Immediate Enforcement Crackdown on FSVP? Not so Fast
UPDATE 01-29-2018 : The next compliance date is March 19, 2018 for most food importers (who purchase food from foreign suppliers with fewer than 500 FTEs) . FDA’s Foreign Supplier Verification Plan (FSVP) first implementation date was May 30, 2017, which had...
Relief for Newly Deemed Tobacco Products: 3 Month Compliance Reprieve
In an email to stakeholders on May 1st FDA alerted the “deemed” tobacco products industry that FDA intends to delay enforcement of all compliance deadlines concerning newly deemed tobacco products for 3 months. Though, this did not come through the usual FDA channels,...
Seafood Regulation under the New Administration: Insights from our Government Panel at Seafood Expo North America
This year the FDAImports.com Government panel at Seafood Expo North America in Boston was again well attended, well reviewed and full of lively dialogue about where the Food & Drug Administration and U.S. Customs & Border Protection are going with respect to...
DUNS Numbers to Play Role in FSVP Compliance
UPDATE: Acceptable temporary Unique Facility Identifier FDA announced that FSVP Importers who do not yet have a DUNS number will be allowed to submit entries using "UNK" (unknown) following the May 30, 2017 compliance date. FDA is allowing this on a temporary basis...
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,...