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Posted April 25, 2013

Vision Supplement Company Warned For Drug Claims

On March 15, 2013, the FDA issued a warning letter to Synticare Corp. because statements made on the company's website about certain supplements, including Maximum Lutein, AREDS 1, AREDS 1 Smokers, AREDS 2, Combo AREDS 1 and 2, and Combo Smokers AREDS 1 and 2, were found to be drug claims.

Maximum Lutein contains lutein, zeaxanthin and bilberry. AREDS 1 contains vitamin A, vitamin C, Vitamin E, zinc, copper, lutein, zeaxanthin and bilberry. AREDS 2 and Combo AREDS 1 and 2 contain the same ingredients, plus DHA and EPA omega-3 oils. The Smokers versions of AREDS products contain the same ingredients, but do not contain vitamin A.

They were promoted for the treatment of macular degeneration on the company's website,

Statements made about these supplements which were found to be drug claims include "These macular degeneration formulas contain specific antioxidant vitamins for the treatment of macular degeneration," and "All of these formulas are useful for treatment of Both Dry and Wet Macular Degeneration."

See's special section on Vision Supplements Used in AREDS Studies for more information about the ingredients used in these formulas, and see the Vision Supplements Review for tests of related products.

Also see Reviews of Vitamin A Supplements, Vitamin C Supplements, Vitamin E Supplements and Zinc Supplements for tests of products containing these ingredients.

To read the FDA's warning letter, use the link below.