Tag:FDA
Dire Wolves Highlight Dire Need for De-extinction Regulation
On April 7, 2025, Colossal Biosciences announced that it had successfully created dire wolves, a species that had been extinct for over 10,000 years, in what is considered a breakthrough in the science of de-extinction. Although it sounds like a work of science fiction, Colossal used dire wolf DNA found in a 13,000-year-old tooth and a 72,000-year-old ear bone to make 20 edits to the DNA of modern gray wolves leading to the birth of 3 dire wolf puppies in the fall and winter of 2024. While the science community both celebrates the breakthroughs in genetic engineering, considers the benefits that this technology can have on modern endangered species, and debates the validity of calling genetically modified gray wolves true dire wolves, it is clear that the regulatory framework of the United States is not yet sufficiently prepared to examine the legal and ethical considerations that come with de-extinction technologies. Though dire wolves were the breakthrough, they are not the end goal for Colossal as it now turns its focus to other popular extinct species such as the wooly mammoth, dodo bird, and Tasmanian tiger. To adequately keep up with these changes in genetic and environmental science, the United States must act quickly to develop an agile multi-agency regulatory framework that can guide the country and world as a whole safely into the new age of de-extinction.
Operation Stork Speed: A Great Opportunity if Executed Correctly
In March, the FDA announced Operation Stork Speed in response to a Consumer Reports investigation which found traces of toxic chemicals in baby formula. Secretary of HHS, Robert F. Kennedy Jr., has directed the FDA to begin several new initiatives and increase the scrutiny of testing to find ways to have better access to safe baby formula. Operation Stork Speed will begin a comprehensive review of the nutrient list that is currently approved by the FDA and increase labeling transparency with industry. Although created in response to the Consumer Reports findings, a ProPublica investigation published on April 4th has led to concerning claims about unsanitary practices within an Abbot Labs factory. The same Michigan-based factory that shutdown in 2022, after reports of infant hospitalizations and deaths due to this facility’s formula, causing a nationwide shortage. Given the added issues with the factory, if done correctly, Operation Stork Speed could begin to solve the safety issues that have recently plagued the baby formula industry.
Trump’s MAHA Commission: What to Expect
President Trump’s return to the White House has sparked a lot of controversy as he takes extensive executive action and appoints contentious figures to his cabinet. At the top of the list of most controversial is arguably the newly confirmed Secretary of Human Health and Services, Robert Kennedy Jr., because of his skepticism towards vaccines and pharmaceutical drugs like Selective Serotonin Reuptake Inhibitors (SSRIs), used to treat various mental disorders. Despite criticisms, Kennedy gained a large following during his 2024 presidential campaign, where he founded the Make America Healthy Again movement and advocated for public health policies that make American food healthier and end the chronic disease epidemic in this country. Aligned with these initiatives, President Trump has taken extensive action in the first sixty days of his second term to reform public health policy. Among these changes is the newly created Make America Healthy Again Commission, which is chaired by Secretary Kennedy and consists of other cabinet and high-ranking executive officials. The Commission is initially tasked with addressing the childhood chronic disease crisis, specifically targeting nutrition, prescription drug misuse, and government transparency related to ethics and public trust.
Subsidized Addiction: America’s Sweet Problem
Today, Americans are becoming more aware and concerned about the additives in their food that have carcinogenic and other adverse health effects. This increased scrutiny in American nutrition, particularly for children, has been spearheaded by the “Make America Healthy Again” Movement, which seeks higher standards in regulations of what is allowed in food and more transparency for food products. The Food and Drug Administration (FDA) is shifting in the same direction of promulgating stricter food standards, as it recently finalized rules banning the artificial food additive Red No. 3 and updating the standards manufacturers must meet to advertise as “healthy.” However, while agencies and activists work to keep chemical and artificial additives out of American foods, a glaring issue remains. Americans have a sugar addiction problem, and the government is their enablers.
