Category:FDA
The Tobacco Loophole: How FDA Tobacco Regulations Let Underregulated Products Slide
On September 2nd, 2026, U.S.-based tobacco companies Helix Innovations, LLC and NJOY, LLC (collectively, Altria) filed a lawsuit against the FDA to vacate its 2021 Pre-Market Tobacco Applications (PMTA) rule. Specifically, Altria seeks to block the enforcement of pre-market review requirements for pending tobacco products which primarily affect smokeless tobacco products and electronic nicotine delivery systems (ENDS). Under the Tobacco Consumer Act (TCA), the FDA is mandated to approve or deny applications for tobacco products within 180 days. However, Altria argues that the promulgation of the 2021 PMTA rule coupled with the 2016 “Deeming” Rule has caused extensive regulatory backlogs for the FDA, resulting in their numerous violations of the statutory deadline to review tobacco product applications.
Altria’s complaint contends that delays have harmed both domestic business and public health by creating a regulatory gridlock. Under the 2021 PMTA rule, tobacco manufacturers are required to submit substantial evidence reports with distinct materials for each product, including risk investigations, marketing plans, environmental and population impacts, and other uniquely relevant documentation. While U.S. manufacturers seeking to comply face excessive red tape stalling scientifically backed products from reaching the market, foreign-sourced tobacco products have flooded the U.S. market with unregulated alternatives that expressly target American youth. By failing to issue timely decisions, the FDA has inadvertently undermined consumer safety and penalized companies attempting to follow the law.
The FDA’s Handle on AI Regulation
Imagine a patient suffering from sporadic unconsciousness is hooked up to a heart monitor. Suddenly, an irregular heart rhythm begins but is flagged almost instantaneously. The irregularity was not spotted by a cardiologist analyzing an EKG but rather by AI trained on millions of other heartbeats. That’s not a scene from the future. It’s already routine.
The FDA has authorized the marketing of over 1,500 AI-enabled medical devices in the United States. The first one dates back to 1995, but the number of devices has sharply increased since then and continues to do so. However, the main caveat for AI devices is that their software can change after authorization, but the FDA’s monitoring of those changes doesn’t. In light of this, the FDA needs stricter and more continuous regulation of AI-enabled medical devices.
The Cyclospora Outbreak and the Difficulty of Governing Food Safety Through Funding Restrictions
This summer, a microscopic parasite exposed a hole in America’s food safety system. More than 12,000 people got sick, hundreds were hospitalized, and two people in Michigan died after eating contaminated iceberg lettuce. After weeks of research, investigators were able to trace the contamination to Taylor Farms de México. The CDC closed the investigation on September 11, 2026, but classifying the investigation as closed is not the same as resolving the issue, and it certainly does not mean future incidents will be prevented. The delay in tracing the contamination was not an accident but a predictable consequence of a recent legislative decision. In 2022, the FDA finalized the Food Traceability Rule, implementing Section 204 of the Food Safety Modernization Act (FSMA), a regulation designed to make this exact type of tracing fast. However, Congress, after a proposal by the FDA, quietly delayed enforcement until 2028, allowing the rule to sit idle through the very season it was meant to help. This restriction should be repealed and authority over the compliance timeline returned to the FDA, so the agency can revisit any delay as new risks emerge. Otherwise, as the 2026 Cyclospora outbreaks show, the American public will bear the costs of an FDA constrained by funding restrictions.
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).