Category:Food and Drug Law
Failing to Protect: The Regulatory Industry’s Challenge in Curbing Nicotine Addiction Among Adolescents
In the battle against nicotine addiction, particularly among our nation’s youth, the regulatory industry stands as a crucial line of defense. However, recent developments suggest that this block is faltering, leaving our young generation increasingly vulnerable to the grips of addiction. Despite well-intentioned efforts, the regulatory landscape surrounding nicotine products has proven inadequate in safeguarding young adults from the harmful effects of addiction. In this blog post, the shortcomings of current regulations and propose actionable solutions to address this pressing issue will be explored.
I Want to be Protected by Vaccines, But How Much is Going Too Far?
On March 6th, 2024, it was announced that a 62-year-old man from Magdeburg, Germany, intentionally got 217 COVID-19 vaccine shots in the span of 29 months, which went against national vaccine recommendations. That’s an average of one vaccine every four days. Although this man is from Germany, what if an American were to attempt the same self-experimentation as him? Would a doctor allow it? Would a regulatory agency get involved? Is it even legal?
Modernization of Cosmetics Regulation Act: Better Late Than Never?
The Food Drug & Cosmetic Act (FDCA) has been relatively unchanged regarding cosmetics since 1938. The United States cosmetics industry is primarily self-policing compared to the food, drugs, or medical device industries. CNN recently noted that around 5,000 adverse events relating to cosmetics are reported to the Food & Drug Administration (FDA), and 25% are considered serious. On December 22, 2022, Joe Biden signed the Modernization of Cosmetic Regulation Act of 2022 (MoCRA) to overhaul the cosmetics regulatory regime. The FDA’s oversight and policing of cosmetics will belatedly resemble that of food, drugs, and medical devices.
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.
When Dangerous Drugs Are No Longer Dangerous- The FDA and Black Box Warnings
Black box warnings are assigned to prescription drugs by the U.S. Food and Drug Administration (FDA) to alert of serious sides effects, such as injury or death. The smoking cessation drug, Chantix, previously had one of these black box warnings attached to it, but that warning has since been removed. This transition from a “dangerous drug” to a non-dangerous drug raises various important regulatory concerns regarding the marketing of this drug and other popular prescription drugs as well as the role of the FDA in regulating “dangerous” drugs.