98021-4421
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 09-17
Carol A. James
509 Southwest Walnut Avenue
Dundee, Oregon 97115-9649
Dear Ms. James:
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address http:///www.inspiredliving.com in May 2009 and has determined that your "ASO (Activated Stabilized Oxygen) 25% Professional Solution," "Allimax Allicin Rich Garlic Rescue Spray," "Harmoniclnnerprizes Etherium Gold," "Harmoniclnnerprizes Colloidal Defense," "Harmoniclnnerprizes Chamae Rose with Black Walnut," and "Harmoniclnnerprizes Gentleman's PQ Higher Octive Dietary Supplement" 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 on your website establish that these products are intended to be used as drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act.
Examples of claims observed on your website include:
ASO (Activated Stabilized Oxygen) 25% Professional Solution
"Individuals with viral or bacterial infections in various body locations have suggested mixing 25 drops of stabilized oxygen... used topically or orally to speed recovery."
Allimax Allicin Rich Garlic Rescue Spray
"Allimax Rescue Spray Liquid can be used to help resolve any condition that is bacterial, fungal, or viral in nature."
"Allimax Rescue Spray can be used for sore throats, chest infections, colds, flu, gum disease, diarrhea and asthma.
Harmoniclnnerprizes Etherium Gold (sold as capsules, oral spray, or powder)
(Testimonials) "My ten year old son Alex has been suffering from [attention problems] since he was a child. He was officially diagnosed with [attention deficit problems] and was put on Ritalin ....[w]hen I became aware of the various positive effects of Etherium Gold I knew I wanted to try it on Alex as I had been determined to wean him off the Ritalin ... "
Harmoniclnnerprizes Colloidal Defense
"Colloidal Defense is a highly effective natural anti-microbial"
"It is electromagnetically formulated to the specific frequency of bone marrow which produces T-cells, the body's first line of defense of outside pathogens,
such as; foreign bacteria, viruses, candida and parasites."
"Additionally, all three products contain Silicia, which is a vital mineral that diminishes as the body ages. Silicia aids in healing wounds, healing fractured bones... "
Harmoniclnnerprizes Chamae Rose with Black Walnut
"Black Walnut has been traditionally used to remove tapeworms and parasites from the body, and eliminate fungal infections."
Harmonic Gentlemen's PQ Higher Octave Dietary Supplement
"Gentlemen's PO Dietary Supplement ... It contains ... Saw Palmento extract to promote prostate health by reducing the size of enlarged prostate... "
Your products are not generally recognized as safe and effective for the above referenced uses and therefore, they are new drugs under section 201 (p) of the Act [21 U.S.C. § 321 (p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. 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. Your "ASO (Activated Stabilized Oxygen) 25% Professional Solution," "Allimax Allicin Rich Garlic Rescue Spray," "Harmoniclnnerprizes Etherium Gold," "Harmoniclnnerprizes Colloidal Defense," Harmoniclnnerprizes Chamae Rose with Black Walnut, and Harmoniclnnerprizes "Gentleman's PO Higher Octive Dietary Supplement" products are also misbranded within the meaning of section 502(f)(1) of the Act in that labeling for these drugs fail to bear adequate directions for use [21 U.S.C. § 352(f)(1)].
In addition, based on the definition of the term ,"dietary supplement" under section 201 (ff)(2)(A) of the Act [21 U.S.C. 321 (ff)(2)(A)], only products that are intended for ingestion may be lawfully marketed as dietary supplements. Topical products and products intended to enter the body directly through the skin or mucosal tissues, such as transdermal or sublingual products, are not dietary supplements. For these products, both disease and structure/function claims may cause them to be new drugs. Based on the claims for your "Allimax Allican Rich Garlic Rescue Spray" ("Allimax Rescue Spray ... can also be used topically for athlete's foot, bites, skin, rash, eczema, etc.") and "ASO (Activated Stabilized Oxygen) 25% Professional Solution" ("Individuals with viral or bacterial infections in various body locations have suggested mixing 25 drops of stabilized oxygen ... used topically ... to speed recovery.") products observed on your website, these products are intended for use in part as a topical treatment for various injuries. Therefore, "Allimax Allican Rich Garlic Rescue Spray" and "ASO (Activated Stabilized Oxygen) 25% Professional Solution" may not be marketed for these intended uses as dietary supplements.
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. We advise you to review your website, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act.
You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in enforcement action without further notice. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334].
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 the violations noted above and to assure that similar violations do not occur. Include any documentation necessary to show that correction has been 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.
Please send your written reply to the Food and Drug Administration, Attention: Michael J. Donovan, Compliance Officer, 22201 23rd Drive SE, Bothell, WA 98021-4421. If you have any questions regarding this letter, please contact Mr. Donovan at (425) 483-4906.
Charles M. Breen
cc: ODA with disclosure statement