Inspections, Compliance, Enforcement, and Criminal Investigations
Herbal Remedies 12-Jul-06
Department of Health and Human Services
Public Health Service
Denver District Office
July 12, 2006
VIA Facsimile and FEDEX
130 W 2nd Street
Casper, WY 82601-2411
Attn : Mike Engberg
Ref #: DEN - 06-19
Dear Mr. Engberg:
This letter concerns your firm's marketing of the product Zimaxx on your website, www.herbalremedies com. A laboratory analysis conducted by the Food and Drug Administration (FDA) concluded that your product contains sildenafil, the active pharmaceutical ingredient in Viagra. Viagra is an FDA-approved drug used to treat erectile dysfunction.
You promote your product as a dietary supplement. However, sildenafil, which is present in your product, is the active pharmaceutical ingredient in Viagra. Under Section 201(ff)(3)(B) of the Act, 21 U.S.C. § 321(ft)(3)(B), dietary supplements may not include articles approved as a new drug under Section 505 of the Act, unless the article was marketed as a dietary supplement or food before its approval as a drug. FDA approved Viagra as a new drug on March 27, 1998, and sildenafil was not marketed as a dietary supplement or as a food before this date. Therefore, Zimaxx is not a dietary supplement.
Statements on your product label and website describe the intended uses of Zimaxx. These statements include, but are not limited to, the following:
"MAY HELP TO ACHIEVE MAXIMUM RESULTS FROM LACK OF SEXUAL DESIRE DYSFUNCTION PERFORMANCE STAMINA AND VITALITY"
"Zimaxx Viga" helps increase blood flow to the lower extremities and therefore hell2s sexually dysfunctional men perform normally."
"Zimaxx Viga produces firmer and longer lasting erections "
"Home > Impotence / Erectile Disfunction (ED)" [Zimaxx is listed under this heading on your website].
These claims are further supplemented by the metatags that you use to bring consumers to your website. The metatags include "impotency," "impotence," "remedy for impotence," "cure impotence," "sexual disfu[c]ntion," "longer erection," "bigger erection," and "harder erection." These statements make clear that Zimaxx is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease (e.g., impotence), and to affect the structure or function of the human body. Accordingly, Zimaxx is a drug, as defined by Section 201(g)(1) of the Federal Food, Drug and Cosmetic Act (Act), 21 U.S.C. § 321(g)(1).
Moreover, this product is a new drug, as defined by section 201(p) of the Act, 21 U.S.C. § 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 U.S.C. §§ 331(d) and 355(a), anew 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 Zimaxx without such an approved application violates these provisions of the Act.
Additionally, your product labeling does not declare that your product contains sildenafil. In fact, your website states that the product is "a natural alternative to Viagra (sildenafil citrate) without the side effects of prescriptions" and that "ZIMAXX is completely safe for the heart, lungs, eyes, and other organs." These statements suggest that your product does not contain sildenafil. They also falsely suggest that the product does not have the potential to cause side effects. These claims render your product's labeling false and misleading. Zimaxx is therefore misbranded under Section 502(a) of the Act, 21 U.S.C. § 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, Zimaxx'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 U.S.C. § 352(f)(1).
Finally, the product is also misbranded under section 502(f)(2) of the Act, 21 U.S.C. § 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 Zimaxx, particularly since someone who takes Zimaxx would be unaware of the presence of sildenafil. Fo example, patients who take nitrates and consume Zimaxx 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 U.S. Food and Drug Administration, P.O. Box 25087, Denver, Colorado, 80225-0087, Attention: Regina A. Barrell, Compliance Officer.
A description of the new drug approval process can be found on FDA's internet website at http://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 Lane, Rockville, Maryland 20857.
B. Belinda Collins
Director, Denver District