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.
FDA’s Response to Baby Formula Shortage
This year the Food and Drug Administration (FDA) has come under fire for its slow response to the nationwide baby formula shortage. In September 2022, FDA Commissioner Robert M. Califf authorized the release of an internal report. The report details how the baby formula shortage occurred, the FDA’s response to the shortage, and the challenges it faced in resolving the shortage. The report also revealed the changes in FDA regulatory procedure to ensure another shortage does not occur.
A New FDA Rule Will Change the Future of the Hearing Aid Industry
Thanks to a new FDA final rule, published in August of this year, Americans can soon purchase specific hearing aids over-the-counter (OTC) without a hearing exam, prescription, or fitting. Although this rule will improve access to hearing aid devices and lower the costs for those with hearing impairments, many critics are convinced the rule will do more harm than good.
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.
Life or Death: The Fast Track to FDA Approval
After five years, the Food and Drug Administration (FDA) has approved a drug for ALS (amyotrophic lateral sclerosis): Relyvrio. While the drug is expected to significantly prolong the life of ALS patients, who typically die within a few years after diagnosis, the fast approval of the drug raises concerns regarding the FDA’s fast-tracking process of approval.
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.
Agency Officials Trade Stock in Companies their Agencies Oversee
More than 2,500 government officials ranging from the Commerce Department to the Treasury Department reported owning stock in companies whose share prices correspond to decisions made by their respective agencies. With obvious conflicts of interest arising, what has happened, and what are some major takeaways from this investigative report?
The Hazards of an Unregulated Cosmetics Industry
The cosmetics industry, unknown to many, is essentially not regulated by a federal regulatory agency. Cosmetics technically fall under the purview of the Food and Drug Administration (“FDA”), but there are few requirements that manufacturers must comply with. The FDA only requires that manufacturers comply with several labeling regulations so companies can avoid listing a product’s total ingredients, and the FDA does not require manufacturers to report health complaints. The FDA instead relies on direct reports of adverse events from consumers, which has the potential to delay remedying a potentially dangerous situation. A study published in JAMA Internal Medicine found that between 2015 and 2016, the number of complaints of adverse health results related to cosmetic products more than doubled from the previous years. Additionally, the FDA only has the equivalent of six full-time inspectors to monitor three million shipments of cosmetics that come into the United States each year. Last year, inspectors only conducted tests on about 364 of those shipments, and 20 % of those shipment that were inspected led to adverse findings.
Medical Marijuana and Maintaining FDA Compliance
Regardless of opinions on legalization, many people accept the idea that medical marijuana, and more specifically CBD, can be a powerful treatment for many medical conditions. However, there has been one major roadblock: the FDA. According to the FDA, more than 90 warning letters over the past 10 years have been released to companies claiming that their cannabis products cure various symptoms. The most common is the claim that marijuana prevents or treats cancer. In 2017, as the medical properties of marijuana continue to be trumpeted to the general public, the FDA is still working to protect the public by issuing warning letters to marijuana providers making unsubstantiated claims.