Department of Health and Human Services
Public Health Service
Office of Compliance
October 12, 2006
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED
811 N Catalina Ave #3000
Redondo Beach, CA 90278
Dear Mr Peters:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address www.sylomar.com and has determined that claims in your labeling cause your products Lytrus™, LDL Antioxidant™ and Lytrus PIus™ to be drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 USC 321(g)(1)]. The therapeutic claims on your website 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: www.fda.gov.
Examples of some of the claims observed on your website include:
- "Stop cancer before it forms. … Lytrus helps you to win the battle."
- "Cancer Prevention"
- "Lytrus stops cancer before it is formed.…"
- LDL Antioxidant™
- "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."
- Lytrus Plus™
- "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 USC 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 USC 321(p)]. Under section 505 of the Act [21 USC 355(a)], a new drug may not be legally marketed in the United States without an approved New Drug Application (NDA).
These products are also misbranded within the meaning of Section 502(f)(1) of the Act, in that the labeling for these drugs fails to bear adequate directions for use [21 USC 352(f)(1)]
This letter is not intended to be an all-inclusive review of your website 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, US Food and Drug Administration, Center for Food Safety and Applied Nutrition, Division of Compliance and Enforcement (HFS-607), 5100 Paint Branch Pkwy, College Park, MD 20740-3835. If you have any questions concerning this letter, please contact Ms Moe at 301-436-2064.
Joseph R. Baca
This page was posted on February 12, 2008.