The False Promise of Smart Pills in a Loosely Regulated Market

by Spencer Andrews

We’ve all had the experience: you receive a targeted ad on your phone or computer which mysteriously seems to read your mind. This happened to me recently when I, a busy law student, began receiving a wave of ads selling supplements which purport to improve brain focus, clarity, and memory. I had been thinking about ways to increase my productivity, and just in the nick of time, a miracle drug appeared to answer my need. As it turns out, the product being advertised was of a little-known class of substances known as nootropics. And as you might expect, nootropics are hardly a miracle drug.

What is a Nootropic?

The word nootropic is colloquially used to describe a wide range of natural and synthetic substances thought to have cognitive enhancing properties. Romanian psychologist and chemist Corneliu Giurgea coined the term nootropic in the 1970s. He first used the term after synthesizing piracetam, a compound which he claimed would improve cognitive functions like memory and learning. Clinical studies have since shown that piracetam is not a dependable cognitive enhancer nor does it have long-term efficacy against cognitive impairment. Nonetheless, it has shown modest efficacy as an anti-depressant, and most recently, it has demonstrated some promise as a neuroprotective drug for patients undergoing coronary bypass surgery. Notwithstanding piracetam’s clinical success, or lack thereof, the term nootropic has since evolved into something else entirely.

Read More

A Brief Quantum Medicine Policy Guide

by Mauritz Kop, Suzan Slijpen, Katie Liu, Jin-Hee Lee, Constanze Albrecht & I. Glenn Cohen

 

I. Introduction: Harnessing Quantum and AI in Precision Medicine

The convergence of artificial intelligence (AI) and quantum technology (QT) in precision medicine promises to revolutionize healthcare by enabling hyper-personalized treatment.

Fundamentally, for our purposes, quantum technology leverages unique properties of quantum physics—such as superposition and entanglement—to solve problems beyond classical capabilities. Second-generation (2G) quantum technologies harness these principles to achieve quantitative (speed, fidelity) and qualitative (novel functionality) advantages over other methods. Quantum-classical hybrids (frameworks, algorithms or devices that integrate both quantum and classical computing resources such as qubits and digital bits) combine elements from both macroscopic and microscopic worlds to solve complex problems.

Read More

BPA-free Does Not Mean Bisphenol-free and How Regulators are Grappling to Deal with It

by Jessica Samuels

You’ve likely seen BPA-free plastic water bottles and Tupperware in stores and opted to grab those over similar, non-labeled products. You probably didn’t know, however, that those products likely just contain other bisphenols, like BPS or BPAF, instead. Regulating bisphenols, a class of endocrine disrupting chemicals, has been challenging due to “regrettable substitution.” This phenomenon allows companies to truthfully label a product “BPA-free” while misleadingly substituting a harmful chemical (BPA) with an unknown or unforeseen hazardous chemical (BPS). Adequate protection of human health requires regulators to consider how bisphenols as a class can be appropriately restricted.

Read More

What Type of Salt Should You Buy? Rethinking 1924 Food Fortification Policy in 2024

by Jessica Samuels

For 100 years, food fortification, the practice of deliberately increasing the content of vitamins and minerals in a food, has been essential to combating public health crises. However, these practices have continued into the modern era. Because overconsumption of nutrients has been linked to toxicity and diseases, public health officials should continue to reflect on the benefits and risks of food fortification today.

History of Food Fortification

In the United States, food fortification (also known as enrichment) began in 1924 to address endemic goiter, enlargement of the thyroid gland. A physician in Cleveland suggested the use of salt since it was so commonly consumed to increase iodine consumption. After some persuasion, the Michigan State Medical Society studied the safety of iodized salt and launched the world’s first food fortification campaign. This was the first time food was deliberately manufactured with an eye towards addressing disease. However, while some members of the salt industry were excited by the potential to improve public health through their product, others were not. The Morton Salt Company argued that furnishing iodine to the populus properly belonged to large pharmaceutical companies. But the results were overwhelming: The incidence of goiter among children in Michigan decreased from 35% to 2.6%.

