KEARNY, N.J.—Pharmachem Laboratories Inc., developer of the Phase 2 Carb Controller, has received a license from the Natural Health Products Directorate of Ottawa, Canada, to market their products using weight […] Read More >>
In June 2014, the FDA has announced the release of the final compliance policy guide for food facility registration entitled “Compliance Policy Guide Sec. 100.250 Food Facility Registration – Human […] Read More >>
The North American Compendium (NAC) has upgraded the software running the Interim Notification Pilot (INP) Program for Low Risk Veterinary Health Products (LRVHP), affecting certain aspects of the notification process. […] Read More >>
MARIHUANA FOR MEDICAL PURPOSES REGULATIONS (MMPR) WEBINAR Understanding the Marihuana for Medical Purposes Regulations (MMPR), Overcoming the Hurdles in Becoming a Licensed Producer of Medical Marihuana, and Understanding Potential Costs […] Read More >>
Under FSMA the FDA has issued a final rule to allow the FDA to copy records for both food and dietary supplements in an emergency situation. To avoid additional problems […] Read More >>
After three years as the director of FDA’s division of dietary supplements, Dr. Daniel Fabricant, has rejoined the Natural Products Association (NPA) as its CEO. In his first presentation to […] Read More >>
Overcoming Regulatory Hurdles with Foods & Health Products: Bringing New Products, Ingredients and Technologies to the Canadian Market How do we differentiate ourselves in a marketplace saturated with me-too products? […] Read More >>
On May 21st,  the NHPD released the Quarterly snapshot for Q4 indicating more streamlined review, aided by the release of new monographs. Readers of dicentra’s Regulatory Updates will know that […] Read More >>
Federal Trade Commission initiates “Operation Failed Resolution” to crack down on companies making false weight loss claims. At the beginning of the New Year many have made resolutions to lead […] Read More >>
Health Canada releases draft food-natural health product classification guidance document with additional classification information. When marketing and selling a food or natural health product in Canada it is important to […] Read More >>
http://issuu.com/rivegauche/docs/ihr_april2014/62 Read More >>
FDA proposes radical changes to Nutrition Facts label to aid consumers. Proposal currently under consultation, so no changes are required yet. The U.S. Food and Drug Administration (FDA) is proposing […] Read More >>
Performance targets for TMAs has been released. Caffeinated Energy Drinks receive TMA in 100 days if in compliance with new guidance document. Health Canada’s Timelines for Receiving Temporary Marketing Authorisation […] Read More >>
FDA proposes drastic changes to update required information on Nutrition Facts label on food packages and dietary supplements. FDA has proposed to update the Nutrition Facts label on food packages […] Read More >>
Toronto, Ontario – March 13, 2014 – dicentra, a leading consultant specializing in regulatory strategies for North American health products, advised CCMP Capital Advisors, LLC (“CCMP”) on its acquisition of […] Read More >>
On April 1, 2014 the Marihuana for Medical Purposes Regulations will come into force providing new opportunities for Licensed Producers. Marihuana (Cannabis) is included in Schedule II of the Controlled […] Read More >>
Congress introduces the new Designer Anabolic Steroid Control Act of 2014 and has full support of major dietary supplement stakeholders.  The ACT is intended to target dietary supplement products that […] Read More >>
The NHPD has introduced a new system for reviewing Natural Health Product (NHP) applications.  Submissions are categorized into one of three classes with different review times based on level of […] Read More >>
On December 6, 2013, the Government of Canada introduced new patient safety legislation, named the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law).  The Law would protect Canadian families and […] Read More >>
FDA publishes guidance to clearly define parameters for classifying liquid dietary supplements from beverages. Guidance is designed to assist industry with dietary supplement compliance and conventional food compliance. In January […] Read More >>