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FDA proposes extended dates for Nutrition Facts and Supplement Facts labels compliance

This past June 2017 the Food and Drug Administration (FDA) put a hold on the compliance dates for Nutrition Facts and Supplement facts compliance dates.  The compliance dates were scheduled for July 26, 2018 for companies with annual sales over $10 million and July 26, 2019 for companies with sales over $10 million.   Scott Gotlieb sent a tweet out in mid-September that FDA would propose a 18 month delay on the compliance dates so we knew this was coming soon.

The new dates are as follows:

January 1, 2020 – companies with annual sales over $10 million

January 1, 2021 – companies with annual sales under $10 million

The details of these changes to the Nutrition Facts tables can be found here.

Quality Smart Solutions has been implementing the new Nutrition Facts and Supplement Facts table regulations for our clients for the last 12 months so they are future-proofed.  We are experts in US Food and Dietary Supplement label compliance. Contact us today if you are seeking affordable US label review assistance.

How We Can Help

At Quality Smart Solutions, we provide you with the guidance to plan your Veterinary Health Products business, navigate the legal requirements, and acquire the appropriate license for your operations.

Quality Smart Solutions has a team of professionals to offer support from day one of starting your business, including formulation and label reviews, Veterinary Health Product notifications and more.

30 Minutes Free Consultation
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News

Changes to Regulation of Veterinary Health Products (VHP) in Canada

As discussed in an earlier post (PLL – Plain Language Labeling: What it means and how it affects you), the Food and Drugs Act (F&DA) underwent drastic revision after the thalidomide crisis of the 1960s. While some amendments have been introduced since then, the F&DA has remained mostly untouched. In 2014, the Regulations Amending the Food and Drug Regulations were passed in order to address several issues that were identified over the previous 50 years. One set of these amendment impacts the registration of veterinary health products, defined as low-risk products such as vitamins, minerals, traditional and homeopathic medicines for companion and food-producing animals. These products promote the health and wellbeing of animals but do not diagnose or treat disease.

On May 17, 2017, the final publication in the Canada Gazette, Part II of the Regulations Amending the Food and Drug Regulations (Veterinary Drugs – Antimicrobial Resistance) formalizes the existing voluntary Interim Notification Pilot Program (INPP).  The regulations are scheduled to come into effect on November 13, 2017.

Background

Health Canada’s INPP for veterinary health products (VHPs) has been in place since 2012. Health Canada leveraged a third-party organization North American Compendiums (NAC – www.lrvhp.ca) and the Canadian Animal Health Institute, launched a voluntary pilot program to launch a pilot as a mechanism to assess how well a risk-based, streamlined process would work to register such products and all learnings were to inform a more permanent program. Nearly 1000 products have been successfully notified by Canadian manufacturers and importers for sale in Canada.

The Veterinary Drugs Directorate of Health Canada will administer the Notification Program that will build on the current pilot’s process structure. The notification of VHPs, the requirements for VHP substances or ingredients as included on List C: Veterinary Health Products, and the reporting of adverse events remains intact.

Rules For VHPs
The risk-based notification program for VHPs will require:

  • companies to notify Health Canada 30 days before selling a VHP or making a change to a marketed VHP
  • All active, homeopathic and traditional medicine substances permitted in VHPs are listed in List C: Veterinary Health Products and must be labeled accordingly
  • labels to state “Veterinary Health Product”
  • mandatory reporting of serious adverse drug reactions to Health Canada
  • adherence to the Good Manufacturing Practices (GMPs) in the Natural Health Products Regulations

How Does This Impact You?

For companies with existing valid notifications, their labels will be transferred over to the new system and companies must update their labels within 18 months, or sooner at the next labeling cycle. New registrants can notify according to the old rules until October 13, 2017, and all VHPs will be required to comply with the new rules as of November 13, 2017.

How QSS Can Help

Our Quality Smart Solutions (QSS) team takes great pride in our client-focused, solutions-oriented approach to resolving your issues and challenges.  Not only will we review your labels to assess your compliance with the new regulations, but we will also submit the registrations and work with the regulator on your behalf. Further to this, we will work with you to make sure you and your supply chain meet GMP. QSS is your solution to ensuring you are compliant with Health Canada’s VHP requirements. Contact Quality Smart Solutions today at 1-800-396-5144 ext. 4 or fill out our online page by clicking here.   To see all we have to offer in regulatory compliance and quality assurance solutions, visit us at www.qualitysmartsolutions.com.

How We Can Help

At Quality Smart Solutions, we provide you with the guidance to plan your Veterinary Health Products business, navigate the legal requirements, and acquire the appropriate license for your operations.

Quality Smart Solutions has a team of professionals to offer support from day one of starting your business, including formulation and label reviews, Veterinary Health Product notifications and more.

30 Minutes Free Consultation
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