FDA WARNING_LETTER - Premier Micronutrient Corporation - April 30, 2011

On April 2011, the FDA reviewed Premier Micronutrient Corporation's website, bioshieldpill.com, and a press release on prnewswire.com, determining that their products, "Bioshield-Radiation R1" and "Bioshield Radiation R2," are promoted for conditions that classify them as drugs under Section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act). The therapeutic claims, such as protecting DNA from radiation damage and reducing cancer risk, establish these products as drugs intended for the cure, mitigation, treatment, or prevention of disease.

Examples of claims include "BioShield Radiation Pill...proven to protect DNA from damage caused by radiation" and "BioShield-Radiation potentially protects the entire body whereas potassium iodide at best can protect only the thyroid gland." The products are also marketed for individuals in high radon environments.

Since these products are not generally recognized as safe and effective for their promoted uses, they are considered "new drugs" under Section 201(p) of the Act. Marketing new drugs in the U.S. without prior FDA approval, as required by Section 505(a), is illegal.

The FDA requires prompt corrective action to address these violations. Failure to comply may result in regulatory actions like seizure or injunction. Premier Micronutrient Corporation must notify the FDA in writing within fifteen working days of receiving the letter, detailing the steps taken to correct the