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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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NeuroScience, Inc. 12/19/11

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Minneapolis District Office
Central Region
250 Marquette Avenue,
Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100
FAX: (612) 334-4142 

 

December 19, 2011
 
 
WARNING LETTER
 
 
CERTIFIED MAIL
RETURN RECEIPT REQUESTED                          
Refer to MIN 12 – 15
 
Gottfried H. Kellerman, Ph.D.
Chief Executive Officer and Chairman
NeuroScience, Inc.
373 280th Street
Osceola, Wisconsin  54020
 
Dear Dr. Kellerman:
 
On August 9, 11, and 15, 2011, the Food and Drug Administration (FDA) conducted an inspection of your facility located at 373 280th Street, Osceola, Wisconsin. During the inspection the investigator collected labeling for a number of the products you manufacture at your facility. FDA reviewed the labeling for these products 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). Further, we also reviewed your websites at http://www.neuroscienceinc.com and http://www.neurorelief.com
 
As discussed further below, your Zymenta and Cerelist products are misbranded under section 403(a)(1) of the Act, 21 U.S.C. § 343(a)(1), because their labeling is false or misleading in that they are labeled and marketed as medical foods but do not meet the statutory definition of a medical food in the Orphan Drug Act, 21 U.S.C. § 360ee(b)(3), or the criteria set forth in 21 CFR 101.9(j)(8). Furthermore, your Avipaxin, Calm-PRT, Cerelist, DL-phenylalanine, GI Reset™, NorLox, Recolonize-1: Th1 Inhibitor™, Taurine, and Zymenta products are promoted for conditions that cause them 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 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 related regulations through links on FDA’s internet home page at www.fda.gov.
 
Misbranded Food
 
Your Cerelist and Zymenta capsule products are each labeled as a “medical food,” and the claims on your product labeling and websites represent these products as medical foods for the “nutritional management of certain metabolic processes associated with dementias of mild-to-moderate Alzheimer’s disease or mild cognitive impairment.” These products are misbranded under section 403(a)(1) of the Act because their labeling is false and misleading in that the products are labeled and marketed as medical foods but do not meet the statutory definition of a medical food in the Orphan Drug Act, 21 U.S.C. § 360ee(b)(3), or the criteria set forth in 21 CFR 101.9(j)(8).
 
The Orphan Drug Act defines “medical food” as “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.” The regulation in 21 CFR 101.9(j)(8) sets forth criteria to clarify the statutory definition of a medical food. Specifically, this regulation provides that a food is a medical food only if:
 
i.    It is a specially formulated and processed product (as opposed to a naturally occurring foodstuff used in its natural state) for the partial or exclusive feeding of a patient by means of oral intake or enteral feeding tube;
ii.    It is intended for the dietary management of a patient who, because of therapeutic or chronic medical needs, has limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone;
iii.    It provides nutritional support specifically modified for the management of the unique nutrient needs that result from the specific disease or condition, as determined by medical evaluation;
iv.    It is intended to be used under medical supervision; and
v.    It is intended only for a patient receiving active and ongoing medical supervision wherein the patient requires medical care on a recurring basis for, among other things, instructions on the use of the medical food.
 
FDA considers the statutory definition of “medical food” to narrowly constrain the types of products that fit within this category.[1] In addition to other criteria, medical foods must be for the dietary management of a specific disorder, disease, or condition for which there are distinctive nutritional requirements and must be intended to be used under medical supervision.[2] Patients with such a disorder, disease, or condition must have a limited capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or have other special medically determined nutrient requirements, which cannot be managed by the modification of the normal diet alone.[3] Medical foods are not those simply recommended by a physician as part of an overall diet to reduce the risk of a disease or condition.[4] As discussed further below, your Zymenta and Cerelist products do not meet the regulatory criteria for a medical food.
 
Pursuant to 21 CFR 101.9(j)(8)(ii), a medical food must be intended for a patient who has a limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone.  While your labeling states that the patients for whom your products are intended have “nutritional deficits in cholinergic function,” FDA is not aware of any evidence that patients with Alzheimer’s Disease (AD) or Mild Cognitive Impairment (MCI) have a limited or impaired capacity to ingest, digest, absorb, or metabolize choline, or other nutrients, or have a distinct requirement for choline or any other nutrient. Further, your labeling, including your website, implies that diet alone may not supply the full amount of nutrients (particularly choline) necessary for patients with AD or MCI, and your Zymenta and Cerelist products include Choline bitartrate and alpha-glycerylphosphorylcholine (part of Alpha-Size®) as source ingredients of choline to ensure adequate choline intake. However, choline is readily available in the food supply and there is no evidence that adequate intake levels[5] cannot be achieved through modification of a normal diet (see USDA Database for the Choline Content of Common Foods, January 2008, www.ars.usda.gov/Services/docs.htm?docid=6232). While changes in consumption behavior (e.g., avoidance of meat, eggs), diet practices (e.g., vegetarianism) and the need to follow specific diets for medical reasons (e.g., low fat/low cholesterol) may affect an individual’s ability to consume an adequate intake level of choline through diet alone, there is no available evidence that adequate intake levels of choline cannot be achieved by the modification of the normal diet alone. 
 
