|Company:||Millennium Health LLC|
|Subject:||Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated|
|Issuer:||Philadelphia District Office|
|Issued:||May 21, 2008||Closed:||
Department of Health and Human Services
Public Health Service
RETURN RECEIPT REQUESTED
May 21, 2008
Millennium Health LLC
619 New York Avenue
Claymont, DE 19703
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.ellagicdirect.com and has determined that the product "Ellagic Acid 1000mg" is promoted for conditions that cause the product to be a drug 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 product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of this product with these claims violates the Act.
Examples of some of the claims observed on your website include:
• "The American Cancer Society reports as follows: Research in cell cultures and lab animals has found that ellagic acid may slow the growth of some tumors caused by certain carcinogens."
• "Ellagic Acid from red raspberries may prevent binding of carcinogens to DNA, and may reduce the incidence of mutations in cultured human cells."
Further, the "Cancer Information and Prevention" page on your website cites an article about the use of Ellegic Acid for treatment or prevention of cancer. When scientific publications are used commercially by the seller or 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 reference citation is used to market Ellagic Acid for disease treatment and prevention on your website:
• "Ricki Lewis, 'Preventing Cancer,' in The Scientist, Vol 17, Supplement 2/6/ September 22, 2003. Examples summarized from 'Preventing Caricer' by Ricki Lewis. 'Phyto-Protect Your Health,' UC Berkeley Wellness Letter, October 2003. Preventing Cancer by Ricki Lewis."
This reference citation and other claims quoted above are supplemented by one of the metatags used to bring consumers to your website. The metatag is "alternative medicine for cancer prevention." Your product is not generally recognized as safe and effective for the above referenced conditions and therefore, the product is a "new drug" 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 product "Ellagic Acid 1000mg" is also misbranded within the meaning of section 502(f)(1) of the Act, in that labeling for this drug fails 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 "Ellagic Acid 1000mg" and its labeling. While reviewing another website you operate (http://www.millenniumh.com), we noticed that you were promoting other products for disease treatment and/or prevention. 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 the 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 Robin M. Rivers, Compliance Officer, U.S. Food and Drug Administration, U.S. Customhouse, 2nd & Chestnut Streets, Room 900, Philadelphia, PA 19106.
Thomas D. Gardine
Philadelphia District Office