Tag:FDA regulations
Investigation into the Rise of Bird Flu in Dairy Farms and the Role of Regulatory Compliance
The recent emergence of highly pathogenic avian influenza (H5N1), commonly known as bird flu, in U.S. dairy farms has raised significant public health and regulatory concerns. While traditionally associated with poultry, the virus’s spread to dairy cattle has prompted urgent investigations into transmission patterns, biosecurity measures, and regulatory compliance. As federal and state agencies respond to this development, businesses must navigate evolving compliance requirements to ensure public safety and maintain industry stability.
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?
Danger in Every Dye: Why the FDA Should Ban Artificial Food Color Additives
Over the last decade, an increasing number of studies have shown that certain food color dyes have toxic and carcinogenic effects on human health, with focuses predominantly on Red No. 3 and Red No. 40. However, in recent years, studies have revealed the toxicity of many other artificial food color dyes in addition to red dyes. Last month, United States Senator Ron Johnson hosted a roundtable discussion, “American Health and Nutrition: A Second Opinion”, with prominent doctors and other health advocates to discuss the changes within agriculture, food processing, and healthcare industries and their impacts on the nation’s health. Among many topics covered during the four-hour-long discussion was the negative effects of artificial color additives in everyday foods on people’s health with toxic and carcinogenic effects. This discussion is coupled with increased calls on the Food and Drug Administration (FDA) to ban artificial food color additives in food products. At the state level, California and Illinois have begun to act to ban these toxic color additives statewide.
Red No. 3 – The Carcinogenic Color
Consumers read product labels regularly to educate themselves on ingredients they are putting on or in their body. More likely than not, most consumers have read a label before and seen “RED 3” as an ingredient, often listed at the end of the lengthy list. What most consumers fail to recognize is what exactly “RED 3” is and the potential hazard it can pose to their health. While the Food and Drug Administration has requirements in place restricting the use of this color additive in cosmetics, it is still permitted to be used in food and drug products despite scientific findings of its cancer-causing effects.
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’s Proposed Global Regulatory Harmonization for Medical Devices
On February 23, 2022, the Food and Drug Administration (FDA) published a proposed regulation to amend current manufacturing practice requirements of the Quality System Regulation (QSR) (21 CFR Part 820). The FDA first announced such harmonization in 2018, however COVID-19 delayed the proposal. The FDA seeks to align Part 820 more closely with the international specific standard for medical device quality management systems set out by the International Organization for Standardizations (ISO) 13485. According to the FDA, such “harmonization should provide patients more efficient access to necessary devices, leading to improvements of life quality of the consumers.” Part 820 is part of the current mandatory regulations that ensure that all medical devices created and developed within the US market are safe. ISO 13485 is the international standard for a quality management system for medical devices required by certain countries. Therefore, any manufacturer that sells outside the US will likely need to be ISO 13485 certified. With the implementation of this new amendment, manufacturers would be able to assure their products are regulatorily compliant in both the US and international markets.
Exploring COVID-19 Vaccine Authorization by the FDA
As of April 22, 2021, 218,947,643 million people have received the COVID-19 vaccine. Before or during the appointment, your provider directs you to a fact sheet for the Pfizer-BioNTech COVID-19 Vaccine or Moderna COVID-19 Vaccine. On the fact sheet, there were a couple of sentences that caught my eye “The Pfizer-BioNTech COVID-19 Vaccine is a vaccine and may prevent you from getting COVID-19. There is no U.S. Food and Drug Administration (“FDA”) approved vaccine to prevent COVID-19.” When I read this, I wanted more information about the difference is between being authorized or approved. Like many people, one can become hesitant when a product is not adequately tested; in fact, a Kaiser research project shows about 30% of people probably or definitely not get the vaccine.
Johnson & Johnson COVID-19 Vaccine Awaits Authorization from FDA
Recently, the U.S. Food & Drug Administration (“FDA”) announced a scheduled meeting of its Vaccines and Related Biological Products Advisory Committee (“VRBPAC”) to discuss the request for emergency use authorization (“EUA”) for a COVID-19 vaccine from Janssen Biotech Inc. The FDA has just under three weeks to complete its report before the VRBPAC’s meeting to make its recommendation on the vaccine. The review process may be more challenging than the past two reviews for Pfizer and Moderna due to the composition differences and effectiveness.
Pre-Approval Access and Pathways to Investigational Drugs
The Federal Food, Drug, and Cosmetic (FDC) Act of 1938 requires pharmaceutical drugs to provide evidence of their safety before they are allowed on the market. As such, pharmaceutical companies submit applications to the Federal Drug Administration for approval. There are situations, however, in which patients seek to receive access to a particular pharmaceutical drug before the FDA approval process is complete. This blog will explore the various pathways to pre-approval access in addition to recent legislation and legal considerations for such pathways, in addition to the principles and common obstacles that pharmaceutical companies face within such pathways.
Establishing Expanded Use Programs
The ability to access experimental drug treatments has long been contentious in the United States. Prior to the 1938 Food, Drug & Cosmetic Act, pharmaceutical drugs were largely unregulated. This Act required, for the first time, that drugs sold to the public were safe. Increasing regulations regarding the marketing, testing, and distribution of pharmaceutical drugs were established throughout the next fifty years. In the 1980s, however, a puzzling illness became known to the public. This illness was called HIV/AIDS, a debilitating virus that caused the body’s own immune system to attack itself. This illness has killed over 32 million people in the United States and worldwide, and particularly impacted the population of gay men. Because homosexuality was still fairly taboo in the 1980s, many argue that the country dragged its foot in researching and approving treatment for HIV/AIDS. Due to significant advocacy, much progress has been made with this particular illness, and the country has slowly evolved from the slow and strict processes that once regulated potential pharmaceutical drug treatments.