Source: https://www.casewatch.net/fdawarning/prod/2013/origin.shtml
Timestamp: 2019-04-26 01:42:48+00:00

Document:
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].
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.

References: § 321
 § 353
 § 353
 § 503
 § 353
 § 331
 § 321