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Vitamin O ? FDA says no

This article was originally published in The Tan Sheet

Executive Summary

R-Garden, marketer of dietary supplement Vitamin O, has been issued a warning letter regarding numerous violations of the FD&C Act, FDA says. Advertising claims made in mailings, customer testimonials and product descriptions found on the firm's website and in literature classify the supplement as a drug, and therefore would require an NDA, the agency states in the Feb. 8 letter. Questionable claims include testimonials that the oxygen-infused salt water, which can be topically applied or internally ingested, "took a skin cancer off my nose," "help[ed] control angina" and "stops gum infection and pain." R-Garden lacks sufficient scientific evidence to back its claims, the agency says, adding the product does not bear adequate dosing instructions, listed ingredients or recommended daily intakes...





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