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

Public Health Service
Food and Drug Administration
 Silver Spring, MD  20993-0002 

CYBER LETTER

July 15, 2013
 
Richard Cervelli
Robert Silverstein
Origin BioMed Inc.
5162 Duke Street, Suite 500
Halifax, Nova Scotia, B3J 1N7
Canada
info@originbiomed.com
 
Dear Messrs. Cervelli and Silverstein:
 
This is to advise you that the U.S. Food and Drug Administration (FDA) has reviewed the information on your firm’s website www.originbiomed.com, Facebook Account (www.facebook.com/Neuragen), Twitter Account (www.twitter.com/Neuragen), and product labels for your marketed products which includes, but may not be limited to, “Neuragen PN” and “Neuragen Cream.” Based on our review of the labeling claims, your products “Neuragen PN” and “Neuragen Cream” are misbranded under sections 503(b) and 301 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 353(b) and 331].
 
Examples of labeling claims observed establishing intended use for “Neuragen PN” and “Neuragen Cream” include, but may not be limited to, the following:
 
Neuragen PN
Neuragen Cream
Neuragen PN and Neuragen Cream 
These claims are supplemented by the common name shared by your products, “neuragen.” The name “neuragen” itself implies an association with “nerve pain,” because of its resemblance to the word “neuralgia” (nerve pain caused by nerve irritation or damage). 
 
Based on the above-mentioned claims for your products “Neuragen PN” and “Neuragen Cream,” they are drugs as defined by section 201(g)(1) of the FD&C Act [21 U.S.C. § 321(g)(1)], because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. You promote your products to treat or manage neuropathic pain caused by various underlying conditions, especially in people with neuropathic pain associated with diabetic neuropathy. Section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)] identifies criteria for determining the prescription status of a product. Your products “Neuragen PN” and “Neuragen Cream” are prescription drugs within the meaning of section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)], because they are intended to treat diseases that require diagnosis and treatment by a physician or are intended to provide treatment for symptoms usually caused by an underlying disease process that requires diagnosis and treatment by a physician.  Because they are subject to § 503(b)(1) of the FD&C Act, “Neuragen PN” and “Neuragen Cream” are misbranded under section 503(b)(4) of the FD&C Act [21 U.S.C. § 353(b)(4)] in that their labels fail to bear the symbol “Rx only.”1 The introduction or delivery for introduction into interstate commerce of misbranded drugs violates section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]. 
 
We recognize that “Neuragen PN” and “Neuragen Cream” are represented as being homeopathic drugs with active ingredients measured in homeopathic strengths.  The definition of “drug” in section 201(g)(1) of the FD&C Act [21 U.S.C. § 321(g)(1)] includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it.  Homeopathic drugs are subject to the same regulatory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, labeling, misbranding, or approval.  We acknowledge that many homeopathic drugs are manufactured and distributed without FDA approval under enforcement policies set out in the Agency’s Compliance Policy Guide entitled, “Conditions Under Which Homeopathic Drugs May be Marketed (CPG 7132.15)” (the CPG).  As its title suggests, the CPG identifies specific conditions under which homeopathic drugs may ordinarily be marketed; thus, in order to fall under the enforcement policies set forth in the CPG, a homeopathic product must meet the conditions set forth in the CPG.  One of those conditions is compliance with section 503(b) of the FD&C Act.  Under the CPG, only homeopathic products intended solely for self-limiting disease conditions amenable to self-diagnosis (of symptoms) and treatment may be marketed over-the-counter (OTC).  Homeopathic products offered for conditions not amenable to OTC use must be marketed as prescription products.
 
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations. 
 
You should take prompt action to correct the violations cited in this letter.  Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.
 
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Your response should be sent to:
 
U.S. Food and Drug Administration
CDER/OC/OUDLC
10903 New Hampshire Avenue, WO51
Silver Spring, MD  20993-0002
OUDLCMail@fda.hhs.gov   
 
 
Sincerely,
/S/
Howard Sklamberg
Director
Office of Compliance
Center for Drug Evaluation and Research 


[1] The Agency’s guidance, “Conditions Under Which Homeopathic Drugs May be Marketed (CPG 7132.15),” states that, in accordance with § 503(b)(1) of the FD&C Act, homeopathic drug products offered for conditions that require diagnosis or treatment by a licensed practitioner must bear the prescription legend, “Caution: Federal law prohibits dispensing without prescription.” This guidance was issued by the agency in 1988.  In 1997, Congress enacted the Food and Drug Administration Modernization Act (FDAMA); section 126 of FDAMA amended § 503(b)(4) of the FD&C Act to require that the label of a prescription drug must bear, at a minimum, the symbol “Rx only.”

This page was posted on August 14, 2017.

Links to Recommended Companies