|Subject:||Labeling/Promotional Claims False & Misleading/New Drug/Misbranded|
|Issuer:||Center for Food Safety and Applied Nutrition|
|Issued:||Oct. 16, 2006||Closed:||
Department of Health and Human Services
Public Health Service
5100 Paint Branch Pkwy, HFS-607
Oct 16 2006
Dr. Julius Peters
811N. Catalina Ave. Suite 3000
Redondo Beach, CA 90278
Dear Dr. Peters :
The Food and Drug Administration (FDA) has reviewed your web site at the Internet address http://www.sylomar.com. and has concluded that claims in your labeling cause your products Lytrus™, LDL Antioxidant™ and Lytrus PIus™ to be drugs as defined in 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 web site establish that these 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. You can find the Act and FDA's regulations through links on FDA's Internet home page: http://www.fda.gov .
"Stop cancer before it forms. * * * Lytrus helps you to win the battle."
"Lytrus stops cancer before it is formed. . . ."
"Prevents heart attack"
"Stops the real culprit of heart attack."
"[O]ther antioxidant products are not formulated to- inhibit the LDL oxidative process and fight arterial inflammation."
"Should patients who already have plaque deposit in the artery take LDL Antioxidant? * * * Yes. LDL Antioxidant can help these patients fight inflammation and stabilize
the plaque reducing the risk of its sudden rupture that leads to strokes and heart attacks."
"A patient should take Lytrus Plus as soon as possible after being diagnosed with a tumor growth."
"Yes, a patient should take Lytrus Plus as recommended by the manufacturer while undergoing chemotherapy or radiation treatments. A recent study showed that Lytrus
Plus is more effective in inhibiting abnormal growth than conventional toxic chemotherapeutic agent fluorouracil (FU). 48% growth inhibition for Lytrus Plus vs
3% inhibition for FU."
These claims cause your products to be drugs, as defined in section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)]. Because your products are not generally recognized as safe and effective when used as labeled, your products are also new drugs as defined in section 201(p) of the Act [21 U.S C. 321(p)]. Under section 505 of the Act [21 U.S.C. 355(a)], a new drug may not be legally marketed in the United States without an approved New Drug Application (NDA).
This letter is not intended to be an all-inclusive review of your web site and products your firm markets . It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations. You should take prompt action to correct any violations, including the violations identified in this letter. Failure to do so may result in enforcement action without further notice. The Act authorizes injunctions against manufacturers and distributors of illegal products and seizure of such products.
Please advise this office, in writing and 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. 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 reply should be addressed to Kristen Moe, Compliance Officer, Food and Drug Administration, Division of Compliance and Enforcement, 5100 Paint Branch Parkway, HFS-607, College Park, Maryland 20740-3835. If you have any questions concerning this letter, please contact Ms. Moe at 301-436-2064.
Joseph R. Baca
Office of Compliance
Center for Food Safety and Applied Nutrition