Inspections, Compliance, Enforcement, and Criminal Investigations
Premier Micronutrient Corporation 4/28/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New Orleans District
April 28, 2011
WARNING LETTER NO. 2011-NOL-15
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Randy L. Looper, President & CEO
Premier Micronutrient Corporation
1801 West End Avenue, Suite 910
Nashville, Tennessee 37203
Dear Mr. Looper:
This is to advise you the U.S. Food and Drug Administration (FDA) has reviewed the web site at the Internet address http://www.bioshieldpill.com in April 2011 and has determined your products, “Bioshield-Radiation® R1” and “Bioshield Radiation® R2,” are promoted for conditions that cause the products to be drugs under Section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) Title 21 of the United States Code (USC) § 321(g)(1) [21 USC 321]. Additionally, we observed claims in your press release titled, “Shortages of Potassium Iodide as Radiation Panic Drives Demand,” at the following URL: http://www.prnewswire.com/news-releases/shortages-of-potassium-iodide-as-radiation-panic-drives-demand-118764214.html. The therapeutic claims on your web site and in your press release at the PRNewswire URL establish these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act.
Examples of the claims observed at http://www.prnewswire.com/news-releases/shortages-of-potassium-iodide-as-radiation-panic-drives-demand-118764214.html include:
• “The Japanese nuclear crisis has caused a surge in the demand of potassium iodide, causing shortages not only in Japan, but as far away as California, western Canada, and even southeastern Russia. Although potassium iodide does not provide generalized radiation protection because it only shields the thyroid, manufacturers and pharmacies are being bombarded with orders as the radiation hysteria mounts.
A new and superior product, known as the BioShield Radiation Pill, could restore calm to worried residents in affected areas. Scientists at Premier Micronutrient Corporation have developed this pill as the first ever that is proven to protect DNA from damage caused by radiation.”
• The title, “Shortages of Potassium Iodide as Radiation Panic Drives Demand,” with the subtitle, “Physician Says New BioShield Pill Offering Superior Radiation Protection Is Available”
Moreover, examples of the claims observed on the website, www.bioshieldpill.com include:
On your home page:
• “Ionizing radiation has been officially classified as a carcinogen by both the World Health Organization and the U.S. Department of Health and Human Services. This is of significant concern because Americans are now exposed to approximately seven times more radiation on average than they were in 1980.
BioShield-Radiation® effectively addresses the major factors in ionizing radiation damage to all cells and tissues. Potassium iodide only saturates the thyroid gland with non-radioactive iodine so it cannot take up radioactive iodine. Thus, BioShield-Radiation® potentially protects the entire body whereas potassium iodide at best can protect only the thyroid gland. Because BioShield-Radiation® affects the basic underlying causes of radiation damage, it can protect against all radioisotopes from nuclear or other sources, such as iodine, strontium, cesium, uranium, plutonium, xenon, zirconium, etc. Potassium iodide can only protect against radioactive iodine.”
On the webpage titled, “FAQs”:
■ “What evidence is there that BioShield-Radiation® works?”
“Numerous animal studies have been performed, proving that the formulations effectively decrease the dangerous levels of mutagenic and carcinogenic free radicals in high oxidative stress states.”
■ “Have any human trials been conducted to demonstrate that BioShield-Radiation® reduces the risk of cancer in humans?”
“Dr. Kuefner’s study found that a single dose of BioShield-Radiation taken before radiation exposure provides a significant reduction in DNA double-strand breaks. Such double-strand breaks are among the most significant radiation-induced DNA lesions since they can initiate carcinogenesis (cancer).”
■“Who should take BioShield-Radiation®?”
“4. Individuals working or living in high radon environments. Radon is an odorless, tasteless and invisible gas produced by the decay of naturally occurring uranium in soil and water. Radon is a form of ionizing radiation and a proven carcinogen.”
Your products are not generally recognized as safe and effective for the above referenced uses; and, therefore, are “new drugs” under Section 201(p) of the Act [21 USC § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in Section 505(a) of the Act [21 USC § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate the drug is safe and effective.
The above list of violations is not meant to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure all of your products and labeling are in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct the violations. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
Please notify this office in writing within fifteen (15) working days from your receipt of this letter as to the specific steps you have taken to correct the violations noted above and to assure similar violations do not occur. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, please explain the reason for the delay and state the date by which the corrections will be completed.
Please send your reply to the U.S. Food and Drug Administration, Attention: Rebecca A. Asente, Compliance Officer at the address above. If you have questions regarding any issues in this letter, please contact Ms. Asente at (504) 219-8818 extension 104.
Laurie C. Farmer
Acting District Director
New Orleans District