Category: Fda regulation

In the United States, about one in five adults in a commercially insured plan receives a prescription for short-term oral corticosteroids over a three-year period [1.9.4]. Yes, many corticosteroids **are FDA approved** for a wide variety of conditions, administered through different routes like oral, topical, and inhaled forms [1.2.3, 1.4.1].

The U.S. Food and Drug Administration (FDA) does not approve dietary supplements for safety or effectiveness before they are marketed. This critical distinction is key when asking, 'Is Recell supplement FDA approved?', as there is public confusion between a legitimate, FDA-approved medical device called the RECELL® System and unapproved products marketed as supplements.

Despite being a widely used mucolytic and expectorant in over 50 countries for decades, ambroxol is not available in the US. The primary reason for **why ambroxol is not available in the US** is the lack of approval from the Food and Drug Administration (FDA) for its respiratory applications.

While over 400,000 prescriptions for ketotifen were filled in the United States in 2023 [1.9.4], many patients still ask, 'Why is ketotifen not available in the US?' The answer lies in a complex history of economics and pharmaceutical regulation.

Following widespread tirzepatide shortages that lasted into late 2024, the U.S. Food and Drug Administration (FDA) has ended the temporary period allowing compounding pharmacies to produce versions of the active ingredient in Zepbound. As of early 2025, compounded Zepbound is no longer widely or legally available, and patients who used these versions must transition to FDA-approved alternatives.

The dietary supplement market includes over 100,000 products, leading many consumers to ask: Is Qunol FDA approved? [1.3.2] The direct answer is no, because the FDA does not "approve" dietary supplements in the way it does for drugs [1.9.4].

Many consumers ask, **'Is ASEA FDA approved?'** The direct answer is no. ASEA Redox Supplement is classified as a dietary supplement, meaning it is *regulated* by the FDA under a different set of rules than prescription drugs, but it is not *approved* by the agency [1.4.1, 1.4.2].