FDA NAC Warning Letter: Targeting N-Acetyl Cysteine (NAC) Supplements
Background on FDA NAC Warning Letters: Navigating the FDA’s NAC system can be overwhelming. Understanding FDA warning letters is key to ensuring compliance, avoiding costly penalties and maintaining a successful business relationship with federal regulators. This guide will teach you how to understand FDA warning letters and provide guidance on how to comply. N-acetyl-L-cysteine (NAC
... Read moreFDA Releases Draft Guidance on Enforcement Discretion for Certain NAC Products
Navigating the FDA and NAC regulations can be intimidating, but with the right information and guidance, you’ll be able to understand and comply with all applicable rules. In this article, we’ll provide a comprehensive overview of the FDA and NAC regulations so you can ensure your product meets all necessary requirements. What is the NAC?
... Read morePrescription Drugs: Interim Implementation of Electronic Labelling
Background On April 22, 2022, Health Canada issued a notice to the industry on the interim implementation of electronic labelling for human prescription drugs. Consultation on the draft guidance “Electronic media in prescription drug labelling” was open between March 12, 2021, and May 7, 2021. The guidance document released by Health Canada outlines the
... Read more7 Principles of HACCP: Everything you need to know before building a HACCP plan
What is HACCP? A common question that comes up in regulated industries, such as food manufacturing and processing, is “What is HACCP?”. HACCP stands for Hazard Analysis Critical Control Point. HACCP is a widely recognized food processing concept that was developed to enhance the production of safe food. 7 principles of HACCP Infographic When is
... Read moreTop 6 Questions to ask about OTC Drugs
1. What are over-the-counter drug products (OTC drugs)? Non-prescription drugs also called over-the-counter (OTC drugs), are health products that can be bought without a doctor’s prescription. OTC drugs can include things like hand sanitizer, sunscreens, cold & flu medication, and medicated topical products such as skin treatments, lip ointment, and anti-fungal creams. 2. What licensing
... Read moreTop 10 Fruitful Medical Device Development Principles
Regulatory agencies across the globe, including the U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), have come together to identify 10 guiding principles that can inform the development of Good Machine Learning Practice (GMLP). The goal of GMLP is to help promote safe, effective,
... Read moreFDA Requests Relevant Info to use NAC as a Dietary Supplement
On November 24, 2021, The Food and Drug Administration (FDA) sent correspondence to industry requesting information on the past use of N-acetyl-L-cysteine (NAC) in products marketed as dietary supplements. NAC has been approved by the FDA to treat liver side effects from an overdose of Tylenol (acetaminophen), and to loosen the thick mucus in the
... Read moreTop 9 Cosmetic Compliance Label Components | Health Canada Cosmetics Regulations
What is a Cosmetic? Cosmetics are a part of just about everyone’s life. Every day, most of us use products like soap, moisturizing creams, or shampoo. In Canada, cosmetic products are defined as “any substance or mixture of substances, manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or
... Read moreFDA Issues Sodium Reduction Final Guidance
On October 13, 2021, the U.S. Food and Drug Administration (FDA) issued final guidance for the food industry that provides voluntary, short-term (2.5 years) sodium reduction targets for a broad range of processed, packaged, and prepared foods to help reduce the amount of sodium in the U.S. food supply. It is widely known that humans
... Read moreUS Establishment Registration Renewals
It’s that time of year again! Any domestic and foreign establishments registered with US FDA must renew their registration annually between October 1st and December 31st. Even facilities that registered as late as September 30th, 2021 are still required to renew their registration. Facilities located outside of the U.S. must also designate a U.S. Agent
... Read morePublic Consultation on Medical Devices Unique Device Identifier Initiative
On June 28, 2021, Health Canada opened a public consultation on a Unique Device Identification (UDI) system for medical devices in Canada. This is Health Canada’s first consultation on the UDI system for medical devices. What is a Unique Device Identifier (UDI)? A Unique Device Identifier (UDI) is a series of numeric or alphanumeric characters
... Read moreHealth Canada Consultation on New Feeds Regulations
On June 12, 2021, the Canadian Food Inspection Agency (CFIA) opened a consultation as part of the process to modernize the Feeds Regulations, 1983. The consultation to obtain feedback from the public will close on September 10, 2021. The pre-published proposed regulations are currently posted in the Canada Gazette, Part I for individuals to read
... Read moreCOVID-19 and Hard Surface Disinfectants
COVID-19 and Hard Surface Disinfectants – What You Need to Know In Canada, chemical products that are used to clean, sanitize or disinfect environmental surfaces and inanimate objects are regulated under different regulatory frameworks. As of recently, these products have been in high demand to help stop the spread of COVID-19. To provide some background,
... Read moreAdditional Packaging and Labelling Requirements for Alcohol Based Hand Sanitizers in Beverage Containers
On October 5, 2020, the Natural and Non-Prescription Health Products Directorate (NNHPD) sent a notice to all Canadian product licence holders to announce a new policy being introduced to help reduce unintentional ingestion of alcohol-based sanitizers packaged in beverage containers. Due to the COVID-19 pandemic and global supply shortages, the high demand for alcohol-based hand
... Read moreRegulatory Considerations for Non-Medical Masks or Face Coverings
Earlier this summer, Health Canada provided a notice to industry on the regulatory considerations for non-medical masks or face coverings, and the circumstances under which such masks or face coverings would be subject to the regulatory requirements for medical devices during the COVID-19 pandemic. Generally, non-medical masks or face coverings are made of fabric and
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