Blog
Cosmetic Ingredients: Potential Presence of Toxic Substances
What is a cosmetic? Under Section 2 of the Food and Drugs Act, a cosmetic is defined as “any substance
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Andrew Lau
May 25, 2022
News
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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Femi Morakinyo
April 29, 2022
Blog
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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Kalpna Mistry
February 9, 2022
News
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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Mitchell Kiernan
February 3, 2022
News
FDA Requests Information Relevant to the Use of 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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Kalpna Mistry
January 4, 2022
News
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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Kalpna Mistry
December 4, 2021
Blog
FDA Warning Letters Targeting N-Acetyl Cysteine (NAC) Supplements
Background on NAC N-acetyl-L-cysteine (NAC supplement) has been approved by the FDA to treat liver side effects from an overdose
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Kalpna Mistry
November 2, 2021
News
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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Kalpna Mistry
October 11, 2021
Blog
GRAS or NDI? Factors to Consider
Say you have a new ingredient and are ready to enter the US food market. To ensure this ingredient is
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Mitchell Kiernan
August 17, 2021
News
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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Mitchell Kiernan
June 9, 2021
News
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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Quality Smart Solutions
September 25, 2020
