Millennium Bioceutics 2/17/11
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||College Park, MD 20740 |
FEB 17 2011
RETURN RECEIPT REQUESTED
c/o Ms. Nancy Matsuura
8975 Valhalla Drive
Delray Beach, FL 33446
Re: CMS Case File, 130431
Dear Ms. Matsuura:
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites at the Internet addresses http://www.millenniumbioceutics.com
in October 2010 and has determined that the product “Caplex Supplement” is promoted for conditions that cause it 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 websites establish that Caplex is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of your product with these claims violates the Act.
• "[E]ffective in preventing and/or slowing the development of cancer cells."
• "[E]ffective in preventing cancer cell growth."
• "[W]ith anti-tumor ... and anti-inflammatory properties."
• "[P]romoting anti-tumor activity."
• "A powerful anti-inflammatory agent."
• "[F]ound to inhibit growth of cancer cells."
• "Featuring the power of ... capsaicin ... shown in recent studies to act as an antitumor agent, and curcumin ... also demonstrating anti-carcinogenic effects in medical studies."
• "[P]owerful nutrients with anti-inflammatory, anti-tumor and immune-enhancing
Your website www.caplexsupplement.com
includes a link labeled “Current Medical Research” from the “Links” tab on the homepage that directs consumers to a page containing excerpts from articles about ingredients in Caplex. Examples of statements on this page that demonstrate the intended use of your product in preventing and treating cancer include:
• "Capsaicin Shows Promise In Inhibiting Growth of Pancreatic Cancer" [article title]
• "A new study suggests that an ingredient in red chili pepper has cancer fighting properties that prevent or slow the growth of pancreatic cancer tumors implanted in mice. The study found that capsaicin, the 'hot' ingredient in red chili pepper, caused pancreatic cancer cells to die ...."
• "'Our results demonstrate that capsaicin is a potent anticancer agent ... indicating its potential use as a novel agent for the prevention and treatment of pancreatic cancer,' said Dr. Srivastava [one of the study researchers]."
Your product is not generally recognized as safe and effective for the above referenced uses and, therefore, it is a “new drug” as defined by section 201(p) of the Act [21 U.S.C. § 321(p)]. A new drug 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.
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 layperson can use the product safely for its intended uses. Thus, Caplex Supplement is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] in that the labeling for this dug fails to bear adequate directions for use. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your websites, 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. 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 cited above and to ensure 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.
Michael W. Roosevelt
Office of Compliance
Center for Food Safety
and Applied Nutrition