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FDA Announces Updated Instructions for Serious Adverse Event Reporting for Cosmetic Products

On December 14, the US Food and Drug Administration (FDA) issued new instructions for cosmetic companies to use when submitting mandatory serious adverse event reports to the agency. As we reported last year, the...more

FDA Announces New Fees for Manufacturers of Over-the-Counter Drugs

As we explained in a previous alert, one of the lesser-known provisions of the March 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act was a significant overhaul of the way that most OTC drugs are regulated in...more

Cannabis Counsel Cast: What Cannabis Companies Need to Know About California’s Prop. 65 (Even if They Aren’t in California) [Audio]

In our first Cannabis Counsel Cast episode, Partners Emily Leongini and Lynn Fiorentino discuss the potential impact of California’s Prop. 65 on manufacturers, distributors, and sellers of cannabis products, particularly in...more

To Facilitate Cannabis Research, DEA Proposes New Role as Marijuana Distributor

On March 23, 2020, the US Drug Enforcement Administration (DEA) issued a proposed rule that, if finalized, would establish processes by which individuals and entities could apply to DEA to lawfully grow marijuana. The...more

FDA, TTB Announce Emergency Policies to Increase the Domestic Supply of Hand Sanitizer

The coronavirus (COVID-19) outbreak has led to a dramatic increase in the demand for, and a shortage of, hand sanitizer in the US. In response, the US Food and Drug Administration (FDA) and the US Treasury Department’s...more

FDA Temporarily Relaxes Requirements For Alcohol Used in Hand Sanitizers

As we reported earlier this week, in an effort to increase the domestic supply of hand sanitizer, the US Food and Drug Administration (FDA) recently announced policies that temporarily relax certain requirements for the...more

California Adds THC to Prop 65 List

California’s Safe Drinking Water and Toxic Enforcement Act of 1986, more frequently referred to as Prop 65, requires businesses whose products reach California consumers to notify consumers about the presence of certain...more

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