15 Feb 2018
U.S. Continues to Detain Mainland Chinese and Hong Kong Food Products for Various Violations
The FDA regularly issues new and updated import alerts on a broad range of products from a number of countries as part of its mission to prevent the importation of food, drugs, biologics, cosmetics, medical devices and radiation-emitting electronic products that fail to meet the requirements of the FD&C Act. The FDA has import alerts in place on a fairly large number of products and companies from Hong Kong and mainland China.
Importers of FDA-regulated goods are responsible for ensuring that such imports are in compliance with FDA laws and regulations. Import alerts inform FDA field staff that the agency has enough evidence or other information to allow a product that appears to be in violation of those laws and regulations to be detained without physical examination at the time of entry (e.g., a product contains illegal colours or food additives or a foreign firm refused an FDA inspection). Import alerts may cover products from designated countries or areas (including from all foreign countries), manufacturers or shippers.
Firms and/or products on the “red list” of an import alert are subject to DWPE, while firms and/or products on the “green list” are not because they have met the criteria for exclusion. Some import alerts include a “yellow list” of firms, products and/or countries subject to intensified surveillance because the nature of the violations may warrant further field examinations of individual entries and/or additional analyses. In addition, depending on the specific import alert, shipments of products subject to DWPE may still be imported into the United States if the importer has demonstrated that the shipment is in compliance.
If a product is detained without physical examination the importer has the right to provide evidence to the FDA in an attempt to overcome the appearance of the violation. If no such evidence is submitted, or if the evidence provided is insufficient to overcome the appearance of the violation, the product will be subject to refusal of entry into the United States.
The FDA currently has more than 250 active import alerts, including 51 import alerts on Hong Kong products and 88 alerts affecting mainland Chinese goods. The import alerts on Hong Kong and mainland Chinese products affect raw agricultural products, certain processed foods, milk-based products, duck eggs, shark fins, frog legs, fresh garlic and garlic products, shrimp and other seafood, fish and fishery products, dried fruits, fruit juice, dates, melon seeds, dried fungus, low acid canned foods and acidified foods, candy, honey and blended syrup, stevia leaves, plantains, herbal medicines, various cosmetics and medical devices, dentifrice products, various human and veterinary drugs, plastic bandages and cotton pads, patient examination gloves, cat food products, animal feeds and pet treats, temporary tattoos, laser products, coffee pots, ceramic ware, enamel ware and condoms, among other products. Mainland China is the U.S. supplier with the largest number of import alerts on its products, followed by Mexico with 73, Canada with 66, India with 59, Hong Kong with 51, Thailand with 49, Taiwan with 46, the United Kingdom with 42, and Japan and South Korea each with 41. Some of these import alerts have been in place for a long time (although most are regularly updated) while others are more recent and reflect emerging concerns. Notably, mainland Chinese companies continue to be added to existing import alerts while a fewer number of companies are removed.
There are four issues that appear to stand out from the rest in terms of the number of new mainland Chinese or Hong Kong companies affected – processed foods containing illegal pesticides (Import Alert 99-08), with six new mainland Chinese companies and seven new products added during 1 January-9 February 2018; devices without an approved pre-market approval or an investigational device exemption as well as other devices not substantially equivalent or without a 510(k) pre-market notification (Import Alert 89-08), with two new Hong Kong companies and three new products added; unapproved new drugs (Import Alert 66-41), with two new mainland Chinese companies and four new products added; and drugs from firms that have not met good manufacturing practices (Import Alert 66-40), with four new mainland Chinese companies and three new Hong Kong companies added. Moreover, one Hong Kong company and eleven of its products were recently added to Import Alert 99-34 on drugs or medical devices from firms without a valid drug or medical device registration.