Inspections, Compliance, Enforcement, and Criminal Investigations
Price, David 27-Jan-06
Department of Health and Human Services
Public Health Service
January 27, 2006
VIA FEDERAL EXPRESS
22618 August Leaf Drive
Tomball, TX 77375
Dear Mr. Price:
This letter concerns your firm's marketing of the products Health Formula sGH-Xtra, Attend, Tri-Cardia Formula+, and ProgestaCare on your website www. vitamins-and.com. According to the claims on your website, as reviewed on December 13, 2005, the products are intended to prevent, treat, or cure disease conditions. Statements documenting these intended uses include, but are not limited to, the following:
Health Formula sGH-Xtra
"Health Formula sGH-Xtra may be expected to reverse human biological aging through:
-Fighting infectious disease . . .
- Helping patients with Alzheimer's Disease
-Helping patients with Parkinson's Disease "
"helps reverse neurological disorders that rob us of our thinking capacities; such as senile dementia . . . as well as Parkinsons and Alzheimers."
"Attend is a safe all-natural Scientifically Advanced Neurological Nutraceutical specifically .formulated to . . . address the . . . neurochemical deficiencies which are thought to occur within the population of Attention Deficited individuals . . . . "
"Cardiovascular disease is the #1 killer in America. Take steps now to prevent a heart attack later! "
"Help eliminate dangerous homocysteine build-up believed to increase the risk of vascular disease."
"Relief of PMS symptoms"
"Easier menopause transition"
"Your body needs natural progesterone to counter-balance the toxic effects of estrogen dominance . . . osteoporosis, breast cancer, fibroids and fibrocystic breasts have a direct correlation in women with estrogen dominance."
These claims are supplemented by the metatags for your website www.vitarnins-and com, which include "attention deficit disorder" and "progesterone."
The products cited above are drugs, as defined by Section 201 (g)(1)(13) and (C) of the Federal Food, Drug and Cosmetic Act (Act), 21 U.S .C. 321(g)(1)(B) and (C), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or to affect the structure or any function of the body of man. Moreover, these products are new drugs, as defined by section 201(p) of the Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for their labeled uses. Under sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a), the introduction or delivery of a new drug into interstate commerce without an FDA-approved application is a prohibited act. No such applications exist for these products.
OTC topical hormone containing products promoted for use as a drug are subject to the final rule under 21 CFR § 310.530(b). This rule states that any OTC drug product other than hydrocortisone that is labeled as a topically applied hormone-containing product for drug use is regarded as a new drug. Your ProgestaCare product falls within this rule because it is labeled as a topical hormone product for drug use . Moreover, OTC topical hormone creams are new drugs because there is no evidence that they are generally recognized by qualified scientific experts as safe and effective for their labeled uses. 21 U.S.C. § 321(p).
Additionally, FDA's regulations state that a drug may be considered a new drug because of the newness of its dosage form or the method or duration of administration or application suggested in its labeling. 21 CFR § 310.3(h)(5). A transdermal delivery system for any drug is not generally recognized by experts to be safe and effective for its intended uses as found in its labeling. Accordingly, FDA considers all transdermal drug delivery products to be new drugs under § 201(p) of the act and under 21 CFR § 310.3(h)(5). Your ProgestaCare product is labeled as having a transdermal delivery system. Therefore it is a new drug under the FDCA and its implementing regulations.
Furthermore, many of the diseases or conditions for which the aforementioned products are offered are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Therefore, adequate directions for use for these conditions cannot be written so that a layman can use these drugs safely for their intended purposes. Because your products' labeling fails to bear adequate directions for their intended uses for those diseases or conditions which are not amenable to self-diagnosis and treatment, they are misbranded under Section 502(f)(1) of the Act, 21 U.S.C. § 352(t)(1).
The above violations are not intended to be an all-inclusive list of your products' deficiencies. It is your responsibility to ensure that the drug products you manufacture or distribute, whether through www.vitamins-and.com or any other venture, 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 correct these violations. If you do not correct these violations, you may be subject to an enforcement action against you without further notice. The Act provides for seizure of illegal products and for an injunction against the manufacturers and distributors of illegal products.
Notify FDA in writing within 15 working days of receipt of this letter about the steps that you have taken to correct the above-listed violations, and the steps taken to assure that similar violations will not occur. 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. Additionally, if your firm does not manufacture the products identified above, your reply should include the name and address of the manufacturers. If the firms from which you receive the products are not the manufacturers, please include the names of your suppliers in addition to the manufacturers.
Address your reply to the U.S. Food and Drug Administration, 4040 North Central Expressway, Ste. 300, Dallas, TX 75204, Attention: James R. Lahar, Compliance Officer.
Michael A. Chappell
Director, Dallas District