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Author: Asebey Law

14 January
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Quaker Issues Limited Recall on Undeclared Milk in Pearl Milling Company Original Pancake & Waffle Mix Distributed in 11 States

Posted by Asebey Law
in FDA News

January 14, 2025 – The Quaker Oats Company today issued a recall of a limited number of two pound boxes of Pearl Milling Company Original Pancake & Waffle Mix that may contain undeclared milk, after being alerted by a retail partner. Those with an allergy or severe sensitivity to milk run the risk o Read More (external link)...

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10 January
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Lifestyle Evolution Voluntarily Recalls NuGo Dark Chocolate Chip and NuGo Dark Pretzel Due to Undeclared Milk

Posted by Asebey Law
in FDA News

Lifestyle Evolution Inc., is recalling select lots of NuGo Dark Chocolate Chip and Dark Chocolate Pretzel nutrition bars because they may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume Read More (external link)...

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09 January
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The Mochi Ice Cream Company LLC Issues Allergy Alert on Undeclared Egg in Peach Mango Sorbet

Posted by Asebey Law
in FDA News

The Mochi Ice Cream Company LLC, Vernon, California is recalling 1350 cases of Peach Mango Sorbet, because it may contain undeclared pasteurized cooked egg white. People who have an allergy or severe sensitivity to eggs, run the risk of serious or life-threatening allergic reaction if they consume t Read More (external link)...

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23 October
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Veteran FDA Attorney Launches Boutique Life Sciences Law Firm, Asebey Life Science Law

Posted by Asebey Law
in Life Science Law Blog

Firm integrates scientific knowledge and regulatory expertise to offer comprehensive legal solutions and scientific guidance to life science companies. FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Edgar J. Asebey, a seasoned attorney with over 20 years of FDA regulatory law experience, has launched Asebey Life Science Law, a boutique law firm specializing in FDA regulatory law, transactional law, and strategic advisory services for the life sciences industry. As a former scientist, biotech founder, venture capital fund advisor, and equity partner at an AM 100 law firm, Edgar is uniquely qualified to lead a firm that provides much needed regulatory guidance, enforcement defense and industry expertise to FDA-regulated...

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19 August
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Gutierrez Distributor Recalls El Servidor Corp Ground Cinnamon Because of Possible Health Risk

Posted by Asebey Law
in FDA News

Gutierrez Distributor of Passaic, NJ is recalling El Servidor Corp brand ground cinnamon because it has the potential to be contaminated with elevated levels of lead. Short term exposures to very low levels of lead may not elicit any symptoms. It is possible that increased blood lead levels may be t Read More (external link)...

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13 August
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El Chilar HF, LLC. Expands Recall of El Chilar Ground Cinnamon Due to Elevated Levels of Lead

Posted by Asebey Law
in FDA News

El Chilar HF, LLC on 03/06/2024 issued a recall of Lots # D-300 EX1024 and F272 EX1026, contained in 127 boxes (12 bags/box) of El Chilar “Cinnamon Ground” (1.25 oz bag), because it may contain traces of lead. Further investigation indicates that the issue could be caused by a potentially adulterate Read More (external link)...

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29 July
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FDA Law and the Psychedelic Renaissance

Posted by Asebey Law
in Publications

By Edgar J. Asebey & James T. O’Reilly* Update Magazine, Food & Drug Law Institute (Spring 2024) On December 11, 2023, the U.S. Food and Drug Administration (FDA) received the first ever New Drug Application (NDA)[1]for a psychedelic-assisted therapy.[2] The application was filed by the Multidisciplinary Association for Psychedelic Studies (MAPS) Public Benefit Corporation (PBC) for MDMA-assisted therapy for Post-Traumatic Stress Disorder (PTSD) and represents the culmination of over a decade of clinical trials by the organization. On February 9, 2024, MAPS-PBC, now known as Lykos Therapeutics, announced that FDA had accepted its NDA, granted the application priority review, and assigned a PDUFA[3]target date of August...

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Asebey Life Science Law is a boutique law firm specializing in FDA regulatory compliance, transactional law, and advisory services for the life sciences industry.

501 E Las Olas Blvd. | Suite 300
Fort Lauderdale, FL 33301

Available by appointment only *