FDA Law and Consulting Practices Expand to South Florida and Hire New Senior Attorney
FDAImports.com, A Fast Growing Consulting Practice Strengthens Resources Miami, FL – Consulting practice FDAImports (http://www.fdaimports.com) is pleased to announce that Roy León, has joined the firm to further develop our growing portfolio of regional and national...
This is a What … Unforeseen Pitfalls when Classifying a Medical Device
Editor’s note: This blog by affiliated attorneys John Johnson and Schevon Salmon was originally published by greenlight.guru. “This is a what” is not only a torturous summer-camp game, but an essential question when working to bring a medical device to market. An...
Animal Food Registration – State, Federal, or … Both?
It’s always time to think about your renewals, since state requirements do not follow a calendar year cycle for Animal Feed and Pet Food licenses and registrations. Even if you are new to the market, now is the time to get your registration in and your labels in...
What does Food Safety Modernization Act Mean to Animal Food?
The animal food industry experienced a sudden increase in the regulatory obligations in recent years. Through the Food Safety Modernization Act (FSMA) and its implemented regulations, food facilities must now operate under legally established current Good...
Trump to Pharma CEOs — 75-80% less FDA regulations…
Recent headline: Trump to Pharma CEOs: 75% to 80% of FDA Regulations Will be Eliminated Our take... Yeah...not so fast. I expect the Trump-team follow up to be, "we meant 75-80% of the really bad regulations will disappear -- and most likely only in...
The Future of Medical Device Labeling is …. Electronic Submission
Last October, FDA published a proposed rule regarding the electronic submission of labels and package inserts for home-use medical devices, which are defined as devices labeled for use outside a professional healthcare facility and include diabetic test strips,...
Ben England to Moderate Panel Discussion at Seafood Expo North America
FDAImports Founder and CEO, Ben England, is moderating a panel discussion, “Why Pick on Me??? How FDA and the Partner Government Agencies Interact on Imports,” at the 2017 Seafood Expo in Boston. This session includes current and former officials from both Customs...
Customs Postpones Transitions of ACE for Certain Transactions
UPDATE 06/13/17: Customs has set an effective date for ACE- read here for more. Customs and Border Protection’s digital system – the “Automated Commercial Environment” (ACE) is only partially implemented. The U.S. trade community has long been aware of Customs and...
Food Facilities News Alert: FDA System Cancelling Registrations
Update: 2/27/2017 Based on our conversations with FDA, some facility registrations were cancelled because the US Agent failed to affirm the agency with FDA. However, we have had experiences where the US Agency was confirmed and the registration still cancelled....
Just Because You Can Make “Dietary Supplements” at Home Doesn’t Mean It’s Legal
Anyone manufacturing a product has a dream of building a brand. Like many other regulated industries, long-term success in the dietary supplement industry is dependent on regulatory compliance. A recent Consumer Reports article stated that anyone with a credit card...