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SILVER SPRING, Md. — The Food and Drug Administration and the Federal Trade Commission last week issued a number of warning letters to distributors of "unapproved medicines," noting that because each of the products identified claimed to prevent or treat the cold or flu, they need to be registered and approved by the FDA. And because none of the ingredients listed are in fact monographed OTC cough, cold or flu symptom relievers, those products would additionally need to be filed as "new drugs."
A total of eight warning letters were issued Feb. 11. Another, addressing Flu and Cold Defense LLC, was issued last month.
A few of the distributors that received the warning letters were hawking generic Tamiflu without a prescription, or circumventing the need for a prescription by having an "on-staff" doctor write a prescription upon a completed transaction. Others were claiming their products were dietary supplements or were making claims outside of those approved under an OTC monograph.
None of these scenarios relieves the distributors of applying for that over-the-counter drug approval, the agencies noted.
The firms issued warning letters included Discount Online Pharmacy, Kosher Vitamin Express, Medsnoscript, Oasis Consumer Healthcare, Secure Medical, Sun Drug Store, Supplementality LLC and Vitalmax Vitamins. Each of the distributors have 15 days to reply to the agencies outlining corrective action.
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