| Public Health Service Food and Drug Administration |
| 4555 Winderley Pl., Ste. 200 Maitland, FI 32751 |
Department of Health and Human Services
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
WARNING LETTER
FLA-10-07
January 7, 2010
Douglas J. Phillips, II,
Director of Research and Development
Cerebral Health, LLC
1100 Sioux Street
Jupiter, FL 33458
Dear Mr. Phillips:
This is to advise you that the Food and Drug Administration (FDA) reviewed your web sites at the internet addresses http://www.alzenia.com, http://memeron.com, and http://www.cerebralhealth.com. in December 2009 and has determined that the products "Alzenia Anti-Aging Brain Formula," "Alzenia with Huperzine A," "Memeron," "Synaptine," "Synaptine Blue," "Synaptine Elite," and "Neurotine," are promoted for conditions that cause the products to be drugs under Section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321 (g)(1)]. The therapeutic claims on your web site establish that the products are 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. You can find the Act and regulations on FDA's website at www.fda.gov.
Examples of some of the claims observed on your web sites include:
Alzenia® Anti-Aging Brain Formula
• "Huperzine A (available in Alzenia® with Huperzine A) ... Huperzine A has been the subject of intense study and evaluation as a treatment for Alzheimer's disease ...Green Tea helps prevent neurodegenerative brain conditions including Alzheimer's disease and Parkinson's disease ". resveratrol has exhibited anticancer, anti-inflammatory... effects."
• "In a recent (2008) study ... resveratrol significantly reduced beta amyloid plaques, which are often associated with ... conditions such as Alzheimer's disease."
• "Alzenia® utilizes coconut milk powder containing monolaurins and lauric acid that act as powerful antiviral agents ... Coconut oil is also showing efficacy in the treatment and prevention of Alzheimer's Disease, Parkinson's Disease, Huntington Disease, and epilepsy (even in children)."
• The image of a diseased brain with the caption "advanced alzheimer's" constitutes a disease claim.
• "Curcumin's [ingredient in Alzenia] ... ability to inhibit TNF (tumor necrosis factor) may help to prevent the build-up of amyloid plaque."
• "Niacinimide (Vitamin B3) [ingredient in Alzenia] is showing quite powerful effects in those with Alzheimer's..."
Your website also includes claims in the form of personal testimonials. For example:
• "'My mom has responded very well to the treatment, she is much more clear in her mind and her memory has improved very much, to me she is almost recovered from her stroke and vascular dementia, she has some memory problems but very little, and her delusions has also almost gone away, much better anyway. '"
Memeronâ„¢ Memory Enhancer
• "'If the studies are what they appear to be, galantamine is perhaps the best treatment yet discovered for. ..dementia progressing to Alzheimer's disease.'Dr. Silvia Petrova, Psychiatrist"
• ''Memeron™ that describe its effectiveness as a superb treatment for Alzheimer's disease, vascular dementia..."
• "The new Memeron™ formula may prove to be the best fight against Alzheimer's and dementia available worldwide."
• "FDA Notice: Galantamine is FDA approved to treat mild to moderate Alzheimer's disease."
• "Memeron Effective for Severe Alzheimer's Disease"
• "Memeron Alzheimer's Treatment Ushers in New Wave of Galantamine Products to Expand on Razadyne"
• "Memeron Alzheimer's Drug Offers Hope to Patients and Caregivers"
• "Memeron® is an unparalleled all-natural supplement designed to enhance brain functions associated with memory in healthy adults and to prevent and treat the early stages of Alzheimer's disease, vascular dementia..."
Neurotineâ„¢ Amino Acid Brain Fuel
• "Active Components- N-Acetyl L-Tyrosine ... L-tyrosine...has been used to support...depression Research on Acetyl-L-Camitine shows it can...possibly be useful for strokes, Down's syndrome .... The effects of supplementing with camitine has been extensively researched in many areas, including treatment of Alzheimer's, Parkinson's, diabetic neuropathy, depression treatment of alcoholism, treatment of cardiovascular disease, insulin resistance ... Gama Amino Butyric Acid [GABA] ... GABA may be an essential element in the nutritional treatment of alcoholism, attention deficit disorder, dementia, schizophrenia...Parkinson's disease...and may be important for anorexia nervosa, bulimia, chronic fatigue syndrome, fibromyalgia, substance abuse, Wilson's disease and helpful for depression and obesity."
Synaptine® Nootropic and Cognitive Enhancer
• "Used and clinically tested to help improve the symptoms of Alzheimer's, down syndrome, autism, senile dementia, dyslexia, post-stroke aphasia, and alcohol withdrawal."
Your website also includes claims in the form of personal testimonials. For example:
• "'I have been diagnosed with ADHD and over the years I've taken ridiculous prescriptions that my doctor has prescribed to me and they all never seem to be effective...However, I have tried out your regular Synaptine®, and I was amazed at the difference.... '-Adam K, Lady Lake, FL"
Synaptine® Blue Brain Health Supplement
• "Active Ingredients ... Organic Brahmi... assists with epilepsy..."
Synaptine® Elite Maximum Strength Nootropic"
• "SYNAPTINE® ELITE is... for. ..those suffering from Alzheimer's, senile dementia, cerebral atrophy, chronic alcoholism ...."
• "Acts as a natural anti-depressant. .."
• "Used and clinically tested to help improve the symptoms of Alzheimer's, down syndrome, autism, senile dementia, dyslexia, post-stroke aphasia, and alcoholism"
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products 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.
The above violations are not meant to be an all-inclusive list of deficiencies in your products or their labeling. It is your responsibility to ensure that all of your products are in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory actions without further notice, such as seizure and/or injunction.
Please respond to this letter within fifteen (15) working days from receipt with the actions you plan to take in response to this letter, including an explanation of each step being taken to correct the current violations and prevent similar violations. Include any documentation necessary to show that correction has been achieved, such as revised labels and/or revised internet website labeling. If you cannot complete corrective action within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction.
You should direct your written reply to Matthew B. Thomaston, Compliance Officer, Food and Drug Administration, Florida District Office, 555 Winderley Place, Suite 200, Maitland, FL 32751.
Sincerely,
/s/
Emma R. Singleton
Director, Florida District
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