The Department of Health and Human Services (HHS) will let pharmacies produce and sell treatments involving six peptides that aren't specifically approved by the Food and Drug Administration (FDA). The move is meant to provide a "controlled alternative" to buying peptides from possibly sketchy foreign pharmacies, HHS said.

Under the new HHS policy, the agency will not "take enforcement action against a State-licensed pharmacy, Federal facility, or licensed physician compounding a drug product" using one of six named "peptide bulk drug substance[s]."

This is a major win for peptide proponents, compounding pharmacies, and health freedom—and hints that HHS Secretary Robert F. Kennedy Jr. may be feeling frustration with the slow pace of things at the FDA.

The six peptides in question—BPC-157, Epitalon, KPV, MOTS-c, Semax, and TB-500—were the subject of a summer meeting of the FDA's Pharmacy Compounding Advisory Committee (PCAC).

Up for debate was whether these six "bulk drug substances" and another, Emideltide, should be put on the FDA's Section 503A Bulks List. That list governs which substances licensed physicians and specialty pharmacies can compound into drug products without them being a component of an already FDA-approved drug or having "an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph."

In July, the panel voted to put six of the seven peptide-related substances under consideration (all except Emideltide) on the bulks list. But the panel's vote is not binding.

It's ultimately up to FDA authorities to decide whether they accept the advisory committee's recommendations. So far, no decision has been released.

But yesterday, HHS unveiled an "Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances." And it effectively puts the committee's recommendations into practice by proxy.

Kennedy can't ensure FDA approval, of course. But he can—and will—stop HHS from taking action against physicians or pharmacies that compound and distribute these substances under his prescribed rules.

In an explainer about the new policy, HHS notes that "compounded drugs are not FDA-approved, which means FDA does not review their safety, effectiveness, or quality before they are marketed." Nonetheless, "compounded drugs can serve an important medical need for certain patients" and "there is significant interest in the use of these peptides in compounding," it says.

Opponents of allowing more peptide-based treatments to be compounded by licensed U.S. pharmacies often focus on the fact that these products don't have FDA approval and may not have the extensive experimental backing required of FDA-approved treatments.

But people are already taking BPC-157, MOTS-c, and other peptides anyway, buying them from companies selling them under "for research use only" labels or obtaining them from foreign distributors. Peptides can even be found on discount everything-marketplaces like the China-based AliExpress.

Allowing licensed physicians and pharmacies in the U.S. to compound these substances without fear of being punished gives people access to safer options than they might otherwise have.

Pharmacies compounding peptide-based products under the rules set forth by federal law still have to be licensed in the states where they operate and follow certain rules, including a requirement that active ingredients used for compounding must be "accompanied by valid certificates of analysis" and "be compounded based on the receipt of a valid patient-specific prescription." Per the new HHS policy, they must also follow several other rules regarding the packaging and labeling of these peptides.

"The Secretary of HHS 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," notes the HHS explainer. "By allowing limited compounding of the substances addressed in this guidance under appropriate safeguards, the policy provides patients with a more controlled alternative."

It's an astoundingly reality-based policy for government health officials, who often act as if matters like this come down to a binary between perfect health and safety on one hand and certain danger on the other.

Rather than relegating peptides to gray or black markets until they (may be) pronounced all clear by the FDA, RFK Jr.'s HHS has chosen to balance safety with "patient choice and freedom," as the HHS states.

The post RFK Jr. Institutes Backdoor Approval of 6 Peptides appeared first on Reason Magazine.

New Yorkers won't be voting on any citywide offices this year, but they do have five ballot initiatives that could shape the city's future more than any politician on this year's ballot. Mayor Zohran Mamdani created a version of the Trump administration's infamous Department of Government Efficiency in New York called the Commission on Government Efficiency (COGE). The plan is for COGE to modernize city operations and accelerate public infrastructure and permitting—in that vein, COGE placed five proposals before voters on the November ballot, largely targeting the bureaucratic processes governing new construction and business activity across the five boroughs.

Questions 1, 2, and 3 on the ballot would end or reduce the use of public hearings in different city review processes. Question 1 would, according to the ballot language, "simplify [the] process to use public space for uses such as ramps, planters and cafes, by removing mandatory hearings and Council disapproval of sidewalk cafes, while maintaining community and Council input." Question 2 would "reduce paperwork for City contractors by authorizing [the] Procurement Policy Board to simplify [the] contractor questionnaire….[And] remove mandatory hearing for required client services report." Question 3 would "simplify review of street safety projects to reduce construction timelines," among other changes. Question 4 is about simplifying permitting.

These policies were not directly introduced by Mamdani, but they reflect a governing philosophy that New York City and other big cities desperately need: a local government that won't allow a small group of organized opponents to obstruct progress for the city at large indefinitely.

Nowhere is the bottleneck against much-needed development clearer than at public review hearings. In theory, a public hearing is democracy at its purest: Every voice is heard. But in practice, it usually becomes a slow-motion filibuster. The most persistent and best-organized opponents get a megaphone, with little to no input from the millions of New Yorkers who would broadly benefit from more housing, better infrastructure, and businesses that can open without getting wrapped in red tape.

The 2026 ballot questions, if approved, would take small steps toward addressing these problems. If they all passed, it wouldn't be a seismic change—a planter here or a parcel of land there. But that's kind of the point: Should routine administrative decisions require another round of formal public review hearings to hold up any change, big or small?

The post Even Under Mamdani, New York City's Ballot Questions Might Cut Red Tape and Public Review Hearings appeared first on Reason Magazine.

"As much as the industrial revolution freed us from the constraints of the human muscle, AI will free us from the constraints of the human brain, pushing productivity beyond our wildest dreams….Keep AI unregulated so that it is free to be developed without the deadly hand of premature and poorly understood regulation."

Argentine President Javier Milei wrote that on June 4 in the Financial Times as part of his push to bring AI companies to Argentina. The prior week, he had introduced legislation to boost AI based on three pillars: leaving AI unregulated, establishing a new legal category for nonhuman corporations operated by AI agents or robots, and keeping corporate taxes low. As of late September, the Senate has held hearings on the legislation but not advanced it.

The post Javier Milei's Case Against AI Regulation appeared first on Reason Magazine.