Import Alert 66-41

Background
FDA has been on high alert looking for imported products which include unapproved, illegal, or fraudulent drug claims in product labels, internet marketing websites, or other flyers and promotional materials. Unapproved drugs present serious safety and effectiveness concerns because consumers may forego FDA-approved remedies or even medical intervention and instead be fooled into using unapproved, illegal and fraudulent drug products.

How do Firms get on this Import Alert?
FDA reviews imported product labels and internet marketing websites looking for unapproved drugs. Some imported products might look like they are only cosmetics or dietary supplements or foods or safe, over-the-counter medicines or alternative medical remedies, including homeopathic, Chinese and Ayurveda Medicinal products. Yet, if FDA determines label or internet marketing claims fall within drug claim categories (intending the products to diagnose, treat, mitigate, cure or prevent disease or to affect the structure or function of the body) FDA will add those products to this Import Alert. Products listed on the Red List for this Import Alert will be Automatically Detained.

Effects on Businesses Involved
Even if future entries of the same products bear corrected labeling and claims, FDA will still Automatically Detain all shipments of listed products.  If the products’ labels or their marketing materials still bear the illegal drug claims, FDA may not permit the importer to relabel the product depending upon which drug charge FDA brings against the imported products.

How do Companies get off this Import Alert?
Removing a company and its products from this Import Alert will require a thorough label and marketing review to remove and revise drug claims. It will still be necessary to prove to FDA that the changes were adequate and have been completed and that future shipments will contain products that bear only legal claims.