FDA Registration Renewals: FDA Increases Facility Enforcement
As a business owner, keeping up with regulatory requirements is a top priority. One such requirement is the FDA’s renewal
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March 22, 2023
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[blog_list]
What to Ask When Registering a Food Facility With the FDA
Quality Smart Solutions offers the best FDA Facility Renewal & Registration services in North America for Medical Devices, Food, and
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March 21, 2023
What Companies Need to Understand About GRAS Ingredients
Introduction to GRAS: Understanding the regulations and safety risks associated with GRAS ingredients can be tricky, but it doesn’t have
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March 16, 2023
Filing a Medical Device 510(k): Timing and Process Explained
Introduction: A 510(k) clearance is a process by which medical device manufacturers notify the FDA of their intent to market
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February 21, 2023
5 Tips to Find the Best Medical Device Regulatory Consultant
Finding the right medical device regulatory consultant is one of the most important steps to ensure your product meets all
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February 15, 2023
What Businesses Need to Know About FDA NAC Guidelines
Introduction: On August 1, 2022, the FDA announced the final guidance on FDA’s policy regarding products labeled as dietary supplements
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February 8, 2023
FDA to tighten regulatory process around CBD food & supplements
Introduction: The FDA may have turned a blind eye to companies like Bio Steel in the past who’ve been selling
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January 27, 2023
How the FDA GRAS Database Supports Your Ingredient Decisions
The FDA GRAS database is often the first place a regulatory team looks when a formulation deadline is closing in.
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January 18, 2023
Does Your Dietary Supplement Label Meet FDA Requirements?
Dietary supplements are regulated as a category of food under the Federal Food, Drug, and Cosmetic Act, as amended by
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January 11, 2023
FDA Prior Notice for Food Importers: Unlocking the FDA Guidelines
Introduction Prior notice is a requirement for all food manufactured, processed, packed, or held outside the United States that is
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December 28, 2022
GRAS, NDI, ODI Food Additives & Generally Recognized as Safe GRAS
Introduction Food additives are chemicals added to food products to enhance flavor, texture, or color. Fortunately, there is a list
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December 21, 2022
GRAS vs NDI: A Simple Guide to Ingredient Compliance
Understanding the differences between GRAS and NDI is essential for any company developing food ingredients or dietary supplements in the
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December 6, 2022
5 FDA Warning Letters: Food Manufacturers of CBD Food Products
Introduction On November 21, 2022, the Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition issued warning
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November 30, 2022
Medical Device License (MDL MDEL SaMD) Under the Microscope
The Medical Device License is a legal document required to manufacture, sell, and distribute medical devices. The Medical Device Licence
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November 15, 2022
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
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November 2, 2022
Inside Scoop FDA Medical Device User Fees (MDUFA) for 2023
The FDA or U.S. Food and Drug Administration recently announced the Fiscal Year Medical Device User Fee (MDUFA) amendments. The
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November 1, 2022
GRAS Consultants: NDIN or FDA GRAS Certification?
Say you have a new ingredient and are ready to enter the US food market. To ensure this ingredient is
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October 28, 2022
5 Key Reasons Why Drug Identification Numbers Matter
Overview Manufacturers of prescription and non-prescription drugs are required to obtain a Drug Identification Number (DIN) before the drug product
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August 10, 2022
Are Toxic Substances Hiding in Your Cosmetics?
What is a cosmetic? Under Section 2 of the Food and Drugs Act, a cosmetic is defined as “any substance
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May 25, 2022
EUA FDA Transition Plan for Medical Devices in 2022
In response to the COVID-19 public health emergency, FDA issued a declaration regarding the appropriateness of utilizing emergency use authorizations
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April 29, 2022
Top 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
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February 9, 2022
FDA Qualified Health Claim for Magnesium 2022
The U.S. Food and Drug Administration (FDA) has communicated via Letter of Enforcement Discretion that it will not oppose or
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February 3, 2022
11 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
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January 11, 2022
FDA 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
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January 4, 2022
FDA 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
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December 4, 2021
US Establishment Registration Renewals
It’s that time of year again! Any domestic and foreign establishments registered with US FDA must renew their registration annually
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October 11, 2021
FDA’s Addition of the 9th Allergen (Sesame)
Sesame will become the 9th major food allergen officially recognized by the United States (FDA) on January 1st, 2023. The
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June 9, 2021
Conventional vs Supplemented Foods: Understanding the Differences in Canada and the USA
Introduction The distinction between conventional and supplemented foods is something many food businesses find confusing. If you are developing or
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April 20, 2021
FDA Announces FSMA Food Traceability Proposed Rule
On Monday September 21st, the U.S. Food and Drug Administration (FDA) announced a proposed rule to establish additional traceability record
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September 25, 2020
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
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September 29, 2017