Department of Health and Human Services
Public Health Service
1431 Harbor Bay Pkwy
July 11, 2006
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED
5620 Mission St
San Francisco, CA 94112
Ref. No. 15-06
This letter concerns your firm's marketing of the product Neophase on your website, www.formulaformen.com. A laboratory analysis conducted by the Food and Drug Administration (FDA) concluded that your product contains homosildenafil, an analogue of sildenafil. Sildenafil is the active pharmaceutical ingredient in Viagra, an FDA-approved drug that is used to treat erectile dysfunction. Statements on your website describe the intended use of Neophase. These statements include, but are not limited to, the following:
- "After years of research. Vigor Nutriceutical Healthcare Inc has formulated Neophase a safe effective all natural herb combination to address male Erectile Dysfunction ED without the side effects that often occur with Via ® [sic] Research has shown that Neophase exerts a prolonged therapeutic effect on cGMP the catalyst for penile erection."
- "In thousands of clinical trials conducted over a 3-year period on men a ed 30 to 75 Neophase has demonstrated an 88% effectiveness rate in addressing ED and improving male sexual response"
- "Greater frequency of erections."
These claims are further supplemented by the metatags that you use to bring consumers to your website. The metatags include "Erectile Dysfunction," "ED," "Impotence," rection Problems," "Erection Problem," "Erection," "Erection Pills," "Penile Erection Pills," "Penile Erection," "Hardon," and "Hard On."
These statements make clear that Neophase is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease (e.g., erectile dysfunction). Accordingly, Neophase is a drug, as defined by Section 201(g)(1)(B) of the Federal Food, Drug and Cosmetic Act (Act), 21 USC 321(g)(1)(B).
Neophase is also a drug under Section 201(g)(1)(C) of the Act, 21 USC 321(g)(1)(C), because it is intended to affect the structure or function of the human body. Under section 201(g)(1) (last sentence), the structure/function claims made for a dietary supplement must be made in accordance with section 403(r)(6) of the Act, 21 USC 343(r)(6), or the product is subject to regulation as a drug. Section 403(r)(6) authorizes claims that describe the role of a nutrient or dietary ingredient intended to affect the structure or function of the body, or characterize the way in which a nutrient or dietary ingredient maintains the structure or function of the body. In the case of Neophase, however, the sexual performance structure/function claims quoted above do not describe the effects of nutrients or dietary ingredients in the product. Rather, these claims are made for the product as a whole and relate to its homosildenafil content. Since homosildenafil is not a nutrient or dietary ingredient but a synthetic analogue of sildenafil, your claims about improvement of sexual function do not conform with 403(r)(6). Accordingly, Neophase is a drug within the meaning of section 201(g)(1)(C).
Moreover, this product is a new drug, as defined by Section 201(p) of the Act, 21 USC 321(p), because it is not generally recognized as safe and effective for its labeled uses.
Under Sections 301(d) and 505(a) of the Act, 21 USC 331(d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of Neophase without such an approved application violates these provisions of the Act.
Additionally, the product labeling does not declare that your product contains homosildenafil. Further, your website states that "…Vigor Nutriceutical Healthcare Inc. has formulated Neophase, a safe, effective all natural herb combination to address male Erectile Dysfunction (ED), without the side effects that often occur with Viagra®" even though homosildenafil likely exhibits similar pharmacological action to sildenafil. This statement falsely asserts that the product does not have the potential to cause side effects. This statement and the failure to disclose the presence of homosildenafil renders your product's labeling false and misleading. Neophase is therefore misbranded under Section 502(a) of the Act, 21 USC 352(a).
Furthermore, because your product is 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 this product safely for its intended uses. Thus, Neophase s labeling fails to bear adequate directions for its intended uses, causing it to be misbranded under Section 502(f)(1) of the Act, 21 USC 352(f)(1). Finally, the product is also misbranded under section 502(f)(2) of the Act, 21 USC 352(f)(2), in that its labeling lacks adequate warnings for the protection of users. As noted, there is potential for adverse events associated with the use of Neophase, particularly since someone who takes Neophase would be unaware of the presence of a sildenafil analogue. For example, patients who take nitrates and consume Neophase are at risk of life-threatening hypotension.
The violations described above are not intended to be an all-inclusive list of your product's deficiencies. It is your responsibility to ensure that the drug products that you manufacture or distribute meet all of the requirements of the Act and its implementing regulations. Federal agencies are advised of the issuance of all warning letters about drugs and devices so that they may take this information into account when considering the award of contracts.
You must immediately correct these violations. If you do not immediately correct them, you may be subject to enforcement action against you without further notice. The Act provides for the seizure of illegal products and for an injunction against the manufacturer and distributors of illegal products. Individuals and businesses that violate the Act may also be subject to criminal prosecution.
You must notify this office in writing within 15 working days of receipt of this letter as to the steps that you have taken to correct the above-listed violations and 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 made. Furthermore, please advise this office what actions you will take to address product that you have already distributed.
If your firm does not manufacture the product identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive the product is not the manufacturer, please include the name of your supplier in addition to the manufacturer. Address your reply to the US Food and Drug Administration, San Francisco District, 1431 Harbor Bay Pkwy, Alameda, CA 94502, Attention: Russell A. Campbell, Compliance Officer.
A description of the new drug approval process can be found on FDA's internet website at www.fda.gov/cder/regulatory/applications/default.htm. Any questions regarding this process should be directed to the Food and Drug Administration, Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, 5600 Fishers Ln, Rockville, MD 20857.
This page was posted on February 12, 2008.