|Company:||Ageless Cure, LLC|
|Subject:||Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated|
|Issuer:||Dallas District Office|
|Issued:||May 20, 2008||Closed:||
Department of Health and Human Services
Public Health Service
May 20, 2008
RETURN RECEIPT REQUESTED
Ageless Cures LLC
Atman Homes LLC
1732b Michigan St
Houston, TX 77066
Ageless Cures LLC
Atman Homes LLC
6418 Ferris Dr
Houston, TX 77081
Ageless Cures LLC
Atman Homes LLC
PO Box 66485
Houston, TX 77266
Dear Sir or Madam:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address www.agelesscures.com and has determined that the products "Curcumin C3 Complex," "Super Curcumin C3 Complex® w/ Bioprerine" and "Super Curcumin C3 Complex® Eco Pack" are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act.
Examples of some of the claims observed on your website include:
• "Curcumin is the major component of Turmeric (Curcuma longa L.) and extensive scientific research on Curcumin has demonstrated its potent . . . cancer curing properties."
• "Scientists at M.D. Anderson wrote in January 2003: "Extensive research over the last 50 years has indicated Curcumin can both prevent and treat cancer. The anticancer potential of curcumin stems from its ability to suppress proliferation of a wide variety of tumor cells. Curcumin can suppress tumor initiation, promotion and metastasis."
"Curcumin. interferes with melanoma cells. Tests show that curcumin made melanoma skin cancer cells more likely to self-destruct in a process known as apoptosis."
• "[C]urcumin helped stop the spread of breast cancer tumor cells to the lungs of mice."
• "The curcumin suppressed two proteins that tumor cells use to keep themselves immortal."
• "Researchers at MD Anderson, UCLA and other premiere institutes, say that Curcumin . . . blocks a key biological pathway needed for development of melanoma and other cancers."
• "Curcumin also causes cancer cell apoptosis (programmed cell death)."
• "The National Cancer Institute is currently developing curcumin as a drug for the treatment of cancer."
• "Curcumin has been shown to prevent a large of number of cancers in animal studies."
• "Laboratory data indicate that curcumin can inhibit tumor initiation, promotion, invasion, angiogenesis and metastasis."
• "Inhibition of proliferation of tumor cells, induction of apoptosis (a mode of cell death), inhibition of transformation of cells from normal to tumor, inhibition of invasion and metastasis and suppression of inflammation have been linked with the anticancer activity of curcumin."
• "How should curcumin be taken?
If you have cancer, you could try the following regimen . . . . By the end of eight weeks, a significant improvement is expected in most patients. If you do not have cancer, 1-2 gins per day is sufficient."
• "Curcumin USES . . . . .
Further, the "Curcumin USES" and "Published Articles" pages of your website cite a number of articles about human and animal studies of your curcumin products or their curcumin ingredient. These articles concern the use of the products or their curcumin ingredient for treatment or prevention of cancer and other diseases. Each citation contains a link to the full text of the article. When scientific publications are used commercially by the seller of a product to promote the product to consumers, such publications may become evidence of the product's intended use. For example, under 21 CFR 101.93 (g)(2)(iv)(C), a citation of a publication or reference in the labeling of a product is considered a claim about disease treatment or prevention if the citation refers to a disease use, and if in the context of the labeling as a whole, the citation implies treatment or prevention of a disease.
The following are examples of reference citations used to market Ageless Cure products for disease treatment and prevention on your website:
• "The inhibitory effect of curcumin on the growth of human colon cancer cells (HT29, WiDr) in vitro Kim, KH, Park HY, Nam JH, Park JE, Kim JY, Park MI, Chung KO, Park KY, Koo JY. Korean J Gastroenterol. 2005 Apr; 45(4): 277-84."
• "Curcumin could block colorectal cancer hormone Nutraingredients.com - Montpellier, France 20/09/2006"
• "Curcumin found to fight tumors Daily News - Galveston County - TX, USA"
• "Turmeric may help against colon cancer United Press International - USA 20 (UPI)"
• "Curcumin fights colorectal cancer Food Consumer - Lisle,IL,USA By Ben Wasserman. 24 Sept."
• "Curcumin -New Weapon Against Colorectal Cancer Medlndia - India"
Your products are not generally recognized as safe and effective for the above referenced uses and therefore, the products are "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. Your products "Curcumin C3 Complex," "Super Curcumin C3 Complex® w/ Bioprerine" and "Super Curcumin C3 Complex® Eco Pack" are also misbranded within the meaning of section 502(f)(1) of the Act, in that labeling for these drugs fail to bear adequate directions for use [21 U.S.C. § 352(f)(1)].
The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. The unlawful disease treatment and prevention claims on your website were too numerous to list in this letter. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your website, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act.
You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in enforcement action without further notice. The Act authorizes seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334].
Please notify this office, in writing, within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur. Include any documentation necessary to show that correction has been achieved. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be directed to James R. Lahar, Compliance Officer at the above address.
Reynado R. Rodriguez, Jr.