FDA's Potential Peptide Reclassification Spurs Telehealth Preparations

The U.S. Food and Drug Administration (FDA) is currently reviewing a decision that could significantly impact the availability and sale of certain peptides. On July 23 and 24, the FDA is scheduled to discuss the reclassification of several peptides. This change would allow pharmacies to legally compound these substances into custom mixes, a process currently restricted by a 2023 Biden administration decision.

Companies within the sector are already gearing up for the potential shift. Myra Ahmad, CEO of the telehealth platform Mochi Health, stated that they are ready to expand their offerings. "We are getting everything ready to go," Ahmad said. "We have pharmacies that have done all their safety testing and are putting pricing together."

Major telehealth corporations have anticipated this moment for over a year. Hims & Hers Health acquired a peptide manufacturing facility in February 2025 and is developing clinical protocols for peptides. Joshua Fritzler, president of compounding pharmacy Olympia Pharmaceuticals, noted significant investment in creating new formulas in anticipation of potential changes.

The potential reclassification follows a surge in interest in peptides, often hyped by influencers and promoted by figures like the U.S. Secretary of Health and Human Services. Despite career scientists at the agency recommending against the changes, many industry insiders believe the FDA will approve the reclassification. Concerns have been raised because the assessment committee includes individuals who promote peptides.

It is important to note that even if the FDA approves the reclassification of peptides, full selling approval will not be immediate. The subsequent steps involve a formal rule-making period and public comment, making the process lengthy. Gerard Olson, former director of research at LegitScript, described the process as drawn-out and complex.