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Malcolm Spicer

US Consumer Health Managing Editor

Washington, DC
Malcolm has expertly covered the OTC drug and nutritional supplement industries and markets since 2006. He provides authoritative and highly analytical insight into how and why the US Food and Drug Administration regulates OTC drugs, including homeopathics, and nutritional supplement manufacturing and marketing and also how companies competing in these industries can most efficiently and effectively comply with FDA regulations, the cornerstone for their success.

Latest From Malcolm Spicer

Valisure Puts FDA Under Microscope In Complaint On Ranitidine Tests Seeking Damages From GSK

Amended complaint filed 21 May after US Attorney General in March said the federal and state governments, named as co-plaintiffs, wouldn’t intervene and the court ordered the complaint unsealed. Complaint, initially filed in 2019, is critical of FDA, generally alleging agency failed to conduct sufficient oversight and evaluation of GSK’s testing data for ranitidine.

Litigation OTC Drugs

House Draft Farm Bill Narrows Hemp Definition While Industry Juggles States' THC Levels

Ag committee members in 23 May markup likely to broach topic of delta-9 THC limit for hemp. Since hemp was de-scheduled in 2018, cannabinoids other than delta-9 but with psychoactive effects have become leading sales drivers. “Most states now have legal marijuana programs, they just don't know it,” says cannabis industry attorney.

Cannabidiol CBD Legislation

Delivery Device Developer Pushes FDA For Better Weight-Based Dosing For Children’s Acetaminophen

Michael Creaturo’s petition isn’t the first suggestion made to FDA and industry that there’s room for improvement in labeling for children’s doses of some OTC formulations. Creaturo's petition comes after he received a US patent in December 2022 for an “integrated container and dosing device for liquid medication delivery.” 

OTC Drugs FDA

Clarifying Marijuana’s Use As Medical Drug In US Won’t Clear Cloud Over Pathway For Hemp’s Use

DEA NPRM to move marijuana from CSA Schedule I to Schedule III says synthetically derived THC “is outside the CSA’s definition of marijuana” and “will remain in Schedule I.”  Synthetically derived THC includes copies of ingredients derived from cannabis plants which qualify as hemp by containing no more than 0.3% delta-9 THC concentration by dry weight and are common in supplements and food available in US.

Regulation Cannabidiol CBD

US Wellness Market People News: Jarrow/Arzón, Whoop/Ronaldo, One A Day/Edelman, More

Kailo models gut and mental health link; AdvoCare has first female CEO; EyePromise enlists athletes across sports; Edelman catches One A Day message; Ronaldo wears Whoop, also invests; and  Jarrow adds “Chief of Superior Starts.”

Dietary Supplements Executive Changes

Michelle Obama’s Plezi Nutritional Beverage Firm Lands Investment From Actress Kristen Bell

Plezi also announces launches “PLEZi FiZZ” carbonated fruit drink with 70% less sugar than the same amount of leading soft drinks, no added sugar, plus 2g fiber, vitamin C and other nutrients. With 10% of profits going to children’s health initiatives, its initial donation was $1m to FoodCorps' Nourishing Futures.

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