Columbia, MD (Vocus) May 14, 2010
On May 11, 2010, U.S. Food & Drug Administration (FDA) re-published Import Alert #66-41, ''Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.'' (IA 66-41). The Alert indicates that FDA has added 25 firms to the Red List since January 1, 2010. FDA enforces laws and regulations related to new drug approvals; FDA often applies these laws to dietary supplements, dietary ingredients and even to cosmetics. According to Benjamin L. England, of FDAImports.com, LLC, “Generally, FDA won’t allow unapproved drugs into the U.S. at all. FDA may exercise some discretion for personal use in certain circumstances…but they are not required to do so. In this alert they are trying to stem the tide of the marketing of unapproved drugs targeting U.S. citizens… companies are trying to exploit the existence of the exception. But FDA is also starting to enforce against products that the importer or shipper thinks are dietary supplements or cosmetics.”
Over 300 foreign manufacturers have been placed on the Import Alert #66-41 “Red List”, charged with promoting unapproved drugs to people in the U.S. A company is placed on IA 66-41 when FDA believes it is marketing an unapproved drug by mail order, when FDA field agents determine that the product represents a health fraud, or when the product represents a direct or indirect health risk. Shipments sent by companies on IA 66-41 will be detained by Customs at the Port of Entry without inspection. FDA considers promotion of unapproved drugs by mail order solicitations, press releases, advertising materials and other public announcements to be evidence of a violation. “If the public knows anything about FDA, they know that it is the agency that approves drugs,'' stated Mr. England. ''FDA’s ability to enforce in this area is key to their legitimacy in the public eye and political arena. Companies that try to circumvent their (FDA’s) authority over drugs can face the strongest penalties.”
FDA surveillance and enforcement over imported products has been increasing for two consecutive years. Even though the economy is weak and tax revenues are down, Congress increased FDA’s budget appropriation by 20% this year and the current administration has proposed an additional 19% for 2011. A significant portion of FDA’s budget is being devoted to drug safety enforcement. This is evidenced by FDA’s addition of 25 companies to this IA 66-41 in the first 5 months of 2010.
Is your firm one of the many that has been subject to placement on the Red List of IA 66-41? Do you currently have shipments that have been detained for alleged violations? Are you concerned about your firm’s FDA compliance? FDAImports.com, LLC can show you ''the way through.'' FDAImports.com, LLC is a consulting firm that can help you avoid violating FDA regulations, as well as help you correct violations that have already caused your firm to be placed on Import Alert #66-41. FDAImports.com, LLC can get your products back on the market! Don’t let FDA shut down your operations. FDAImports.com urges manufacturers to contact them promptly for advice to your specific situation regarding any of the above mentioned circumstances.