FDAImports.com and ExportToUSA.com.cn Attend 15th SIAL China Show
ExportToUsa.com.cn attended the 15th SIAL China Show in Shanghai on May 13-15. Many food suppliers gathered together in Shanghai, looking for opportunities. ExportToUsa.com.cn spoke with many food suppliers regarding various problems that might occur if they want to...
A Lovers’ Quarrel: FDA’s and the Cosmetic Industry’s Efforts to Update the Law Regulating Cosmetics
FDA and the cosmetic industry recently separated ways as their talks to modernize how FDA regulates cosmetics collapsed. In March, FDA expressed a “profound disappointment” with the legislation proposed by the cosmetic industry and implied that FDA would proceed...
Medical Device Firms Should Pay Attention to the Recent CDRH Recall Report
FDA’s Center for Devices and Radiological Health published its Medical Device Recall Report for the last decade. The number of recalls almost doubled, approximating the increase in device spending over the same period of time. However, the report attributes the bulk...
Honey and Sweetener: Coexisting No Longer
Last month, FDA issued a new Draft Guidance, requiring the labels of honey products to declare sweeteners in the statement of identity. This sounds ridiculous. Consumers have accepted that honey marketers routinely mix honey and sweeteners – for example, sugar or corn...
More than E-Cigs: FDA’s Proposed Rule about Extending Jurisdiction to All Tobacco Products
The news media is flooded with stories about FDA proposing to regulate electronic cigarettes (e-cigs) for the first time, according to the proposed rule published on April 24. Despite the news stories and FDA’s talking points, the proposed rule talks very little...
Boston Seafood Show 2014: Presentation and Discussion
FDAImports.com and ExportToUsa.com.cn attended the Boston Seafood Show this year on Mar.16-18. The team took the opportunity to speak with seafood producers from around the world, who think 2014 will be a harvest year. US importers at the show expressed the desire...
USDA and Catfish: Do They Really Want It?
U.S. Department of Agriculture (USDA) officials testified before Congress on April 10, 2014 that the Department responsible for protecting agricultural interests in the U.S.A. will not meet the 60-day deadline to issue a proposed rule governing its new authority to...
Lawsuit Against FDA Gets Seafood Exporter Onto Green List
The team at FDAImports.com successfully persuaded FDA to return an exporter to the Green List for Import Alert 16-131 (Detention Without Physical Examination of Aquacultured Catfish, Basa, Shrimp, Dace, and Eel from China- Presence of New Animal Drugs and/or Unsafe...
USDA’s New Jurisdiction over Catfish, Pangasius, Swai, Tra, and Basa
On February 7, 2014, the U.S. federal government enacted the Agricultural Act of 2014 (the “Farm Bill”). This bill gives USDA exclusive authority to regulate and inspect all farm-raised catfish sold in the U.S. In doing so, it removes FDA’s regulatory control over...
The Five W’s of Adverse Event Reporting for OTC Drugs
The Dietary Supplement and Nonprescription Drug Consumer Protection Act amended the FFDCA to subject those OTC drugs marketed without an approved NDA or ANDA to OTC drug reporting requirements, which had previously only applied to those OTC drugs with an approved...