Kratom-Navigating the Murky Regulatory Waters

Kratom-Navigating the Murky Regulatory Waters

On March 29, 2021, the Food and Drug Administration (FDA) updated and republished Import Alert 54-15, which allows for the detention without physical examination of dietary supplements containing Mitragyna Speciosa, otherwise known as  Kratom. Kratom is a botanical...

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Is Sesame Going to be a New Major Food Allergen?

Is Sesame Going to be a New Major Food Allergen?

Update 04/27/2021 On April 23, President Biden signed the FASTER Act into law, requiring that all packaged food labels disclose sesame ingredients beginning January 1, 2023. Orignal Post 04/05/2021 Sesame is a common ingredient in many of the foods in the U.S.,...

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OTC Drug User Fees Officially Republished for FY 2021

OTC Drug User Fees Officially Republished for FY 2021

On March 26, 2021, the Food and Drug Administration (FDA) republished the Over the Counter (OTC) Monograph Drug user fee rates for the fiscal year 2021 under the OTC Monograph Drug User Fee Program (OMUFA). While most OTC facilities will now be required to pay a...

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FDA Announces New and Updated Drug and Medical Device User Fees

FDA Announces New and Updated Drug and Medical Device User Fees

UPDATE Dec 30, 2020: FDA publishes new OTC drug user fees, read more here. Aug 27, 2020: FDA has officially announced the updated drug and medical device fees for the 2021 fiscal year (October 1, 2020 – September 30, 2021). This includes fees associated with the newly...

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