Inspections, Compliance, Enforcement, and Criminal Investigations
NeuroResearch, Inc 18-Oct-05
Department of Health and Human Services
Public Health Service
Minneapolis District Office
October 18, 2005
Refer to MIN 06 -08
RETIIRN RECEIPT REQUESTED
1150 - 88th Avenue West
Duluth, MN 55808
Dear Mr. Hinz:
The Food and Drug Administration (FDA) has reviewed the labeling of your products on your web site at http://www.neuroreplete.com. This review shows serious violations of the Federal Food, Drug and Cosmetic Act in the labeling of your NeuroReplete, Replete Extra, D5 Dietary, D5 Extra, and other products. The review was conducted to determine your firm's compliance with the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations contained within Title 21 of the Code of Federal Regulations (21 CFR). You can find the Act and implementing regulations through links on FDA's Internet home page at http://www.fda.gov.
Under the Act, articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man are drugs under section 201(g) (1) (B) of the Act [21 U.S.C. 321(g) (1) (B)].
Examples of some of the claims on your web site include:
" Treat pediatric ADHD by starting the patient on NeuroReplete. . ."
" Depression, Anxiety, and Panic Attacks. . .Treatment: Start 4 pills of NeuroReplete. . ."
" It was formulated to be used, in addition to NeuroReplete, in patients who need additional amino acids to control disease symptoms:. ."
" The amino acid treatment protocols, on page 19, were formulated by medical doctors based on the treatment of thousands of patients.
"It [D5] is the recommended starting point for complex neurotransmitter diseases. Complex neurotransmitter diseases are difficult to get under control, they include obesity, panic attacks, obsessive compulsive disorder (OCD), and severe anxiety."
D 5 Extra
" It [D5 Extra] is to be used, in addition to D5, when additional amino acids are needed to control symptoms. . ."
In addition, you offer a brochure that can be viewed on the website, entitled "The Phase 3 Response Home Page," that explains how the application of your products will treat various diseases and their symptoms. For example, your products are said to provide:
". . . [u]nder protocols developed, 100% resolution of the symptoms of depression. . .ADHD, fibromyalgia, Chronic pain, anxiety, panic attacks, insomnia, Obsessive Compulsive disorder (OCD), Parkinsonism, bulimia, anorexia . . .psychotic illness, migraine headaches, hormone dysfunction, adrenal dysfunction, cortisol dysfunction, irritable bowel syndrome, Chrones disease [sic], obesity. .."
This list of claims is not intended to be all-inclusive, but represents the types of claims found on your product labeling.
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, anew 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(f)(1) of the Act in that they fail to bear adequate directions for use [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. FDA regulations are available on FDA's website at www.fda.gov.
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