Inspections, Compliance, Enforcement, and Criminal Investigations
NeuroScience, Inc. 11-Oct-06
Department of Health and Human Services
Public Health Service
Minneapolis District Office
October 11, 2006
RETURN RECEIPT REQUESTED
Refer to MIN 07-02
Gottfried H. Kellerman, Ph.D.
President/Chief Executive Officer
375 280th Street
Osceola, WI 54020
Dear Dr. Kellerman:
An inspection of your facility was conducted by an investigator from the Food and Drug Administration (FDA) on June 27, 2006. During the inspection, our investigator collected promotional literature, including product labels, brochures and guides about your products and services. The labeling of your products promotes them for use in the cure, mitigation, treatment, or prevention of disease. Products intended for such uses are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)). You can find the Act and implementing regulations on FDA's website at http://www.fda.gov.
Under the Act, "labeling" is not limited to labels on the immediate containers for your products. "Labeling" is defined in section 201(m) the Act [21 U.S.C. 321(m)] as "all labels and other written, printed or graphic matter upon any article . . .or accompanying such article." Our inspection of your facility disclosed that you distribute a wide-range of brochures in connection with your products, some for use by health care professionals and others for use by their patients. These materials are "labeling" for your products under the Act.
The labeling for your products includes numerous statements that your line of products assists in treating specific diseases and disease conditions through correcting imbalances in "neurotransmitters" through a program you call "Targeted Amino Acid Therapy (TAAT)." As indicated in your "Product and Services Guide for Healthcare Professionals," the following products are part of TAAT: 5-HTP Capsules, AddoGen, AdreCor, Balance D, Calm-PRT, CysNAC, DL-Phenylalanine, ExcitaCor, ExcitPlus, GabaMax, N-Acetyl Tyrosine, Neuro Vitamin, OptiMan, Optimum-C, PrevAmine, ProQuil, SanoX, Serene, SerenePlus, TransLean-Plus, TravaCor, TravaCor Jr. Examples of some of the specific claims in the labeling for your products include:
NeuroScience Product and Services Guide for Healthcare Professional
Page 17 for the product Flam X:
"As the subject of numerous clinical studies, it has been shown to effectively reduce pain and inflammation."
"Suggested uses: chronic inflammatory conditions."
Page 19 for the product OptiMan: "Suggested uses: [u]rinary incontinence."
Technical Guide 4th Edition-May 2006
Page 6 - "Inadequate or imbalanced neurotransmitter levels can result in disrupted or distorted signals between neurons. Many apparently dissimilar conditions can have a common underlying neurotransmitter imbalance[s]. The following is a list of commonly occurring neurotransmitter-related symptoms.
Chronic muscle/joint pain . . .
Depression. . .
Obsessive/ compulsive behaviors. . .
Recurrent diarrhea/constipation. . .
Many conditions, which patients seek relief from, are due to a neurotransmitter imbalance. Consider the following frequency of neurotransmitter-related conditions in the US:
Depression. . .
Migraine. . .
Anxiety. . .
Obesity. . .
Irritable Bowel Syndrome
TAAT programs work to address the underlying neurotransmitter imbalances responsible for the symptoms frequently seen in these disorders."
Professional Series ADD 8a ADHD The Neurochemical Difference
"Neurotransmitter testing can be useful when distinguishing between ADD and ADHD. Observations by NeuroScience have demonstrated that patients experiencing both lack of focus and hyperactivity (ADHD) generally have elevated levels of epinephrine, norephinephrine, and/or PEA."
Options for Weight Control Brochure
"Conditions related to obesity . . .Diabetes, Osteoarthritis, Some Cancers, High Blood Pressure, Kidney Disease, Liver Disease, Depression. . . ."
"Weight Loss & Neurotransmitter. . . [d]espite all the efforts and attention given to obesity. . . ."
"How Neurotransmitter Therapy Works .. .NeuroScience, Inc ., a world leader in neurotransmitter research and therapy, has pioneered a simple urine test to measure neurotransmitter levels in your body. If an imbalance is detected, the technical staff at NeuroScience works with your healthcare provider to develop a Targeted Amino Acid Therapy™ protocol to address the imbalance."
Options for ADHD (Attention Deficit Hyperactivity Disorder) Brochure
"Neurotransmitter imbalances can trigger ADHD"
"If your child is struggling with behavioral issues and you suspect ADHD may be the cause, ask your healthcare provider to do a simple urinary lab test to measure neurotransmitter levels. If the levels are out of balance, ask about NeuroScience's Targeted Amino Acid Therapy™ program-an effective approach to addressing ADHD."
Options for Depression Brochure
"Neurotransmitter imbalances can trigger depression."
"If you suspect that you might suffer from depression, complete the following self-test. Keep in mind: depression is a treatable condition . . . . [i]f you checked one or more of the shaded boxes it might be worthwhile to discuss your answers with your healthcare provider to determine if NeuroScience products and services are right for you."
These claims cause your products to be drugs, as defined in section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)] because they establish that these products are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease. 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(a) of the Act, a new drug may not be legally marketed in the United States without an approved New Drug Application (NDA) [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.
Further, your products are misbranded under section 502(fl(1) of the Act in that they fail to bear adequate directions for their intended uses [21 U.S.C. 352(f)(1)].
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 labeling for products distributed by your firm are in compliance with the Act and its implementing regulations.
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.
Your reply should be sent to the attention of Compliance Officer Tyra S. Wisecup at the address on the letterhead.
W. Charles Becoat