Therapeutic vs. Non-Therapeutic Claims Classification Guide
What is a claim? A claim is a representation for sale. It can be presented as “a word, a sentence, a picture, a symbol, a paragraph or an implication on product labels, package inserts or advertisements, including company websites”. It explains what the product is for and what it does. There are two types of
... Read moreHow Your NHP & Drug Products are Reviewed in Canada CTA v.s NDS
In general, all drug products (including over-the-counters and biologics) must be authorized for sale by Health Canada, before they can be distributed in the Canadian market. Drugs include both prescription and non-prescription pharmaceuticals; biologically derived products such as vaccines, blood derived products, and products produced through biotechnology; tissues and organs; disinfectants; and radiopharmaceuticals. Natural health products,
... Read moreTop Components of your Class III NHP PLA
All Natural Health Products (NHPs) sold in Canada are subject to the Natural Health Products Regulations (NHPR). Natural Health Products have 3 different classes of application – Class I, II and III. Determining the correct Class of NHP is important, and if the class is not identified correctly the application may be refused. Learn more
... Read more11 Ways MoCRA will enhance FDA Cosmetics Regulations in 2023
Introduction: The Consolidated Appropriations Act, recently passed by the US Congress, incorporates revisions to US cosmetics laws. The Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which has been in the works for years, is the biggest change to cosmetics legislation in recent U.S. history. The U.S. Food and Drug Administration (FDA) can now impose
... Read moreUpdate on Performance Standards for NHP Applications
Summary of Health Canada Licensing and Update Reports Product Licensing A combined 1390/5045 (28%) of NHP product license application submissions were refused from April to September 2021. Class I – 90% of product applications are meeting the 60-day performance timeline. The refusal rate for these is 14%. Class II – 90% of applications are meeting
... 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
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