On April 26, 2018, the French administrative Supreme Court (Conseil d'Etat) issued a ruling that annulled Decree 2016-1716 of December 13, 2016 ("2016 Decree") related to the summary of characteristics for medical devices....more
5/24/2018
/ Disclosure Requirements ,
Distributors ,
EU ,
France ,
French National Drug and Health Product Agency (ANSM) ,
Manufacturers ,
Medical Devices ,
Member State ,
Pharmaceutical Industry ,
Popular ,
Regulatory Standards ,
Sanctions
The Situation: Class actions (action de groupe) were implemented in France in 2014. Three-and-a-half years after its entry into force, the French class action has not met the expected results.
The Result: Only a few class...more
Top News -
FDA Announces Intention to Not Enforce Certain FSMA Final Rules Provisions -
On January 4, 2018, the U.S. Food and Drug Administration ("FDA") issued a guidance announcing that it does not intend to enforce...more
1/16/2018
/ Amended Regulation ,
Animal Food ,
CGMP ,
ECHA ,
EU ,
European Food Safety Authority (EFSA) ,
Farms ,
Final Rules ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Safety ,
Foreign Suppliers ,
FSMA ,
FSVP ,
Proposed Rules ,
Public Meetings ,
REACH ,
USDA ,
Wetlands
USDA Inspector General Recommends Reform of AMS Organic Program for Imports -
The USDA Inspector General ("IG") reviewed the Agricultural Marketing Service's ("AMS") process used in determining whether exporting...more
11/21/2017
/ Additive Manufacturing ,
APHIS ,
Draft Guidance ,
EU ,
European Food Safety Authority (EFSA) ,
Exports ,
Federal Register ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Manufacturers ,
France ,
Grain & Feed Commoditites ,
Imports ,
Interim Final Rules (IFR) ,
Lumber Industry ,
Menu-Labeling ,
Natural Products ,
Nutrition Facts Labels ,
Organic ,
Safety Training ,
Supply Chain ,
USDA
TOP NEWS -
FDA Proposes New Compliance Dates for the Water Provisions of the Produce Safety Final Rule -
On September 13, 2017, the Food and Drug Administration issued a proposed rule to extend, for covered produce...more
9/30/2017
/ Agricultural Sector ,
APHIS ,
Bioengineering ,
Crop Insurance ,
EU ,
European Commission ,
European Food Safety Authority (EFSA) ,
Farms ,
Food and Drug Administration (FDA) ,
Food Contamination ,
Food Labeling ,
Food Manufacturers ,
Food Safety ,
FSMA ,
Organic ,
Pesticides ,
Product Packaging ,
Regulatory Standards ,
UK Brexit ,
USDA
On June 13, 2017, FDA delayed the compliance date for the Nutrition Facts and Supplement Facts Label and Serving Size final rules, providing additional time for implementation. The rules were finalized in May 2016 and...more
7/6/2017
/ Agricultural Sector ,
APHIS ,
China ,
EU ,
European Food Safety Authority (EFSA) ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Safety ,
FSVP ,
Harmonization Rules ,
Imports ,
Menu-Labeling ,
Nutrition Facts Labels ,
Poultry Products Inspection Act (PPIA). ,
Regulatory Standards ,
Risk Assessment ,
USDA
The European Food Safety Authority ("EFSA") has launched a public consultation on a draft guidance document on the risk assessment of genetically modified organisms ("GMOs") present at low levels in food and feed material....more
On April 28, 2017, the European Commission issued Regulation 2017/752, amending Regulation 10/2011 on plastic materials and articles intended to come into contact with food...more
On May 9, 2017, the Senate confirmed Dr. Scott Gottlieb as the next FDA commissioner. With a 57-42 vote, the Senate filled the commissioner position most recently held by Dr. Robert Califf, who resigned in January 2017 and...more
5/19/2017
/ Amended Regulation ,
Australia ,
Dairy Farmers ,
European Commission ,
European Food Safety Authority (EFSA) ,
FDA Commissioner ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Safety ,
FSVP ,
GMO ,
Italy ,
Organic ,
Pesticides ,
Senate Confirmation Hearings ,
USDA
FDA Amends Waivers to Sanitary Transportation Rule -
On April 6, 2017, the Food and Drug Administration ("FDA") notified industry regarding the amendment of waivers available under the Sanitary Transportation of Human...more
4/13/2017
/ Animal Food ,
Annual Reports ,
Chemicals ,
EU ,
European Food Safety Authority (EFSA) ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Safety ,
FSMA ,
Imports ,
National Security ,
Pesticides ,
Sanitary Food Transportation Act (SFTA)