Tag:FDA
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.
Got (Plant-Based) Milk? New FDA Guidance for Plant-Based Milk
Plant-based milks have been on the rise congruently with the movement towards living a plant-based diet and lifestyle. The FDA calls these products Plant-Based Milk Alternatives (PBMA). There are many different PBMA’s on the market, because there are a wide array of sources that can be used to produce PBMA’s and methods for processing. Some of the most popular examples of PBMA’s include oat milk, almond milk, and soy milk, but there are many PBMA’s made from other nuts, seeds, and alternative sources. PBMA’s are currently in the news because the FDA has just released draft labeling guidance (guidance) and recommendations for nutrition fact labeling. This draft guidance applies to any PBMA that uses “milk” in its name. The FDA’s draft labeling guidance will likely help educate more consumers on PBMA’s and their nutrition facts, hopefully leading to generally more informed consumers and labeling transparency.
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.
Expansion of Generic Labeling for Food
The United States Department of Agriculture (USDA) and Food Safety and Inspection Service (FSIS) has loosened the approval for labels on meat, poultry, and egg products. By March 2023, the process for approval of certain labels on certain food products will essentially be discontinued under the Expansion of Generic Labeling Rule.
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.