Department of Health and Human Services
Public Health Service
4040 N. Central Expwy
January 27, 2006
VIA FEDERAL EXPRESS
Arthur Ericsson, MD
6560 Fannin St #720
Houston, TX 77030
Ref. No. 2006-DAL-WL-13
Dear Dr Ericsson:
This letter concerns your firm's marketing of the products N-reX, Diab-eX, MD-eX, V- reX, and Aller-eX on your website, www.healtharising.com, and the products N-reX II Professional Series, Add-eX II Professional, and CuNeXuS II Professional on your Website, www.healtharisingpro.com. According to the claims on your website, as reviewed on December 13, 2005, the products are intended to prevent; treat, or cure disease conditions. Statements documenting these intended uses include, but are not limited to, the following:
"contains nerve growth factors … that are responsible for regenerating or activating the regeneration of neurons and are used for the treatment of Alzheimer's disease, Parkinson's Disease, Amyotrophic Lateral Sclerosis (Orghan [sic] Drug) Down's Syndrome."
"In Parkinson's Disease the clinical signs of the disease improved 69% while, at the same time the dosage of traditional anti-Parkinson medications were reduced significantly."
- "appears to activate the insulin receptors in the oral cavity that, in turn, may activate the production and release of insulin as well as the reduction in the release of glucogan from the pancreas."
"MD-eX is produced for Manic-Depressive and Dependency states."
"This product is indicated for the treatment of emotional states of euphoria alternating with periods of depression. It is useful in treating depression, melancholia, neuroasthenia, nervousness, exhaustion and collapse, psychological conditions that are associated with marked alteration of good mood with depression."
- "for the purpose of effectively treating influenza, respiratory infections, recurrent herpes (DNA viral infections), chronic recurring eczema and chronic fatigue syndromes."
- N-re™ Il Professional Series
- "appear responsible for activating the regeneration of neurons/myelin and may be used for treatment of Alzheimer's Disease, Parkinson's Disease, Amylotrophic [sic] Lateral Sclerosis, Down's Syndrome, peripheral neuropathy and neuro- muscular diseases."
- Add-e™ II Professional
- "Professional pharmaceutical formula that may be used for the treatment of children with attention deficit disorders or other learning disorders including Hyperactive Learning Disorder Syndrome and Down's Syndrome."
- CuNeXuS™ II Professional
- "This pharmaceutical is for use by the health professional in promoting wound healing. It contains five peptides that appear to stimulate wounds to bridge the wound gaps that develop as/sic] set a matrix for healing without scaring."
- "or the treatment of allergic conditions, asthma, acute and chronic bronchitis, wheezing, cough, suffocative breathing, rhinitis and edema of the nasal passages as well as certain immune diseases."
These claims are supplemented by the metatags for your website www.healtharising.com, which include "Diabetes Products," "Parkinson's Disease," "Alzheimer's Disease," "pharmaceuticals," "biologicals," "drug," "medicine," "heart failure," "HIV," "AIDS," and "measles."
The products cited above are drugs, as defined by Section 201(g)(1)(B) of the Federal Food, Drug and Cosmetic Act (Act), 21 USC 321(g)(1)(B), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Moreover, these products are new drugs, as defined by section 201(p) of the Act, 21 USC 321(p), because they are not generally recognized as safe and effective for their labeled uses. Under sections 301(d) and 505(a) of the Act, 21 USC 331(d) and 355(a), the introduction or delivery of a new drug into interstate commerce without an FDA-approved application is a prohibited act. No such applications exist for these products.
In addition, the Aller-eX is also a biological product as defined in Section 351(i) of the Public Health Service Act (PHS Act), 42 USC 262(i). In order to introduce or deliver for introduction a biological product into interstate commerce, a valid biologics license application (BLA) or a new drug application (NDA) must be in effect (21 USC 355(a) ; 42 USC 262(a)). A BLA or NDA is issued only after showing of safety and effectiveness (for an NDA) or safety, purity, and potency (for a BLA) for the product's intended use. While in the development stage, drug and biological products may be distributed for clinical use in humans only if the sponsor has on file an accepted investigational new drug application (IND) that is in effect. (21 USC 355(i); 21 CFR Part 312) Your products are not the subject of an approved BLA or NDA, or of an IND that is in effect.
Furthermore, many of the diseases or conditions for which the aforementioned products are offered are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Therefore, adequate directions for use for these conditions cannot be written so that a layman can use these drugs safely for their intended purposes. Because your products' labeling fails to bear adequate directions for their intended uses for those diseases or conditions which are not amenable to self-diagnosis and treatment, the products are misbranded under Section 502(f)(1) of the Act, 21 USC 352(f)(1).
The above violations are not intended to be an all-inclusive list of your products' deficiencies. It is your responsibility to ensure that the drug products that you manufacture or distribute, whether through RxIBR Corporation or any other venture, meet all of the requirements of the Act and its implementing regulations. Federal agencies are advised of the issuance of all warning letters about drugs and devices so that they may take this information into account when considering the award of contracts.
We expect you to correct these violations. If you do not correct these violations, you may be subject to an enforcement action against you without further notice. The Act provides for seizure of illegal products and for an injunction against the manufacturers and distributors of illegal products.
Notify the FDA in writing within 15 working days of receipt of this letter about the steps that you have taken to correct the above-listed violations, and the steps taken to assure that similar violations will not occur. If corrective action cannot be completed within 15 working days, please state the reason for the delay and the time within which the corrections will be made. Additionally, if your firm does not manufacture the products identified above, your reply should include the name and address of the manufacturers. If the firms from which you receive the products are not the manufacturers, please include the names of your suppliers in addition to the manufacturers.
Address your reply to the US Food and Drug Administration, 4040 N Central Expwy #300, Dallas, TX 75204, Attention: James R. Lahar, Compliance Officer.
Michael A. Chappell
This page was posted on February 12, 2008.