January 18, 2011
PROVO, UtahFDA issued a warning letter in late December to the marketers of Dr. Christophers dietary supplements and Wholistic Botanicals LLC, after a review of product claims on two company websites were determined to position several dietary supplements as unapproved new drugs. The agency determined the therapeutic claims made for the products position the items as drugs; because FDA has not OKd the products for sale as drugs, they are unapproved new drugs and misbranded in violation of federal law. Among the products and claims at issue were:
Bilberry Eye Capsule: known to prevent glaucoma" and prevents myopia"
Cayenne Pepper Extract: traditionally used for arthritis, atherosclerosis cancer heart disease [etc.]"
Hawthorn Berry Heart Syrup: traditionally used for angina atherosclerosis coronary artery disease glaucoma [etc.]"
Blood Circulation Formula: has freed many people of tumors", irreplaceable in battling the consequences of diabetes" and specific citations for the antibacterial effects of garlic bulb extract, an ingredient in the formula.
Chest Formula: has a strong antipyretic, anti-inflammatory effect" and may be helpful in the treatment of infections, colitis"
Immune System Formula: designed to prevent and treat cancer and tumors"
Pancreas Formula: prevents the development of diabetes"
FDA noted if the violations described above or any other products in violation of federal law are not corrected, the agency may take regulatory action including possible seizure and/or injunction.
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