Further, your labeling states that Acetyl-L-Carnitine, an ingredient in both Zymenta and Cerelist, provides an acetyl group which is a precursor for acetylcholine synthesis. While this statement is accurate, we note that an individual does not have to consume certain foods to enable acetylcholine synthesis. Acetylcholine can only be synthesized by the enzyme choline acetyltransferase, which is available endogenously from the compounds choline and acetyl-CoA. 
 
Because your Cerelist and Zymenta products are intended to support conditions (AD and MCI) that do not have distinct requirements for certain nutrients, and also is intended to provide a level of nutrients that can be met through the modification of the normal diet alone, these products do not meet the regulatory criteria for medical foods set forth in 21 CFR 101.9(j)(8)(ii). Accordingly, these products are misbranded within the meaning of section 403(a)(1) of the Act because their labeling is false or misleading in that the products are labeled as a medical food but do not meet the definition of a medical food.
 
New Drugs
 
Under section 201(g)(1)(B) of the Act, 21 USC § 321(g)(1)(B), articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease are drugs. The therapeutic claims in your labeling establish that your Avipaxin, Calm-PRT, Cerelist, DL-phenylalanine, GI Reset™, NorLox, Recolonize-1:Th1 Inhibitor™, Taurine, and Zymenta products are intended to be used as drugs.  The marketing of these products with these claims violates the Act.
 
Specific examples of claims in your product labeling that promote your products as drugs are as follows:
 
Avipaxin
  • “Regulates Proinflammatory Cytokines…”
  • “Decreases pro-inflammatory cytokines”
  • “After Avipaxin patients report…[p]ain reduction…”
  • “Avipaxin decreases pro-inflammatory levels…[t]he cytokine-induced neurotransmitter imbalances is observed…during an acute viral or bacterial infection.”
Calm-PRT
  • “May be indicated when:…[h]igh blood pressure…”
DL-phenylalanine
  • “May be indicated when:…[m]ild pain…”
GI Reset™
  • “[D]ecreases pro-inflammatory cytokines.”
  • “Reduces pro-inflammatory cytokine levels”
NorLox
  • “May be indicated when:…[p]ain and swelling…”
Recolonize-1: Th1 Inhibitor™
  • “Reduces pro-inflammatory cytokines”
Taurine
  • “May be indicated when:…[h]igh blood pressure…”
Zymenta and Cerelist
  • “Zymenta helps by slowing the progress and reducing the symptoms of MCI and AD!”
  • “Medical studies of MCI and AD have found damage to an unusually large number of certain brain cells…Zymenta’s multi-pronged approach is specifically targeted to…people with MCI or early AD.”
  • “Alzheimer’s Disease and Mild Cognitive Impairment are characterized by degenerative loss of cholinergic neurons which results in low acetylcholine production and symptoms of cognitive decline (1,2). Choline supplementation may support acetylcholine synthesis(3)…”
  • “Reduces pro-inflammatory cytokines…”
  • “Both Zymenta and Cerelist are indicated for MCI and mild-to-moderate Alzheimer’s disease.”
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, they are also new drugs under section 201(p) of the Act, 21 U.S.C. § 321(p).  New drugs may not be legally marketed in the United States 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.
 
Furthermore, because your products Avipaxin, Calm-PRT, Cerelist, GI Reset™, Taurine, and Zymenta are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use the products safely for their intended uses.  Thus, their labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1).  The introduction of a misbranded drug into interstate commerce is a violation of § 301(a) of the Act, 21 U.S.C. § 331(a).
 
This letter may not be an all inclusive review of your product labeling, website, or the products your firm markets.  It is your responsibility to ensure that all products marketed by your firm are in compliance with the requirements of the Act and all applicable regulations.  Failure to promptly correct violations may result in regulatory action being initiated by FDA without further notice, such as seizure and/or injunction.
 
Please respond in writing within 15 working days from your receipt of this letter.  Your response should outline the specific actions you are taking to correct these violations and to prevent similar violations.  You should include in your response documentation such as revised labels, or other useful information that would assist us in evaluating your corrections.  If you cannot complete all corrections before you respond, please explain the reason for the delay and state when you will correct any remaining violations.
 
Your response should be directed to Melissa I. Michurski, Compliance Officer, at the address listed above.  You can contact Ms. Michurski at (612) 758-7185 with any questions regarding this letter.
 
Sincerely,
/S/
Elizabeth A. Waltrip
Acting Director
Minneapolis District
 


[1]See 56 Fed. Reg. 60366, 60377 (Nov. 27, 1991); see also Guidance for Industry: Frequently Asked Questions About Medical Foods, May 2007.
[2] See 21 U.S.C. § 360ee(b)(3); see also 56 Fed. Reg. at 60377.
[3] See 21 CFR 101.9(j)(8)(ii); see also 56 Fed. Reg. at 60377.
[4] See 56 Fed. Reg. at 60377.
[5] Adequate Intake for Women and Men is 425 mg/day and 550 mg/day, respectively (Dietary Reference Intakes for Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin, and Choline,” Institute of Medicine, National Academy Press, Washington D.C., 1998.)