Department of Health and Human Services' logo Department of Health and Human Services

Public Health Service
Food and Drug Administration
 

Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3128

May 20, 2008

CERTIFIED MAIL 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

WARNING LETTER
Ref: 2008-DAL-WL-11

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:

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:

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.

Sincerely,

/S/

Reynado R. Rodriguez, Jr.
Director
Dallas District

This page was posted on July 19, 2010.

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