Read More

Legal Responses to the Potential Dangers of Menstrual Products

by Rebekah Ninan

This summer, a startling study from researchers at University of California, Berkeley revealed tampons from several brands contain toxic heavy metals like lead, arsenic, and cadmium. This finding follows the 2023 discovery that many menstrual products contain per- and polyfluoroalkyl substances (PFAS), even those marketed as PFAS-free. All of these contaminants are linked to major health problems. This article explores the emerging policy and legal responses to this issue.

Read More

Out of the Shadows: Menopause and the Law

by Rupa Palanki

In May 2024, a bipartisan group of female senators introduced the Advancing Menopause Care and Mid-Life Women’s Health Act. The bill allocates $275 million over five years toward strengthening and expanding federal research, health care provider training, and public health education on menopause and mid-life women’s health issues. If enacted, it would be the most comprehensive federal effort to improve health care related to menopause. However, further action related to the labeling of low-dose estrogen and workplace support is still necessary to support individuals experiencing menopause.

Unmet Needs for Legislative and Policy Action

Menopause is the natural stage of life when an individual has not had a menstrual period for twelve consecutive months, signifying the end of their fertile years. Half of the American population will eventually experience this transition. Currently, 75 million American individuals are either in menopause, perimenopause (the time before menopause when menstrual cycles may become irregular), or postmenopause (when an individual has not had a menstrual period for longer than a year). Another 6,000 reach menopause daily. Read More

Evidence and Authority in Abortion Law

by Rachel Rebouché

Two years after deciding the case that overturned a constitutional right to abortion, the Supreme Court heard two cases on abortion law this term. The first involved a challenge to the U.S. Food and Drug Administration’s approval and regulation of mifepristone, the first drug in a medication abortion. The second concerned the intersection of Idaho’s state abortion ban, which has no exceptions for medical emergencies, and the application of the federal law, the Emergency Medical Treatment and Labor Act (EMTALA), which requires that emergency departments stabilize patients needing emergency care in Medicare-funded hospitals.

Read More

Going to New Orleans? You may need to leave your ulcer medication behind

by Leslie P. Francis

 

That’s correct: unless your prescription for misoprostol meets strict new conditions, possession of the drug is now illegal in Louisiana.  In late May 2024, Louisiana governor Jeff Landry signed a bill making misoprostol and mifepristone schedule IV drugs, the most highly regulated controlled substances.  Violating the law may result in jail sentences or fines.

Read More

Silver Spring, MD, USA - June 25, 2022: The U.S. Department of Health and Human Services (HHS), U.S. Public Health Service (USPHS) and FDA logos are seen at the FDA headquarters, the White Oak Campus.

The FDA Backdoor to MDMA Rescheduling

By Vincent Joralemon

MDMA (also known as the club drug “molly” or “ecstasy”) is a Schedule I controlled substance — the most restrictive drug class with the most severe criminal consequences linked to it. But, perhaps not for long.

A recent effort to get MDMA approved by the U.S. Food and Drug Administration (FDA) for post-traumatic stress disorder (PTSD) means the drug may be rescheduled, which will lead to substantially decreased regulations attached to it. This provides a compelling model for efforts to decriminalize and destigmatize other substances moving forward.

Read More

Doctor working with modern computer interface.

Thank Ketamine for the Telehealth Extension

By Vincent Joralemon

In my last post, I discussed the rise of psychedelic lobbying — how companies with vested economic interests in psychedelics have applied pressure to shape regulations that favor their business models.

One such initiative — the ketamine therapy industry’s push to extend the COVID-era telemedicine flexibilities for prescriptions of controlled substances — highlights how sophisticated these campaigns can be, and how their impact stretches beyond the psychedelic industry.

Read More