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FDA News


RFK Jr. Calls for an End to Self-Affirmed GRAS – What This Means for the Supplement Industry
Big changes could be coming to the supplement industry. Robert F. Kennedy Jr. is pushing the FDA to do away with self-affirmed GRAS (...
Mar 172 min read


Navigating the GLP-1 Supplement Boom: Compliance Risks and Best Practices for Brands
The rise of GLP-1 supplements presents a lucrative opportunity for brands looking to capitalize on consumer interest in weight management...
Mar 53 min read


Teething Medicines Now a Concern for FDA
Babies are bundles of joy who at times can become somewhat difficult to handle. Especially, when it comes to the teething phase. Cutting...
Oct 22, 20242 min read


How To Avoid the Consequences of FDA Regulations on Your Startup?
The FDA began regulating around the time they began to notice that the food and drugs that can sustain us can also be just as dangerous....
Oct 12, 20244 min read


What are FDA Export Certificates?
Businesses looking to export food, dietary supplements, or cosmetics manufactured in the US may be required to present an export...
Oct 8, 20241 min read


FDA Publicizes OMUFA Fees Arrears List 2021
Facilities who have not complied with paying the annual OTC Monograph User Fee Program (OMUFA) fees required under section 744M of the...
Jul 16, 20221 min read


Reminder: FDA is Now Beginning To Collect OTC Monograph User Fees
As we reported in our previous blog post, the FDA is now collecting OTC Monograph User Fees beginning May 10, 2021. These fees will apply...
Jul 16, 20221 min read


FDA Releases First-Ever OTC Monograph Facility Fees For 2021, exempting some hand sanitizer makers
On March 27th, the FDA released the new OTC Monograph Facility Fees. The new rates are for the period of October 1st, 2020 through...
Jul 16, 20222 min read


Hand Sanitizers From Mexico On Import Alert-FDA
"FDA has taken action to place all alcohol-based hand sanitizers from Mexico on import alert to help prevent entry of violative and...
Jul 16, 20221 min read


Correction: Pfizer’s vaccine is not FDA approved; it’s authorized.
There is a consensus that the Food and Drug Administration (FDA) is rushing the decision to “approve” Pfizer's Covid-19 vaccine. Before...
Jul 16, 20222 min read


Need Hand Sanitizer? FDA Has You Covered
We are very proud that our firm is on the front lines helping businesses gain compliance and continue to increase the supply of hand...
Jul 15, 20221 min read

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