Category:FDA
Cooking in the Dark: The Rise and Fall of Ghost Kitchens
Online food delivery is a growing industry worth over $240 billion, serving consumers who appreciate eating their favorite meals from the comfort of their home. Ghost kitchens are one way restaurant entrepreneurs are taking advantage of this growing market. Ghost kitchens operate as takeout and delivery only venues, needing only a fraction of traditional restaurant space to operate. Today there are over 7,000 businesses in the ghost kitchen industry in the United States. This model was embraced by celebrities like Mr. Beast and large restaurant chains, including Chili’s, and was particularly popular during the COVID-19 pandemic. While these kitchens operate in the dark, they are still responsible for complying with food quality and safety rules like traditional restaurants. However, this has proven to be difficult and resulted in closures – and even lawsuits. Ghost kitchens require greater investigation and monitoring from governmental agencies to better meet consumer concerns.
The Rise of Compounding: Why Section 503A Should Be Strengthened
The popularity of glucagon-like peptide-1 receptor agonists (GLP-1 drugs) such as Ozempic and Wegovy has transformed the market for weight-loss medications in the United States. Originally developed to treat type 2 diabetes, these drugs are now widely prescribed for weight management. However, demand has created nationwide shortages, prompting compounding pharmacies to produce customized versions of GLP-1 medications intended to replicate FDA-approved medications. In practice, however, this has enabled the rapid expansion of compounded GLP-1 drugs that mimic highly popular brand-name medications. Evidence of contamination, dosing errors, and serious adverse events linked to these products suggests that the current regulatory framework does not sufficiently protect consumers. Given these risks, Section 503A should be strengthened to prohibit pharmacies from producing copies of commercially available GLP-1 drugs altogether, even during shortages.
Adderall Shortages: Regulatory Compliance and Enforcement Risks in the Big-Pharma Ecosystem
Since October 2022, the United States has been grappling with an ongoing shortage of Adderall, a cornerstone prescription stimulant for millions of Americans. What began as intermittent shortages due to manufacturing disruptions has evolved into a prolonged supply constraint affecting patients, providers, and regulators. Behind this shortage lies a complex overlap of regulatory frameworks, legal reporting obligations, and compliance risks that are present across the pharmaceutical industry. Thus, the Adderall shortage is not simply a manufacturing hiccup. It is a case study in how overlapping regulatory regimes can collectively constrain supply in ways that neither regulators nor companies can easily fix in real time. Thus, ensuring sustainable access to ADHD medications and promoting proper use will require clearer authority, better data integration, and shared accountability across drug regulators and the Big-Pharma industry. Without these reforms, shortages will remain a recurring crisis to manage, rather than a systemic problem to prevent.
Beyond Weight Loss: How Ozempic Exposed Cracks in U.S. Drug Compliance
A viral weight-loss craze that promised to trim waistlines has become one of the most urgent compliance battles for the U.S. Food and Drug Administration (FDA). In early 2025, the FDA uncovered counterfeit Ozempic circulating through unauthorized distributors and compounding pharmacies, some containing unknown ingredients that put patients at serious risk. The discovery exposed the continued fragility of the nation’s pharmaceutical supply chain, even after years of reform under the Drug Supply Chain Security Act (DSCSA). As demand for GLP-1 drugs like Ozempic and Wegovy skyrockets, regulatory gaps in manufacturing, compounding, and distribution have created new avenues for fraud, forcing the FDA to tighten enforcement and redefine the rules of pharmaceutical oversight.
Modern Marketing v. FDA Enforcement: The Unregulated Frontier of Trendy Skincare and Digital Labeling
“Slugging”, “glass skin”, and “mineral mixing”, oh my! These are just a few of the current trends present in the skincare scene today. With the boom of social media advertising, non-professionals posting advice to TikTok, and companies’ budgets for trendy skincare campaigns in the millions, where do we draw the line between FDA-regulated skincare and “digital labeling” in this new generation of cosmetic advertising?
The Regulation of Cosmetics in the U.S.: Where It’s Been and Now Is Headed
The cosmetics industry in the U.S. has fallen behind in safety regulations compared to its European counterparts. The European Union has banned roughly 1,300 different ingredients in personal care products while the U.S. has banned merely 11. The last major update to regulations in the U.S. was in 2022 with the Modernization of Cosmetics Regulation Act (MoCRA). However, there is still work that needs to be done to address the health and safety risks that the cosmetic industry poses. The “Safer Beauty Bill Package” is just one proposed regulation that would majorly alter how personal care products are regulated in the U.S.
The Cost of Beauty: Chemical Compliance in Cosmetics
Have you ever considered the cost of beauty? The health cost, not the financial one, although both are considerably pricey. A bonded lash, a swipe of nail polish, a hair straightening treatment, and many other cosmetic and personal care products may contain harmful chemicals, including formaldehyde – a colorless carcinogen – or formaldehyde-releasers, like methylene glycol or dimethyl hydantoin (DMDM).
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.
The Stained Story of Red Dye No. 3
In January 2025, the U.S. Food and Drug Administration (FDA) announced a ban on the use of Red Dye No. 3 (erythrosine) in food and ingested drugs. The main concern regarding the dye is that it is a potential carcinogen; studies from the 1980s found laboratory rats which were fed Erythrosine developed thyroid cancer. According to the Environmental Working Group, there are approximately 2,900 food products currently in the market that contain the dye, such as cherry sodas, candies, and frosting (not to mention medicines and supplements). While the ban is a step in the right direction, it is far overdue and leaves questions about what should be done about other artificial dyes that remain in the market.
Eggflation: The Rising Cost of Eggs and Its Impact on Consumers
Egg prices are soaring, but is it just supply issues—or something more? While avian flu and regulations have strained production, major suppliers are raking in record profits, raising suspicions of price manipulation. A federal jury recently found top producers guilty of price-fixing, fueling concerns that consumers are being taken advantage of. As grocery bills climb, the question remains: who’s really cracking under pressure?