Category:

Food and Drug Law

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.

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.

Clean Beauty: Navigating Regulatory Challenges in the Cosmetics Industry

“Clean Girl” makeup went viral on TikTok in 2024 following the usual pattern of micro trends. Along with the clean girl hashtag trending, social media influencers are making money off marketing products that allegedly create the “clean girl” look. Although influencers may be promoting little foundation, natural colors, and slick styles when marketing the clean look, the clean beauty market has grown significantly as consumers become more conscious of ingredient safety and environmental impact. This trend focuses on products free from potentially harmful ingredients, often marketed as natural, organic, or eco-friendly. The current regulatory scheme for clean and natural beauty fails to capture the goals of clean beauty.

A Fresh Perspective: How FSMA Compliance is Revolutionizing Large Food Distribution Corporations

As the world becomes increasingly concerned with food safety, large food distribution corporations find themselves grappling with a novel challenge: the Food Safety Modernization Act (FSMA). Mandated by the FDA, the FSMA aims to prevent foodborne illnesses through stringent regulations, thus compelling food corporations to adapt or face penalties. This writing will delve deeper into how the FSMA will reshape the food distribution landscape by influencing operational strategies, implementing accountability measures, and fostering an environment ripe for innovation.

FDA Oops: Two Orphan Drugs Approved for Same Disease or Condition

An orphan drug treats a rare disease or condition that occurs so infrequently in the United States that there is no reasonable expectation that the cost of making the drug will ever be recovered by the manufacturer. The Orphan Drug Act of 1983 incentivizes pharmaceutical manufacturers to investigate and develop drugs for rare diseases with a low probability of profitability. Orphan drugs have been approved and used to treat various cancers, Huntington’s disease, Fragile X syndrome, pulmonary fibrosis, myelomas, carcinomas, and other rare and unfortunate ailments that impact people’s lives. According to the National Organization for Rare Disorders, the number of approved drugs for treating rare diseases soared from 38 drugs before the act to 6,583 orphan-drug designations by the Food & Drug Administration (FDA) today. Undoubtedly, the Orphan Drug Act has had a positive impact on both patients suffering from rare conditions and the manufacturers that utilized the law.

FDA’s Role in Food Chemical Safety

The U.S. Food and Drug Administration (FDA) protects people from exposure to adverse chemicals in food through the implementation of rigorous regulations. The FDA can do so through the close evaluation of the use of chemicals as food ingredients and the substances that come into contact with food, as well as the broad monitoring of the food supply for chemical contaminants.  This can include the food packaging process, storage process, and other handling measures.

FDA Restrictions, State Action, and Pharmaceutical Responses to the Abortion Pill

As of March 3, 2023, Walgreens, the second-largest pharmacy store in the United States, has announced that it will not offer mifepristone, the abortion pill, in twenty-one states. This decision followed letters written by Republican attorneys generals in the twenty-one states urging Walgreens not to stock the product, and even threatening legal action against Walgreens if they did decide to move forward with stocking mifepristone in those twenty-one states. Rite Aid and other pharmacies have not yet made a decision on whether they will sell mifepristone.

Federal Safeguards Against Drug Shortages

From October 2022 to January 2023, there was a nationwide Adderall shortage. This recent shortage is no surprise since the Food and Drug Administration (FDA) has announced several Adderall shortages since 2019. Although the recent shortage has ended, researchers fear there will be more Adderall shortages in the coming year as prescribing rates continue to rise. More importantly, the recent shortage has made patients worried about future shortages and concerned about why the federal government has not done more to prevent drug shortages.

A Concerning Combination: Heavy Metals and Baby Food

On January 24, 2023, the Food and Drug Administration (FDA) announced their plans to work towards drafting regulation to limit lead levels in baby food. The FDA has found that lead in products such as food, supplements, and cosmetics can have detrimental and long term effects on humans, and especially on certain groups such as young children. Young children are specifically vulnerable to harmful effects of lead consumption because they are still physically smaller and going through development. While the FDA has regulated lead in food and other products, the FDA’s recent focus on decreasing lead levels in baby food highlights the concerning trend of federal regulations which are under-inclusive.