Category: Fda regulations

Salicylic acid is a well-established topical medication used to treat various skin conditions like acne, warts, and psoriasis. Yet, because of its versatile properties, the answer to **is salicylic acid considered a drug?** is nuanced, as its classification depends heavily on its concentration and intended purpose.

First approved by the FDA as a topical ophthalmic medication in 1978, natamycin has a complex regulatory history. To determine whether **is natamycin FDA approved**, one must consider its distinct applications in both medical treatment and food preservation.

Despite its wide availability and use for treating vertigo in over 80 countries, **betahistine is banned in the US** by the Food and Drug Administration (FDA) for general marketing. The primary reason for this U.S. prohibition is not safety, but a decades-old determination that the drug lacked sufficient evidence of effectiveness.

The FDA issues numerous guidance documents annually to help regulated industries, including those in pharmacology, understand the agency's current thinking. A specific type, a Level 2 FDA guidance, is distinguished by its less complex nature, focusing on existing practices and minor policy adjustments.

In July 2020, the FDA issued warning letters citing a decades-old legal provision, which caused confusion and led retailers like Amazon to restrict sales of NAC supplements. This sparked the widespread question, **why is NAC banned**, and ignited a major regulatory debate over the status of N-acetyl cysteine as a dietary ingredient.