Information for Consumers and Patients | Drugs - FDA.gov

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Information for Consumers and Patients | Drugs - FDA.gov

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FDA Approves First Nonprescription Daily Oral Contraceptive - FDA.gov

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According to the announcement:

"[T]he U.S. Food and Drug Administration approved Opill (norgestrel) tablet for nonprescription use to prevent pregnancy— the first daily oral contraceptive approved for use in the U.S. without a prescription. Approval of this progestin-only oral contraceptive pill provides an option for consumers to purchase oral contraceptive medicine without a prescription at drug stores, convenience stores and grocery stores, as well as online."

Read the full news release:  FDA Approves First Nonprescription Daily Oral Contraceptive - FDA.gov

Do Not Use Infant Head Shaping Pillows to Prevent or Treat Any Medical Condition - FDA.gov

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According to the FDA:

"The U.S. Food and Drug Administration (FDA) recommends that parents and caregivers do not use infant head shaping pillows intended to change an infant’s head shape or symmetry or claim to prevent or treat any medical condition. The FDA is not aware of any demonstrated benefit with the use of infant head shaping pillows for any medical purpose. The use of head shaping pillows can create an unsafe sleep environment for infants and may contribute to the risk of suffocation and death.

Infant head shaping pillows are not FDA-approved. The safety and effectiveness of these products have not been established ... "

Source: 

Do Not Use Infant Head Shaping Pillows to Prevent or Treat Any Medical Condition: FDA Safety Communication - FDA.gov

Your Favorite Cereal May No Longer Be 'Healthy' Under New FDA Guidance - Food and Wine

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According to the article:

"The FDA has proposed a change to the definition of "healthy," and breakfast cereal brands, in particular, could suffer.  ...

"Under the proposed definition," the FDA wrote, "more foods that are part of a healthy dietary pattern and recommended by the Dietary Guidelines would be eligible to use the claim on their labeling, including nuts and seeds, higher fat fish (such as salmon), certain oils and water."

However, as the FDA admits, the changes could also force some foods to drop their healthy claims — and one example the agency has tossed around multiple times is breakfast cereal, in large part due to the proposed definition's increased emphasis on added sugars."

Read the full source article: Your Favorite Cereal May No Longer Be 'Healthy' Under New FDA Guidance - Food and Wine

Additional Reading: FDA NEWS RELEASE - FDA Proposes Updated Definition of ‘Healthy’ Claim on Food Packages to Help Improve Diet, Reduce Chronic Disease - FDA.gov

Do Not Use Baby Neck Floats Due to the Risk of Death or Injury - FDA.gov

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According to the safety communication:

"The U.S. Food and Drug Administration (FDA) is warning parents, caregivers, and health care providers not to use neck floats with babies for water therapy interventions, especially with babies who have developmental delays or special needs, such as spina bifida, spinal muscular atrophy (SMA) type 1, Down syndrome, or cerebral palsy. The use of these products can lead to death or serious injury."

Read the full safety communication:  Do Not Use Baby Neck Floats Due to the Risk of Death or Injury: FDA Safety Communication - FDA.gov

FDA Denies Authorization to Market JUUL Products - FDA.gov

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According to the news release:

"Today, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) to JUUL Labs Inc. for all of their products currently marketed in the United States. As a result, the company must stop selling and distributing these products. In addition, those currently on the U.S. market must be removed, or risk enforcement action." 

Read the full news release: FDA Denies Authorization to Market JUUL Products - FDA.gov

The FDA Proposes Rules To Ban Menthol In Cigarettes, And More!

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According to the FDA news release:

"Today, the U.S. Food and Drug Administration is announcing proposed product standards to prohibit menthol as a characterizing flavor in cigarettes and prohibit all characterizing flavors (other than tobacco) in  cigars. These actions have the potential to significantly reduce disease and death from combusted tobacco product use, the leading cause of preventable death in the U.S., by reducing youth experimentation and addiction, and increasing the number of smokers that quit." 

Read the full FDA news release: FDA Proposes Rules Prohibiting Menthol Cigarettes and Flavored Cigars to Prevent Youth Initiation, Significantly Reduce Tobacco-Related Disease and Death - FDA.gov

U.S. Senate narrowly confirms Dr. Robert Califf to lead FDA for second time – Reuters

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U.S. Senate narrowly confirms Dr. Robert Califf to lead FDA for second time – Reuters

Welcome Back, Commissioner Califf! Robert M. Califf, M.D., was sworn in as the Commissioner of Food and Drugs on February 17, 2022. – FDA.gov

The FDA’s Cigarette Health Warning Rule Is Postponed to April 2023

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U.S. Graphic Health Warnings Postponed Again

According to the article:

Source: FDA.gov

"The U.S. Food and Drug Administration has postponed the effective date of its “Required Warnings for Cigarette Packages and Advertisements” final rule to April 9, 2023, following a Feb. 10, 2022, ruling by the U.S. District Court for the Eastern District of Texas.

The move marks at least the fifth delay for graphic warning health warnings in the United States when counting previously set launch dates of June 18, 2021, Oct. 16, 2021, Jan. 14, 2022, April 14, 2022, and July 13, 2022."

