Tag:FDA
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.
FDA Approves Flavored Vape Products for the First Time Ever
The popularity of vaping in the United States peaked in 2018 when the company Juul Labs attracted young customers with its variety of flavors and an easily concealable nicotine delivery device. At that time, the FDA had not approved Juul products for use in the United States but had not banned the products either. Instead, the FDA issued a few limitations regarding the sale of Juul products –in 2018, the FDA limited what flavor Juul pods could be sold, and in 2019 required that customers in all states be at least 21 years of age. This marks the beginning of the FDA’s struggle to regulate the availability of flavored nicotine products, which continues today.
EPA Finalizes Rule Requiring Reporting of “Forever Chemicals”
On September 28, 2023, the U.S. Environmental Protection Agency (EPA) finalized its rule for manufactures of per- and polyfluoroalkyl substances (PFAS), which requires that these manufacturers provide information about what chemicals and the amount that they produce. Effective November 13, 2023, persons that manufacture, have manufactured, or have imported PFAS in any year since January 1, 2011, will now be required to report a wide range of information of PFAS including chemical identity and structure, uses, production volumes, exposures, by-products and health and environmental effects. EPA is taking this action not only to fulfill its obligations under the Toxic Substances Control Act (TSCA) Section 8(a)(7), but also to address this legacy pollution that has been, and continues to be, endangering people across the nation.
Fragrance Regulations Prioritize Wealth Over Health
Whether it is recognized or not, humans are exposed to a variety of products containing fragrances every single day. However, for something that is so common in the average human’s life, these chemicals are not as highly regulated as consumers would expect. While the Food and Drug Administration has requirements in place that fragrance formulas must meet in order to be incorporated in products, these formulas can also be considered “trade secrets.” This means that the formulas do not have to be disclosed to the public after FDA review. As a result, consumers should become more educated about potentially hazardous fragrance chemicals. These chemicals may lead to negative health consequences because they have gone unnoticed by the public.
From Chatbots to Diagnosis: The Power and Pitfalls of AI in Healthcare
The capabilities of generative artificial intelligence (AI) could completely transform our healthcare system as we know it. For better or for worse, the technology advancements in healthcare are rapidly growing. Given the accelerated rollout, experts have yet to predict all the risks associated with such high-functioning computations in the healthcare system. Even though the Food and Drug Administration (FDA) regulates software being used as medical devices (SaMD), there is an overall lack of urgency, agency oversight, and sufficient regulations to tame AI technology in the healthcare system.
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.
The FDA Steps in to Stop Unlawful Tranquilizer Imports
The FDA has taken action to stop the unlawful importation of a drug called xylazine by announcing on February 28 that they have issued an Import Alert for drug products or ingredients that have xylazine active products within them. Xylazine is a drug used in the veterinary field and is contained in drugs that sedate animals such as horses and deer (animal tranquilizers). It has increasingly been found within drugs in the illegal drug trade and has been linked to overdose deaths all over the country including California and Pennsylvania. The FDA’s action is part of its initiative to protect public health and stop the presence of xylazine in the nation’s illicit drugs.
Infant Formula Shortage: How has the FDA Altered Regulations to Help?
Over the past year, the nation has been concerned over an infant formula shortage that has become a crisis for many families in the United States. The Food and Drug Administration (FDA) is responsible for offering support and relief to families affected by this shortage in any way they can. Accordingly, the FDA loosened infant formula regulations. Specifically, the FDA allowed for an increased supply of infant formula by the announcement to infant formula manufacturers of the agency’s intention to temporarily exercise enforcement discretion. Enforcement was on a case-by-case basis, for specific infant formula requirements. This went into effect from May 16, 2022, through November 14, 2022, and was specifically designed to protect infants’ health. Essentially, selective enforcement would allow the FDA to grant permission for formulas despite not meeting all the regulations.