MorningRX: August 31, 2023


The FDA issues warning letters to 3 infant formula manufacturers for violations, and officials with the Department of Health and Human Services recommend reclassifying marijuana as a schedule III drug.

FDA Issues Warnings to 3 Infant Formula Manufacturers

The FDA has issued a warning letter to 3 infant formula manufacturers for violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the FDA’s Infant Formula regulations, according to a release from the agency. The warnings were issued to ByHeart, Mead Johnson Nutrition, and Perrigo Wisconsin after inspections at their facilities revealed that some products had potentially been contaminated with the bacteria Cronobacter sakazakii. At the time of the inspections, the FDA issued inspectional observations and exercised oversight as each company initiated recalls in December 2020, February 2023, and March 2023.

The new warnings are part of the FDA’s normal regulatory process to reinforce the importance of instituting and maintaining appropriate corrective actions. The FDA noted it is not advising parents to throw away or avoid purchasing any particular formula at this time.

“Infant formula manufacturers are responsible for ensuring they make safe products, and the agency has remained in ongoing discussions with the infant formula industry to address the agency’s concerns,” Donald Prater, acting director of the FDA’s Center for Food Safety and Applied Nutrition, said in a release. “The FDA is committed to identifying and acting on issues early to prevent any firms from reaching the level of concern that prompted last year’s large-scale recall and contributed to the infant formula shortage.”

HHS Officials Call for Ease on Marijuana Restrictions

Officials with the US Department of Health and Human Services are recommending easing restrictions on marijuana and reclassifying it under the Controlled Substances Act, Bloomberg reported. A top official with the department wrote a letter to Anne Milgram, an administrator with the Drug Enforcement Agency, saying that marijuana should be classified as a Schedule III drug, which means it has a low potential for abuse. Marijuana is currently a Schedule I drug, indicating it has a high potential for abuse and no medically accepted use. HHS made the recommendation based on an extensive review of marijuana’s classification conducted by the FDA, which recommended that marijuana be placed in the schedule III category based on eight different factors.

“It’s a huge day for the cannabis industry,” Bryan Barash, co-chair of the Coalition for Cannabis Scheduling Reform, an advocacy group, and deputy general counsel of Dutchie, a platform for cannabis commerce, told Bloomberg. “We would just hope that the federal government follows through on their recommendation.”

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