Read the full source article:  U.S. Graphic Health Warnings Postponed Again - Tobacco Reporter

Learn more at: Cigarette Labeling and Health Warning Requirements - FDA.gov

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Injectable Skin Lightening and Skin Bleaching Products May Be Unsafe - FDA.gov

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According to the FDA:

"Consumers need to beware of products to lighten or whiten their complexion. These products, which include both injectable skin whitening and skin bleaching products, are potentially unsafe and ineffective, and might contain unknown harmful ingredients or contaminants.

Injectable skin whitening products are marketed for injection into a vein or muscle or under the skin. They are sold online and in some retail outlets and health spas. They often promise to lighten the skin, correct uneven skin tone, and reduce blemishes. Some products even claim to treat conditions such as liver disorders and Parkinson’s disease.

Although the average consumer might not assume so, these products are unapproved new drugs whose sales are not condoned by the U.S. Food and Drug Administration (FDA). The FDA has not approved any injectable drugs for skin whitening or lightening."

Source:  Injectable Skin Lightening and Skin Bleaching Products May Be Unsafe - FDA.gov

Coronavirus (COVID-19) Update: FDA Authorizes First Oral Antiviral for Treatment of COVID-19 - FDA.gov

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According to the article:

The "U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms or about 88 pounds) with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset."

Read the full source article: Coronavirus (COVID-19) Update: FDA Authorizes First Oral Antiviral for Treatment of COVID-19 - FDA.gov

FDA Issues Updated Advice For Eating Fish

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According to the updated advice:

"This advice can help those who might become or are pregnant or breastfeeding as well as parents and caregivers who are feeding children make informed choices when it comes to the types of fish that are nutritious and safe to eat. This advice supports the recommendations of the Dietary Guidelines for Americans."

The advice also features a chart that makes it easy to choose dozens of healthy and safe options and includes information about the nutritional value of fish.

View the entire updated advice: Advice about Eating Fish - FDA.gov

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FDA Approves First Long-Acting HIV Drug Combo - VOA

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According to the article:

"The two-injection combination treatment is called Cabenuva. The drug is expected to make it easier for people to receive their HIV medicines and to do so with more privacy. The injections mark a big change from methods used in the past. Those treatments required patients to take multiple pills several times a day, carefully timed around meals.

Dr. Steven Deeks is an HIV specialist at the University of California, San Francisco. He told The Associated Press that the new treatment can make patients’ lives better because it is only needed once a month. “People don’t want those daily reminders that they’re HIV infected,” Deeks said."

Read the full source article:  FDA Approves First Long-Acting HIV Drug Combo - VOA

First rapid concussion blood test approved by FDA - WGN News (video)

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Source YouTube Video:  First rapid concussion blood test approved by FDA - WGN News (video)

FDA sends CBD warning letters to five companies - Food Business News

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According to the article:

"The US Food and Drug Administration on Dec. 22 issued five warning letters to companies for selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act. The five companies illegally were marketing unapproved CBD products claiming to treat medical conditions, according to the FDA."

Read the full source article:   FDA sends CBD warning letters to five companies - Food Business News

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FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine - FDA. gov

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According to the news release:

Action Follows Thorough Evaluation of Available Safety, Effectiveness, and Manufacturing Quality Information by FDA Career Scientists, Input from Independent Experts

The "U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older."

Read the full news release:  FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine - FDA. gov

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FDA Authorizes First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19 - FDA. gov

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According to the news release:

"Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with reactive molecules. The test detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample from any individual 2 years of age or older. 

“Today’s authorization is a major milestone in diagnostic testing for COVID-19. By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes,” said FDA Commissioner Stephen M. Hahn, M.D. “As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes.” "

Read the full news release:

Coronavirus (COVID-19) Update: FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19 - Test is authorized for individuals two years of age or older, including those not showing symptoms - FDA.gov

FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine - FDA .gov

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According to the news release:

Action Follows Thorough Evaluation of Available Safety, Effectiveness, and Manufacturing Quality Information by FDA Career Scientists, Input from Independent Experts

"The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” said FDA Commissioner Stephen M. Hahn, M.D. “Today’s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization. The tireless work to develop a new vaccine to prevent this novel, serious, and life-threatening disease in an expedited timeframe after its emergence is a true testament to scientific innovation and public-private collaboration worldwide."

Read the full news release: FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine -  FDA.gov

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Recommendations About the Use of Dental Amalgam in Certain High-Risk Populations: FDA Safety Communication - FDA.org

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Updated April 11, 2024

The original link broke.

You might also be interested in:

Dental Amalgam Fillings - FDA.gov

---  the original post follows below  --

Read the full FDA Safety Communication:  

Recommendations About the Use of Dental Amalgam in Certain High-Risk Populations: FDA Safety Communication - FDA.org

According to the communication:

"The U.S. Food and Drug Administration (FDA) is providing recommendations about the use of dental amalgam in certain groups of people who may be at greater risk to the potential adverse health effects of mercury exposure, to include:

• Pregnant women and their developing fetuses;
• Women who are planning to become pregnant;
• Nursing women and their newborns and infants;
• Children, especially those younger than six years of age;
• People with pre-existing neurological disease;
• People with impaired kidney function; and
• People with known heightened sensitivity (allergy) to mercury or other components of dental amalgam."

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