Quality Smart Solutions

We are happy to announce that our regulatory specialists Grant Emoff and Angelica will be attending Cosmoprof 2024 at Mandalay Bay Convention Center, Las Vegas from July 23-25, 2024. If you're looking for expert guidance on FDA MoCRA or Health Canada cosmetic compliance, please feel free to connect with them! ⏰ Important Update: The deadline for FDA MoCRA facility registration and product listing enforcement was July 1st, 2024. Ensure your business remains compliant to avoid any disruptions. 📅 You may book a time with us in advance to discuss your compliance needs: https://lnkd.in/gQb-2qRm We look forward to connecting at Cosmoprof LV! #Cosmoprof2024 #CosmeticCompliance #FDACosmetics #FDA #MoCRA #HealthCanada #QualitySmartSolutions #MeetUsInVegas #HereToServeYou

Um.....I just realized I showed up to Expo West way too early!!! 😦 Just kidding. 😉 I made this video on the last day of last year's Natural Products Expo West as things were winding down. Considering it was the quietest day during the tradeshow it was the opportune time to record a few short videos. Over the next few days I'll be posting these videos that cover various regulatory requirements to launch your consumer packaged goods in Canada and the United States. LAUNCHING A DIETARY SUPPLEMENT IN CANADA? HERE'S WHAT YOU NEED TO KNOW. This video is about the 3 requirements to launch a dietary supplement in Canada. Dietary supplements are referred to as natural health products or NHP, for short, in Canada. Those requirements are: 1. A Natural Product Number (NPN) - Health Canada (not including preparation time) takes 60 to as long as 300 calendar days. There are 3 classes of NHPs. Class 1 are those NHPs whose medicinal / active ingredient(s), source material, dosage form, directions of use, duration of use, if applicable, risk statements are within one NHP monograph. Class 2 are referencing more than 1 monograph. Class 3 are products where at least 1 medicinal ingredient is not listed on a NHP monograph or are outside the parameters of a NHP monograph. 2. A NHP compliant, bilingual label - your Canadian label is very different than a FDA dietary supplement label. English and French must be on the label. 3. If your NHP is manufactured outside Canada you must partner with a Health Canada licensed importer of record (like Quality IMPORT Solutions) to act as import agent. Companies often get confused with a non-resident importer of record. That refers to logistical related importer and is different than the Health Canada requirement. At #expowest most dietary supplement brands will be exhibiting in Hall D with some found in the North Hall and ACC Level 3. If you have questions about NHPs in Canada and are attending Expo West next week let's meet. I would happy to answer your questions and discuss the regulatory and retail and e-tail landscape. Feel free to pick a day and time from this link: 👇👇👇👇👇👇👇👇 https://lnkd.in/g-rUrZ4M #ExpoWest, #Anaheim, #HealthCanada, #NPN, #NHP, #Dietarysupplement, #IOR, #QualitySmartSolutions, #HeretoServeYou

Getting ready for Cosmoprof North America in #Miami for its inaugural show! I've attended Cosmoprof in #LasVegas in July. Oven heat weather!! Fortunately it's cooler (22 C/ 75 F) in Miami in January. I might to consider a winter office for Quality Smart Solutions and Quality IMPORT Solutions down here. 🤔 Since I'm attending a cosmetics and skincare tradeshow let's talk compliance and what exactly you need to sell your cosmetic or sunscreen in North America. FDA Requirements (MoCRA) #MoCRA (Modernization of Cosmetic Regulations Act) officially came into effect on December 29, 2023. However, enforcement is postponed for 6 months, until July 1, 2024. There requirements are as follows: -Product listing -Compliant label -Safety substantiation of all ingredients in each cosmetic product (more on this in a seperate post) -Adverse event reporting -GMP must be followed by every cosmetic manufacturer -Facility registration -US Agent associated with foreign registered cosmetic facilities HEALTH CANADA REQUIREMENTS: -Compliant bilingual label (all package components must be in English and French) -Notification to Health Canada within 15 days of commencement of sale of cosmetic As always, ingredients must not have any ingredients on the cosmetic hot list. What about sunscreen, acne, diaper rash products? FDA categorizes these as drugs. They require a NDC, drug listing, drug compliant label. OTC manufacturer must be registered and foreign sites must have a US agent registered (FDA fees for OTC manufacturers are over $25,000 USD/year!!!) Health Canada categorizes sunscreens as either natural health products or drugs depending on the ingredients. Titanium dioxide, zinc oxide, para-aminobenzoic acid sunscreens are natural health products and require a NPN. This video summarizes the requirements to sell a natural health product in Canada: https://lnkd.in/gyQS8RDv If the sunscreen is a drug (eg. avobenzone, ensulizole, homosalate and many others) they require a DIN. To sell a DIN in Canada you require the DIN license, drug compliant bilingual label and, if manufactured outside Canada, a Health Canada licenesd Drug Establishement License (DEL) holder to import drugs. Acne products, diaper rash, anti-itch, eczema treating products follow similar requirements. If you're attending Cosmprof in Miami I will be here until Thursday afternoon and would be happy to meet with you and answer any questions you may have, give you some pointers to avoid pitfalls and costly mistakes and not get into trouble with FDA or Health Canada. DM me or book a meeting using this link: https://lnkd.in/gShucRhB #Mocra, #FDA, #HealthCanada, #NDC, #Druglisting, #NPN, #NHP, #SiteLicense, #importerofrecord, #DEL, #QualitySmartSolutions, #qualityimportsolutions, #heretoserveyou