Tag:FDA
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 This draft guidance applies to any PBMA that uses “milk” in its name.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.
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.
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?
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.