FDA News Announcements and Press Releases of Interest

In October 2006, FDA announced a joint enforcement action brought by FTC and FDA against marketers of products bearing fraudulent claims regarding curing diabetes.  FDA also announced it issued warning letters to 24 firms marketing dietary supplements that claimed to prevent, mitigate, treat or cure diabetes.  These are illegal disease claims for dietary supplements (see FDAImports.com discussion regarding dietary supplement labeling or responding to FDA warning letters):

See FTC and FDA Act Against Internet Vendors of Fraudulent Diabetes Cures and Treatments (Oct. 19, 2006).  See also FDA WARNS 24 dietary supplement manufacturers regarding illegal diabetes claims.  

In September 2006, FDA asked the U.S. Marshal Service to seize $55,000 worth of "dietary supplements" for which drug claims were being made in advertising and other labeling.  There was no indication in the press release (or any other press releases regarding the seizure) of any judicial action in the case.  FDA generally lacks the authority to directly seize an article under the Food Drug and Cosmetic Act without first asking a federal court to condemn it, unless the article is a "counterfeit drug."  For this concerning development, see FDA Asks U.S. Marshals to Seize Dietary Supplements: Products Being Promoted With Drug Claims (Sept. 6, 2006).   FDA had previously issued a warning letter to the firm on March 25, 2005.   (Advantage Nutraceutical LLC WL 032505)For an FDAImports.com discussion on FDA civil and criminal enforcement authorities, please go to our FDA Enforcement Authorities page.  

In August 2006, FDA issued a proposed regulation that would completely revamp the agency's Drug Establishment Registration and Listing and National Drug Coding (NDC) system.  The proposed rule was initially viewed by many as a clarification of and consolidation of existing regulatory requirements with the addition of an electronic registration and listing system.  Upon closer review it was apparent the agency was proposing to dramatically affect the way drugs move across the U.S. borders and the information that would be required when any foreign manufacturer registered with the agency or listed its drugs.  The FDA regulation, if promulgated, would revoke exemptions currently enjoyed by foreign manufacturers whose drugs are imported into Foreign Trade Zones (FTZs) or imported for further processing or incorporation into other articles and then exported.  Under the current regulatory regime, such foreign manufacturers are exempt from registration and their drugs going into the FTZs or entering the U.S. as IFE entries are exempt from listing.  The proposal revokes these exemptions completely.  Comments are due to the FDA by January 26, 2007 from interested parties.  The regulation can be found in pdf version by clicking here:  FDA Proposed Registration Listing NDC Rule (pdf) or, for a text version, follow this link:  FDA Proposed Registration Listing NDC rule (txt).  In January 2007, FDA extended the comment period for this rule a second time.  The comment period now expires on February 26, 2007

In July 2006, FDA issued a warning to consumers against drinking 35% Food Grade hydrogen peroxide.  Many dietary supplements on the U.S. market include this ingredient in their formulation.  The fact that FDA has taken the time to warn consumers indicates the likelihood that the agency will be pursuing FTC and FDA enforcement actions against manufacturers or distributors of such products.  See FDA Warns Consumers Against Drinking High-Strength Hydrogen Peroxide for Medicinal Use: Ingestion Can Lead to Serious Health Risks and Death (July 27, 2006).  FDA issued warning letters to three firms selling such products.  

Also in July 2006, FDA issued a warning to consumers about using "dietary supplements" that are promoted as sexual performance enhancement products, claiming FDA has analyzed a number of these products and found they contain residues of approved drug active ingredients or their unapproved analogs.   Therefore, FDA considers the products unapproved drugs.  FDA also executed several criminal search warrants seizing some the products discussed in the press release.  See FDA Warns Consumers About Dangerous Ingredients in "Dietary Supplements" Promoted for Sexual Enhancement (July 12, 2006).  For more information regarding FDA criminal enforcement authority, see FDAImports.com at our FDA Enforcement Authority page.

***This Page is Under Construction.  Check Back Often as We Will Continue to Update It With Examples of FDA Enforcement Actions***