FDA and industry leaders have made clear that many peptide drugs used in “peptide therapy” are not legal for use in compounded drugs. Unfortunately, the unlawful status hasn’t stopped a  disturbing trend of some compounding pharmacies transitioning from selling peptides as drugs to selling the same peptides as dietary supplements.

On September 29, 2024, FDA officially placed a number of peptide drugs, including BPC-157, Dihexa, KPV, and TB-4 Frag in Category 2. Besides their designation under Category 2, these drugs share another trait – although they have each been sold primarily as injectable drugs, they are thought to be orally bioavailable and have also been consumed as capsules or tablets. Because of this, several compounding pharmacies have marketed these drugs in bottles labeled as dietary supplements, in an effort to dodge the regulations that make them illegal to compound.

Dietary supplements, by law, must be consumed orally. But while this is a necessary component for any legal dietary supplement, standing alone, this requirement does not imply that anything consumed orally may be a legitimate dietary supplement. Simply because something is consumed orally does not automatically make it a potential dietary supplement.

Placement in Category 2 makes these drugs non-compliant for use in compounded drugs. But does that automatically mean they are illegal to use in dietary supplement form? In a word, YES. A substance, previously known to be a drug (either by marketing or published studies), may not be used as an ingredient in a dietary supplement under the Dietary Supplement Health and Education Act ("DSHEA"). DSHEA created "dietary supplements" as a new regulatory category under FDA authority, while specifically excluding ingredients that are or have been drugs(both OTC and prescription).

Put another way:

[A] substance that was first approved as a drug or was the subject of substantial public clinical drug studies before being marketed as a dietary supplement or food cannot be used in dietary supplements unless the FDA issues a regulation allowing its use.

This is known as “drug preclusion” in the dietary supplement field. Congress specifically included this language to prevent drug manufacturers from circumventing the FDA's premarket drug approval process and instead releasing their drug as a dietary supplement, which would then be subject only to post-market regulation. This is exactly what some compounding pharmacies have done. But simply relabeling a drug as a dietary supplement does not make it one, and certainly does not place these pharmacies beyond the reach of the law.

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