January 14, 2016
FDA recently advised field personnel that they could detain a number of dietary supplements coming from outside the United States without a physical inspection. FDA issued its Dec. 8 import alert based on a finding that certain foreign firms have not met U.S. manufacturing regulations.
The products and 11 firms that are subject to the import alert originate from India and Mexico. Two of the businesses are based in India, while the remainder are from Mexico.
The import alert explained field personnel may detain products without a physical inspection if FDA determines through foreign inspections that businesses are operating out of compliance with cGMPs (current Good Manufacturing Practices).
“Foreign processors listed on the Red List of this import alert may request removal from that list by submitting documentation demonstrating that the firm is in compliance with the cGMP regulation (21 CFR, Part 111)," FDA stated in the import alert. “The documentation may include reports from a third- party (e.g., a government inspection authority) demonstrating that an inspection of the processor was conducted and that dietary supplement products are manufactured in accordance with cGMPs."
Marianna Naum, an FDA spokeswoman, said the import alert was the result of FDA inspections indicating cGMP violations. She said the agency does not need to issue firms a warning letter first before adding them to the alert.
“If the findings of the inspection support serious non-compliance with GMPs, we can move directly to adding the firm to the Import Alert Red List and issuing them a DWPE letter (detention without physical examination)," which is an indication the companies have been added to the alert, Naum said in an emailed statement to INSIDER.
FDA provided no specific details on the nature of the cGMP violations other than to call them “serious" in the alert.
Such alerts are issued when FDA determines a company’s products may be adulterated or misbranded, explained Anthony Young, a partner in Washington with the law firm Kleinfeld, Kaplan & Becker LLP. The agency first used detention without physical inspection in 1974, according to an FDA regulatory procedures manual.
“Detention without physical examination has the effect of reminding the importing community that FDA is a regulatory agency, not a quality control laboratory," the agency stated in the manual. “Often, importers wait until the Agency has issued a Notice of Detention to determine whether the articles they are offering for import comply with the FD&C Act [Federal Food Drug & Cosmetic Act]."
Loren Israelsen, president of the United Natural Products Alliance (UNPA), expressed support for FDA’s action.
“This is a useful action that will now connect FDA’s foreign inspections of dietary supplement facilities to specific regulatory barriers to get products into the United States, should such facilities be sub-par," Israelsen said in an emailed statement. “Much more needs to be done, but we commend FDA for taking sensible action here."
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