Department of Health and Human Services
Public Health Service
19900 MacArthur Blvd., Ste 380
July 22, 2003
W/L Number: 46 - 03
Ref: # 03-HFD-3 lo- 15
Green Shack Direct
143 5 South Shamrock Avenue
Monrovia, California 91016
Ms. Sandie Smith-Fuller
600 East Fig Ave
Monrovia, California 91016
This letter concerns the marketing of No-Rad, Body Gold (potassium iodide) on your firms website, www.iherb.com. Your Internet website, from which the product may be ordered, promotes No-Rad, Body Gold tablets as a product that can protect the consumer against radioactive iodine after a nuclear emergency. Based on the intended uses, the product is a Vrug as defmed in Section 201(g) of the Federal Food, Drug, & Cosmetics Act (henceforth Act) because it is intended to cure, mitigate, treat or prevent disease.
No-Rad, Body Golds intended uses are documented on your firms website, as follows:
Protect your family against the ansorption [sic] of radioactive iodine
after a nuclear emergency! WARNING: Use only in the event of a nuclear emergency!
Be Prepared! . . . During a nuclear disaster radioactive particles can become
airborne or enter water
supplies affecting areas as far as 200 miles away, putting more than 75% of the US population at risk. The greatest threat comes from exposure to radioactive iodine. . . , No-Bad offers your family the same protection provided by the government to the military and emergency workers. No-Bad contains Potassium Iodide (KI) which protects your thyroid gland from the radioactive iodine which can be released during a nuclear accident or attack. When you take Potassium Iodide, your thyroid gland absorbs as much normal iodine as it can hold. This blocks the uptake of radioactive iodine, protecting you form [sic] its harmful effects. . . . Take immediately if exposure to radiation is likely, such as the fallout from a nuclear reactor accident or a nuclear explosion. . . . Do not use unless exposure to radiation is imminent.
SUGGESTED USE: During a nuclear emergency, adults take two tablets once a day. Children take just once a day. Children under three years old take 1/2 tablet. Stop use promptly when the threat of exposure to radiation has passed.
We are unaware of any evidence that establishes that this drug is generally recognized as safe and effective for the intended uses. Therefore, your product is a new drug as defined by section 201(p) of the Act. Under Section 505(a) of the Act, a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved new drug application (NDA) is in effect for such drug. The continued distribution of No-Bad, Body Gold for these intended uses without an approved NDA is a prohibited act as set forth in Section 301(d) of the Act.
This letter is not intended to be an all-inclusive review of your Internet
web site or all of your firms labeling and products, and it is not intended
to be an all-inciusive list of violations concerning your firm and its products.
You are responsible for ensuring that all products marketed by your firm are
in compliance with applicable United States laws.
With copies of this letter, we are advising the regulatory drug officials in the State of California of these violations. We request that you take prompt action to correct these violations. Failure to promptly correct violations may result in enforcement action being initiated by the U. S. Food and Drug Administration without further notice. The Federal Food, Drug, and Cosmetic Act provides for seizure of illegal products and for an injunction against the manufacturer and/or distributor of illegal products.
You are instructed to cease these practices, and you must notify this office, in writing, within fifteen (15) working days of your receipt of this letter as to the specific actions you have taken to correct the stated violations. You should also include an explanation of each step you have taken to assure that similar violations will not recur. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be made. Further, if your firm does not manufacture the product, your reply should also include the name and address of the manufacturer. If the firm from which you receive the product is not the manufacturer, please include the name of your supplier in addition to the manufacturing firm.
Address your reply to:
Director of Compliance Branch
U.S. Food and Drug Administration
19900 MacArthur Blvd.; Suite # 300
Irvine, California 92612-2445
Scott A. Goff, ADD for Alonza E. Cruse
Los Angeles District
This page was posted on July 9, 2005.