Glass Skin Meets Red Tape: How Korean Beauty Navigates FDA Rules
Among the trends of self-care lies skincare. As self-care has increased in popularity over the last few years, skincare has become increasingly trendy. In 2022, there was a boost in skincare sales with products such as anti-aging products and moisturizers. In the skincare industry, there are known and established brands, but what has recently emerged through popularity on social media and TikTok is Korean beauty (“K-beauty”) products. K-beauty products help consumers achieve “glass skin,” which is clear, poreless, and shiny skin that looks like glass by using specific K-beauty products. In the states, sunscreen is a staple K-beauty product that has emerged.
From Lab to Table: The Future of Regulating Lab-Grown Meat
Human organs grown in labs, lab-grown diamonds, lab-grown plants, and now lab-grown meat. Companies like Upside Foods and GOOD Meat are growing meat from animal cells. Companies have developed a cell line to produce high-quality meat, grow and feed the cells with a “blend of nutrients,” and in two to three weeks, meat is ready to be cultivated and molded into the shape of meat, like a chicken filet. Now, lab-grown meat is commercialized and has been approved by the Agriculture Department for production and sale. Although it could be a few years until lab-produced meat is in grocery stores, regulations need to be approved and put into place just like slaughterhouse meat.
Have a Safe Trip: How Psychedelic Therapy in Oregon and Colorado Could Guide National Legalization
As the mental health crisis continues to challenge the United States, the need for innovative treatments is becoming increasingly evident. Psychedelic therapy, using substances like psilocybin and MDMA, is gaining attention as a promising approach to treating conditions such as post- traumatic stress disorder (PTSD), depression, and anxiety. Oregon and Colorado have pioneered the movement toward legalizing psychedelics for therapeutic use, and their progressive policies have the potential to provide a roadmap for the rest of the country. The question arises: should the entire U.S. follow in their footsteps? Oregon and Colorado’s frameworks could serve as a model for other states seeking to legalize psychedelics in therapeutic settings.
Navigating the Genetic Frontier: 23andMe and the Challenges of Data Security
A recent situation involving millions of 23andMe users has raised significant concerns about data privacy and regulatory oversight. After sending a small tube of saliva to uncover ancestral roots, many individuals discovered that their genetic data had been compromised. 23andMe has transformed genetic testing by offering accessible health and ancestry information to consumers from the comfort of their homes. Since its inception, the company has faced regulatory challenges and became the first direct-to-consumer genetic genealogy test to receive FDA approval. While the company has largely avoided legal trouble over the years, recent data breaches have sparked legal action and underscored gaps in consumer protection.
Caffeine Can Cause a Scene: Why the FDA Should Require Disclosure of Caffeine Content
On May 7, 2024, Panera Bread removed its popular line of ‘charged’ lemonade beverages from its menu following multiple lawsuits alleging that the caffeine content of the drink led to death or serious health problems of customers. One such death occurred in September 2022 when a 21-year-old woman unknowingly consumed 390 milligrams of caffeine in one charged lemonade drink which aggravated her heart condition and led to cardiac arrest. These lawsuits highlight the dangerous reality of caffeine consumption which likely could have been avoided if Panera Bread had clearly displayed the caffeine content of its drinks. However, Panera Bread was under no regulatory obligation to display the caffeine content due to a major gap in the current beverage labeling regulation from the Food and Drug Administration (FDA) which does not require any disclosure of caffeine quantity. This regulatory gap poses a growing risk to consumers as new energy drink brands continue to enter the market and push competition by increasing the amount of caffeine packed into each product. In order to fulfill its obligation to public safety, the FDA must introduce regulations to standardize the disclosure of caffeine content to allow consumers to make informed decisions about the products they are choosing.
What a Lack of Regulatory Structures Means for Food in Prisons
There is practically no regulation of prison food, making access to fresh produce and adequate nutrition a central crisis in prisons. While the dreadful nature of prison food is no secret, the structures that enable such undesirable conditions tend to be overlooked in mainstream discourse. Prison reforms have a long history of substantial difficulty in garnering popular support. Though food is one of the most protected prisoner rights to date, there is growing concern from prisoners’ rights organizations and experts on what lack of food regulations in prisons means for the ever-growing incarcerated population.