RFK Jr. Removes Restrictions On Unapproved Peptide Injections

Authored by Zachary Stieber via The Epoch Times,

The Department of Health and Human Services (HHS) is letting pharmacies use unapproved peptides under a decision from Health Secretary Robert F. Kennedy Jr.

The peptide injections can be used as officials with the Food and Drug Administration and other parts of the department consider permanent action, the agency stated in a notice. It stated that no enforcement actions will be taken against companies that produce and use the peptides, even though they are not approved.

Kennedy, according to the notice, “has determined that this limited enforcement-discretion policy will discourage the continued, widespread use of certain research-use-only peptides supplied by foreign manufacturers that pose a safety risk to US patients.” The health secretary, it also states, “has determined that the policy advances patient choice and freedom while appropriately protecting patient safety.”

Peptides, or molecules that contain amino acids, are used by fitness enthusiasts and have been promoted by Kennedy on podcasts.

A spokeswoman for HHS told The Epoch Times in an email on Oct. 29 that the department is confronting the risks of black-market peptides.

“The policy does not grant FDA approval or establish clinical safety and effectiveness,” the spokeswoman said. “It requires patient-specific prescriptions, traceable ingredients, quality testing, and safety reporting to hold compounders accountable and give patients an alternative to unregulated sellers.”

The interim policy was sent to the White House earlier in October before being made public. It covers six peptides, including BPC-157 and Epitalon.

The FDA used to list five of the six peptides as substances with significant safety risks, before Kennedy had that designation removed in the spring. The FDA then asked an advisory panel whether regulators should place them on the list of ingredients compounding pharmacies can manufacture and mix. The panel recommended that regulators place six peptides on the list, and those six are the same ones covered by the new policy.

FDA staffers had opposed letting compound pharmacies manufacture the peptides because of safety concerns.

The FDA’s review of the peptides continues as it considers action beyond the interim policy, according to HHS, and officials can revisit the interim policy if safety or quality concerns emerge.

The Collaborative for Evidence-Based Medicines, in a recent statement, said allowing usage of the peptides by bypassing the rulemaking procedures was concerning, in part because much of the data on the peptides comes from animal and laboratory studies.

“Opening compounding to unapproved and poorly characterized peptides that FDA’s own reviewers flagged for significant safety risks sidesteps the process designed to protect patients,” said John Hertig, chair of the collaborative’s board of directors. “Patients deserve medicines they can trust, and that trust has to be earned through evidence.”

A peptide industry association welcomed the move.

“The American Peptide Association applauds the efforts of the Trump Administration and the HHS to greenlight certain peptides into production by compound pharmacies,” Jeff Cohen, co-founder of the association, told The Epoch Times via email. “It is much-needed clarity that the peptide industry, clinicians, and consumers have hoped and worked for for the past couple years and is a bold step outside the usual pharma-driven, FDA-managed pathway.”