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FDA News


Oct 28, 20241 min read
Does Your Vote Really Matter Business-Wise?
Today is Election Day and most of us are nervously biting our nails while awaiting the results. Some because it could affect their legal...


Oct 3, 20242 min read
Heather M. Bustos “Best Lawyers to Watch in America” Award
The Woodlands, Texas, August 19, 2022 (GLOBE NEWSWIRE) – Heather M. Bustos, Esq., Partner at FDA compliance firm, Bustos Law Group, has...


Sep 26, 20242 min read
Introducing a New Dietary Ingredient to the Market
Discovering a new ingredient for a dietary supplement can be exciting. Not only is there a possibility of the ingredient helping...


Sep 20, 20241 min read
Hydroxychloroquine Removed From FDA Emergency Use Authorization
Guided by their scientific findings, the FDA has removed Hydroxychloroquine and Chloroquine from the FDA emergency authorization citing...


Jul 14, 20231 min read
FDA Releases List of Class II 510(k) Exempt Devices
Today the Food and Drug Administration (FDA) released a list of 1,003 class II medical devices that it believes do not require premarket...


Aug 23, 20222 min read
FDA Issues Warning Letter to Online Retail Giant, Amazon
Earlier this month, on August 4th, the FDA issued Amazon a warning letter beginning, “ This letter concerns your firm’s distribution of...


Jul 16, 20221 min read
Partner, Heather Bustos, Selected as 2022 Texas Rising Star by Super Lawyers
Partner, Heather Bustos, Selected as 2022 Texas Rising Star by Super Lawyers. We are pleased to announce that our managing partner,...


Jul 16, 20222 min read
Parents Be Aware: FDA Warns Owlet To Cease Smart Socks Sales
If you are the parent of a newborn or infant in 2021, you most likely know about all the innovative new tech gadgets coming to market for...


Jul 16, 20221 min read
Bustos Law Group is Celebrating Its Five Year Anniversary!
A Note From Our Partner: Starting Bustos Law Group was always a dream of mine. I was fortunate enough to be introduced to the area of FDA...


Jul 16, 20222 min read
FDA Releases Drug Facility Fees for 2021
The Food and Drug Administration (FDA) announced last week the fee rates under the Over-the-Counter (OTC) Monograph Drug user fee program...


Jul 15, 20221 min read
FDA Removes EUA for N-95 Masks Manufactured in China
In case you missed it, the FDA has now shifted course (as anticipated) and removed the availability of the EUA (Emergency Use...


Jul 15, 20221 min read
FDA Warns Consumers About Hand Sanitizer Packaged in Food and Drink Containers
Did your hand sanitizer come inside of a beer can? Is it chocolate scented? FDA has begun receiving reports of hand sanitizers packaged...


Jul 15, 20221 min read
Bustos Law Group Partner Featured In Houston Lawyer Magazine
The article titled: A COVID Success Story discusses the rise of Texas oil and gas companies moving into the hand sanitizer industry in...


Jul 15, 20221 min read
Industry Beware: FDA Releases List of Non-Compliant Hand Sanitizers
The FDA has released a list of over 100 products that either contain methanol or have less than the required amount of ethyl or isopropyl...


Jul 15, 20221 min read
Some Hand Sanitizers Can Cause More Harm Than Good
During this pandemic, hand sanitizer has become vital. Household product to have “on hand” (excuse the pun). This has inspired many...


Jul 15, 20221 min read
Ordering PPE from a foreign manufacturer? Not so fast.
The FDA just removed 50 manufacturers from its PPE Emergency Use Authorization (EUA) out of fear that the masks do not meet the...


Jul 15, 20223 min read
What's The Deal With Masks and Coronavirus?
The internet is being bombarded with pictures of people in masks, people sewing masks out of fabric at home and some even making masks...


Jul 15, 20222 min read
FDA is Relaxing Requirements for Hand Sanitizer Manufacturers
The FDA yesterday announced that it will not be taking action against manufacturers of hand sanitizer as long as they meet certain...


Jul 15, 20222 min read
FDA Postponing Foreign Inspections Due to Coronavirus Threat
The outbreak of the Coronavirus (COVID-19) has resulted in chaos worldwide, especially after proven to be past containment. The FDA just...


Jul 15, 20221 min read
FDA Recently Released a Number of Warning Letters to CBD Companies - What Does it Mean?
On November 25th, the FDA released 15 warning letters to companies selling products containing CBD ( cannabidiol ). It was very sudden...

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