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FDA Releases New Guidance on Oral Phenylephrine, Xlear Responds

by Eric Munson | December 2, 2024

On Nov. 7, the U.S. Food and Drug Administration (FDA) proposed removing oral phenylephrine from over the counter (OTC) medications due to “effectiveness concerns.” According to FDA, oral phenylephrine is widely used as an active ingredient in nasal decongestants. The agency conducted a comprehensive review of all available data on the safety and efficacy of ...

FDA Warns Selling of Topical CBD Products Violates FD&C Act

by Angela Sabarese | March 26, 2021

On March 22, the U.S. Food and Drug Administration stated that it has issued warning letters to two companies for selling topical pain relief products labeled as containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the warning letters addressed the illegal marketing of unapproved drugs labeled ...

Operating a Health Food Retail Establishment in the Age of the Coronavirus

by Steven Shapiro | July 1, 2020

In the space of a few short weeks, what we thought of as our comfortable reality was changed; probably forever. In February, the most important thing was finding a potential pathway to market for CBD. By mid-March, everyone’s primary concern seemed to be a search for an adequate supply of toilet paper and perhaps washing ...

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